中药治疗阿片类药物依赖的临床疗效评价

CLINICAL EFFICACY OF SIX TRADITIONAL CHINESE MEDICINES FOR OPIOID WITHDRAWAL SYNDROME

本文对四川大学华西医院临床研究的6种治疗阿片类依赖的中药进行了综述,以了解中药治疗阿片类药物依赖的临床疗效评价。所有临床研究按照纳入标准,排除标准和终止标准纳入研究对象,采用阳性药对照、多中心、随机、双盲、双模拟的临床对照试验和开放试验方法,采用戒断症状评定量表,汉密顿焦虑评定量表和不良反应评定量表评定研究对象的戒断症状、焦虑症状和药物不良反应的严重程度;实验室检查包括血液常规、尿常规、血液生化、心电图、尿液吗啡定性试验等,并以戒断症状评定量表总分前3d的减分率作为主要疗效评定指标。结果发现中国传统药物能够有效控制阿片类戒断症状,不良反应轻微,不具有成瘾性,对于轻度到中度的戒断症状效果较好。

This article reviews the evaluation of clinical efficacy of 6 traditional Chinese medicines （TCM） for opioid withdrawal syndrome, which were conducted in Huaxi Hospital Sichuan University. In all these positive control, multiple- centre, doubleblind randomized clinical trails, all subjects were recruited according to the including criteria, excluding criteria and termination criteria. The main outcome ~ures were a record of acute withdrawal syndrome rating scale, blood routine ,urine routine, liver function,renal function and ECG, qualitative detection of opioid in urine, vital sign and side effects. These results demonstrated that these 6 TCMs were effective for the treatment of minor - to - moderate acute heroin withdrawal syndrome ,with considerable safety and no dependence- producing potential.