Flórez Gerardo, Saiz Pilar A, García-Portilla Paz, Álvarez Sandra, Nogueiras Luis, Bobes Julio
Unidad de Conductas Adictivas, Servicio Gallego de Salus, Ourense, España.
Adicciones. 2011;23(2):149-56.
6-month naturalistic, open-label trial to compare amisulpride versus topiramate and naltrexone as a treatment for patients with alcohol dependence, with assessments at enrolment and after 3 and 6 months of treatment.
274 alcohol-dependent patients who had been drinking heavily during the past month were included. Once detoxified, patients were assigned to one of three treatment groups (naltrexone 50 mgr per day, topiramate 200 mgr per day or amisulpride 100 mgr per day). Patients were assessed at baseline and after 3 and 6 months of follow-up. Outcome was measured using tools that assessed alcohol intake (EuropASI and Alcohol Timeline Followback), craving (OCDS), disability (WHO/DAS), and quality of life (EQ-5D); changes in biomarkers of alcohol intake were also noted.
at the 6-month follow-up patients taking amisulpride had poorer results than those taking topiramate in direct measures of alcohol intake (OCDS, alcohol intake, number of drinks per day and heavy drinking days), but no significant differences were found in these measures on comparing the amisulpride patients with those taking naltrexone.
in this study, amisulpride, at a dose of 100 mgr per day, was less effective than topiramate, at a dose of 200 mg per day, but as effective as naltrexone, at a dose of 50 mg per day, for reducing alcohol intake and craving over the period of the study.
一项为期6个月的自然主义、开放标签试验,比较氨磺必利与托吡酯和纳曲酮作为酒精依赖患者的治疗方法,并在入组时以及治疗3个月和6个月后进行评估。
纳入274名在过去一个月中大量饮酒的酒精依赖患者。一旦脱毒,患者被分配到三个治疗组之一(每天50毫克纳曲酮、每天200毫克托吡酯或每天100毫克氨磺必利)。在基线以及随访3个月和6个月后对患者进行评估。使用评估酒精摄入量(欧洲酒精和药物使用情况调查问卷及酒精时间线追溯法)、渴望程度(强迫性饮酒量表)、残疾程度(世界卫生组织残疾评定量表)和生活质量(欧洲五维健康量表)的工具来衡量结果;还记录了酒精摄入量生物标志物的变化。
在6个月的随访中,在直接衡量酒精摄入量的指标(强迫性饮酒量表、酒精摄入量、每日饮酒量和重度饮酒天数)方面,服用氨磺必利的患者比服用托吡酯的患者结果更差,但在这些指标上,将服用氨磺必利的患者与服用纳曲酮的患者进行比较时,未发现显著差异。
在本研究中,在研究期间,每天服用100毫克的氨磺必利在减少酒精摄入量和渴望程度方面不如每天服用200毫克的托吡酯有效,但与每天服用50毫克的纳曲酮效果相当。