中药康复新、福康片和可乐定对阿片类戒断症状的双盲对照研究

Random double blind test study of detoxicated effect of Kangfuxin, Fukangpian &clonidine hydrochloride on opiate withdrawal syndromes

目的评价康复新胶囊、福康片、盐酸可乐定对海洛因依赖的脱毒效应、不良反应及安全度。方法海洛因依赖者,按区组随机进入康复新胶囊组33例,可乐定组30例,福康片组28例,安慰剂组29例。3次/d口服给药。在规定时间内按照原卫生部药政管理局制定的《阿片类戒断症状药物临床试验指导原则》评定药物疗效和不良反应;按照汉密顿焦虑量表(HAMA),评定焦虑情绪变化情况。肝肾功能、血常规、心电图、尿吗啡定性检测(TLC)治疗前后各查1次。结果(1)康复新胶囊、福康片和可乐定疗效相当,疗程结束后戒断症状无反复。(2)吸毒史、末次用量、末周平均用量、汉密顿焦虑量表评分以及戒断症状总分与药物的疗效呈高度相关。(3)康复新胶囊不良反应评分介于可乐定组与福康片组之间。结论发现中药戒毒药物疗效明确,可用于治疗较重度戒断症状,无依赖性,不良反应轻。

Objective To investigate the clinical detoxicated effect, adverse effects and safety of Kangfuxin, Fukangpian and clonidine through random double blind test. Methods 120 patients were randomly divided into Group Kangfuxin(33 cases), group Fukangpian(28 cases), group clonidine (30 cases) and group placebo (29 cases). Take the same dose medicine 3 times every day. At the defined time, estimate the dependence symptoms, the adverse effects and the degree of anxiety with standard measuring scale. Examine the function of liver and kidney, blood cell count and Hb, ECG and TLC. Results (1)The three drugs almost acquired the same effects.(2)The influence factors of the effects were the time of opiate addiction, the dose of last time, the average dose of last week, the degrees of the dependence symptoms and the anxieties.(3)The adverse effects of Kangfuxin were between with the ones of Fukang and clonidine. Conclusion The Chinese traditional detoxicated drug has the definite effect to inhibit the withdrawal symptoms.