Terapia combinada con bevacizumab y alteplasa para el tratamiento de hemorragias submaculares / Combined therapy with bevacizumab and alteplasa for the treatment of submacular hemorrhages

INTRODUCCIÓN: El uso combinado de bevacizumab y alteplasa intrarretiniano supone una alternativa de tratamiento de las hemorragias maculares que adquiere cada vez más relevancia. Además, su utilización en una única jeringa evita una inyección intrarretiniana reduciendo los posibles riesgos que conllevan. OBJETIVO: Confirmar la efectividad y seguridad de la combinación de bevacizumab y alteplasa in vivo para el tratamiento de hemorragias submaculares en pacientes con degeneración macular asociada a la edad y determinar si supone una alternativa de tratamiento válida. METODOLOGÍA: Estudio retrospectivo observacional de pacientes tratados con bevacizumab y alteplasa para hemorragias submaculares desde febrero de 2017 a febrero de 2018. Se revisó la situación clínica pre-intervención y a los 3 meses. Las variables revisadas para determinar la efectividad del tratamiento fueron el tamaño de la superficie de la hemorragia, el grosor retiniano y la agudeza visual. La seguridad se evaluó con la aparición de reacciones adversas. RESULTADOS: Fueron incluidos cinco pacientes, cuatro con un ojo afectado y uno con ambos, 60% hombres, con una mediana de edad de 78 años (68-89). Objetivamente se redujo el porcentaje de ocupación de la hemorragia de una media del 70% al 6% tras la intervención. El grosor retiniano disminuyó de 1.531 micras (1.891-1.195) a 516,8 micras (324-667). La agudeza visual mejoró en dos pacientes manteniéndose en el resto. Todos los pacientes refirieron subjetivamente mejoría tras la intervención. El tratamiento fue seguro por la ausencia de aparición de reacciones adversas. CONCLUSIONES: El tratamiento estudiado ha demostrado ser efectivo y seguro clínicamente

INTRODUCTION: The combined use of bevacizumab and intraretinal alteplase is an alternative treatment for macular hemorrhage that is becoming more and more relevant. In addition, its use in a single syringe prevents an intraretinal injection reducing the possible risks involved. OBJECTIVE: To confirm the effectiveness and safety of the combination of bevacizumab and alteplase in vivo for submacular hemorrhage in patients with macular degeneration associated with age and to determine whether it is a valid treatment alternative. MATERIAL AND METHODS: Observational retrospective study of patients treated with bevacizumab and alteplase for submacular hemorrhages from February 2017 to February 2018. The clinical situation was reviewed pre-intervention and at 3 months later. The variables reviewed to determine the effectiveness of the treatment were the size of the hemorrhage surface, the retinal thickness and the visual acuity. Safety was determined with the appearance of adverse reactions. RESULTS: Six eyes of five patients were included, 60% men, with a median age of 78 years (68-89). Objectively the percentage of occupation of the hemorrhage was reduced from an average of 70% to 6% after the intervention. The retinal thickness decreased from 1,531 microns (1,891-1,195) to 516.8 microns (324-667). Visual acuity improved in two patients and remained in the rest. All patients reported subjectively improvement after the intervention. The treatment was safe due to the absence of adverse reactions. CONCLUSIONS: The reviewed treatment has shown to be clinically effective and safe

[Analysis of the causes leading to withdrawal of the treatment with triple antiviral therapy for hepatitis C patients]. / Análisis de las causas de suspensión de tratamiento con triple terapia antiviral en pacientes con hepatitis C.

OBJECTIVE: To assess causes of suspension of hepatitis C treatment in patients receiving triple antiviral therapy (peginterferon+ ribavirin + protease inhibitor). METHODS: Retrospective observational study of patients who received triple antiretroviral therapy against hepatitis C between January 2012 - March 2013 and discontinued their treatment. RESULTS: Of 156 patients who initiated therapy, 41 discontinued treatment: Nineteen due to adverse events, being dermatological events in seven patients ( 36.8 %), intolerance in six(31.6%) and hematologic toxicity in four (15.8%) . Sixteen patients discontinued treatment for being ineffectiveness.Patients with higher inefficacy failure rate were "null-responders"(32.3% ) while the group of "relapsers" were the one with the highest rate of toxicity suspensions (15.6%). Two patients died during treatment for pneumonia. CONCLUSIONS: Triple therapy with boceprevir and telaprevir is associated with a significant number of treatment failures due to toxicity and ineffectiveness.

Objetivo: Evaluar las causas de suspensión de tratamientofrente a Hepatitis C que reciben triple terapia antiviral (peginterferon+ ribavirina + inhibidor de proteasa).Métodos: Estudio observacional retrospectivo de pacientes queiniciaron triple terapia antiviral entre enero 2012 - marzo 2013y suspendieron el tratamiento antes de completar el mismo.Resultados: De 156 pacientes que iniciaron triple terapia, 41interrumpieron el tratamiento: Diecinueve por toxicidad, siendodermatológica en siete pacientes (36,8%), intolerancia en seis(31,6%) y hematológica en cuatro (15,8%). Dieciséis pacientessuspendieron todo el tratamiento por ineficacia. El grupo depacientes con mayor porcentaje de fracasos por ineficacia fueronlos "no respondedores" (32,3%) mientras que el grupo depacientes "recidivantes" fueron el grupo con mayor porcentajede suspensiones por toxicidad (15,6%). Dos pacientes fallecierondurante el tratamiento por neumonía.Conclusiones: La triple terapia frente a VHC está asociada a unnúmero importante de fracasos terapéuticos tanto por toxicidadcomo por ineficacia.

Análisis de las causas de suspensión de tratamiento con triple terapia antivrial en pacientes con hepatitis C / Analysis of the causes leading to withdrawal of the treatment with triple antivial therapy for hepatitis C patients

Objetivo: Evaluar las causas de suspensión de tratamient of rente a Hepatitis C que reciben triple terapia antiviral (pegin-terferon + ribavirina + inhibidor de proteasa).Métodos: Estudio observacional retrospectivo de pacientes que iniciaron triple terapia antiviral entre enero 2012 - marzo 2013y suspendieron el tratamiento antes de completar el mismo. Resultados: De 156 pacientes que iniciaron triple terapia, 41interrumpieron el tratamiento: Diecinueve por toxicidad, siendo dermatológica en siete pacientes (36,8%), intolerancia en seis(31,6%) y hematológica en cuatro (15,8%). Dieciséis pacientes suspendieron todo el tratamiento por ineficacia. El grupo de pacientes con mayor porcentaje de fracasos por ineficacia fueron los "no respondedores" (32,3%) mientras que el grupo de pacientes "recidivantes" fueron el grupo con mayor porcentaje de suspensiones por toxicidad (15,6%). Dos pacientes fallecieron durante el tratamiento por neumonía. Conclusiones: La triple terapia frente a VHC está asociada a un número importante de fracasos terapéuticos tanto por toxicidad como por ineficacia

Objective: To assess causes of suspension of hepatitis C treatment in patients receiving triple antiviral therapy (peginterferon+ ribavirin + protease inhibitor).Methods: Retrospective observational study of patients who recived triple antiretroviral therapy agaisnst hepatitis C between January 2012 - March 2013 and discontinued their treatment. Results: Of 156 patients who initiated therapy, 41 discontinued treatment: Nineteen due to adverse events, being dermatological events in seven patients ( 36.8 %), intolerance in six(31.6%) and hematologic toxicity in four (15.8%) . Sixteen patients discontinued treatment for beeing ineffectiveness. Patients with higher inefficacy failure rate were "null-responders" (32.3% ) while the group of "relapsers" were the one with the highest rate of toxicity suspensions (15.6%). Two patients died during treatment for pneumonia. Conclusions: Triple therapy with boceprevir and telaprevir is associated with a significant number of treatment failures due to toxicity and ineffectiveness (AU)

Experiencia clínica con los cannabinoides en la terapia de la espasticidad en la esclerosis múltiple / Clinical experiences with cannabinoids in spasticity management in multiple sclerosis

Introducción: La espasticidad es un síntoma muy frecuente entre los pacientes con esclerosis múltiple (EM). El objetivo del presente estudio es evaluar la efectividad y la seguridad de la combinación de delta-9-tetrahidrocannabinol (THC) y cannabidiol (CBD) en la práctica clínica del tratamiento de la espasticidad en EM. Métodos: Estudio observacional retrospectivo con los pacientes tratados con THC/CBD inhalado de abril del 2008 a marzo del 2012. Se recogieron variables descriptivas de paciente y tratamiento. La respuesta se evaluó mediante impresión global de respuesta terapéutica analizada por el médico. Resultados: Cincuenta y seis pacientes iniciaron tratamiento, 6 fueron excluidos por falta de datos. Se evaluó a 50 pacientes (42% hombres), mediana de edad 47,8 años, el 38% de ellos diagnosticados de EM primaria progresiva, el 44% de EM secundaria progresiva y el 18% de EM remitente recurrente. El motivo de prescripción fue espasticidad (44%), dolor (10%) o ambos (46%). Se suspendió tratamiento en 16 pacientes por inefectividad (7 pacientes), abandono (4) y efectos adversos (5). La mediana de tiempo de exposición de los pacientes que suspendieron tratamiento fue 30 días y 174 días para los que continuaban tratamiento al final del estudio. THC/CBD fue efectivo en un 80% de pacientes, con dosis mediana de 5 (2-10) pulverizaciones/ día. El perfil de efectos adversos fue: mareo (11 pacientes), somnolencia (6), debilidad muscular (7), molestias bucales (2), diarrea (3), sequedad de boca (2), visión borrosa (2), agitación (1), náuseas (1), ideas paranoides (1). Conclusiones: THC/CBD se muestra como una buena alternativa al tratamiento habitual mejorando la espasticidad refractaria en la EM con perfil de toxicidad aceptable

Introduction: Spasticity is a common symptom among patients with multiple sclerosis (MS). This study aims to assess the effectiveness and safety of the combination of delta- 9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in clinical practice for the treatment of spasticity in MS. Methods: Retrospective observational study with patients treated with inhaled THC/CBD between April 2008 and March 2012. Descriptive patient and treatment variables were collected. Therapeutic response was evaluated based on the doctor’s analysis and overall impression. Results: Of the 56 patients who started treatment with THC/CBD, 6 were excluded because of missing data.We evaluated 50 patients (42% male) with a median age 47.8 years (25.6-76.8); 38% were diagnosed with primary progressive MS, 44% with secondary progressive MS, and 18% with relapsing-remitting MS. The reason for prescribing the drug was spasticity (44%), pain (10%), or both (46%). Treatment was discontinued in 16 patients because of ineffectiveness (7 patients), withdrawal (4), and adverse effects (5). The median exposure time in patients whose treatment was discontinued was 30 days vs 174 days in those whose treatment continued at the end of thestudy. THC/CBD was effective in 80% of patients at a median dose of 5 (2-10) inhalations/day. The adverse event profile consisted of dizziness (11 patients), somnolence (6), muscle weakness (7), oral discomfort (2), diarrhoea (3), dry mouth (2), blurred vision (2), agitation (1), nausea (1), and paranoid ideation (1). Conclusions: THC/CBD appears to be a good alternative to standard treatment as it improves refractory spasticity in MS and has an acceptable toxicity profile

Anidulafungin-induced alopecia.

OBJETIVE: To report a case of a woman in whom alopecia appeared after several months of treatment with anidulafungin. CASE SUMMARY: A 34-year-old woman with chronic femoral osteomyelitis with the presence of persistent suppuration, developed a Candida albicans infection, isolated in the fistula exudate cultures. After initial failures of single therapy with azoles, it was decided to administer fluconazole and anidulafungin 100 mg/d. One month after starting the treatment, the patient mentioned a greater hair loss than usual. At 3 months, the patient stopped taking the drug on noting the loss and easy falling out of her hair, with alopecia plaques 1 to 2 cm in size. At 2 months after stopping the anidulafungin, it was decided to restart combined antifungal treatment using micafungin and fluconazole; there was no mention of new or greater loss of hair. It was decided to change micafungin to anidulafungin again 90 days after starting treatment. In the first month of treatment, there appeared to be a reactivation in hair loss that later stabilized and improved. DISCUSSION: Drug-induced hair loss is an adverse reaction that has been identified during different hair growth phases. It has been described for the azoles group and has not been associated with candins until now. Results of the causality analysis, using the probability scale established by Naranjo, found the relationship as probable. CONCLUSIONS: Anidulafungin could be associated with hair loss. Physicians must be aware of this adverse effect in order to approach it properly and to detect possible nonadherence to treatment.

[Boceprevir and telaprevir utilization: evaluation for the treatment of chronic hepatitis C]. / Estudio de utilización de boceprevir y telaprevir para el tratamiento de la hepatitis C crónica.

INTRODUCTION: Protease inhibitors, boceprevir and telaprevir, have changed the treatment paradigm of chronic hepatitis C (CHC). The objective is analyzing the degree of compliance with the recommendations for boceprevir and telaprevir use that have been issued for the Spanish Agency for Medicines and Health Products in patients with CHC on a tertiary hospital. METHOD: All patients who started treatment with triple therapy between March and September 2012 were included. Compliance the initiation criteria were assessed and whether the rules of discontinuation due to ineffectiveness were made. RESULTS: 76 patients, 24 treated with boceprevir and 52 with telaprevir were included. In 11 patients (14.5%) triple therapy was initiated without keeping the Spanish Agency criteria, 6 were monoinfected patients and 4 with liver transplantation. In the group of boceprevir viral load (VL) at 12th week of treatment in 19 patients was measured (79.2%) and in 13 patients at 24th week (61.9 %). For telaprevir VL at week 4 the in 48 patients was determined (92.3%), at week 12 in 45 (91.8%) and at week 24 in 42 patients (93.3%). In all patients that the VL was determined its outcome was linked with the treatment continuation or not. CONCLUSIONS: In most patients (80.3%) start and suspension requirements for triple therapy were kept. There is leeway for action and improvement that requires the involvement of all the acting agents.

Estudio de utilización de boceprevir y telaprevir para el tratamiento de la hepatitis C crónica / Boceprevir and telaprevir utilization evaluation for the treatment of chronic hepatitis C

INTRODUCCIÓN: Los inhibidores de la proteasa, boceprevir y tela-previr, han modificado el paradigma del tratamiento de la hepa-titis C crónica (HCC). El objetivo es analizar el grado de cumplimiento de las recomendaciones de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) para la utilización de boceprevir y telaprevir en pacientes con HCC en un hospital de tercer nivel. MÉTODO: Se incluyeron todos los pacientes que iniciaron tratamiento con triple terapia entre marzo y septiembre de 2012. Seanalizó si se cumplieron los criterios de inicio de tratamientoestablecidos por la AEMPS y se determinó si se efectuaban lasreglas de suspensión del tratamiento por inefectividad. RESULTADOS: Se incluyeron 76 pacientes, 24 tratados con boce-previr y 52 con telaprevir. En 11 pacientes (14,5%) se inició triple terapia sin cumplir los criterios de la AEMPS, 6 monoinfec-tados y 4 trasplantados de hígado. En el grupo de bocepreviren la semana 12 de tratamiento se cuantificó la carga viral (CV)en 19 pacientes (79,2%) y en la 24 en 13 pacientes (61,9%). En el de telaprevir en la semana 4 la CV se determinó en 48 pacientes (92,3%), en la semana 12 a 45 (91,8%) y en la 24 a 42 (93,3%). En todos los que se determinó la CV su resultado vinculó la continuación o no del tratamiento. CONCLUSIONES: En la mayoría de los pacientes (80,3%) se cumplen tanto los requisitos de inicio de triple terapia como los desuspensión. Existe un margen de mejora que necesita la implicación de todos los agentes actuantes

INTRODUCTION: Protease inhibitors, boceprevir and telaprevir, havechanged the treatment paradigm of chronic hepatitis C (CHC). The objective is analyzing the degree of compliance with therecommendations for boceprevir and telaprevir use that havebeen issued for the Spanish Agency for Medicines and HealthProducts in patients with CHC on a tertiary hospital. METHOD: All patients who started treatment with triple therapybetween March and September 2012 were included. Compliance the initiation criteria were assessed and whether the rulesof discontinuation due to ineffectiveness were made. RESULTS: 76 patients, 24 treated with boceprevir and 52 with telaprevir were included. In 11 patients (14.5%) triple therapy was initiated without keeping the Spanish Agency criteria, 6 were monoinfected patients and 4 with liver transplantation. In the group of boceprevir viral load (VL) at 12th week of treatment in 19 patients was measured (79.2%) and in 13 patients at 24th week (61.9 %). For telaprevir VL at week 4 the in 48 patients was determined (92.3%), at week 12 in 45 (91.8%) and at week 24 in 42 patients (93.3%). In all patients that the VL was determined its outcome was linked with the treatment continuation or not. CONCLUSIONS: In most patients (80.3%) start and suspension requirements for triple therapy were kept. There is leeway for action and improvement that requires the involvement of all the acting agents

Clinical experiences with cannabinoids in spasticity management in multiple sclerosis.

INTRODUCTION: Spasticity is a common symptom among patients with multiple sclerosis (MS). This study aims to assess the effectiveness and safety of the combination of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in clinical practice for the treatment of spasticity in MS. METHODS: Retrospective observational study with patients treated with inhaled THC/CBD between April 2008 and March 2012. Descriptive patient and treatment variables were collected. Therapeutic response was evaluated based on the doctor's analysis and overall impression. RESULTS: Of the 56 patients who started treatment with THC/CBD, 6 were excluded because of missing data. We evaluated 50 patients (42% male) with a median age 47.8 years (25.6-76.8); 38% were diagnosed with primary progressive MS, 44% with secondary progressive MS, and 18% with relapsing-remitting MS. The reason for prescribing the drug was spasticity (44%), pain (10%), or both (46%). Treatment was discontinued in 16 patients because of ineffectiveness (7 patients), withdrawal (4), and adverse effects (5). The median exposure time in patients whose treatment was discontinued was 30 days vs 174 days in those whose treatment continued at the end of the study. THC/CBD was effective in 80% of patients at a median dose of 5 (2-10) inhalations/day. The adverse event profile consisted of dizziness (11 patients), somnolence (6), muscle weakness (7), oral discomfort (2), diarrhoea (3), dry mouth (2), blurred vision (2), agitation (1), nausea (1), and paranoid ideation (1). CONCLUSIONS: THC/CBD appears to be a good alternative to standard treatment as it improves refractory spasticity in MS and has an acceptable toxicity profile.