Revistas
Revista:
SURGERY TODAY
ISSN:
0941-1291
Año:
2023
Vol.:
53
N°:
2
Págs.:
269 - 273
Wrong surgery (wrong-site, wrong-procedure, or wrong-patient surgery) is among the most feared patient safety problems in hospitals. We aimed to evaluate associations between numeric assessment of risk assigned to wrong surgery with that of other healthcare quality and patient safety challenges. This nationwide study collected information from healthcare quality experts in charge of a clinical quality and/or patient safety department in general hospitals of >= 150 beds in Spain. Out of the 100 included hospitals, the highest strength of associations were observed with risk priority number (RPN) for hospital-acquired pressure ulcers, RPN for venous thromboembolism in hospitalized patients, RPN for incorrect patient identification, RPN for lack of informed consent for diagnostic or therapeutic procedures, RPN for catheter-related bacteremia, and RPN for adverse events and injuries due to medical devices related to use and/or design. These results are of potential interest for designing combined and coordinated strategies to improve patient safety in hospitals.
Revista:
JOURNAL OF INVESTIGATIONAL ALLERGOLOGY AND CLINICAL IMMUNOLOGY
ISSN:
1018-9068
Año:
2023
Vol.:
33
N°:
2
Págs.:
131 - 133
Revista:
JOURNAL OF NEUROSURGICAL ANESTHESIOLOGY
ISSN:
0898-4921
Año:
2023
Vol.:
35
N°:
1
Págs.:
74 - 79
Background: The identification of factors associated with perioperative red blood cell (RBC) transfusion provides an opportunity to optimize the patient and surgical plan, and to guide perioperative crossmatch and RBC orders. We examined the association among potential bleeding risk factors and RBC requirements to develop a novel predictive model for RBC transfusion in patients undergoing brain tumor surgery. Methods: This retrospective study included 696 adults who underwent brain tumor surgery between 2008 and 2018. Multivariable logistic regression with backward stepwise selection for predictor selection was used during modeling. Model performance was evaluated using area under the receiver operating characteristic curve, and calibration was evaluated with Hosmer-Lemeshow goodness-of-fit ¿2-estimate. Results: Preoperative hemoglobin level was inversely associated with the probability of RBC transfusion (odds ratio [OR]: 0.50; 95% confidence interval [CI]: 0.39-0.63; P<0.001). The need for RBC transfusion was also greater in patients who had a previous craniotomy (OR: 2.71; 95% CI: 1.32-5.57; P=0.007) and in those with larger brain tumor volume (OR: 1.01; 95% CI: 1.00-1.02; P=0.009). The relationship between number of planned craniotomy sites and RBC transfusion was not statistically significant (OR: 2.11; 95% CI: 0.61-7.32; P=0.238). A predictive model for RBC requirements was built using these 4 variables. The area under the receiver operating characteristic curve was 0.79 (95% CI: 0.70-0.87; P<0.001) showing acceptable calibration for predicting RBC transfusion requirements. Conclusions: RBC requirements in patients undergoing brain tumor surgery can be estimated with acceptable accuracy using a predictive model based on readily available preoperative clinical variables. This predictive model could help to optimize both individual patients and surgical plans, and to guide perioperative crossmatch orders.
Revista:
ALLERGY
ISSN:
0105-4538
Año:
2023
Vol.:
78
N°:
1
Págs.:
299 - 301
Revista:
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
ISSN:
1422-0067
Año:
2022
Vol.:
23
N°:
17
Págs.:
9895
Multiple myeloma (MM) is the second most common haematological malignancy and remains incurable despite therapeutic advances. 18F-FDG (FDG) PET/CT is a relevant tool MM for staging and it is the reference imaging technique for treatment evaluation. However, it has limitations, and investigation of other PET tracers is required. Preliminary results with L-methyl-[11C]- methionine (MET), suggest higher sensitivity than 18F-FDG. This study aimed to compare the diagnostic accuracy and prognostic value of 1FDG and MET in MM patients. We prospectively compared FDG and MET PET/CT for assessment of bone disease and extramedullary disease (EMD) in a series of 52 consecutive patients (8 smoldering MM, 18 newly diagnosed MM and 26 relapsed MM patients). Bone marrow (BM) uptake patterns and the detection of focal lesions (FLs) and EMD were compared. Furthermore, FDG PET parameters with known MM prognostic value were explored for both tracers, as well as total lesion MET uptake (TLMU). Median patient age was 61 years (range, 37-83 years), 54% were male, 13% of them were in stage ISS (International Staging System) III, and 31% had high-risk cytogenetics. FDG PET/CT did not detect active disease in 6 patients, while they were shown to be positive by MET PET/CT. Additionally, MET PET/CT identified a higher number of FLs than FDG in more than half of the patients (63%). For prognostication we focussed on the relapsed cohort, due to the low number of progressions in the two other cohorts. Upon using FDG PET/CT in relapsed patients, the presence of more than 3 FLs (HR 4.61, p = 0.056), more than 10 FLs (HR 5.65, p = 0.013), total metabolic tumor volume (TMTV) p50 (HR 4.91, p = 0.049) or TMTV p75 (HR 5.32, p = 0.016) were associated with adverse prognosis. In MET PET/CT analysis, TMTV p50 (HR 4.71, p = 0.056), TMTV p75 (HR 6.27, p = 0.007), TLMU p50 (HR 8.8, p = 0.04) and TLMU p75 (HR 6.3, p = 0.007) adversely affected PFS. This study confirmed the diagnostic and prognostic value of FDG in MM. In addition, it highlights that MET has higher sensitivity than FDG PET/CT for detection of myeloma lesions, including FLs. Moreover, we show, for the first time, the prognostic value of TMTV and TLMU MET PET/CT in the imaging evaluation of MM patients.
Revista:
BRITISH JOURNAL OF ANAESTHESIA
ISSN:
0007-0912
Año:
2022
Vol.:
128
N°:
3
Págs.:
E239 - E241
Revista:
FRONTIERS IN MEDICINE
ISSN:
2296-858X
Año:
2022
Vol.:
9
Págs.:
1023583
BackgroundTo better understand the patient's heterogeneity in fatty liver disease (FLD), metabolic dysfunction-associated fatty liver disease (MAFLD) was proposed by international experts as a new nomenclature for nonalcoholic fatty liver disease (NAFLD). We aimed to evaluate the cardiovascular risk, assessed through coronary artery calcium (CAC) and epicardial adipose tissue (EAT), of patients without FLD and patients with FLD and its different subtypes. MethodsCross sectional study of 370 patients. Patients with FLD were divided into 4 groups: FLD without metabolic dysfunction (non-MD FLD), MAFLD and the presence of overweight/obesity (MAFLD-OW), MAFLD and the presence of two metabolic abnormalities (MAFLD-MD) and MAFLD and the presence of T2D (MAFLD-T2D). MAFLD-OW included two subgroups: metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The patients without FLD were divided into 2 groups: patients without FLD and without MD (non-FLD nor MD; reference group) and patients without FLD but with MD (non-FLD with MD). EAT and CAC (measured through the Agatston Score) were determined by computed tomography. ResultsCompared with the reference group (non-FLD nor MD), regarding EAT, patients with MAFLD-T2D and MAFLD-MUHO had the highest risk for CVD (OR 15.87, 95% CI 4.26-59.12 and OR 17.60, 95% CI 6.71-46.20, respectively), patients with MAFLD-MHO were also at risk for CVD (OR 3.62, 95% CI 1.83-7.16), and patients with non-MD FLD did not have a significantly increased risk (OR 1.77; 95% CI 0.67-4.73). Regarding CAC, patients with MAFLD-T2D had an increased risk for CVD (OR 6.56, 95% CI 2.18-19.76). Patients with MAFLD-MUHO, MAFLD-MHO and non-MD FLD did not have a significantly increased risk compared with the reference group (OR 2.54, 95% CI 0.90-7.13; OR 1.84, 95% CI 0.67-5.00 and OR 2.11, 95% CI 0.46-9.74, respectively). ConclusionMAFLD-T2D and MAFLD-OW phenotypes had a significant risk for CVD. MAFLD new criteria reinforced the importance of identifying metabolic phenotypes in populations as it may help to identify patients with higher CVD risk and offer a personalized therapeutic management in a primary prevention setting.
Revista:
JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT
ISSN:
1610-0379
Año:
2022
Vol.:
20
N°:
1
Págs.:
102 - 105
Revista:
NEW ENGLAND JOURNAL OF MEDICINE
ISSN:
0028-4793
Año:
2022
Vol.:
386
N°:
26
Págs.:
2471 - 2481
Background: Pediatric patients with diffuse intrinsic pontine glioma (DIPG) have a poor prognosis, with a median survival of less than 1 year. Oncolytic viral therapy has been evaluated in patients with pediatric gliomas elsewhere in the brain, but data regarding oncolytic viral therapy in patients with DIPG are lacking.
Methods: We conducted a single-center, dose-escalation study of DNX-2401, an oncolytic adenovirus that selectively replicates in tumor cells, in patients with newly diagnosed DIPG. The patients received a single virus infusion through a catheter placed in the cerebellar peduncle, followed by radiotherapy. The primary objective was to assess the safety and adverse-event profile of DNX-2401. The secondary objectives were to evaluate the effect of DNX-2401 on overall survival and quality of life, to determine the percentage of patients who have an objective response, and to collect tumor-biopsy and peripheral-blood samples for correlative studies of the molecular features of DIPG and antitumor immune responses.
Results: A total of 12 patients, 3 to 18 years of age, with newly diagnosed DIPG received 1×1010 (the first 4 patients) or 5×1010 (the subsequent 8 patients) viral particles of DNX-2401, and 11 received subsequent radiotherapy. Adverse events among the patients included headache, nausea, vomiting, and fatigue. Hemiparesis and tetraparesis developed in 1 patient each. Over a median follow-up of 17.8 months (range, 5.9 to 33.5), a reduction in tumor size, as assessed on magnetic resonance imaging, was reported in 9 patients, a partial response in 3 patients, and stable disease in 8 patients. The median survival was 17.8 months. Two patients were alive at the time of preparation of the current report, 1 of whom was free of tumor progression at 38 months. Examination of a tumor sample obtained during autopsy from 1 patient and peripheral-blood studies revealed alteration of the tumor microenvironment and T-cell repertoire.
Conclusions: Intratumoral infusion of oncolytic virus DNX-2401 followed by radiotherapy in pediatric patients with DIPG resulted in changes in T-cell activity and a reduction in or stabilization of tumor size in some patients but was associated with adverse events. (Funded by the European Research Council under the European Union's Horizon 2020 Research and Innovation Program and others; EudraCT number, 2016-001577-33; ClinicalTrials.gov number, NCT03178032.).
Revista:
JOURNAL OF NEUROSURGICAL ANESTHESIOLOGY
ISSN:
0898-4921
Año:
2022
Vol.:
34
N°:
2
Págs.:
251 - 252
Revista:
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER
ISSN:
1048-891X
Año:
2022
Vol.:
32
N°:
2
Págs.:
117 - 124
Objective To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009). Methods A multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width <= 0.2 standard deviations of the logit odds of the estimated propensity score. Results We obtained a weighted cohort of 374 patients (187 patients with prior conization and 187 non-conization patients). We found a 65% reduction in the risk of relapse for patients who had cervical conization prior to radical hysterectomy (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.16 to 0.75, p=0.007) and a 75% reduction in the risk of death for the same sample (HR 0.25, 95% CI 0.07 to 0.90, p=0.033). In addition, patients who underwent minimally invasive surgery without prior conization had a 5.63 times higher chance of relapse compared with those who had an open approach and previous conization (HR 5.63, 95% CI 1.64 to 19.3, p=0.006). Patients who underwent minimally invasive surgery with prior conization and those who underwent open surgery without prior conization showed no differences in relapse rates compared with those who underwent open surgery with prior cone biopsy (reference) (HR 1.94, 95% CI 0.49 to 7.76, p=0.349 and HR 2.94, 95% CI 0.80 to 10.86, p=0.106 respectively). Conclusions In this retrospective study, patients undergoing cervical conization before radical hysterectomy had a significantly lower risk of relapse and death.
Revista:
THROMBOSIS AND HAEMOSTASIS
ISSN:
0340-6245
Año:
2022
Vol.:
122
N°:
2
Págs.:
295 - 299
Thromboprophylaxis with low molecular weight heparin in hospitalized patients with COVID-19 is mandatory, unless contraindicated. Given the links between inflammation and thrombosis, the use of higher doses of anticoagulants could improve outcomes. We conducted an open-label, multicenter, randomized, controlled trial in adult patients hospitalized with nonsevere COVID-19 pneumonia and elevated D-dimer. Patients were randomized to therapeutic-dose bemiparin (115 IU/kg daily) versus standard prophylaxis (bemiparin 3,500 IU daily), for 10 days. The primary efficacy outcome was a composite of death, intensive care unit admission, need of mechanical ventilation support, development of moderate/severe acute respiratory distress, and venous or arterial thrombosis within 10 days of enrollment. The primary safety outcome was major bleeding (International Society on Thrombosis and Haemostasis criteria). A prespecified interim analysis was performed when 40% of the planned study population was reached. From October 2020 to May 2021, 70 patients were randomized at 5 sites and 65 were included in the primary analysis; 32 patients allocated to therapeutic dose and 33 to standard prophylactic dose. The primary efficacy outcome occurred in 7 patients (22%) in the therapeutic-dose group and 6 patients (18%) in the prophylactic-dose (absolute risk difference 3.6% [95% confidence interval [CI], -16% -24%]; odds ratio 1.26 [95% CI, 0.37-4.26]; p = 0.95). Discharge in the first 10 days was possible in 66 and 79% of patients, respectively. No major bleeding event was registered. Therefore, in patients with COVID-19 hospitalized with nonsevere pneumonia but elevated D-dimer, the use of a short course of therapeutic-dose bemiparin does not appear to improve clinical outcomes compared with standard prophylactic doses. Trial Registration: ClinicalTrials.gov NCT04604327.
Revista:
SCIENTIFIC REPORTS
ISSN:
2045-2322
Año:
2022
Vol.:
12
N°:
1
Págs.:
6564
Non-alcoholic fatty liver disease (NAFLD) is associated with cardiovascular disease morbimortality. However, it is not clear if NAFLD staging may help identify early or subclinical markers of cardiovascular disease. We aimed to evaluate the association of liver stiffness and serum markers of liver fibrosis with epicardial adipose tissue (EAT) and coronary artery calcium (CAC) in an observational cross-sectional study of 49 NAFLD patients that were seen at Clínica Universidad de Navarra (Spain) between 2009 and 2019. Liver elastography and non-invasive fibrosis markers were used to non-invasively measure fibrosis. EAT and CAC, measured through visual assessment, were determined by computed tomography. Liver stiffness showed a direct association with EAT (r = 0.283, p-value = 0.049) and CAC (r = 0.337, p-value = 0.018). NAFLD fibrosis score was associated with EAT (r = 0.329, p-value = 0.021) and CAC (r = 0.387, p-value = 0.006). The association of liver stiffness with CAC remained significant after adjusting for metabolic syndrome features (including carbohydrate intolerance/diabetes, hypertension, dyslipidaemia, visceral adipose tissue, and obesity). The evaluation of NAFLD severity through liver elastography or non-invasive liver fibrosis biomarkers may contribute to guide risk factor modification to reduce cardiovascular risk in asymptomatic patients. Inversely, subclinical cardiovascular disease assessment, through Visual Scale for CAC scoring, may be a simple and effective measure for patients with potential liver fibrosis, independently of the existence of other cardiovascular risk factors.
Revista:
BRITISH JOURNAL OF ANAESTHESIA
ISSN:
0007-0912
Año:
2021
Vol.:
127
N°:
2
Págs.:
245 - 253
Background: Dexmedetomidine is frequently used for sedation during deep brain stimulator implantation in patients with Parkinson's disease, but its effect on subthalamic nucleus activity is not well known. The aim of this study was to quantify the effect of increasing doses of dexmedetomidine in this population. Methods: Controlled clinical trial assessing changes in subthalamic activity with increasing doses of dexmedetomidine (from 0.2 to 0.6 mg kg(-1) h(-1)) in a non-operating theatre setting. We recorded local field potentials in 12 patients with Parkinson's disease with bilateral deep brain stimulators (24 nuclei) and compared basal activity in the nuclei of each patient and activity recorded with different doses. Plasma levels of dexmedetomidine were obtained and correlated with the dose administered. Results: With dexmedetomidine infusion, patients became clinically sedated, and at higher doses (0.5-0.6 mg kg(-1) h(-1)) a significant decrease in the characteristic Parkinsonian subthalamic activity was observed (P<0.05 in beta activity). All subjects awoke to external stimulus over a median of 1 (range: 0-9) min, showing full restoration of subthalamic activity. Dexmedetomidine dose administered and plasma levels showed a positive correlation (repeated measures correlation coefficient=0.504; P<0.001). Conclusions: Patients needing some degree of sedation throughout subthalamic deep brain stimulator implantation for Parkinson's disease can probably receive dexmedetomidine up to 0.6 mg kg(-1) h(-1) without significant alteration of their characteristic subthalamic activity. If patients achieve a 'sedated' state, subthalamic activity decreases, but they can be easily awakened with a non-pharmacological external stimulus and recover baseline subthalamic activity patterns in less than 10 min.
Revista:
ERJ OPEN RESEARCH
ISSN:
2312-0541
Año:
2021
Vol.:
7
N°:
2
Págs.:
00773 - 2020
Rationale: Idiopathic pulmonary fibrosis (IPF) has a dismal prognosis. Mesenchymal stromal cells (MSCs) have shown benefit in other inflammatory diseases. Objectives: To evaluate the safety and feasibility of endobronchial administration of bone marrow autologous MSCs (BM-MSC) in patients with mild-to-moderate IPF. Methods: A phase I multicentre clinical trial (ClinicalTrials.gov NCT01919827) with a single endobronchial administration of autologous adult BM-MSCs in patients diagnosed with mild-to-moderate IPF. In a first escalating-dose phase, three patients were included sequentially in three dose cohorts (10×106, 50×106 and 100×106 cells). In a second phase, nine patients received the highest tolerated dose. Follow-up with pulmonary function testing, 6-min walk test and St George¿s Respiratory Questionnaire was done at 1, 2, 3, 6 and 12 months, and with computed tomography at 3, 6 and 12 months. Results: 21 bone marrow samples were obtained from 17 patients. Three patients were excluded from treatment due to chromosome aberrations detected in MSCs after culture, and one patient died before treatment. Finally, 13 patients received the BM-MSC infusion. No treatment-related severe adverse events were observed during follow-up. Compared to baseline, the mean forced vital capacity showed an initial decline of 8.1% at 3 months. The number of patients without functional progression was six (46%) at 3 months and three (23%) at 12 months. Conclusions: The endobronchial infusion of BM-MSCs did not cause immediate serious adverse events in IPF patients, but a relevant proportion of patients suffered clinical and/or functional progression. Genomic instability of BM-MSCs during culture found in three patients may be troublesome for the use of autologous MSCs in IPF patients
Revista:
MOVEMENT DISORDERS CLINICAL PRACTICE
ISSN:
2330-1619
Año:
2021
Vol.:
8
N°:
5
Págs.:
701 - 708
Background During magnetic resonance-guided focused ultrasound for essential or parkinsonian tremor, adverse events (headache, nausea/vomiting, or anxiety) may alter the outcome of the procedure despite being mostly transient and mild. Objectives Our aim was to analyze the relationship between demographic, procedural, and anesthetic characteristics with magnetic resonance/ultrasound-related events. Methods This was a retrospective study at the Clinica Universidad de Navarra of patients undergoing thalamotomy with magnetic resonance-guided focused ultrasound between September 2018 and October 2019. The anesthesia protocol included headache and nausea/vomiting prophylaxis and rescue therapy. Dexmedetomidine was used for anxiolysis in some patients after thorough multidisciplinary assessment. Results A total of 123 patients were included. Headache was directly related to skull density ratio (P < 0.001) and skull thickness (P = 0.02). Patients with a skull density ratio less than 0.48 had 3 times the odds of experiencing moderate or severe headache (odds ratio [OR], 3.08; 95% confidence interval [CI], 1.21-7.82) and had a higher odds of aborting sonication due to pain. Sex was associated with increased nausea (P = 0.007). Women had 4 times the odds of nausea than men (OR, 4.4; 95% CI, 1.61-12.11). Dexmedetomidine did not reduce headache or nausea incidence. Patients who received dexmedetomidine had a higher number (P = 0.01) and total minutes of sonication (P = 0.01). Conclusions Patients with lower skull density ratios and higher skull thicknesses could benefit from an aggressive analgesic prophylaxis. Women are more likely to experience nausea. Dexmedetomidine did not reduce headache and nausea, but increased the number and duration of sonications. Its exact effect on tremor is still unclear.
Revista:
JOURNAL OF PATIENT SAFETY
ISSN:
1549-8417
Año:
2021
Vol.:
17
N°:
8
Págs.:
541 - 547
Objective The aim of the study was to identify and rank leading healthcare quality and patient safety challenges of general hospitals in Spain. Methods A novel online cross-sectional survey for hospitals with 150 or more beds carried out between June and September 2018. Sample frame is hospitals of the National Catalogue of Hospitals of the Ministry of Health in Spain (N = 888). Eligibility criteria are quality experts of clinical quality and/or patient safety services of general hospitals with 150 or more beds. Challenges were ranked using a risk priority number (RPN) calculated from the product of severity, frequency, and detectability scores. Results Targeted hospitals were 234. The contact rate was 97.4%, representing 63% of total beds nationwide. One hundred hospitals completed the questionnaire. According to the RPN, the top five challenges were incorrect hand hygiene of health professionals (mean RPN = 334.5, SD = 198.5), ineffective interprofessional communication (mean RPN = 334.3, SD = 169.5), medication errors in transitions of care (mean RPN = 254.0, SD = 151.0), low reporting rates of patient safety incidents and adverse events (mean RPN = 252.3, SD = 176.3), and antimicrobial resistance due to inappropriate use of antibiotics (mean RPN = 243.5, SD = 158.7). Conclusions This pioneer study of ranking quality and patient safety challenges of hospitals in Spain provides an evidence-based and context-specific foundation for quality improvement decision-making.
Revista:
JOURNAL OF ADVANCED NURSING
ISSN:
0309-2402
Año:
2021
Vol.:
77
N°:
7
Págs.:
3168 - 3175
Aims To identify and prioritize the root causes of adverse drug events (ADEs) in hospitals and to assess the ability of artificial intelligence (AI) capabilities to prevent ADEs. Design A mixed method design was used. Methods A cross-sectional study for hospitals in Spain was carried out between February and April 2019 to identify and prioritize the root causes of ADEs. A nominal group technique was also used to assess the ability of AI capabilities to prevent ADEs. Results The main root cause of ADEs was a lack of adherence to safety protocols (64.8%), followed by identification errors (57.4%), and fragile and polymedicated patients (44.4%). An analysis of the AI capabilities to prevent the root causes of ADEs showed that identification and reading are two potentially useful capabilities. Conclusion Identification error is one of the main root causes of drug adverse events and AI capabilities could potentially prevent drug adverse events. Impact This study highlights the role of AI capabilities in safely identifying both patients and drugs, which is a crucial part of the medication administration process, and how this can prevent ADEs in hospitals.
Revista:
JOURNAL OF THORACIC IMAGING
ISSN:
0883-5993
Año:
2020
Vol.:
35
N°:
1
Págs.:
64 - 70
Purpose: Routine manual tracing of cardiac contours is time-consuming and subject to variability. A fully automated software tool may improve reading efficiency. This study was performed to assess the accuracy, reliability, and time-efficiency of a fully automated left ventricular (LV) segmentation software tool to calculate LV volumes and function compared with conventional manual contouring. Materials and Methods: Sixty-seven consecutive patients (53 male, mean age 62.5 +/- 10.9 y) underwent adenosine stress/rest perfusion cardiac magnetic resonance examination to rule out myocardial ischemia. Double-oblique short-axis 6-mm slice thickness steady-state free precession cine images were acquired to assess LV ejection fraction (EF), end-diastolic volume (EDV), end-systolic volume (ESV), and stroke volume (SV) using manual contour tracing and a recently developed fully automated software tool. The length of time needed to obtain LV volumes with each segmentation method was also compared. Results: Compared with manual contouring, the fully automated software tool minimally underestimated LV-EF (mean difference of 2.9%+/- 3.9%) and SV (mean difference of 4.4 +/- 8.5 mL) and slightly overestimated ESV (mean difference of -6.4 +/- 10.8 mL) and LV mass (mean difference of -14 +/- 20.4 g). EDV quantification did not statistically differ. Reliability for EF (concordance correlation coefficient [CCC]=0.92, 95% confidence interval [CI], 0.88-0.95), EDV (CCC=0.98, 95% CI, 0.97-0.99), ESV (CCC=0.96, 95% CI, 0.94-0.97), SV (CCC=0.93, 95% CI, 0.89-0.95), and LV mass (CCC=0.84, 95% CI, 0.76-0.89) was very good. The evaluated software allowed to quantify LV parameters with a 79% reduction in the time required for manual contouring (414.7 +/- 91 s vs. 85 +/- 16.1 s, respectively, P<0.001). Conclusion: Quantification of LV volumes using the evaluated fully automated segmentation software is accurate and time-efficient.
Revista:
EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY. JOURNAL
ISSN:
1468-3083
Año:
2020
Vol.:
34
N°:
7
Págs.:
1464 - 1470
Background: Organ transplant recipients (OTR) have a higher risk of actinic keratosis (AK) and keratinocyte carcinomas (KC). There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR.
Objectives: To determine whether repeated treatments of field cancerization with DPDT are effective in preventing new AK and KC in OTR.
Methods: A randomized, intra-subject controlled, evaluator-blind, split-face and/or scalp trial, from April 2016 to October 2018. Participants were OTR older than 18 years, 1-year posttransplant, with at least 5 AK on each hemi-face/hemi-scalp. One side received six field treatments with DPDT: two sessions 15 days apart at baseline, two at 3 months and two at 9 months after baseline. Control side received lesion-directed treatment with cryotherapy (double freeze-thaw) at baseline, 3 and 9 months. Total number of lesions (AK and KC) at 21 months, number of new AK and KC at 3, 9, 15 and 21 months and treatment preferences were analysed.
Results: Of 24 men included, 23 were analysed at 3 months; and 21, at 9, 15 and 21 months. Mean (SD) age was 69.8 years (9.2). The total number of lesions at 21 months was 4.7 (4.3) for DPDT and 5.8 (5.0) for control side; P = 0.09. DPDT showed significantly lower means [SD] of new lesions compared to control side at 3 months (4.2 [3.4] vs. 6.8 [4.8]; P < 0.001), 9 months (3.0 [3.3] vs. 4.3 [3.4]; P = 0.04) and 15 months (3.0 [4.6] vs. 4.8 [5.0]; P = 0.02), and non-significant at 21 months (3.7 [3.5] vs. 5.0 [4.5]; P = 0.06). Most participants preferred DPDT.
Conclusion: DPDT showed potential effectiveness in preventing new AK and KC in OTR by consecutive treatments of field cancerization. The preference for DPDT could facilitate adherence to the long-term treatment necessary in these patients.
Revista:
BRITISH JOURNAL OF HAEMATOLOGY
ISSN:
0007-1048
Año:
2020
Vol.:
189
N°:
6
Págs.:
1064 - 1073
Anti-cluster of differentiation 20 (CD20) monoclonal antibodies (mAbs) have shown promise in follicular lymphoma (FL) as post-induction therapy, by enhancing antibody-dependent cellular cytotoxicity (ADCC). However, cytotoxic cells are reduced after this treatment. We hypothesised thatex vivoexpanded lymphokine-activated killer (LAK) cells administered to FL-remission patients are safe and improve anti-CD20 efficacy. This open, prospective, phase II, single-arm study assessed safety and efficacy ofex vivoexpanded LAK cells in 20 FL-remission patients following rituximab maintenance. Mononuclear cells were obtained in odd rituximab cycles and stimulated with interleukin 2 (IL-2) for 8 weeks, after which >5 x 10(8)LAK cells were injected. Patients were followed-up for 5 years. At the end of maintenance, peripheral blood cells phenotype had not changed markedly. Natural killer, LAK and ADCC activities of mononuclear cells increased significantly after recombinant human IL-2 (rhIL-2) stimulation in all cycles. Rituximab significantly enhanced cytotoxic activity. No patients discontinued treatment. There were no treatment-related serious adverse events. Three patients had progressed by the end of follow-up. After a median (interquartile range) follow-up of 59.4 (43.8-70.9) months, 85% of patients remained progression free. No deaths occurred. Quality-of-life improved throughout the study. Post-induction LAK cells with rituximab seem safe in the long term. Larger studies are warranted to confirm efficacy.
Revista:
JOURNAL OF TRANSLATIONAL MEDICINE
ISSN:
1479-5876
Año:
2020
Vol.:
18
N°:
1
Págs.:
356
Background Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 x 10(6)bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF (R)) as adjuvant in a randomized clinical trial. Methods A phase II, multicenter, randomized clinical trial with active control was conducted. Sixty patients diagnosed with knee OA were randomly assigned to 3 weekly doses of PRGF (R) or intraarticular administration of 100 x 10(6)cultured autologous BM-MSCs plus PRGF (R). Patients were followed up for 12 months, and pain and function were assessed using VAS and WOMAC and by measuring the knee range of motion range. X-ray and magnetic resonance imaging analyses were performed to analyze joint damage. Results No adverse effects were reported after BM-MSC administration or during follow-up. According to VAS, the mean value (SD) for PRGF (R) and BM-MSC with PRGF (R) went from 5 (1.8) to 4.5 (2.2) (p = 0.389) and from 5.3 (1.9) to 3.5 (2.5) (p = 0.01), respectively at 12 months. In WOMAC, the mean (SD) baseline and 12-month overall WOMAC scores in patients treated with PRGF (R) was 31.9 (16.2) and 22.3 (15.8) respectively (p = 0.002) while that for patients treated with BM-MSC plus PRGF (R) was 33.4 (18.7) and 23.0 (16.6) (p = 0.053). Although statistical significances between groups have been not detected, only patients being treated with BM-MSC plus PRGF (R) could be considered as a OA treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage. Conclusions Treatment with BM-MSC associated with PRGF (R) was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registrationClinical Trials.gov identifier NCT02365142. No EudraCT: 2011-006036-23
Revista:
NEURO-ONCOLOGY ADVANCES
ISSN:
2632-2498
Año:
2020
Vol.:
2
N°:
1
Págs.:
vdaa010
Background: Glioblastoma (GBM) is the most common malignant primary brain tumor in adults. Circulating biomarkers may assist in the processes of differential diagnosis and response assessment. GBM cells release extracellular vesicles containing a subset of proteins and nucleic acids. We previously demonstrated that exosomes isolated from the serum of GBM patients had an increased expression of RNU6-1 compared to healthy subjects. In this exploratory study, we investigated the role of this small noncoding RNA as a diagnostic biomarker for GBM versus other brain lesions with some potential radiological similarities.
Methods: We analyzed the expression of RNU6-1 in circulating exosomes of GBM patients (n = 18), healthy controls (n = 30), and patients with subacute stroke (n = 30), acute/subacute hemorrhage (n = 30), acute demyelinating lesions (n = 18), brain metastases (n = 21), and primary central nervous system lymphoma (PCNSL; n = 12) using digital droplet PCR.
Results: Expression of RNU6-1 was significantly higher in GBM patients than in healthy controls (P = .002). RNU6-1 levels were also significantly higher in exosomes from GBM patients than from patients with non-neoplastic lesions (stroke [P = .05], hemorrhage [P = .01], demyelinating lesions [P = .019]) and PCNSL (P = .004). In contrast, no significant differences were found between patients with GBM and brain metastases (P = .573). Receiver operator characteristic curve analyses supported the role of this biomarker in differentiating GBM from subacute stroke, acute/subacute hemorrhage, acute demyelinating lesions, and PCNSL (P < .05), but again not from brain metastases (P = .575).
Conclusions: Our data suggest that the expression of RNU6-1 in circulating exosomes could be useful for the differentiation of GBM from non-neoplastic brain lesions and PCNSL, but not from brain metastases.
Revista:
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
ISSN:
0190-9622
Año:
2020
Vol.:
83
N°:
1
Págs.:
222 - 224
Revista:
ACTA DIABETOLOGICA
ISSN:
0940-5429
Año:
2019
Vol.:
56
N°:
3
Págs.:
373 - 375
Revista:
JOURNAL OF TRANSLATIONAL MEDICINE
ISSN:
1479-5876
Año:
2019
Vol.:
17
Págs.:
48
Background and aims: Obesity is associated with impaired glucose tolerance which is a risk factor for cardiovascular risk. However, the oral glucose tolerance test (OGTT) is not usually performed in patients with normal fasting glycaemia, thus offering false reassurance to patients with overweight or obesity who may have post-prandial hyperglycaemia. As an alternative to resource demanding OGTTs, we aimed to examine the predictive value of anthropometric measures of total and central fat distribution for post-prandial hyperglycaemia in patients with overweight and obesity with normal fasting glycaemia enrolled in the DICAMANO study. Methods: We studied 447 subjects with overweight/obesity with a fasting glucose value <= 5.5 mmol l(-1) (99 mg dl(-1)) and BMI >= 25 kg/m(2) who underwent a 75-g OGTT. Post-prandial hyperglycaemia was defined as a glucose level >= 7.8 mmol l(-1) (140 mg dl(-1)) 2-h after the OGTT. The anthropometric measurements included body mass index, body adiposity index, waist circumference, neck circumference, waist-to-hip ratio and waist-to-height ratio. Results: The prevalence of post-prandial hyperglycaemia was 26%. Mean 1-h OGTT glucose levels, insulin resistance and beta cell dysfunction was higher in those subjects in the highest tertile for each anthropometric measurement, irrespective of fasting glucose level. Central fat depot anthropometric measurements were strongly and independently associated with an increased risk of post-prandial hyperglycaemia. After multivariable-adjustment for fasting plasma glucose level, smoking, and physical activity level, the odds ratio (95% confidence intervals) for the presence of post-prandial hyperglycaemia for neck circumference, waist circumference and waist-to-height ratio were 3.3 (1.4, 7.7), 2.4 (1.4, 4.4) and 2.5 (1.4, 4.5), respectively. Conclusions: In this large and comprehensively phenotyped cohort, one in four subjects had post-prandial hyperglycaemia despite normal fasting glycaemia. Anthropometric indices of central fat distribution were strongly and independently associated with an increased risk of post-prandial hyperglycaemia. These results support the association between central adiposity and glucose derangements and demonstrate the clinical usefulness of anthropometric measurements as screening tools for the selection of patients who are most likely to benefit from an OGTT.
Revista:
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. IN PRACTICE
ISSN:
2213-2198
Año:
2019
Vol.:
7
N°:
5
Págs.:
1599-1609
BACKGROUND: Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature.
OBJECTIVE: To explore the safety and efficacy of omalizumab in controlling UCOL.
METHODS: We conducted a multicenter randomized mixed double-blind and open-label (first 4 months blinded followed by 8 months open-label) placebo-controlled clinical trial in 22 patients suffering from UCOL who were unresponsive to a double dose of antihistamines. We performed an exercise challenge test during each visit as our main outcome variable.
RESULTS: The overall rate of exercise challenge test negative at week 48 was 31.3%, with an average increase in exercise challenge test negative rate of 2.9% points (95% CI, 1.5-4.2) per visit. Statistically significant differences in the negative exercise challenge test rate between the placebo and active intervention groups were not observed during the blinded period (first 4 months of the study). However, from the fourth dose, a progressive improvement was observed. When comparing before and after treatment, statistically significant improvements in all secondary outcome measures were noted after 4 doses (UCOL score: P = .0015; visual analog scale score: P = .0108; days with symptoms: P [.0125) and after 8 doses (UCOL score: P = .0005; chronic urticaria quality of life questionnaire: P = .0105; visual analog scale score: P = .0008; and days with symptoms: P = .0144). In the followup visit after the cessation ...
Revista:
NEUROUROLOGY AND URODYNAMICS
ISSN:
0733-2467
Año:
2019
Vol.:
38
N°:
7
Págs.:
1924 - 1931
Aims: Abdominal hypopressive technique (AHT) is gaining popularity as an alternative to pelvic floor muscle training (PFMT) during postpartum. Although, there is no solid evidence for its recommendation. Methods: We conducted a prospective observational cohort study in a university hospital with 105 primiparae who performed a two-month PFMT or AHT program. The aim was to compare the effectiveness of both treatments in terms of morphofunctional changes in 3D transperineal ultrasound, manometry, dynamometry, and differences in urinary incontinence symptoms (ICIQ-IU-SF) and satisfaction. Results: The average change in levator ani muscle was 1.2 mm higher in AHT group vs PFMT (95% confidence interval [CI], -2.2 to -0.2; P = .017). No statistically significant differences were shown in maximal strength changes between groups. After AHT, basal tone change was 63.0 g/cm(2) higher than PFMT (95% CI, -129 to 2.9; P = .06). A statistically significant reduction in ICIQ-IU-SF was observed after both treatments [(PFMT, -0.8 points; 95% CI, -1.4 to -0.1; P = .015), (AHT, -0.7 points; 95% CI, -1.3 to -0.1; P = .018]. AHT showed a higher median satisfaction score than PFMT (P = .004). Conclusions: This preliminary study is the first that analyses the effect of AHT vs PFMT during postpartum. The results suggest a higher improve for AHT in levator muscle thickness and satisfaction compared to PFMT. These must be considered with caution due to the limitations of the study. Further randomized clinical trials about both techniques during postpartum are required.
Revista:
JMIR PUBLIC HEALTH AND SURVEILLANCE
ISSN:
2369-2960
Año:
2019
Vol.:
5
N°:
4
Págs.:
e11997
Web-based questionnaires allow collecting data quickly, with minimal costs from large sample groups and through Web-based self-administered forms. Until recently, there has been a lack of evidence from large-scale epidemiological studies and nutrition surveys that have evaluated the comparison between traditional and new technologies to measure dietary intake.
Revista:
BLOOD CANCER JOURNAL
ISSN:
2044-5385
Año:
2019
Vol.:
9
N°:
4
Págs.:
36
Disease control at 5 years would be a desirable endpoint for elderly multiple myeloma (MM) patients, but biomarkers predicting this are not defined. Therefore, to gain further insights in this endpoint, a population of 498 newly diagnosed transplant-ineligible patients enrolled in two Spanish trials (GEM2005MAS65 and GEM2010MAS65), has been analyzed. Among the 435 patients included in this post-hoc study, 18.6% remained alive and progression free after 5 years of treatment initiation. In these patients, overall survival (OS) rate at 10 years was 60.8% as compared with 11.8% for those progressing within the first 5 years. Hemoglobin (Hb) >= 12 g/dl (OR 2.74, p = 0.001) and MGUS-like profile (OR 4.18, p = 0.005) were the two baseline variables associated with long-term disease-free survival. Upon including depth of response (and MRD), Hb >= 12 g/dl (OR 2.27) and MGUS-like signature (OR 7.48) retained their predictive value along with MRD negativity (OR 5.18). This study shows that despite the use of novel agents, the probability of disease control at 5 years is still restricted to a small fraction (18.6%) of elderly MM patients. Since this endpoint is associated with higher rates of OS, this study provides important information about diagnostic and post-treatment biomarkers helpful in predicting the likelihood of disease control at 5 years.
Revista:
CLINICAL ORAL INVESTIGATIONS
ISSN:
1432-6981
Año:
2019
Vol.:
23
N°:
1
Págs.:
391 - 397
ObjectivesTo evaluate the relationship between pharmacokinetic descriptors of dexmedetomidine (predicted area under the curve during the procedure, predicted plasma level at the end of the procedure, and duration of procedure) and sedation depth (proportion of time with bispectral index <85 during the procedure) with recovery time after ambulatory procedures.Materials and methodsClinical observational study of patients undergoing oral and maxillofacial ambulatory surgery with dexmedetomidine as sole sedative agent. Patients received a loading dose of dexmedetomidine (0.25-1gkg(-1)) followed by a maintenance infusion (0.2-1.4gkg(-1)h(-1)) to keep a bispectral index <85 until 5min before the end of the procedure, and were transferred to a post-anesthesia care unit until criteria for discharge were met.ResultsData from 75 patients was analyzed. Sedation depth was directly associated with recovery time (Pearson correlation coefficient [r]=0.26; p=0.024). Around 7% of the variation in recovery time was explained by the proportion of time with bispectral index <85. No association with procedure duration (r=0.01; p=0.9), predicted area under the curve (r=0.1; p=0.4), or predicted plasma level of dexmedetomidine at the end of the procedure (r=0.12; p=0.3) with recovery time was observed.ConclusionsSedation depth with dexmedetomidine could play a role in increasing recovery time after oral and maxillofacial ambulatory surgery. In our study, the pharmacokinetic descriptors of dexmedetomidine did not seem to influence recovery time.Clinical relevanceSedation depth with dexmedetomidine could play a role in increasing recovery time after ambulatory procedures.
Revista:
ACTA DIABETOLOGICA
ISSN:
0940-5429
Año:
2018
Vol.:
55
N°:
1
Págs.:
103 - 106
Revista:
JOURNAL OF NUTRITION HEALTH AND AGING
ISSN:
1279-7707
Año:
2018
Vol.:
22
N°:
4
Págs.:
526 - 533
To examine the association between a dietary fat quality index (FQI), and the risk of incident cardiovascular events or deaths in the Seguimiento Universidad de Navarra (SUN) cohort.
Longitudinal analysis during 10.1 years of median follow-up. Cox models were used to estimate adjusted hazard ratios (HR) of incident cardiovascular diseases (CVD) according to tertiles of FQI and of different fat subtypes.
University of Navarra, Spain.
19,341 middle-aged adults.
Fat intake was measured with a validated food-frequency questionnaire. The FQI was calculated according to the ratio: (monounsaturated+polyunsaturated) / (saturated+trans fatty acids).
We observed 140 incident cases of CVD. No association was found for FQI (HR=0.94, 95 %CI 0.61-1.47 for the highest vs the lowest tertile, p for trend=0.884). No significant associations were found for different dietary fat subtypes on CVD risk. The results suggest no clear association between a higher FQI and a higher amount of energy from fat and incidence of CVD (p for interaction: 0.259 and p for trend only among participants with a percentage of energy from fat ae<yen>35% of total energy: 0.272).
In this Mediterranean cohort, the FQI was not associated with cardiovascular events. A "heart-healthy diet" should focus its attention on dietary fat sources and should use an overall dietary pattern approach, rather than limiting the focus on fat subtypes. More research is needed to validate dietary advice on specific fatty acids intake or saturated fatty acids replacements for reducing CVD risk.
Revista:
ANESTHESIA AND ANALGESIA
ISSN:
0003-2999
Año:
2018
Vol.:
127
N°:
2
Págs.:
414 - 419
BACKGROUND: Differentiating between immunoglobulin E (IgE)-dependent and IgE-independent hypersensitivity reactions may improve the etiologic orientation and clinical management of patients with allergic reactions in the anesthesia setting. Serum tryptase levels may be useful to discriminate the immune mechanism of allergic reactions, but the diagnostic accuracy and optimal cutpoint remain unclear. We aimed to compare the diagnostic accuracy of tryptase during reaction (TDR) alone and the TDR/basal tryptase (TDR/BT) ratio for discriminating IgE- from non-IgE-mediated allergic reactions, and to estimate the best cut point for these indicators. METHODS: We included 111 patients (45% men; aged 3-99 years) who had experienced an allergic reaction, even though the allergic reaction could be nonanaphylactic. Allergy tests were performed to classify the reaction as an IgE- or non-IgE-mediated one. The area under the curve (AUC) of the receiver operating characteristic analysis was performed to estimate the discriminative ability of TDR and TDR/BT ratio. RESULTS: An IgE-mediated reaction was diagnosed in 49.5% of patients, of whom 56% met anaphylaxis criteria. The median (quartiles) TDR for the IgE-mediated reactions was 8.0 (4.9-19.6) and 5.1 (3.5-8.1) for the non-IgE-mediated (P = .022). The median (quartiles) TDR/BT ratio was 2.7 (1.7-4.5) in IgE-mediated and 1.1 (1.0-1.6) in non-IgE-mediated reactions (P < .001). The TDR/BT ratio showed the greatest ability to discriminate IgE- from non-IgE-mediated reactions compared to TDR (AUC TDR/BT = 0.79 [95% confidence interval (CI), 1.1-2.2] and AUC TDR = 0.66 [95% CI, 1.1-2.2]; P = .003). The optimal cut point for TDR/BT (maximization of the sum of the sensitivity and specificity) was 1.66 (95% CI, 1.1-2.2). CONCLUSIONS: The TDR/BT ratio showed a significantly better discriminative ability than TDR to discriminate IgE- from non-IgE-mediated allergic reactions. An optimal TDR/BT ratio threshold of approximately 1.66 may be useful in clinical practice to classify allergic reactions as IgE- or non-IgE-mediated.
Revista:
JOURNAL OF TRANSLATIONAL MEDICINE
ISSN:
1479-5876
Año:
2018
Vol.:
16
Págs.:
213
Background: Mesenchymal stromal cells (MSCs) are a promising option to treat knee osteoarthritis (OA). Their safety and usefulness have been reported in several short-term clinical trials but less information is available on the long-term effects of MSC in patients with osteoarthritis. We have evaluated patients included in our previous randomized clinical trial (CMM-ART, NCT02123368) to determine their long-term clinical effect. Materials: A phase I/II multicenter randomized clinical trial with active control was conducted between 2012 and 2014. Thirty patients diagnosed with knee OA were randomly assigned to Control group, intraarticularly administered hyaluronic acid alone, or to two treatment groups, hyaluronic acid together with 10 x 10(6) or 100 x 10(6) cultured autologous bone marrow-derived MSCs (BM-MSCs), and followed up for 12 months. After a follow up of 4 years adverse effects and clinical evolution, assessed using VAS and WOMAC scorings are reported. Results: No adverse effects were reported after BM-MSCs administration or during the follow-up. BM-MSCs-administered patients improved according to VAS, median value (IQR) for Control, Low-dose and High-dose groups changed from 5 (3, 7), 7 (5, 8) and 6 (4, 8) to 7 (6, 7), 2 (2, 5) and 3 (3, 4), respectively at the end of follow up (Low-dose vs Control group, p = 0.01; High-dose vs Control group, p = 0.004). Patients receiving BM-MSCs also improved clinically according to WOMAC. Control group showed an increase median value of 4 points (-11;10) while Low-dose and High-dose groups exhibited values of -18 (-28;-9) and -10 (-21;-3) points, respectively (Low-dose vs Control group p = 0.043). No clinical differences between the BM-MSCs receiving groups were found. Conclusions: Single intraarticular injection of in vitro expanded autologous BM-MSCs is a safe and feasible procedure that results in long-term clinical and functional improvement of knee OA.
Revista:
WORLD NEUROSURGERY
ISSN:
1878-8750
Año:
2018
Vol.:
109
Págs.:
e845 - e852
BACKGROUND:
Corticosteroids are routinely used to treat brain tumors. Although steroids have an immediate clinical benefit, their use can lead to a number of relevant complications, and a negative association with overall survival has been shown in glioblastoma (GBM) patients. There is no evidence in the literature regarding the ideal dose. We assessed the use of steroids in patients with GBM after resection surgery.
METHODS:
This is a cohort study of 131 newly diagnosed GBM patients that underwent tumor resection surgery. Dose of steroids was as low as possible, without a formal guideline. Fifteen patients were lost at baseline (retention rate, 88.5%). Our population for analysis included 114 patients that were still at risk of death at a landmark time point 2 months after surgery.
RESULTS:
Within 1 month of surgery, 93.9% of patients came off steroids, and 84.7% came off steroids before 2 weeks. One month after radiotherapy, 86 (75.4%) patients remained steroid-free and 28 (24.6%) were steroid-dependent. During 2235 person-months of follow-up, we documented 101 incident deaths. After adjusting for age, sex, Karnofsky Performance Scale score, MGMT promoter methylation, and extent of tumor resection, and time to surgery, the hazard ratio for the steroid-free group of patients was 0.46 (95% confidence interval, 0.28-0.77) compared with steroid-dependent patients.
CONCLUSIONS:
This study provides evidence for an inverse association between the lack of steroid dependency and mortality risk in patients whose steroid dosage was rapidly tapered after surgery. After resection, most patients can stop steroids within 2 weeks and finish radiotherapy without steroids.
Revista:
REVISTA ESPAÑOLA DE ANESTESIOLOGÍA Y REANIMACIÓN
ISSN:
0034-9356
Año:
2017
Vol.:
64
N°:
4
Págs.:
206 - 213
Introduction: Dexdor® do not include the possibility of loading dose, which could increase time to achieve adequate sedation for ambulatory procedures. The objective of this study was to evaluate the effect of several loading dose of dexmedetomidine in the time to achieve and maintain an optimal level of sedation and its clinical hemodynamic repercussion.
Material and methods: The IRB approved this observational study for patients that underwent oral and maxillofacial ambulatory surgery under dexmedetomidine at the University of Navarra Clinic from February 2013 to November 2014. According to the loading dose the patients were grouped into 3 categories:<0.5, 0.5, and>0.5¿g/kg. Optimal level of sedation was defined as bispectral index<85. Data were analyzed using survival analysis techniques. Vasoactive drugs requirements was evaluated using exact logistic regression.
Results: Eighty-one patients were evaluated. Hazard ratios for patients in 0.5 and >0.5¿g/kg loading dose categories for achieving a bispectral index<85 were 1.5 (95% CI 0.9, 2.6) and 1.8 (95% CI 0.8, 3.9), respectively, compared with the lowest category. Five patients (6.2%) required atropine for bradycardia. Patients in the group>0.5¿g/kg showed greater risk of requiring atropine compared with the group<0.5¿g/kg (odds ratio 2.2; 95% CI 0.03, 183).
Conclusion: Loading dose of dexmedetomidine>0.5¿g/kg appears minimize the time to achieve and maintain an optimal level of sedation during the first 60min of procedure. Further investigation to elucidate the association between loading dose of dexmedetomidine and subsequent atropine requirements may be warranted.
Revista:
ANESTHESIOLOGY
ISSN:
0003-3022
Año:
2017
Vol.:
126
N°:
6
Págs.:
1033 - 1042
Background: Deep brain stimulation electrodes can record oscillatory activity from deep brain structures, known as local field potentials. The authors' objective was to evaluate and quantify the effects of dexmedetomidine (0.2 mu g.kg(-1).h(-1)) on local field potentials in patients with Parkinson disease undergoing deep brain stimulation surgery compared with control recording (primary outcome), as well as the effect of propofol at different estimated peak effect site concentrations (0.5, 1.0, 1.5, 2.0, and 2.5 mu g/ml) from control recording.
Methods: A nonrandomized, nonblinded controlled clinical trial was carried out to assess the change in local field potentials activity over time in 10 patients with Parkinson disease who underwent deep brain stimulation placement surgery (18 subthalamic nuclei). The relationship was assessed between the activity in nuclei in the same patient at a given time and repeated measures from the same nucleus over time.
Results: No significant difference was observed between the relative beta power of local field potentials in dexmedetomidine and control recordings (- 7.7; 95% CI, - 18.9 to 7.6). By contrast, there was a significant decline of 12.7% (95% CI, - 21.3 to - 4.7) in the relative beta power of the local field potentials for each increment in the estimated peak propofol concentrations at the effect site relative to the control recordings.
Conclusions: Dexmedetomidine (0.2 mu g.kg(-1).h(-1)) did not show effect on local field potentials compared with control recording. A significant deep brain activity decline from control recording was observed with incremental doses of propofol.
Revista:
EUROPEAN JOURNAL OF ANAESTHESIOLOGY
ISSN:
0265-0215
Año:
2017
Vol.:
34
N°:
2
Págs.:
81 - 88
BACKGROUND Four predictive models for acute kidney injury associated with cardiac surgery were developed by Demirjian in the United States in 2012. However, the usefulness of these models in clinical practice needs to be established in different populations independent of that used to develop the models. OBJECTIVES Our aim was to evaluate the predictive performance of these models in a Spanish population. DESIGN A multicentre, prospective observational study. DATA SOURCES Twenty-three Spanish hospitals in 2012 and 2013. ELIGIBILITY CRITERIA Of 1067 consecutive cardiac patients recruited for the study, 1014 patients remained suitable for the final analysis. MAIN OUTCOME MEASURES Dialysis therapy, and a composite outcome of either a doubling of the serum creatinine level or dialysis therapy, in the 2 weeks (or until discharge, if sooner) after cardiac surgery. RESULTS Of the 1014 patients analysed, 34 (3.4%) required dialysis and 95 (9.4%) had either dialysis or doubled their serum creatinine level. The areas under the receiver operating characteristic curves of the two predictive models for dialysis therapy, which include either presurgical variables only, or combined presurgical and intrasurgical variables, were 0.79 and 0.80, respectively. The model for the composite endpoint that combined presurgical and intrasurgical variables showed better discriminatory ability than the model that included only presurgical variables: the areas under the receiver operating characteristic curves were 0.76 and 0.70, respectively. All four models lacked calibration for their respective outcomes in our Spanish population. CONCLUSION Overall, the lack of calibration of these models and the difficulty in using the models clinically because of the large number of variables limit their applicability.
Revista:
REVISTA ESPAÑOLA DE ANESTESIOLOGÍA Y REANIMACIÓN
ISSN:
0034-9356
Año:
2017
Vol.:
64
N°:
4
Págs.:
206 - 213
Introduction: Dexdor® do not include the possibility of loading dose, which could increase time to achieve adequate sedation for ambulatory procedures. The objective of this study was to evaluate the effect of several loading dose of dexmedetomidine in the time to achieve and maintain an optimal level of sedation and its clinical hemodynamic repercussion.
Material and methods: The IRB approved this observational study for patients that underwent oral and maxillofacial ambulatory surgery under dexmedetomidine at the University of Navarra Clinic from February 2013 to November 2014. According to the loading dose the patients were grouped into 3 categories:<0.5, 0.5, and>0.5¿g/kg. Optimal level of sedation was defined as bispectral index<85. Data were analyzed using survival analysis techniques. Vasoactive drugs requirements was evaluated using exact logistic regression.
Results: Eighty-one patients were evaluated. Hazard ratios for patients in 0.5 and >0.5¿g/kg loading dose categories for achieving a bispectral index<85 were 1.5 (95% CI 0.9, 2.6) and 1.8 (95% CI 0.8, 3.9), respectively, compared with the lowest category. Five patients (6.2%) required atropine for bradycardia. Patients in the group>0.5¿g/kg showed greater risk of requiring atropine compared with the group<0.5¿g/kg (odds ratio 2.2; 95% CI 0.03, 183).
Conclusion: Loading dose of dexmedetomidine>0.5¿g/kg appears minimize the time to achieve and maintain an optimal level of sedation during the first 60min of procedure. Further investigation to elucidate the association between loading dose of dexmedetomidine and subsequent atropine requirements may be warranted.
Revista:
SCIENTIFIC REPORTS
ISSN:
2045-2322
Año:
2017
Vol.:
7
N°:
1
Págs.:
8985
Omalizumab (OmAb) is a humanized anti-IgE antibody approved for the treatment of chronic spontaneous urticaria (CSU). OmAb's mechanism of action is known to include actions on free IgE and on pre-bound IgE. However, OmAb is equally and rapidly effective against autoimmune and non-autoimmune urticaria where IgE involvement is not clear, suggesting the involvement of additional mechanisms of action. In this study, we sought to investigate the ability of OmAb to inhibit mast cell and basophil degranulation induced by sera from CSU patients. For this purpose, we performed a comparison between the in vitro incubation of sera from CSU patients treated with OmAb and the in vivo administration of OmAb in a clinical trial. We found that OmAb added in vitro to sera from CSU patients did not modify the ability of the sera to induce cell degranulation. Similarly, the sera from patients treated with OmAb in the context of the clinical trial who had a good clinical outcome maintained the capacity to activate mast cells and basophils. Thus, we conclude that the beneficial activity of OmAb does not correlate with the ability of patient sera to induce cell degranulation
Revista:
WORLD NEUROSURGERY
ISSN:
1878-8750
Año:
2017
Vol.:
101
Págs.:
114 - 121
BACKGROUND: The anesthetic management of patients requiring surgery for movement disorders needs to balance microrecording quality and patient cooperation with safety and comfort. Anesthetics can alter microrecording, although the effect on outcome is debatable. They also provide a rested and cooperative patient and minimize complications such as intracranial hemorrhage by providing better hemodynamic control. Most teams use local anesthesia with monitored anesthesia care or conscious sedation with propofol. Recently, dexmedetomidine has emerged as an alternative that, at low doses, does not affect microrecording, and that does not impair respiratory drive. METHODS: In the past 15 years, we have used in our institution local anesthesia, remifentanil, or dexmedetomidine sedation. We compared functional outcome and rate of complications in a group of 145 patients with similar characteristics. RESULTS: We found 5 (3.4%) intracranial hemorrhages. Two (1.4%) were symptomatic. The remifentanil group had the highest risk of having systolic blood pressure > 160 mm Hg during surgery (odds ratio [OR], 2.8; 95% confidence interval [CI], 0.9-9.9), whereas the dexmedetomidine group had the lowest (OR, 0.7; 95% CI, 0.2-1.8), compared with the local anesthesia group. Surgical time was shortest with dexmedetomidine (mean, 283 minutes) and longest with local anesthesia only (mean, 328 minutes). Functional outcome (Unified Parkinson's Disease Rating Scale, Part III motor component scale) was similar among groups. The dexmedetomidine group had a statistically significant lower risk of perioperative neurologic events compared with the local anesthesia group (OR, 0.09; 95% CI, 0.002-0.68). CONCLUSIONS: Sedation can be used safely without affecting outcome, and dexmedetomidine provides better hemodynamic management. Clinical significance remains unclear and larger studies need to be undertaken.
Revista:
WORLD NEUROSURGERY
ISSN:
1878-8750
Año:
2017
Vol.:
101
Págs.:
114 - 121
Background: The anesthetic management of patients requiring surgery for movement disorders needs to balance microrecording quality and patient cooperation with safety and comfort. Anesthetics can alter microrecording, although the effect on outcome is debatable. They also provide a rested and cooperative patient and minimize complications such as intracranial hemorrhage by providing better hemodynamic control. Most teams use local anesthesia with monitored anesthesia care or conscious sedation with propofol. Recently, dexmedetomidine has emerged as an alternative that, at low doses, does not affect microrecording, and that does not impair respiratory drive.
Methods: In the past 15 years, we have used in our institution local anesthesia, remifentanil, or dexmedetomidine sedation. We compared functional outcome and rate of complications in a group of 145 patients with similar characteristics.
Results: We found 5 (3.4%) intracranial hemorrhages. Two (1.4%) were symptomatic. The remifentanil group had the highest risk of having systolic blood pressure >160 mm Hg during surgery (odds ratio [OR], 2.8; 95% confidence interval [CI], 0.9-9.9), whereas the dexmedetomidine group had the lowest (OR, 0.7; 95% CI, 0.2-1.8), compared with the local anesthesia group. Surgical time was shortest with dexmedetomidine (mean, 283 minutes) and longest with local anesthesia only (mean, 328 minutes). Functional outcome (Unified Parkinson's Disease Rating Scale, Part III motor component scale) was similar among groups. The dexmedetomidine group had a statistically significant lower risk of perioperative neurologic events compared with the local anesthesia group (OR, 0.09; 95% CI, 0.002-0.68).
Conclusions: Sedation can be used safely without affecting outcome, and dexmedetomidine provides better hemodynamic management. Clinical significance remains unclear and larger studies need to be undertaken.
Revista:
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES
ISSN:
0930-2794
Año:
2017
Vol.:
31
N°:
10
Págs.:
3847 - 3857
Laparoscopic organ-sparing pancreatectomy (LOSP) is an ideal therapeutic option in selected cases of pancreatic neuroendocrine tumors (PNETs). Nevertheless, given the low frequency of PNETs, there is scarce evidence regarding short and particularly long-term outcomes of LOSP in this clinical setting. All patients with PNETs who underwent surgery (under a LOSP policy) were retrospectively reviewed from a prospective database maintained at our center. Preoperative characteristics, operative data, pathological features and postoperative outcomes were analyzed. Between December 2003 and December 2015, 36 patients with PNETs underwent laparoscopic resections. Ten were functional tumors, 26 non-functional and 16 were "incidental" cases. The following procedures were performed: one enucleation, eight central pancreatectomies (LCP), one resection of the uncinate process and 26 distal pancreatectomies (DP) (15 of them laparoscopic vessels-preserving). There were no conversions to open surgery, and no drains were routinely left. Mean operative time was 288 min (SD 99). Hospital stay was 6 days. Eighteen patients (50%) experienced some complication of which most were mild (Clavien-Dindo I/II). Three postoperative bleedings occurred: two grade B/one grade C; two required laparoscopic reoperation. Thirteen (36.1%) patients developed peripancreatic fluid collections: two were symptomatic and were managed with transgastric drainage (one presented post-puncture abscesification requiring surgical drainage and splenectomy). Four patients (11%)-one DP and three LCP-developed new-onset pancreatogenic diabetes mellitus (NODM) in the long term. According to the European Neuroendocrine Tumor Society, 19 cases were stage I, seven IIA, two IIIA, one IIIB and seven stage IV. Over a mean follow-up of 51 months, two patients died, one due to recurrence of the tumor and another due to cirrhosis. The existing different surgical options must be individually considered according to the location and particular characteristics of every tumor. Results from this single-center study document the effectiveness of LOSP in selected cases of PNETs.
Revista:
REVISTA ESPAÑOLA DE ENFERMEDADES DIGESTIVAS
ISSN:
1130-0108
Año:
2016
Vol.:
108
N°:
11
Págs.:
689 - 696
Background: Pancreatic neuroendocrine tumors (pNETs) comprise a heterogeneous group of tumors with a varied biological behavior. In the present study, we analyzed the experience of 79 pNETs resected between 1993 and 2015. The pathologic prognostic factors (European Neuroendocrine Tumor Society, ENETS; and AJCC) classification, vascular invasion (VI), proliferation index (ki-67) and the presence of necrosis were retrospectively reviewed. Methods: The clinical data of 79 patients with pNETs who underwent surgery were retrospectively analyzed. Mortality rates and Kaplan-Meier estimates were used to evaluate survival over time for pathologic stages, tumor functionality, and vascular invasion. Cox proportional hazards models were used to calculate the hazard ratio regarding ENETS, AJCC staging, sex, tumor functionality and vascular invasion. Results: The male: female ratio was 40: 39. Twenty-one patients (26%) had functional tumors and 58 (73.4%) had nonfunctional tumors, of which 35 (44.3%) were diagnosed incidentally. Seventeen Whipple procedures, 46 distal pancreatectomies (including 26 laparoscopic and 20 open procedures), 8 laparoscopic central pancreatectomies, 1 laparoscopic resection of the uncinated process and 7 enucleations (one laparoscopic) were performed. Vascular invasion and necrosis were observed in 29 of 75 cases (38.6%) and in 16 cases (29%), respectively. The comparison between survivor functions of ENETS staging categories showed statistically significant differences (p = 0.042). Mortality rate was higher in patients with non-functioning tumors compared with hormonally functioning tumors (p = 0.052) and in those with vascular invasion (p = 0.186). Conclusions: In spite of the heterogeneity of pNETs, the ENETS TNM classification efficiently predicts long-term prognosis. The non-functioning tumors and the presence of vascular invasion are associated with poor prognosis.
Revista:
LUNG CANCER
ISSN:
0169-5002
Año:
2016
Vol.:
97
Págs.:
81-86
A major drawback of lung cancer screening programs is the high frequency of false-positive findings on computed tomography (CT). We investigated the accuracy of selective 2-[fluorine-18]-fluoro-2-deoxy-d-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan in assessing radiologically indeterminate lung nodules detected in lung cancer screening. Methods: FDG PET/CT was performed to characterize 64 baseline lung nodules >10 mm and 36 incidence nodules detected on low-dose CT screening in asymptomatic current or former smokers (83 men, age range 40¿83 years) at high risk for lung cancer. CT images were acquired without intravenous contrast. Nodules were analyzed by size, density, and metabolic activity and visual scored on a 5-point scale for FDG uptake. Nodules were classified as negative for malignancy when no FDG uptake was observed, or positive when focal uptake was observed in the visual analysis, and the maximum standardized uptake value (SUVmax) was measured. Final diagnosis was based on histopathological evaluation or at least 24 months of follow-up. Results: A total of 100 nodules were included. The prevalence of lung cancer was 1%. The sensitivity, specificity, NPV and PPV of visual analysis to detect malignancy were 84%, 95%, 91%, and 91%, respectively, with an accuracy of 91% (AUC 0.893). FDG PET/CT accurately detected 31 malignant tumors (diameters 9¿42 mm, SUVmax range 0.6¿14.2) and was falsely negative in 6 patients. With SUVmax threshold
Revista:
JOURNAL OF TRANSLATIONAL MEDICINE
ISSN:
1479-5876
Año:
2016
Vol.:
14
N°:
1
Págs.:
246
The single intraarticular injection of in vitro expanded autologous BM-MSCs together with HA is a safe and feasible procedure that results in a clinical and functional improvement of knee OA, especially when 100 × 10(6) cells are administered. These results pave the way for a future phase III clinical trial.
Revista:
JOURNAL OF INVESTIGATIONAL ALLERGOLOGY AND CLINICAL IMMUNOLOGY
ISSN:
1018-9068
Año:
2015
Vol.:
25
N°:
4
Págs.:
283 - 287
Fifteen of 201 patients with negative results for LTP in the SPT were sensitized to this allergen in the in vitro tests, and 18 of 41 patients with positive results for LTP in the SPT were not sensitized according to the in vitro tests. Seventeen of 186 patients with negative results for profilin in the SPT were sensitized to Phl p 12 by serum sIgE, and 30 out of 56 patients with positive results for profilin in SPT were not sensitized to Phl p 12 according to the other tests. Moderate agreement was observed between the 3 techniques studied.
CONCLUSIONS:
SPT is a sensitive technique for detecting sensitization to LTP and profilin. Its results are similar to those of in vitro techniques, especially in patients with negative SPT results for peach LTP and palm tree profilin.
Revista:
JAMA DERMATOLOGY
ISSN:
2168-6068
Año:
2015
Vol.:
151
N°:
8
Págs.:
897 - 899
Revista:
STEREOTACTIC AND FUNCTIONAL NEUROSURGERY
ISSN:
1011-6125
Año:
2015
Vol.:
93
N°:
6
Págs.:
393-399
Dexmedetomidine provides adequate sedation during surgery for PD, but it might affect motor signs making intraoperative testing difficult or even impossible. Dosage appears not to be the determining factor in motor changes, whose cause remains unclear.
Revista:
PLOS ONE
ISSN:
1932-6203
Año:
2015
Vol.:
10
N°:
10
Págs.:
e0139702.
These results suggest that SAPS II and 3 should be customized with additional patient-risk factors to improve mortality prediction in patients undergoing NIV in intermediate car
Revista:
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
ISSN:
0190-9622
Año:
2015
Vol.:
73
N°:
2
Págs.:
e73 - e74
Revista:
JOURNAL OF PAIN AND SYMPTOM MANAGEMENT
ISSN:
0885-3924
Año:
2015
Vol.:
50
N°:
6
Págs.:
874-81
The Spanish version of the PDI showed adequate psychometric properties when tested with advanced cancer patients. This research provides a three-factor alternative in Spanish to the PDI.
Revista:
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
ISSN:
0190-9622
Año:
2015
Vol.:
72
N°:
1
Págs.:
151 - 158.e1
Background Sturge-Weber syndrome (SWS) is characterized by port-wine stains (PWS) affecting the face, eyes, and central nervous system. Pulsed dye laser (PDL) is the standard treatment for PWS. Unfortunately, recurrence is frequent because of reformation and reperfusion of blood vessels. Objective We sought to assess the clinical efficacy of topical rapamycin combined with PDL in PWS of patients with SWS.
Methods We conducted a phase II, randomized, double-blind, intraindividual placebo-controlled, clinical trial. We recruited 23 patients with SWS and facial PWS (12 women; median age 33 years, age range 17-65 years) from the University Clinic of Navarra, Spain. Four interventions were evaluated: placebo, PDL + placebo, rapamycin, and PDL + rapamycin. Clinical and histologic responses were evaluated using a chromatographic computerized system, spectrometry, and histologic analyses at 6, 12, and 18 weeks after the intervention.
Results PDL + rapamycin yielded the lowest digital photographic image score and the lowest percentage of vessels in histologic analysis, and showed a statistically significant improvement compared with the other interventions. The treatment was generally well tolerated.
Limitations PDL was only applied to the lateral parts of the PWS area. Conclusion Topical rapamycin associated with PDL seems to be an effective treatment for PWS in patients with SWS.
Revista:
ALLERGY
ISSN:
0105-4538
Año:
2013
Vol.:
68
N°:
6
Págs.:
820 - 822
Allergic skin tests have to be performed 4-6 weeks after an allergic anesthetic reaction. Patients with allergic reactions during anesthesia were prospectively included (n = 44). Skin tests were performed in two stages: (i) Stage 1 (S1), 0-4 days after the reaction; and (ii) Stage 2 (S2), 4-8 weeks after. Five (11.5%) surgical procedures were suspended due to the reaction. Positive skin tests were obtained in 25/44 patients (57%). Allergic diagnosis was carried out at S1 in 15/25 (60%) and at S2 in 10/25 (40%). Three patients resulted positive only in S1. Overall agreement among S1 and S2 skin tests was 70.45%. The kappa statistic was 0.41 (P-value = 0.002). Odds ratio of obtaining a false negative in S1 (compared with S2) was 3.33. Early allergological study is useful, could minimize false negatives, but should be considered as a complement to late skin tests.
Revista:
BMC PUBLIC HEALTH
ISSN:
1471-2458
Año:
2012
Vol.:
12
Págs.:
954
Background: Longitudinal studies assessing the long-term association between alcohol intake and depression are scarce. The type of beverage may also be important. Therefore we aimed to prospectively evaluate the influence of alcohol intake on incident depression in a Mediterranean cohort. Methods: We assessed 13,619 university graduates (mean age: 38 years, 42% men) participating in a Spanish prospective epidemiological cohort (the SUN Project), initially free of depression. They were recruited between 1999-2008 and biennially followed-up during 2001-2010. At baseline, a 136-item validated food-frequency questionnaire was used to assess alcohol intake. Wine was the preferred beverage. Participants were classified as incident cases of depression if they reported a new clinical diagnosis of depression by a physician and/or initiated the use of antidepressant drugs. Cox regression and restricted cubic splines analyses were performed over 82,926 person-years. Results: Only among women, an U-shaped relationship between total alcohol intake and depression risk was found (P=0.01). Moderate alcohol intake (5-15 g/day) was associated with lower risk (Hazard Ratio: 0.62; 95% Confidence Interval: 0.43-0.89). No association was apparent for higher intakes of alcohol or for any specific type of alcoholic beverage. Conclusions: Moderate alcohol intake might protect against depression among women. Further confirmatory studies are needed.
Revista:
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
ISSN:
0360-3016
Año:
2012
Vol.:
83
N°:
2
Págs.:
587-593
PURPOSE:
To validate tolerance and pathological complete response rate (pCR) of a 4-week preoperative course of intensity-modulated radiation therapy (IMRT) with concurrent capecitabine and oxaliplatin (CAPOX) in patients with locally advanced rectal cancer.
METHODS AND MATERIALS:
Patients with T3 to T4 and/or N+ rectal cancer received preoperative IMRT (47.5 Gy in 19 fractions) with concurrent capecitabine (825 mg/m(2) b.i.d., Monday to Friday) and oxaliplatin (60 mg/m(2) on Days 1, 8, and 15). Surgery was scheduled 4 to 6 weeks after the completion of chemoradiation. Primary end points were toxicity and pathological response rate. Local control (LC), disease-free survival (DFS), and overall survival (OS) were also analyzed.
RESULTS:
A total of 100 patients were evaluated. Grade 1 to 2 proctitis was observed in 73 patients (73%). Grade 3 diarrhea occurred in 9% of the patients. Grade 3 proctitis in 18% of the first 50 patients led to reduction of the dose per fraction to 47.5 Gy in 20 treatments. The rate of Grade 3 proctitis decreased to 4% thereafter (odds ratio, 0.27). A total of 99 patients underwent surgery. A pCR was observed in 13% of the patients, major response (96-100% of histological response) in 48%, and pN downstaging in 78%. An R0 resection was performed in 97% of the patients. After a median follow-up of 55 months, the LC, DFS, and OS rates were 100%, 84%, and 87%, respectively.
CONCLUSIONS:
Preoperative CAPOX-IMRT therapy (47.5 Gy in 20 fractions) is feasible
Revista:
Nutrition
ISSN:
0899-9007
Año:
2011
Vol.:
27
N°:
7-8
Págs.:
802 - 808
Objective: The effects of alcohol on body weight might be modulated by the total amount of alcohol intake and type of alcoholic beverage. However, available results are contradictory. There is a scarcity of studies on this topic in Mediterranean areas where wine consumption is high. We prospectively evaluated the association between the type of alcoholic beverage intake and weight change in a Mediterranean cohort.
Methods: We followed for an average of 6.1 y 9318 adults without previous chronic disease at baseline. Validated data on diet including alcohol consumption were collected at baseline. Weight was recorded at baseline and updated every 2 y during follow-up. The outcomes were average weight gained every year and incidence of overweight/obesity after a 6-y follow-up.
Results: During follow-up, 1006 incident cases of overweight/obesity were identified in participants with normal weight at baseline. Beer and spirits consumption (>= 7 drinks/wk) was associated with a +119 g/y (95% confidence interval +27 to +212) higher average yearly weight gain after adjusting for relevant confounders. It was also associated with a higher risk of developing overweight/obesity compared with non-drinkers. No association between wine consumption and yearly weight change or the risk of developing overweight/obesity was apparent.
Conclusion: The type of alcoholic beverage can modulate the effect of alcohol intake on the risk of developing overweight/obesity.
Revista:
Clinical & Experimental Allergy (print)
ISSN:
0954-7894
Año:
2010
Vol.:
40
N°:
12
Págs.:
1760 - 1766