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７１４３％，可乐定为５８４７％，两组结果类似，安慰剂组仅为１０５３％。灵益胶囊与可乐定的疗效显著优于安慰剂（Ｘ２＝２２８２９８，Ｐ＝０００００）。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＜００５），与安慰剂类似（Ｐ＜００５）。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.
出处
《华西医学》
CAS
1999年第1期18-21,共4页
West China Medical Journal
