[Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix]. / Efectividad y seguridad de erlotinib en 2 pacientes con carcinoma de cérvix uterino.

OBJECTIVE: To assess the effectiveness and safety of the use of erlotinib in the treatment of refractory cervical cancer after retrospective analysis of two clinical cases. METHODS: The clinical records were assessed for the patients who started treatment with erlotinib, on a compassionate-use basis, with an oral dosage of 150 mg/day until June 2008. The pharmacy dispensing records were also assessed to evaluate adherence to treatment. Progression-free survival was assessed and adverse reactions were recorded in the medical records. RESULTS: Three patients with recurrent, advanced cervical cancer were candidates for treatment with erlotinib, two of whom were only starting treatment. In both cases, the women had previously received between 3 and 4 different treatment lines. Progression-free survival was 6 months and 4 months in each case. The adverse reactions to the treatment were slight. CONCLUSIONS: Erlotinib presented some similar results to those obtained from cisplatin doublets in women with refractory cervical cancer, with minor adverse effects. However, these results need to be corroborated in the clinical studies field on a wider section of the population.

[Efficacy and safety of topical diltiazem 2 % in anal fissure]. / Efectividad y seguridad de diltiazem 2 % tópico en fisura anal.

OBJECTIVES: To evaluate the effectiveness and safety of 2 per cent diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment and the number of applications. METHODS: A prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient's clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment and number of applications, among others. Follow-up was carried out for up to one year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs and Chi-square. RESULTS: A total of 70 patients were included in the study and anal fissure healed in 48.6 % of them. Healing occurred in 54.5 % of patients with anal fissure and in 33.3 % of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30 % of patients. Therapy was abandoned due to adverse reactions for 5.7 %. The fissure was cured for 60 % of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results. CONCLUSIONS: Despite not having found statistical differences between the analysed variables, treatment of anal fissures with 2 per cent diltiazem ointment has avoided surgery in nearly 50 % of patients, with few adverse effects.

Efectividad y seguridad de diltiazem 2 % tópico en fisura anal / No disponible

Objetivo: Evaluar la efectividad y la seguridad de la pomada de diltiazem al 2 % en el tratamiento de la fi sura anal. Analizar la relación entre la cicatrización de la fi sura y diagnóstico, duración del tratamiento y número de aplicaciones. Métodos: Estudio prospectivo observacional de todos los pacientes diagnosticados de fi sura anal que comenzaron tratamiento con diltiazem tópico entre enero y junio de 2007. La pomada de diltiazem al 2 % se preparó como fórmula magistral en el servicio de farmacia. La efectividad y la seguridad se evaluó mediante encuesta telefónica a cada paciente tras 8 semanas de tratamiento, completándose con la historia clínica del paciente. Las variables analizadas fueron cicatrización, efectos adversos, diagnóstico, duración del tratamiento y número de aplicaciones, entre otras. Se realizó seguimiento hasta resolución de la fi sura hasta un período de 1 año. El análisis de los datos se realizó mediante estadística descriptiva y frecuencia, tablas de contingencia y 2 (..) (AU)

Objectives: To evaluate the effectiveness and safety of 2 per cent diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment and the number of applications. Methods: A prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient’s clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment and number of applications, among others. Follow-up was carried out for up to one year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs and Chi-square. Results: A total of 70 patients were included in the study and anal fissure healed in 48.6 % of them. Healing occurred in 54.5 % of patients with anal fissure and in 33.3 % of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30 % of patients. Therapy was abandoned due to adverse reactions for 5.7 %. The fissure was cured for 60 % of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results. Conclusions: Despite not having found statistical differences between the analysed variables, treatment of anal fissures with 2 per cent diltiazem ointment has avoided surgery in nearly 50 % of patients, with few adverse effects (AU)

Efectividad y seguridad de erlotinib en 2 pacientes con carcinoma de cérvix uterino / Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix

Objetivo: Evaluar la efectividad y la seguridad del tratamiento con erlotinib en cáncer de cérvix uterino refractario a través del análisis retrospectivo de 2 casos clínicos. Métodos: Se revisaron las historias clínicas de las pacientes que iniciaron tratamiento con erlotinib vía oral a dosis de 150 mg/día como uso compasivo hasta junio del 2008, así como los registros de dispensación de farmacia para valorar la adherencia al tratamiento. Se evaluó la supervivencia libre de progresión y se recogieron las reacciones adversas descritas en la historia clínica. Resultados: Tres pacientes con cáncer de cérvix avanzado recurrente fueron candidatas a tratamiento con erlotinib, 2 de las cuales iniciaron tratamiento. En ambos casos las mujeres habían recibido entre 3 y 4 líneas de tratamiento previas. La supervivencia libre de progresión fue de 6 y 4 meses en cada caso. Las reacciones adversas al tratamiento fueron leves. Conclusiones: El erlotinib presentó unos resultados similares a los logrados con los dobletes de cisplatino en mujeres con cáncer de cérvix refractario, con leves efectos adversos. Sin embargo, habrá que corroborar estos resultados en el ámbito de los ensayos clínicos con poblaciones más amplias (AU)

Objective: To assess the effectiveness and safety of the use of erlotinib in the treatment of refractory cervical cancer after retrospective analysis of two clinical cases. Methods: The clinical records were assessed for the patients who started treatment with erlotinib, on a compassionate-use basis, with an oral dosage of 150 mg/day until June 2008. The pharmacy dispensing records were also assessed to evaluate adherence to treatment. Progression-free survival was assessed and adverse reactions were recorded in the medical records. Results: Three patients with recurrent, advanced cervical cancer were candidates for treatment with erlotinib, two of whom were only starting treatment. In both cases, the women had previously received between 3 and 4 different treatment lines. Progression-free survival was 6 months and 4 months in each case. The adverse reactions to the treatment were slight. Conclusions: Erlotinib presented some similar results to those obtained from cisplatin doublets in women with refractory cervical cancer, with minor adverse effects. However, these results need to be corroborated in the clinical studies field on a wider section of the population (AU)

[Stability and in vitro activity of voriconazole eyedrops at a concentration of 3 microg/mL]. / La estabilidad y actividad in vitro de voriconazol en colirio a una concentración de 3 microg/mL.

OBJECTIVE: To assess the stability and activity of voriconazole 3 microg/mL eyedrops as prepared for use against amphotericin B- and fluconazole-resistant fungal endophthalmitis. METHOD: Stability (concentration using UV-spectrophotometry; pH, osmolarity, and particle formation) and sterility were analyzed under various preservation conditions--room temperature (22-24 degrees C) or refrigerated (2-8 degrees C). The preparation's in vitro efficacy was analyzed using the standard National Committee for Clinical Laboratory Standards method for 30 days. RESULTS: Voriconazole concentrations were found to be within limits allowed by the United Stated Pharmacopeia (90-115%). pH (room temperature: 6.96-7.60; refrigerated: 6.84-7.21) and osmolarity (room temperature: 265-284 mOsm/l; refrigerated: 270-285 mOsm/l) remained within eye physiological ranges throughout the study under the analyzed conditions. The preparation s antifungal activity remained stable during the first three weeks. CONCLUSIONS: The voriconazole 3 microg/mL eyewash preparation remained stable, sterile and with full antifungal activity for 21 days when stored both at room temperature and under refrigeration conditions.

Estabilidad y actividad in vitro de voriconazol en colirio a una concentración de 3 µg/mL / Stability and in vitro activity of voriconazole eyedrops at a concentrations of 3 mg/mL

Objetivo: Evaluar la estabilidad y actividad de un colirio devoriconazol 3 µg/mL, preparado para su uso en endoftalmitis fúngicasresistentes a anfotericina B y fluconazol.Método: Se analizaron la estabilidad (concentración medianteespectrofotometría-UV; pH, osmolaridad y aparición de partículas)y la esterilidad bajo condiciones de conservación diferentes:temperatura ambiente (22-24 °C) o refrigerado (2-8 °C) y la eficaciain vitro del preparado, mediante el método estándar delNacional Committee for Clinical Laboratory Standards duranteun periodo de 30 días.Resultados: Las concentraciones de voriconazol se encontrarondentro de los márgenes permitidos por la United StatesPharmacopeia (90-115%). El pH (ambiente 6,96-7,60; refrigerado:6,84-7,21) y la osmolaridad (ambiente: 265-284 mOsm/l;refrigerado: 270-285 mOsm/l) se mantuvieron en los intervalosfisiológicos para el ojo, a lo largo de todo el estudio en las doscondiciones analizadas. La actividad antifúngica del colirio permanecióestable durante las tres primeras semanas.Conclusiones: El colirio preparado de voriconazol 3 µg/mLpermanece estable, estéril y con plena actividad antifúngica durante21 días cuando se almacena tanto a temperatura ambientecomo en refrigeración

Objective: To assess the stability and activity of voriconazole3 µg/mL eyedrops as prepared for use against amphotericin Bandfluconazole-resistant fungal endophthalmitis.Method: Stability (concentration using UV-spectrophotometry;pH, osmolarity, and particle formation) and sterility were analyzedunder various preservation conditions – room temperature(22-24 °C) or refrigerated (2-8 °C ). The preparation's in vitroefficacy was analyzed using the standard National Committee forClinical Laboratory Standards method for 30 days.Results: Voriconazole concentrations were found to be withinlimits allowed by the United Stated Pharmacopeia (90-115%). pH(room temperature: 6.96-7.60; refrigerated: 6.84-7.21) andosmolarity (room temperature: 265-284 mOsm/l; refrigerated:270-285 mOsm/l) remained within eye physiological rangesthroughout the study under the analyzed conditions. The preparation'santifungal activity remained stable during the first threeweeks.Conclusions: The voriconazole 3 µg/mL eyewash preparationremained stable, sterile and with full antifungal activity for 21days when stored both at room temperature and under refrigerationconditions

Requisitos de uniformidad para manuscritos remitidos a revistas biomédicas: redacción y edición de la publicación biomédica Comité Internacional de Editores de Revistas Médicas (ICMJE) / Uniformity requirements for manuscripts submitted to biomedical journals-writing and editing biomedical reports

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Análisis de los tratamientos de alta en base a la evidencia, de pacientes con síndrome coronario agudo en una unidad de Cuidados Intermedios / Evidence based analysis of discharge therapy in patients with acute coronary syndrome in an Intermediate Care Unit

Fundamento: En los síndromes coronarios agudos existen guías de práctica clínica donde se establece el consenso sobre medidas farmacoterapéuticas basadas en la evidencia. En el ámbito de la prevención secundaria, a pesar de esto, existen estudios que demuestran que el tratamiento médico está lejos de ser el idóneo. Dada la importancia de estas patologías, se ha realizado un análisis de los tratamientos de los pacientes de alta, para conocer el grado de aplicación de las directrices publicadas en la práctica clínica. Sujetos y método: Se han utilizado los informes de alta de los pacientes diagnosticados de un síndrome coronario agudo en los tres primeros meses del año 2001 de la Unidad de Cuidados Intermedios de nuestro centro. A partir de ellos, se ha realizado un estudio de la utilización de los medicamentos prescritos, así como un análisis y valoración de los tratamientos en base a los niveles de evidencia descritos por las últimas guías de consenso publicadas por las sociedades científicas de Cardiología Española y Americana. Resultados: Los porcentajes de adecuación de las prescripciones al nivel de evidencia I han sido de forma global los siguientes: 76 por ciento para antiagregantes, 42 por ciento para betabloqueantes, 35,5 por ciento para IECAs y 58 por ciento para estatinas. Las estatinas se utilizaron en un amplio número de pacientes (83 por ciento) tanto con hipercolesterolemia como sin dislipemia previa o al ingreso. Los nitratos se prescribieron de forma mayoritaria en casi el 100 por ciento de los pacientes. Los calcioantagonistas se utilizaron en un 26 por ciento, siendo el uso más elevado en el angor inestable, con un 38,2 por ciento, prescribiéndose en ciertas ocasiones sin que existiera contraindicación al uso de betabloqueantes. Conclusión: Los porcentajes de adecuación a la evidencia I fueron claramente insuficientes para IECAs y betabloque antes. Las estatinas se utilizaron de forma mayoritaria, independientemente del criterio de dislipemia. La utilización de nitratos resulta excesivamente elevada, en especial para el IAMEST. La prevención secundaria aplicada a los SCA, en base a los tratamientos farmacológicos analizados, admite un amplio margen de mejora si se comparan con los estándares establecidos (AU)