Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial.

OBJECTIVE: We aimed to compare the response rates between two different hepatitis B virus vaccination schedules for cirrhotic subjects who were non-responders to the first three 40 µg doses (month 0-1-2), and identify factors associated with the final response. DESIGN: A total of 120 cirrhotic patients (72.5% decompensated) were randomised at a 1:1 ratio to receive a single 40 µg booster vaccination at month 6 (classical arm) versus an additional round of three new 40 µg doses administered at monthly intervals (experimental arm). The main outcome was the rate of postvaccinal anti-hepatitis B surface antibodies levels ≥10 mIU/mL. RESULTS: Efficacy by ITT analysis was higher in the experimental arm (46.7%) than in the classical one (25%); OR 2.63, p=0.013. The experimental arm increased response rates compared with the classical one from 31% to 68% (OR 4.72; p=0.007), from 24.4% to 50% (OR 3.09; p=0.012) and from 24.4% to 53.8% (OR 3.62; p=0.007), in Child A, Model for End-Stage Liver Disease (MELD) <15 and MELD-Na<15 patients, respectively. Patients with more advanced liver disease did not benefit from the reinforced scheme. Both regimens showed similar safety profiles. Multivariable analysis showed that the experimental treatment was independently response associated when adjusted across three logistic regression models indicating equivalent cirrhosis severity. CONCLUSION: For cirrhotic patients, the revaccination of non-responders to the first three dose cycle, with three additional 40 µg doses, achieved significantly better response rates to those obtained with an isolated 40 µg booster dose. TRIAL REGISTRATION NUMBER: NCT01884415.

Bloqueo poplite por via lateral en pacientes de alto riesgo en cirugía vascular

INTRODUCCIÓN: En cirugía vascular son frecuentes las intervenciones sobre lesiones isquémicas no revascularizables localizadas en el tercio distal de las extremidades inferiores. Estos pacientes suelen ser portadores de multipatología y con frecuencia presentan un elevado riesgo anestésico. Entre las técnicas anestésicas destaca por sus escasas repercusiones hemodinámicas y respiratorias el bloqueo poplíteo que se realiza habitualmente con el paciente en decúbito prono, siendo éste su principal y mayor inconveniente. Describimos en este trabajo, nuestra experiencia en este tipo de cirugía, con una nueva vía de abordaje que obvia este inconveniente. MATERIAL Y METODOS: Estudio prospectivo y descriptivo sobre 75 pacientes intervenidos de lesiones isquémicas no revascularizables localizadas infracondíleamente. La técnica anestésica se realizó con el paciente en decúbito supino y con ayuda de un neuroestimulador, mediante bloqueo del hueco poplíteo vía lateral de los nervios ciático-poplíteos interno (CPI) y externo (CPE) asociándose cuando fue necesario bloqueo del nervio crural (C). El anestésico local (AL) empleado fue ropivacaina al 0’5% a dosis de 0’9, 0’5 y 0’7 mg/kg para el CPI, CPE y C respectivamente. Se evaluaron las características de los pacientes, de las intervenciones, la eficacia del bloqueo ciático y la aparición de incidentes y complicaciones durante el acto anestésico-quirúrgico y los primeros siete días del postoperatorio. RESULTADOS: Se realizaron 75 bloqueos, siendo las intervenciones más frecuentes las amputaciones de dedos y los desbridamientos de heridas. En 10 casos se asoció un bloqueo del nervio crural. No hubo ningún bloqueo fallido. Todos los pacientes presentaban pluripatología. Los tiempo de realización de la técnica y el de latencia fueron de 7 y 10 minutos respectivamente, mientras que la duración de la analgesia fue de 16 horas. No se observó durante el periodo que duró el estudio incidente o complicación alguna. CONCLUSIÓN: Debido al no requerimiento del decúbito prono para su realización, a la elevada tasa de bloqueos exitosos y a la ausencia de incidentes y complicaciones, pensamos que el bloqueo poplíteo vía lateral es una técnica de gran utilidad para el manejo anestésico de este tipo de pacientes.

INTRODUCTION: In vascular surgery, operations on ischemic lesions located in the third distal part of the lower extremity are frequent. These patients use to be multipathology carriers and frequently present a high anesthetic risk. From among the several anaesthetic techniques, popliteal blockade stands out for its few haemodinamics and respiratory aftermaths, which is usualy accomplished with the patient in prone position, being this fact its principal and bigger inconvenience itself. We describe in this study our experience in this type of surgery, with a new approach that obviates this inconvenient. METHODS: A prospective and descriptive study on 75 patients operated on non-revascularizabled ischemic infracondileal lesions. Anaesthetic technique was accomplished through the lateral approach to the popliteal fossa with the patient in supine position with the help of a nerve stimulator, by blocking the internal popliteal sciatic nerve and external popliteal sciatic nerve, in addition with the crural nerve blockade when necessary. The local anaesthetic used was ropivacaine (0,5 %) with a dose of 0.9, 0.5 and 0.7 mg/kg respectively. We assessed the characteristics of the patients, the type of the surgical operation, the efficacy of the sciatic blockade, and the incidents and complications appeared during the anaesthetic and surgical procedure and during the first seven days in the postoperative period. RESULTS: 75 blockades were made, being amputations of the fingers and wounds debridements the most frequent operations. In 10 cases crural nerve blockade was associated. There was no unsuccessful blockade. All the patients were multipathology carriers. Time to perform the technique and onset time were 7 and 10 minutes respectively, while the length of the analgesia was 16 hours. Neither incident nor complication appeared during the study performance. CONCLUSION: Due to the absence of the prone position requirement for its realization, the elevated rate of successful blockades and the absence of any incident nor complication, we thought that popliteal blockade through lateral approach is a technique of great utility for the anaesthetic management of these patients.