Expression of CD47 antigen in Reed-Sternberg cells as a new potential biomarker for classical Hodgkin lymphoma.

INTRODUCTION: CD47 over expression has been reported in several tumor subtypes. CD47 interacts with SIRPalpha on macrophages inhibiting phagocytic signal, providing a survival advantage to tumor. CD47, therefore, represents a valuable target for immunotherapy and is currently under clinical investigation. We aimed to study CD47 expression in Hodgkin Reed Sternberg cells (HRS). METHODS: We tested a polyclonal CD47 antibody (LifeSpan Biosciences, Seattle, WA) expression along with classical HRS cell markers on a tissue array of 16 classical Hodgkin Lymphoma (CHL) tumor biopsies obtained from newly diagnosed, non-selected patients (8 Female, 8 Male patients) in our institution from October 2016 to January 2018. Histologic subtypes were nodular sclerosis in 11 cases, mixed Cellularity in 3 cases and lymphocyte rich in 2 additional cases. Median age was 53 years (Range: 8, 74). Early stage disease was found in three patients without unfavorable prognostic factors according to EORTC and GHSG criteria, one patient with unfavorable prognostic factors and nine patients had advanced disease. Bulk disease was present in one patient. Normal lymphoid tissue and normal prostate epithelium were used as normal controls as recommended by manufacturer. Approval from the Local Ethical committee was obtained before any analysis. RESULTS: CD47 was overexpressed on all HRS cells with a characteristic dot-like pattern in 13/13 cases of CHL. HRS clearly expressed CD47 more intensely than infiltrating T and stromal cells. DISCUSSION: We propose that HRS cells, by up-regulating CD47, might avoid innate immunity check on tumor growth, which could be circumvented using blocking monoclonal antibodies.

¿Qué medicamento prescribiría a un paciente con enfermedad celiaca? / What medication should be prescribed to a patient with coeliac disease?

La enfermedad celiaca es una intolerancia permanente a las proteínas del gluten de trigo, centeno, cebada y triticale. El único tratamiento eficaz es una dieta sin gluten durante toda la vida, aunque la adherencia estricta es complicada. Incluso algunos medicamentos contienen almidón como excipiente. La legislación vigente obliga a analizar el contenido en proteínas del almidón de trigo utilizado como excipiente o la ausencia de almidones de otro origen en caso de que se empleen almidones de arroz, maíz o patata. Sin embargo, no especifica que se haga referencia a las trazas de gluten que sean residuos del proceso de producción de los principios activos de los medicamentos. A propósito del caso que se describe, es necesario reflexionar sobre la importancia de informar adecuadamente al paciente y de revisar/actualizar la legislación actual para garantizar el uso seguro de los medicamentos

Coeliac disease is a permanent intolerance to gluten proteins from wheat, rye, barley and triticale. Although strict adherence is complicated, the only effective treatment is a gluten-free diet throughout life. Some drugs contain starch as an excipient, and there is a risk related to the gluten content, which must be avoided in these patients. Current legislation requires the analysis of the protein content of wheat starch, or the absence of starches from another source where rice, maize, or potato starches are used as excipients. But, it does not specify that reference should be made to traces of gluten that are residues of the process of production of the active ingredient. As regards the case described, there needs to be awareness of the importance of adequately informing patients and reviewing/updating current legislation to ensure the safe use of drugs

Ultrafast optical ranging using microresonator soliton frequency combs.

Light detection and ranging is widely used in science and industry. Over the past decade, optical frequency combs were shown to offer advantages in optical ranging, enabling fast distance acquisition with high accuracy. Driven by emerging high-volume applications such as industrial sensing, drone navigation, or autonomous driving, there is now a growing demand for compact ranging systems. Here, we show that soliton Kerr comb generation in integrated silicon nitride microresonators provides a route to high-performance chip-scale ranging systems. We demonstrate dual-comb distance measurements with Allan deviations down to 12 nanometers at averaging times of 13 microseconds along with ultrafast ranging at acquisition rates of 100 megahertz, allowing for in-flight sampling of gun projectiles moving at 150 meters per second. Combining integrated soliton-comb ranging systems with chip-scale nanophotonic phased arrays could enable compact ultrafast ranging systems for emerging mass applications.

[What medication should be prescribed to a patient with coeliac disease?] / ¿Qué medicamento prescribiría a un paciente con enfermedad celiaca?

Coeliac disease is a permanent intolerance to gluten proteins from wheat, rye, barley and triticale. Although strict adherence is complicated, the only effective treatment is a gluten-free diet throughout life. Some drugs contain starch as an excipient, and there is a risk related to the gluten content, which must be avoided in these patients. Current legislation requires the analysis of the protein content of wheat starch, or the absence of starches from another source where rice, maize, or potato starches are used as excipients. But, it does not specify that reference should be made to traces of gluten that are residues of the process of production of the active ingredient. As regards the case described, there needs to be awareness of the importance of adequately informing patients and reviewing/updating current legislation to ensure the safe use of drugs.

Trascendencia clínica del contenido en sodio de la antibioticoterapia intravenosa / Clinical significance of the sodium content of intravenous antibiotic therapy

No disponible

[Clinical significance of the sodium content of intravenous antibiotic therapy]. / Trascendencia clínica del contenido en sodio de la antibioticoterapia intravenosa.

-

Study of renal function in living kidney donors: estimated or measured glomerular filtration.

INTRODUCTION: In living kidney donations the accuracy of renal function is fundamental, especially for potential donors who have limited renal function (creatinine clearance levels [CCr] <90 mL/m/1.73 m(2)), are >50 years old, and who have cardiovascular risk factors that might favor the development of kidney diseases. OBJECTIVE: To compare the direct measured glomerular filtration (mGFR) using 51Cr-EDTA and the estimations based on creatinine (estimated glomerular filtration rate [eGFR]): CCr with 24-hour urine, and estimated using Cockroft-Gault (adjusted using body surface area, Mosteller formula), modification of diet in renal disease-4 (MDRD-4), MDRD-6, and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) to determine the usefulness of different methods to evaluate the kidney function. PATIENTS AND METHODS: The kidney function evaluation was performed for 37 potential kidney donors using the 51Cr-EDTA method. The GFR obtained through the 51Cr-EDTA was compared with the CCr values in 24-hour urine and eGFR based on creatinine (Cockcroft-Gault, MDRD-4, MDRD-6, and CKD-EPI). RESULTS: Using the Bland Altman graph, the most dispersed results were obtained with the eGFR using CCr in 24-hour urine and CKD-EPI. By means of Passing and Bablok, MDRD-4 and MDRD-6 showed the highest approximation to the reference method proposed to be substituted, whereas CCr showed a high dispersion. CONCLUSION: The eGFR using MDRD-4 and MDRD-6 formulas revealed the best adjustment to the measure by 51Cr-EDTA. This might represent the best option if a direct eGFR measure is not available.

Validation on the simplified medication adherence questionnaire (SMAQ) in renal transplant patients on tacrolimus.

BACKGROUND: Non-adherence to immunosuppressive medication is associated with graft loss and death. The simplified medication adherence questionnaire (SMAQ) is a short and reliable instrument for assessing adherence to medication. OBJECTIVE: Validation of a version of the SMAQ instrument adapted for use in transplant patients in a sample of kidney graft recipients. METHODS: Observational, longitudinal prospective study in 150 renal transplant patients on tacrolimus, over 18 years old, who had received a graft at least one year before. Basic sociodemographic and clinical data were recorded; patients completed the SMAQ twice (administered by doctor/nurse) and self-administered the Morisky-Green scale. The analysis database included 144 patients that met selection criteria and that provided the required data. Descriptive characteristics for all recorded parameters and psychometric characteristics of the questionnaire (reliability and validity) were studied. RESULTS: Mean age in the sample was 50.63 (12.44) years, 60.42% were men. Some 20.14% of patients had sub-target tacrolimus levels (<5 ng/ml), and unjustified variations in immunosuppressive drug levels were reported for 13.48%. Regarding SMAQ results, 39.01%/41.84% of patients were non-adherent (doctor/nurse administration); 22.38% according to the Morisky-Green scale. Interobserver agreement (kappa) was 0.821 (P<.001). The Cramer's-V statistic for convergent validity was 0.516 (P<.001). SMAQ scores were associated with unjustified variations in tacrolimus levels. In the prediction of tacrolimus levels (target vs subtarget), SMAQ compared to Morisky-Green provided a better classification of patients, with greater sensitivity and lower specificity. CONCLUSION: The questionnaire provides good levels of validity and interobserver agreement. An enhanced sensitivity is advantageous to better detect non-adherent patients for a better follow-up.

Information channels and the dynamics of uptake of living kidney donors: a retrospective study in a reference area.

INTRODUCTION: Activity in renal transplantation at our center continues to grow due to the gradual increase in living donor kidney transplantations (LDKT). Our objective was to describe the generation process of living donation in our area of influence including two provinces and 18 chronic kidney disease (CKD) treatment units in particular the origin of paired donor/recipients and information channels. METHODS: We included all actual and discarded potential donors from 2005 to 2009. History and telephone interviews provided a description of the cases, sources and process information. RESULTS: Among 95 potential pairs we performed 44 LDKT during this period. The recipients were predialysis (38%), on dialysis (54%), or after prior transplantation (8%). Among the 10 dialysis centers, the referral rate ranged between 0 and 8.6 pairs per 100 patients. We contacted 78 (83%) donors for an interview, among whom 53% first learned of LDKT when the recipient already had advanced CKD at predialysis or dialysis stages. Television was the main means of this first knowledge (38%), followed by the health care staff. LDKT was not primarily a treatment option offered by the nephrologist for 65% of subjects; however, the nephrologists were the major reference sources followed by the Internet and transplant coordinators. CONCLUSIONS: The majority of donations are initiated before the recipient is on dialysis, but eventuates predialysis in only 38% of cases. The possibility of being referred seems to be influenced by the recipient's treatment center. We need a more proactive role of nephrologists to offer this therapeutic option. This study identified the importance of public information to identify targets and design strategies to disseminate quality information on LDKT.

Mejora de la calidad de la especificación de la inclusión en ensayo clínico sobre prescripciones en quimioterapia / Improving the specification quality of inclusion criteria of patients in chemotherapy clinical trials

Objetivos: Evaluar la mejora de la calidad de las prescripciones de quimioterapia para pacientes en ensayo clínico (EC) y analizar si en la orden médica se especifica la participación en el ensayo tras determinar los principales factores de riesgo y mediante la aplicación de medidas correctoras. Método: Estudio retrospectivo de omisiones recogidas durante 2006 y 2007. Con los datos del 2006 se analizaron los factores de riesgo y se implantaron medidas de mejora (información a prescriptores e inicio de prescripción electrónica). Posteriormente, se evaluaron los datos del 2007. Variables analizadas: EC, número de prescripciones, investigador principal, prescriptor, servicio, antineoplásicos y enfermedad. Resultados: Los servicios de Oncología y Hematología realizaron el 57,1% de los ensayos del hospital. En 2006 se recibieron 1.625 prescripciones y se detectaron 151 incorrectas (9,3%), y en 2007 se recibieron 1.858 prescripciones y se detectaron 65 incorrectas (3,5%). En 2006 se observó mayor frecuencia de prescripciones incorrectas en Hematología (34,1%) que en Oncología (8,6%). En 2007 Hematología apenas tuvo omisiones (1,8%) y en Oncología disminuyeron al 3,6%. Respecto a la enfermedad, la tasa de error desapareció prácticamente en mieloma múltiple (del 34,1 al 2,2%) y disminuyó en mama (del 10,8 al 4,4%). El incumplimiento siempre fue mayor cuando el prescriptor difería del investigador principal. Conclusiones: La frecuencia de las prescripciones con error se redujo (pasó del 9,3 al 3,5%). Destaca la reducción extraordinaria en Hematología relacionada con ensayos en mieloma múltiple. Las medidas correctoras han resultado útiles en la mejora de la calidad (AU)

Objectives: To assess the quality improvement of chemotherapy prescriptions for patients included in clinical trials (CT) analyzing whether the prescription is specified for patient participation, after having identified the major risks factors and the appropriate corrective measures are applied. Methods: Retrospective study of omissions collected during 2006 and 2007. After collecting all the information, we analyzed the risks factors and introduced improvement measures (information to prescribers and the beginning of electronic prescription). The 2007 data were then evaluated. Variables analyzed: CT, number of prescriptions, principal investigator, prescriber, department, anti-neoplastic involved and pathology. Results: Oncology and Haematology make up 57.1% of hospital trials. In 2006, 1625 chemotherapy prescriptions were received and there were 151 incorrect prescriptions (9.3%), and in 2007, 1858 prescriptions with 65 (3.5%) incorrect. In 2006, there was a higher frequency of incorrect prescriptions in Haematology (34.1%) and (Oncology (8.6%)). In 2007 Hematology had just 1.8% of omissions and in Oncology it decreased to 3.6%. As regards the pathology, the error rate has virtually disappeared in multiple myeloma prescriptions (34.1 to 2.2%) and decreased in breast cancer (10.8 to 4.4%). The non-fulfilment rate is higher when the prescriber is not the principal investigator. Conclusions: The overall frequency of prescriptions with errors decreased significantly from 9.3% to 3.5%, with an extraordinary reduction in Haematology (34.1% to 1.8%) related to the multiple myeloma trials. The corrective measures implemented have proved to be useful in CT (AU)

[Improving the specification quality of inclusion criteria of patients in chemotherapy clinical trials]. / Mejora de la calidad de la especificación de la inclusión en ensayo clínico sobre prescripciones en quimioterapia.

OBJECTIVES: To assess the quality improvement of chemotherapy prescriptions for patients included in clinical trials (CT) analyzing whether the prescription is specified for patient participation, after having identified the major risks factors and the appropriate corrective measures are applied. METHODS: Retrospective study of omissions collected during 2006 and 2007. After collecting all the information, we analyzed the risks factors and introduced improvement measures (information to prescribers and the beginning of electronic prescription). The 2007 data were then evaluated. Variables analyzed: CT, number of prescriptions, principal investigator, prescriber, department, anti-neoplastic involved and pathology. RESULTS: Oncology and Haematology make up 57.1% of hospital trials. In 2006, 1625 chemotherapy prescriptions were received and there were 151 incorrect prescriptions (9.3%), and in 2007, 1858 prescriptions with 65 (3.5%) incorrect. In 2006, there was a higher frequency of incorrect prescriptions in Haematology (34.1%) and (Oncology (8.6%)). In 2007 Hematology had just 1.8% of omissions and in Oncology it decreased to 3.6%. As regards the pathology, the error rate has virtually disappeared in multiple myeloma prescriptions (34.1 to 2.2%) and decreased in breast cancer (10.8 to 4.4%). The non-fulfillment rate is higher when the prescriber is not the principal investigator. CONCLUSIONS: The overall frequency of prescriptions with errors decreased significantly from 9.3% to 3.5%, with an extraordinary reduction in Haematology (34.1% to 1.8%) related to the multiple myeloma trials. The corrective measures implemented have proved to be useful in CT.

Calcimimetics and bone mineral density in renal transplant patients with persistent secondary hyperparathyroidism.

BACKGROUND: The persistence of secondary hyperparathyroidism plays an important role in posttransplant bone loss. Calcimimetics are efficient to control metabolic alterations associated with this problem, but there are few publications that assess their effects on bone density. PATIENTS AND METHODS: This prospective study assessed the effects of a single daily dose of cinacalcet on calcemia, phosphatemia, parathyroid hormone (PTH), and bone densitometry (femur and spine) values of 27 renal transplant patients with stable kidney function, calcium > 10.5 mg/dL, and PTH > 65 pg/mL. RESULTS: A preliminary study after 6 months showed decreased calcemia (11.05 +/- 0.5 to 10.18 +/- 0.6 mg/dL; P < .0001), reduced levels of intact PTH (iPTH; 258 +/- 104 to 209.61 +/- 127 pg/mL; P < .05), and increased phosphatemia (2.38 +/- 0.45 to 2.54 +/- 0.3 mg/dL; P < .05). We also observed an increase in femoral neck bone mass with improved T score (-1.36 +/- 1.19 to -1.05 +/- 0.84 g/cm(2); P < .05). CONCLUSIONS: Cinacalcet was effective in the management of posttransplant persistent secondary hyperparathyroidism, resulting in decreased calcemia and iPTH, while also improving femoral neck bone loss. Longer-term studies with control groups are needed to determine the drug's influence on overall bone mineral density.

Cardiotoxicity associated with trastuzumab in normal clinical practice.

OBJECTIVE: To evaluate the incidence of cardiotoxicity associated with treatment with trastuzumab in clinical practice by describing its characteristics, progress and associated risk factors. METHODS: Retrospective observational study of patients with HER2-positive breast cancer treated with trastuzumab in the fi rst quarter of 2007 in a tertiary hospital. Follow-up was performed from start of treatment until the end of March 2008. The data sources used were the oncological computer program Oncowin® from the pharmacy department and the patient clinical history. We gathered variables related to patient baseline characteristics, treatment and safety. RESULTS: The study included 61 patients. 19 women (32.8%) presented cardiotoxicity, which was the second most common adverse affect of those frequently attributed to the treatment. The average time for toxicity to appear was 7 months, with an average FEVI decrease of 15.6 +/- 9.1 points. In 63.2% of the patients it was symptomatic, and its most frequent manifestation was stress-induced dyspnoea, with a single case of congestive heart failure. Cardiotoxicity led to suspension of treatment in 22.9% of the total patients, which was definitive for 7 out of the 14 patients who interrupted the treatment. No statistically significant differences were found for the possible risk factors. CONCLUSIONS: The incidence of cardiotoxicity in clinical practice is much higher than expected. The important clinical implication of this information and the increasing use of trastuzumab mean that there is a new challenge for the optimal treatment of HER2-positive breast cancer.

Cardiotoxicidad asociada a trastuzumab en la práctica clínica asistencial / Cardiotoxicity associated with trastuzumab in normal clinical practice

Objetivo: Evaluar la incidencia de cardiotoxicidad asociada al tratamiento con trastuzumab en la práctica clínica asistencial, describiendo sus características, su manejo y los factores de riesgo asociados.Método: Estudio observacional retrospectivo que incluyó a pacientes con cáncer de mama HER-2 positivo en tratamiento con trastuzumab durante el primer trimestre de 2007 en un hospital de tercer nivel. Se realizó un seguimiento desde el inicio del tratamiento hasta fi nales de marzo de 2008. Las fuentes de datos utilizadas fueron el programa informático de oncología del servicio de farmacia, Oncowin®, y la historia clínica del paciente. Se recogieron variables relacionadas con las características basales del paciente, con el tratamiento y con la seguridad.Resultados: Se incluyó a 61 pacientes en el estudio; 19 (32,8 %) mujeres presentaron cardiotoxicidad, que supuso el segundo efecto adverso atribuido el tratamiento en frecuencia. La mediana de tiempo de aparición de la toxicidad fue de 7 meses, con un descenso medio de fracción de eyección del ventrículo izquierdo (FEVI) de 15,6 ± 9,1 puntos. En el 63,2 % fue sintomática, la manifestación más frecuente fue la disnea de esfuerzo y hubo un único caso de fallo cardíaco congestivo. La cardiotoxicidad supuso la suspensión del tratamiento en el 22,9 % del total de pacientes, y fue de forma defi nitiva en 7 de las 14 pacientes que interrumpieron el tratamiento. No se hallaron diferencias estadísticamente signifi cativas en cuanto a los posibles factores de riesgo.Conclusiones: La incidencia de cardiotoxicidad en la práctica clínica asistencial se muestra mucho más elevada que la esperada. Su importante implicación clínica y el uso creciente de trastuzumab hacen que suponga un nuevo reto para el tratamiento óptimo del cáncer de mama HER-2 positivo (AU)

Objective: To evaluate the incidence of cardiotoxicity associated with treatment with trastuzumab in clinical practice by describing its characteristics, progress and associated risk factors.Methods: Retrospective observational study of patients with HER2-positive breast cancer treated with trastuzumab in the fi rst quarter of 2007 in a tertiary hospital. Follow-up was performed from start of treatment until the end of March 2008. The data sources used were the oncological computer program Oncowin® from the pharmacy department and the patient clinical history. We gathered variables related to patient baseline characteristics, treatment and safety.Results: The study included 61 patients. 19 women (32.8 %) presented cardiotoxicity, which was the second most common adverse affect of those frequently attributed to the treatment. The average time for toxicity to appear was 7 months, with an average FEVI decrease of 15.6 ± 9.1 points. In 63.2 % of the patients it was symptomatic, and its most frequent manifestation was stress-induced dyspnoea, with a single case of congestive heart failure. Cardiotoxicity led to suspension of treatment in 22.9 % of the total patients, which was defi nitive for 7 out of the 14 patients who interrupted the treatment. No statistically signifi cant differences were found for the possible risk factors.Conclusions: The incidence of cardiotoxicity in clinical practice is much higher than expected. The important clinical implication of this information and the increasing use of trastuzumab mean that there is a new challenge for the optimal treatment of HER2-positive breast cance (AU)

Influence of renal insufficiency on pharmacokinetics of ACYL-glucuronide metabolite of mycophenolic acid in renal transplant patients.

The acyl glucuronide of mycophenolic acid (AcMPAG) is a metabolite with in vitro immunosuppressive activity. The chemical properties of acyl glucuronides have been associated with the toxicity of some drugs. The aim of our study was to analyze the influence of renal insufficiency on the pharmacokinetics of AcMPAG. Areas under the 12-hour curve (AUC(0-12h)) of MPA, glucuronide of MPA (MPAG), and AcMPAG were determined by high performance liquid chromatography performed in 20 renal transplantation patients under treatment with mycophenolate mofetil (MMF), cyclosporine, and steroids. They were divided between a group with preserved renal function (group I, mean creatinine clearance [Clcr] of 105 +/- 7 mL/min) and one with advanced renal insufficiency (group II, mean Clcr of 27 +/- 5 mL/min). There was no difference in MMF dose or MPA-AUC(0-12h) values between groups. Mean predose levels of AcMPAG-C0 and AcMPAG-AUC(0-12h) were much higher in group II than in group I (0.5 +/- 2 vs 1.6 +/- 1 microg/mL and 12 +/- 2 vs. 32 +/- 19 microg*h/mL respectively, P < .005). The present data suggested that AcMPAG, a metabolite with immunosuppressive activity that may be related to toxic effects of MPA, is renally eliminated. Its levels can significantly rise in patients with renal insufficiency. Although further studies with more patients are required to determine the role of AcMPAG in MPA toxicity, we believe that this accumulation may be of clinical relevance.

Evaluación de la calidad de la identificación de las muestras para investigación clínica tras la aplicación de la normativa europea / Quality identification evaluation on investigational drugs after European regulatory requirements application

Objetivo: Evaluar la calidad de la identificación de las muestras para investigación clínica tras la aplicación de la normativa vigente. Método: Estudio retrospectivo. Fuentes de recogida de datos: registros de los controles de recepción realizados por el Servicio de Farmacia. Resultados: Se evaluaron 339 controles de recepción correspondientes a 76 muestras diferentes de 52 ensayos clínicos. El 71,1% de las muestras (n=54) correspondieron a ensayos en los que el promotor fue un laboratorio farmacéutico, para un 23,7% (n=18) fue una sociedad científica y en un 5,2% (n=4) un grupo de investigadores. La identificación fue correcta para el 21,1% (n=16) de las muestras. El cumplimiento medio en función de la entidad promotora fue del 93,7% para los laboratorios farmacéuticos, 91,1% para las sociedades científicas y 88,5% para los grupos de investigadores. Conclusiones: 1. El grado de adecuación del etiquetado a la normativa vigente es bajo (21,1% de las muestras). 2. Cuando el promotor es un laboratorio farmacéutico se alcanza el mayor porcentaje de cumplimiento (93,7% de los ítem)

Aim: To evaluate the quality on identification of investigational drugs, by analysing their adaptation to the regulatory requirements. Method: Retrospective study. Data sources: registries of reception control made by Pharmacy Service. Results: 339 reception controls were evaluated corresponding 76 differents investigational drugs and 52 clinical trials. 71,1% (n=54) investigational drugs were belonging to clinical trials sponsored by pharmaceutical laboratory, 23,7% (n=18) by scientific society and 5,2% (n=4) by a group of investigators. Identification was corrected in 21,1% (n=16) of investigational drugs. The average fulfillment based on promotional organization was 93,7% for pharmaceutical laboratories, 91,1% for scientific societies and 88,5% for group of investigators. Conclusion: 1. Identification adjustment to the regulatory requirements was low (21,1% of investigational drugs). 2. When sponsor was a pharmaceutical laboratory the greater percentage of fulfillment (93,7% of item) was reached

Influencia del género en investigación clínica / No disponible

Objetivo: Analizar desde la perspectiva de género los ensayos clínicos llevados a cabo en nuestro medio en los tres últimos años. Material y métodos: Estudio retrospectivo sobre una muestra de 101 ensayos realizados con la participación del servicio de farmacia de un hospital universitario de 1.240 camas. Fuentes de datos: protocolos e informes-resumen elaborados por el servicio de farmacia, programa informático Gecos®, fichas de seguimiento de ensayos, registro de recepción, dispensación y devolución de muestras e informes anuales.Resultados: 17 ensayos analizados incluían exclusivamente mujeres, 13 sólo hombres y 71 pacientes de ambos sexos. En ensayos de participación exclusivamente femenina la patología más estudiada fue cáncer de mama (70,6%), las fases de ensayo más frecuentes la III (47,1%) y la II (41,2%) y los medicamentos más investigados docetaxel (17,7%) y trastuzumab (11,8%).En ensayos de participación exclusivamente masculina disfunción eréctil fue la patología más estudiada (92,3%), la fase III lamás frecuente (76,9%) y tadalafilo (38,5%) y vardenafilo (30,8%)los fármacos más implicados. En ensayos sin criterios de inclusión según género las patologíasmás estudiadas fueron cáncer de colon (11,3%) y pulmón (11,3%) einsuficiencia renal (9,9%), la fase más repetida la III (57,7%) y losmedicamentos más ensayados interferón alfa 2a, gemcitabina y riba-virina. El porcentaje de participación global fue 62,3% para hombresy 37,7% para mujeres.Conclusiones:a) la patología más estudiada, sin considera-ción de género, ha sido el cáncer, en ensayos de mujeres cáncerde mama y disfunción eréctil en los de hombres; b) en los ensayossin criterios de inclusión según género se observa que la participa-ción de hombres y mujeres está en una relación de 2 a 1; y c) lafase III ha sido la más frecuente en todos los ensayos, destacandola fase II en los de mujeres de acuerdo con las directrices quepotencian su inclusión en fases tempranas del ensayo (AU)

Objective: To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint.Material and methods: A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part.Data sources: protocols and summary reports by the pharmacy department, Gecos® software program, trial follow-up cards,reception records, sample dispensation and returns, and yearly reports.Results: 17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders.In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III(47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%).In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phaseIII (76.9%) and the most commonly studied drugs were tadalafil(38.5%) and vardenafil (30.8%).In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer(11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females.Conclusions: a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b)male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most commonamongst all trials considered, with phase II having a relevant role inwomen-only trials as per guidelines favoring inclusion in early trials (AU)

[Influence of gender on clinical research]. / Influencia del género en investigación ckínica.

OBJECTIVE: To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint. MATERIAL AND METHODS: A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part. DATA SOURCES: protocols and summary reports by the pharmacy department, Gecos software program, trial follow-up cards, reception records, sample dispensation and returns, and yearly reports. RESULTS: 17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders. In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III (47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%). In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phase III (76.9%) and the most commonly studied drugs were tadalafil (38.5%) and vardenafil (30.8%). In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer (11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females. CONCLUSIONS: a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b) male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most common amongst all trials considered, with phase II having a relevant role in women-only trials as per guidelines favoring inclusion in early trials.

Ensayos clínicos en Oncología y Hematologíadurante seis años / Clinical trials in Oncology and Hematology during six years

El objetivo de este estudio es revisar los ensayos clínicos realizados en Oncología Médica y Hematología durante 6 años. Se analiza: fármaco en investigación, grupo terapéutico, tipo de tumor, promotor, fase y diseño del ensayo, ámbito de desarrollo, objetivo principal, criterios de evaluación de la respuesta, duración del ensayo y número de sujetos incluídos. Se han realizado 41 ensayos en Oncología Médica y 2 en Hematología incluyendo un total de 321 pacientes. Los tumores más frecuentes han sido mama (37,2 por ciento), pulmón (20,9 por ciento) y colon (18,6 por ciento).Se han ensayado 29 medicamentos diferentes siendo los más utilizados docetaxel y gemcitabina , agentes antineoplásicos presentes cada uno en el 18,6 por ciento de los ensayos. La mayoría de los ensayos han sido aleatorizados, en fase III y de ámbito nacional. El objetivo principal ha sido la eficacia (74,5 por ciento) y los criterios de evaluación más frecuentes la tasa de respuesta (46,5 por ciento) y la supervivencia (46,5 por ciento) (AU)

Teratogénesis: clasificaciones / Teratogenesis: classifications

La prevalencia de malformaciones debidas a fármacos es baja pero también evitable. Esto hace necesario la información precisa y actualizada sobre el potencial teratogénico de los fármacos ya que la prescripción de fármacos durante el embarazo es elevada. Se han desarrollado múltiples clasificaciones de fármacos en función de su riesgo teratogénico entre las cuales la más usada es la de la Food and Drug Administration en la que los fármacos se dividen en cinco grupos (A, B, C, D, X). Existen clasificaciones similares desarrolladas en otros países (Australia, Suecia o Alemania). Otras clasificaciones de fármacos aluden a la probabilidad o frecuencia de teratogenia. La ausencia de una clasificación única, la inespecificidad de las definiciones y la falta de estudios, no nos permiten muchas veces poder valorar adecuadamente el posible riesgo para el feto. (AU)