替曲朵辛治疗急性海洛因依赖戒断综合征的随机双盲临床试验  

A CLINICAL STUDY OF THE EFFECTS OF TETRODOTOXIN ON ACUTE HEROIN WITHDRAWAL

作　　者：吴萍[1] 孙艳[1] 李素霞[1] 梁军成[1] 肖早香 杨建辉 邓艳萍[1] 陆林[1] 时杰[1] 

机构地区：[1]北京大学中国药物依赖性研究所,北京100191 [2]宜昌市强制戒毒所,宜昌443001

出　　处：《中国药物依赖性杂志》2015年第1期18-22,共5页Chinese Journal of Drug Dependence

摘　　要：目的:初步评价替曲朵辛(TTX)治疗急性海洛因依赖戒断综合征的疗效和安全性。方法:采用随机双盲、安慰剂对照设计。126例海洛因依赖者随机分为3组,接受疗程为7 d的相应治疗:安慰剂组、5μg TTX和10μg TTX组,bid,肌肉注射;在治疗前及治疗期间每天上午注射给药后1 h采用戒断症状评定量表(OWS)、汉密尔顿焦虑量表(HAMA)和临床总体印象量表(CGI)进行疗效评价,并于治疗前和治疗结束时进行阿片类药物尿检。安全性评价包括在基线和治疗末期进行的实验室检查及每天给药后的生命体征和心电图监测、不良反应报告。结果:3组海洛因依赖者的人口学资料(年龄、性别构成)、海洛因用药特征、基线戒断症状总分和基线焦虑评分没有统计学差异。TTX组的戒断症状评分变化与安慰剂组有显著差异(P<0.05)。3组受试者的焦虑评分在治疗期间逐渐下降,10μg TTX组d4的焦虑评分显著低于安慰剂组(P<0.05)。安慰剂组、5μg TTX组和10μg TTX组分别发生了6例、3例和9例不良事件,严重程度为轻度和中度,各组之间没有显著差异。10μg TTX组的一例受试者因不良事件而停止研究。结论:替曲朵辛注射液每日使用剂量5μg-10μg,疗程7日,对急性海洛因戒断症状的疗效显著优于安慰剂组,且安全性良好。Objective：To evaluate the safety and efficacy of tetrodotoxin（TTX）in the treatment of withdrawal symptoms in abstinent heroin addicts. Methods：During the double- blind clinical trial, 126 patients with heroin dependence were randomly assigned to three treatment groups：placebo,5μg TTX, and 10μg TTX. We measured the severity of their Opiate Withdrawal Symptoms （OWS）, administered the Clinical Global Impression （CGI） scale, and assessed anxiety daily before （ dO ）, during （ dl - d7 ） and after （d8） drug treatment. Urinary heroin levels were measured on Day 8. We also assessed the safety of TTX by measuring vital signs and side effects and conducting laboratory tests. Results：Withdrawal symptom and anxiety scores in the Trx groups gradually decreased during the treatment period, with a significant difference between the groups and placebo group. No severe adverse events occurred during treatment. Conclusion：Tetrodotoxin may be an effective and safe agent in the management of acute opiate withdrawal.

关 键 词：替曲朵辛 戒断综合征 有效性 安全性 海洛因依赖 

分 类 号：R749.64[医药卫生—神经病学与精神病学]