益安口服液用于海洛因依赖者脱毒Ⅳ期临床评价

EVALUATION ON PHASE Ⅳ CLINICAL TRIAL OF YI'AN ORAL LIQUORFOR DETOXIFICATION OF HEROIN ADDICTS

目的·· :评价益安口服液治疗海洛因依赖的戒断症状及稽延性戒断症状的效果及不良反应。方法··:固定疗程、固定剂量的多中心Ⅳ期临床开放实验。海洛因中度依赖者单纯使用益安口服液 ;重度依赖者 ,前3d与美沙酮联合用药。疗程为10d。稽延性戒断症状的治疗于脱毒后d10开始 ,疗程30d ;稽延性戒断症状于用药后每5d测评一次。结果··:单独使用益安口服液组 (495例 )和与美沙酮联合组 (75例 )用药后每日戒断症状总分与各自用药前比较 ,差异有显著性(P<0.01) ;稽延性戒断症状治疗组 (109例 )每次测评稽延性症状总分与用药前相比明显下降 ,差异有显著性 (P<0.01)。益安口服液的不良反应主要有口干、腹泻、食欲不振、恶心等胃肠道反应 ,一般表现较轻 ,药物减量即可缓解。结论·· :益安口服液能有效地控制海洛因依赖者的戒断症状 ;治疗稽延性戒断症状效果肯定 ;不良反应小 。

Objective: To evaluate the effect and adverse drug reaction of Yi'an oral liquor in the detoxification of heroin addicts, according to the requirements of Phase Ⅳ clinical trial. Method: Multi-centric open clinical trial of unchanged course and dosage was adopted. A 10-day treatment for detoxification and methadone added for the serious addicts during the first three days. Treatment for protracted withdrawal syndrome began from the 10th day after detoxification and continued for 30 days. Result: Yi'an oral liquor was administered to 570 cases for detoxification, of which 75 cases simultaneously administered methadone during the first three days. Yi'an was given to 109 cases for the treatment of their protracted withdrawal syndrome. Both withdrawal syndrome scores and protracted withdrawal syndrome scores were greatly reduced after administration, compared with those assessed before treatment. The main adverse reaction was dry mouth, diarrhea, inappetence, nausea. Conclusion: Yi'an is effective both in controlling acute withdrawal syndrome and protracted withdrawal syndrome of heroin addicts. Its adverse reaction is mild, which will be recovered without special treatment.