灵益胶囊控制阿片类戒断症状的临床疗效评价  

Clinical Trial of Ningyi Capsule in Treatment of Opioid Withdrawal Syndrome

作　　者：李静[1,2,3] 黄明生[1,2,3] 万文鹏 田维才[1,2,3] 刘闯 陈小蓉[1,2,3] 张波 杨芳[1,2,3] 刘波 王应龙[1,2,3] 

机构地区：[1]华西医科大学附属第一医院精神科 [2]云南省药物依赖防治研究所 [3]湖北省沙市复员退伍军人精神病医院

出　　处：《华西医学》1999年第1期18-21,共4页West China Medical Journal

摘　　要：中药灵益胶囊是用于控制阿片类药物依赖戒断症状的复方中药制剂，已被卫生部批准进行临床试验。本研究采用随机双盲和开放多中心临床试验，共完成３３０例海洛因依赖者的脱毒效应评定。结果发现灵益胶囊于治疗的第三日控制海洛因戒断症状的显著好转率为７１４３％，可乐定为５８４７％，两组结果类似，安慰剂组仅为１０５３％。灵益胶囊与可乐定的疗效显著优于安慰剂（Ｘ２＝２２８２９８，Ｐ＝０００００）。疗程结束时戒断症状反复。提示灵益胶囊具有明显的控制阿片类戒断症状的效应，其总体疗效与可乐定相当。灵益胶囊治疗中，其不良反应明显低于可乐定组（Ｐ＜００５），与安慰剂类似（Ｐ＜００５）。开放性试验显示，灵益胶囊的疗效与不良反应出现情况与双盲试验类似。Ningyi capsule is a compound Chinese traditional medicine in treatment of opioid withdrawal syndrome.The efficacy and safety of Ningyi capsule has been compared with Clonidine and Placebo in 330 cases of heroin addicts though multi-center clinical trial(random controlled,double-blinded and open trial).The result showed that the prominence improvement rate of Ningyi capsule was 71 43%,while Clonidine was 58 47%( P >0 05),Placebo was 10 53%( P <0 05).The side effect of Ningyi capsule was lighter than Clonidine( P <0 05).The result of open trial was similar to that of doubleblinded trial.The primary conclusion is that both Ningyi capsule and Clonidine was effective in the treatment of opioid withdrawal syndrome,but Ningyi capsule showed lighter side effect than Clonidine.

关 键 词：灵益胶囊 阿片类戒断症状 中医药疗法 药物依赖 

分 类 号：R259.955[医药卫生—中西医结合]