复方防风颗粒治疗海洛因急性戒断症状的多中心临床研究  

FU-FANG-FANG-FENG-KE-LI ALLEVIATES ACUTE HEROIN WITHDRAWAL SYNDROME:A MULTI-CENTERED CLINICAL TRIAL

作　　者：李冰[1] 李素霞[2] 查浩民 康林[1] 李静[1] 

机构地区：[1]四川大学华西医院心理卫生中心,成都610041 [2]北京大学中国药物依赖性研究所,北京100191 [3]贵阳市公安局戒毒中心,贵阳550025

出　　处：《中国药物依赖性杂志》2009年第3期189-194,共6页Chinese Journal of Drug Dependence

摘　　要：目的:评价中药复方防风颗粒对海洛因急性戒断症状的疗效及安全性。方法:采用多中心随机双盲、双模拟阳性对照试验设计,复方防风颗粒组入组112例,完成104例,盐酸洛非西定组入组113例,完成103例。疗效评价主要指标有戒断症状总分逐日减分率,次要指标有临床疗效、HAMA量表评分。安全性指标为血、尿常规检查、血生化检查、心电图检查、生命体征测定,以及每天观察记录不良事件。结果:复方防风颗粒10d脱毒治疗显示,与盐酸洛非西定比较,两组脱毒疗效差异无统计学意义。两组的急性戒断症状量表逐日减分率、临床疗效及HAMA量表总分比较差异无显著性。复方防风颗粒组不良事件发生率显著低于盐酸洛非西定组(P<0.0001);两组不良事件严重程度、生命体征、血、尿常规检查、血生化检查、心电图检查指标比较差异无显著性。结论:复方防风颗粒治疗海洛因急性戒断症状有效,不良反应较轻。Objective：To evaluate the efficacy and safety of Fu -Fang-Fang-Feng-Ke - Li（FFFFKL, traditional Chinese medicine）in the treatment of patients with acute heroin withdrawal syndrome. Methods： We designed a multi -centered clinical trial as a double -blind, double -dummy, positive -controlled, and randomized trial. One hundred and twelve patients were recruited in FFFFKL group, among which 104 finished the trial;113 patients were recruited in lofexidine group among which 103 finished the trial. The reduction rate of sum scores for withdrawal symptoms was served as the primary effective index for treatment, the clinical effective rate and the scores for HAMA were treated as the secondary effective index. Routine blood and urine test, biochemistry test of blood, ECG, and determination of vital signs were treated as the safety index. Results： There was no significant difference overall between lofexidine and FFFFKL in efficacy or safety, and there was no significant difference in the reduction rate of sum scores for withdrawal symptoms, clinical efficacy and scores between the two groups. The total incidence rate of adverse effects of the FFFFKL group was significantly lower than that in the lofexidine group（P 〈0. 0001 ）, and the severity of adverse effects, vital sign, laboratory parameters showed no significant differences between the two groups. Conclusion：The present results support the efficacy and safety of FFFFKL in alleviating the severity of acute withdrawal syndrome in patients with heroin addiction.

关 键 词：复方防风颗粒 盐酸洛非西定 急性戒断症状 海洛因依赖 Ⅱ期临床试验 

分 类 号：R595.505[医药卫生—内科学] R511.6[医药卫生—临床医学]