双硫仑在随机临床试验中用于治疗酒精和可卡因依赖的安全性：临床实践指南
The safety of disulfiram for the treatment of alcohol and cocaine dependence in randomized clinical trials: guidance for clinical practice.
作者信息
Malcolm Robert, Olive M Foster, Lechner William
机构信息
Medical University of South Carolina, Institute of Psychiatry, 67 President Street, MSC 861, Charleston, SC 29425, USA.
出版信息
Expert Opin Drug Saf. 2008 Jul;7(4):459-72. doi: 10.1517/14740338.7.4.459.
BACKGROUND
Disulfiram has demonstrated efficacy in six randomized clinical trials for the treatment of cocaine dependence, but is rarely used in clinical settings because of safety concerns.
OBJECTIVE
What are the common and serious side effects of disulfiram in cocaine-dependent individuals with and without alcohol dependence in randomized clinical trials?
METHODS
We located Phase I and II randomized trials that discussed the safety of disulfiram.
RESULTS/CONCLUSIONS: In randomized clinical trials that eliminated subjects with serious cardiovascular, hepatic, and psychiatric disorders, the most frequent side effects of disulfiram over placebo or index groups include headaches, fatigue, sleepiness, and anxiety. Disulfiram in a dose of <or= 250 mg/day led to only mild interactions with alcohol. When patients are screened for medical and psychiatric stability, and are evaluated for drug interactions, disulfiram has an acceptable side-effect profile for the treatment of cocaine dependence with or without alcohol dependence.
背景
双硫仑在六项治疗可卡因依赖的随机临床试验中已证明有效，但由于安全问题在临床环境中很少使用。
目的
在随机临床试验中，双硫仑在有或没有酒精依赖的可卡因依赖个体中常见和严重的副作用有哪些？
方法
我们查找了讨论双硫仑安全性的I期和II期随机试验。
结果/结论：在排除患有严重心血管、肝脏和精神疾病受试者的随机临床试验中，与安慰剂或指标组相比，双硫仑最常见的副作用包括头痛、疲劳、嗜睡和焦虑。每日剂量≤250毫克的双硫仑与酒精仅产生轻微相互作用。当对患者进行医学和精神稳定性筛查，并评估药物相互作用时，双硫仑对于治疗有或没有酒精依赖的可卡因依赖具有可接受的副作用谱。
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