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Otero M.J.,Complejo Asistencial Universitario Of Salamanca | Moreno-Gomez A.M.,Hospital Santos Reyes | Agra Y.,Direccion General de Salud Publica
European Journal of Internal Medicine | Year: 2014

Background Patients with chronic diseases often receive multiple medications and are associated with increased vulnerability to medication errors. Identifying high-alert medications for them would help to prioritize the interventions with greatest impact for improving medication safety. The aim of this study was to develop a list of high-alert medications for patients with chronic illnesses (HAMC list) that would prove useful to the Spanish National Health Service strategies on chronicity.Methods The RAND/UCLA appropriateness method was used. Drug classes/drugs candidates to be included on the HAMC list were identified from a literature search in MedLine, bulletins issued by patient safety organizations, incidents recorded in Spanish incident reporting systems, and previous lists. Eighteen experts in patient/medication safety or in chronic diseases scored candidate drugs for appropriateness according to three criteria (evidence, benefit and feasibility of implementing safety practices). Additionally they rated their priority of inclusion on a Likert scale.Results The final HAMC list includes 14 drug classes (oral anticoagulants, narrow therapeutic range antiepileptics, antiplatelets - including aspirin -, antipsychotics, β-blockers, benzodiazepines and analogues, corticosteroids long-term use, oral cytostatics, oral hypoglycemic drugs, immunosuppressants, insulins, loop diuretics, nonsteroidal anti-inflammatory drugs, and opioid analgesics), and 4 drugs or pairs of drugs (amiodarone/ dronedarone, digoxin, oral methotrexate and spironolactone/eplerenone).Conclusions An initial list of high-alert medications for patients with chronic diseases has been developed, which can be built into the medication management strategies for chronicity to guide the implementation of efficient safety strategies and to identify those patients at greater risk for preventable adverse drug events. © 2014 European Federation of Internal Medicine.


Lonial S.,Emory University | Dimopoulos M.,National United University | Palumbo A.,A.O.U. San Giovanni Battista di Turin Ospedale Molinette | White D.,Dalhousie University | And 24 more authors.
New England Journal of Medicine | Year: 2015

Background: Elotuzumab, an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 (SLAMF7), showed activity in combination with lenalidomide and dexamethasone in a phase 1b-2 study in patients with relapsed or refractory multiple myeloma. Methods: In this phase 3 study, we randomly assigned patients to receive either elotuzumab plus lenalidomide and dexamethasone (elotuzumab group) or lenalidomide and dexamethasone alone (control group). Coprimary end points were progression-free survival and the overall response rate. Final results for the coprimary end points are reported on the basis of a planned interim analysis of progression-free survival. Results: Overall, 321 patients were assigned to the elotuzumab group and 325 to the control group. After a median follow-up of 24.5 months, the rate of progression-free survival at 1 year in the elotuzumab group was 68%, as compared with 57% in the control group; at 2 years, the rates were 41% and 27%, respectively. Median progression-free survival in the elotuzumab group was 19.4 months, versus 14.9 months in the control group (hazard ratio for progression or death in the elotuzumab group, 0.70; 95% confidence interval, 0.57 to 0.85; P<0.001). The overall response rate in the elotuzumab group was 79%, versus 66% in the control group (P<0.001). Common grade 3 or 4 adverse events in the two groups were lymphocytopenia, neutropenia, fatigue, and pneumonia. Infusion reactions occurred in 33 patients (10%) in the elotuzumab group and were grade 1 or 2 in 29 patients. Conclusions: Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab, lenalidomide, and dexamethasone had a significant relative reduction of 30% in the risk of disease progression or death. Copyright © 2015 Massachusetts Medical Society. All rights reserved.


Mendoza Sanchez M.C.,Complejo Asistencial Universitario Of Salamanca
Pediatria Integral | Year: 2016

The main cause of death in children older than one year in Europe is cancer, being acute lymphoblastic leukemia the most frequent. Advances in treatment strategies and supportive care have resulted in great improvements in survival, with 5-year survival next to 80%, or even 90% in lower risk patients. However, this improvement has lead to an increase of long term morbidities, being essential long-term follow-up and the use of established guidelines for this concern. Communication between Cancer Specialist and Primary Care Physician is an essential component for successful collaborative care, and continual communication is necessary. The Primary Care Physician must be part of the multidisciplinary team caring for survivors to minimize the impact of these late effects in their quality of life. Patients also need to be informed of their risks and encouraged them to maintain a healthy lifestyle” © 2016, Ediciones Ergon SA. All rights reserved.


Casas Ferreira A.M.,University of Salamanca | Moreno Cordero B.,University of Salamanca | Crisolino Pozas T.P.,Complejo Asistencial Universitario Of Salamanca | Perez Pavon J.L.,University of Salamanca
Journal of Chromatography A | Year: 2016

A novel methodology for the determination of ornithine, putrescine, cadaverine, spermidine and gamma-amino butyric acid in urine samples has been developed. The method uses in situ aqueous derivatization followed by automated microextraction by packed sorbent coupled to a gas chromatography-mass spectrometry system equipped with a programmed temperature vaporizer. This instrumental configuration minimizes sample manipulation due to from the mixing of the reagents, the process is completely automated. The analytes were derivatized using ethyl chloroformate as derivatization reagent. The reaction occurred in aqueous medium and was carried out in 1 min in the vial of an autosampler used to perform microextraction by packed sorbent. The parameters affecting derivatization, extraction and separation were optimized in order to obtain maximum sensitivity. Calibration curves were obtained for five calibration levels in three different matrices. All the calibration models displayed good linearity, with R2 values higher than 0.95. The validity of the models was checked using ANOVA, and it was observed that they did not exhibit any lack of fit. Repeatability and reproducibility was evaluated, with values below 15% in both cases. LOD and LOQ values were found to be in the low μg/L level. Influence of the matrix was confirmed, thus quantification was performed using the standard additions method and normalization to IS. The method developed was applied to the analysis of these compounds in urine samples from healthy individuals and cancer diagnosed patients (Internal Medicine Unit of the Virgen de la Vega Hospital, Salamanca, Spain). Significant differences (Mann-Whitney U test) were observed for putrescine and ornithine concentrations. © 2016 Elsevier B.V.


Sastre J.A.,Complejo Asistencial Universitario Of Salamanca | Lopez T.,Complejo Asistencial Universitario Of Salamanca | Garzon J.C.,Complejo Asistencial Universitario Of Salamanca
Revista Espanola de Anestesiologia y Reanimacion | Year: 2012

Background and objectives: The use of supraglottic devices as a means of rescue in patients difficult to intubate or ventilate has increased in the field of anaesthetics and in emergency medicine. This study is designed to evaluate the success rate of blind intubations using two supraglottic devices, the Fastrach ILMA and the i-gel mask. Patients and methods: A total of 80 patients (40 per group) were included. After positioning them a leak test was performed, the glottis view was checked with a fibrobronchoscope, and an attempt was made to introduce an endotracheal tube through the device, and the procedure was repeated. Adequate ventilation was evaluated, as well as the grade of fibrobronchoscope view, the success of the intubation, and the complications observed after their use. Results: There were no differences in the incidence of adequate ventilation with either device. The glottis view (Brimacombe scale) was better with i-gel (77.78% versus 68.42%) at the second attempt, but not on the first. A higher percentage of intubations were achieved with the Fastrach ILMA (70% versus 40%; P=.013). The incidence of throat pain was similar with both devices, but post-operative dysphonia was more frequent with i-gel (20% versus 0; P=.0053). Conclusions: Both devices were equally effective in achieving adequate ventilation; however, the Fastrach ILMA enabled a higher number of intubations to be made than i-gel and with a lower incidence of post-operative dysphonia. © 2012 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.


Gonzalez-Calle V.,Complejo Asistencial Universitario Of Salamanca
Leukemia | Year: 2016

The diagnosis of smoldering multiple myeloma (SMM) includes patients with a heterogeneous risk of progression to active multiple myeloma (MM): some patients will never progress, whereas others will have a high risk of progression within the first 2 years. Therefore, it is important to improve risk assessment at diagnosis. We conducted a retrospective study in a large cohort of SMM patients, in order to investigate the role of Bence Jones (BJ) proteinuria at diagnosis in the progression to active MM. We found that SMM patients presenting with BJ proteinuria had a significantly shorter median time to progression (TTP) to MM compared with patients without BJ proteinuria (22 vs 88 months, respectively; hazard ratio=2.3, 95% confidence interval=1.4–3.9, P=0.002). We also identified risk subgroups based on the amount of BJ proteinuria: ⩾500 mg/24 h, <500 mg/24 h and without it, with a significantly different median TTP (13, 37 and 88 months, P<0.001). Thus, BJ proteinuria at diagnosis is an independent variable of progression to MM that identifies a subgroup of high-risk SMM patients (51% risk of progression at 2 years) and ⩾500 mg of BJ proteinuria may allow, if validated in another series, to reclassify these patients to MM requiring therapy before the end-organ damage development.Leukemia advance online publication, 27 May 2016; doi:10.1038/leu.2016.123. © 2016 Macmillan Publishers Limited


Garzon Sanchez J.C.,Complejo Asistencial Universitario Of Salamanca | Lopez Correa T.,Servicio de Anestesiologia y Reanimacion | Sastre Rincon J.A.,Complejo Asistencial Universitario Of Salamanca
Revista Espanola de Anestesiologia y Reanimacion | Year: 2014

Background and objectives: Supraglottic airway devices are increasingly used in anesthesia and emergency medicine as a rescue for intubation and ventilation. This study was designed to investigate the air-Q® supralaryngeal device and compare it with the ILMA-Fastrach™ for airway rescue and intubation. Patients and methods: The devices were inserted in 80 patients (40 patients in each group) according to manufacturer' instructions. An inspiration pressure of 20cmH2O was applied through a ventilator for checking air leaks. If no air leak was detected, the glottis status was checked using a pediatric fiberoptic bronchoscope, followed by introducing an endotracheal tube through the supraglottic device. If the first attempt was unsuccessful, the device was removed and a second attempt was made in the same way. The primary outcome was the overall success rate for intubation. Other measurements were: successful ventilation, fiberoptic glottis view and adverse events. Results: Successful first-attempt ventilation was better with the Fastrach™ than with the air-Q® (90 vs. 60%, P= .0019) and overall ventilation success (first plus second attempts) was also better with ILMA-Fastrach™ (95 vs. 80%, P= .04). View of the glottis,according to Brimacombe scale, was better with air-Q® (84.62 vs. 37.50%, P= .0017) at the second, but not at the first, attempt. There were no differences in the percentage of successful intubations between the 2 devices. The incidence of sore throat was similar with both devices. Two patients in the air-Q® group suffered hoarseness and arterial desaturation, but the difference was not statistically significant. Conclusions: Both the ILMA-Fastrach™ and the air-Q® provided a similar rate of successful intubation, but ILMA-Fastrach™ was better for ventilation. The rate of adverse events was similar with both devices. Because no additional maneuver was used to facilitated intubation, there needs to be further studies to confirm these findings. © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.


Lorenzo-Gomez M.F.,Complejo Asistencial Universitario Of Salamanca | Padilla-Fernandez B.,Complejo Asistencial Universitario Of Salamanca | Garcia-Criado F.J.,University of Salamanca | Miron-Canelo J.A.,University of Salamanca | And 3 more authors.
International Urogynecology Journal and Pelvic Floor Dysfunction | Year: 2013

Introduction and hypothesis: Urinary tract infections (UTIs) are considered the most common bacterial infections, especially in women. The objective of this study was to evaluate the use of the sublingual bacterial vaccine Uromune® in order to prevent recurrent UTIs (RUTIs). Methods: This study was conceived as a multicenter observational study. The clinical history of 319 women who presented at least 2 episodes of UTI in the last 6 months or 3 in 12 months was reviewed. Data related to treatment and clinical evolution were recorded and analyzed. A total of 159 patients received prophylactic treatment with Uromune® for a period of 3 months (group A) and 160 with sulfamethoxazole/trimethoprim 200/40 mg/day for a period of 6 months (group B). Uromune® contained an inactivated bacterial cell suspension of selected strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis. Results: Patients in group A experienced a highly significant reduction in the number of infections compared to patients in group B. In the first 3 months, the mean number of infections was 0.36 versus 1.60 (P < 0.0001), respectively. A significant reduction was also observed after 9 and 15 months (P < 0.0001). The numbers of patients who did not have any UTI at 3, 9, and 15 months were 101, 90, and 55 in group A versus 9, 4, and 0 in group B (P < 0.0001). Conclusions: The results obtained in this study favor the use of this bacterial-based therapeutic vaccine as an effective strategy to reduce frequency, duration, severity, and costs of RUTIs. © 2012 The Author(s).


Del Nogal Sanchez M.,University of Salamanca | Callejo Gomez P.A.,University of Salamanca | Perez Pavon J.L.,University of Salamanca | Moreno Cordero B.,University of Salamanca | And 2 more authors.
Analytical Chemistry | Year: 2014

With a view to improving the sensitivity of direct coupling of a headspace sampler (HS) with a mass spectrometer (MS), here we propose the use of a programmed temperature vaporizer (PTV) in solvent-vent injection mode before the sample is introduced into the MS. This preconcentration scheme has been used for some time in many methods based on gas chromatography (GC), but to the best of our knowledge it has not yet been used in an electronic nose based on MS. The increase in the S/N ratio with the proposed instrumental configuration (HS-PTV/MS) lies between 6.9- and 22-fold. The main advantage of using this injector lies in the fact that it does not involve time-consuming steps. To check the possibilities of this methodology, saliva samples from healthy volunteers and patients with different types of illnesses (including some types of cancer) were analyzed. None of the compounds studied was detected in the samples corresponding to the healthy volunteers. One or more biomarkers, at levels ranging from 13 to 500 μg/L, were found in five of the samples from the patients. Additionally, separative analysis by HS-PTV-GC/MS was performed for confirmatory purposes and both methods provided similar results. The main advantage of the proposed methodology is that no prior chromatographic separation and no sample manipulation are required. © 2014 American Chemical Society.


Mateos M.-V.,Complejo Asistencial Universitario Of Salamanca
Expert Opinion on Orphan Drugs | Year: 2016

Introduction: Multiple myeloma remains an incurable disease; the introduction of novel drugs has improved outcomes but patients become eventually refractory.Areas covered: Monoclonal antibodies targeting multiple myeloma-related antigens can complement currently available therapies. SLAMF7, a cell surface glycoprotein receptor that is a member of the signaling lymphocytic activation molecule (SLAM) family, is highly and nearly uniformly expressed in myeloma cells and Natural Killer (NK) cells, but is not detected on normal solid tissues or on hematopoietic stem cells. Elotuzumab is a humanized IgG1 monoclonal antibody targeting SLAMF7. It has been shown to be effective in preclinical studies and in the clinical setting, although only stabilization of the disease was reported when used as a single-agent. Its combination with antimyeloma therapies was positive and several trials have confirmed this hypothesis. The results of these trials in terms of efficacy and safety will be covered in this review.Expert opinion: Elotuzumab, plus lenalidomide and dexamethasone, is the first immunostimulatory monoclonal antibody demonstrating a benefit in progression free survival in a large phase 3 study in patients with relapsed or relapsed and refractory disease, representing a new standard of care for this patient population. © 2016 Taylor & Francis.

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