参附脱毒胶囊控制海洛因戒断症状的多中心临床研究  

MULTIPLE CENTERED, DOUBLE BLIND CLINICAL TRIAL OF THE EFFECT OF SHENFUTUODU CAPSULE COMPARED WITH CLONIDINE ON WITHDRAWAL SYNDROME OF HEROIN ADDICTS

作　　者：黄明生[1] 李静[1] 郝伟[2] 李建华[3] 王小平[2] 张锐敏[3] 李吉祥[3] 刘铁桥[2] 康林[1] 李国海[1] 孙学礼[1] 

机构地区：[1]四川大学华西医院,成都610041 [2]中南大学湘雅二医院精神卫生研究所,长沙410011 [3]云南省药物依赖防治研究所,昆明650228

出　　处：《中国药物依赖性杂志》2002年第3期193-196,共4页Chinese Journal of Drug Dependence

摘　　要：目的··:为客观评价参附脱毒胶囊对海洛因依赖的脱毒效应、不良反应及安全度。方法·· :按照卫生部原药政管理局制定的《抗阿片类戒断症状药物临床试验指导原则》 ,采用多中心随机双盲对照临床研究。纳入病例临床观察指标为《戒断症状评定量表》、《Hamilton焦虑评定量表》、《不良反应评定量表》 ;实验室检查指标为血尿常规、肝肾功能、心电图、尿液吗啡定性测定。结果··:纳入病例293人 ,随机进入参附脱毒胶囊组203例 ,可乐定组90例。从治疗后戒断症状总分、《Hamilton焦虑评定量表》的评分来看 ,两组无显著性差异。参附脱毒胶囊控制戒断症状的有效率83.3 % ,可乐定的有效率为81.1%。参附脱毒胶囊组的不良反应总分、对血压的影响明显较可乐定为低 (P<0.05)。未发现对肝、肾功能、血尿常规的明显影响。结论··:参附脱毒胶囊控制戒断症状的疗效肯定 ,与可乐定类似。不良反应主要为口干、思睡、头晕 ,多为轻度反应 ,无需处理自行消失。在治疗的初期应给予充分剂量 ,每次1.2 -1.6g ,每日3次。d4起逐日减量至d10疗程结束。Objective: To evaluate the curative effect and the safety of Shenfutuodu capsule on withdrawal syndrome of heroin addicts. Methods: Multi-centered, randomized, double blind clinical trail was adopted, while the Scale for Withdrawal Symptoms, HAMA, the Scale for Side Effect were evaluated to every patient, the routine blood and urine test, ECG, and the biochemistry test of blood were carried out. Results: 203 patients were treated with Shenfutuodu capsule, 90 patients were treated with clonidine. The efficacy rates of these two groups were 83.3% and 81.1%, respectively. Both groups showed significant reduction of the scores of withdrawal symptoms and HAMA. Compared with Clonidine group, the group of Shenfutuodu capsule showed not only lower scores of side effect but also lower reduction of blood pressure(P<0.05). There were no significant differences in the routine blood and urine test, ECG, and the biochemistry test of blood pre and after treatment. Conclusion: Shenfu_ tuodu capsule is effective in the treatment of withdrawal syndrome of heroin addicts and produces fewer and mild side effects.

关 键 词：参附脱毒胶囊 戒断症状 多中心临床研究 海洛因依赖 不良反应 脱毒效应 

分 类 号：R595.5[医药卫生—内科学] R964[医药卫生—临床医学]