丁丙诺啡舌下含片用于海洛因依赖者脱毒治疗临床评价

目的 :评价丁丙诺啡舌下含片对海洛因依赖者脱毒的效果及不良反应。方法 :采用多中心随机双盲双模拟对照试验及无对照开放试验设计。对照试验选择 2 39例中度海洛因依赖者 ,按照 1:1:2的比例随机分入丁丙诺啡10d组、丁丙诺啡 14d组和美沙酮 14d组。另外 4 9例重度海洛因依赖者使用丁丙诺啡进行 10 - 14d脱毒治疗 ,进行开放观察。结果 :丁丙诺啡舌下含片控制戒断症状总分和主要戒断症状评分与美沙酮比较差异无显著性 (P >0 .0 5 )。焦虑量表评分丁丙诺啡组与美沙酮组比较差异也无显著性 (P >0 .0 5 )。用药前 3d丁丙诺啡单次用量最大可达 6mg ,日剂量最大为 18mg。不良反应较少 ,主要为便秘。停药后无明显戒断症状。结论 :足量使用丁丙诺啡舌下含片用于海洛因依赖脱毒治疗安全有效

Detoxification treatment for heroin addicts by sublingual buprenorphine tablets

Objective :To evaluate the efficacy and safety of sublingual buprenorphine tablets for the treatment of heroin addicts. Methods : 239 heroin addicts with median withdrawal symptoms were randomly assigned to 10-day buprenorphine treatment group ,14-day buprenorphine treatment group and 14-day methadone treatment group separately in a 1∶1∶2 ratio. All dosing was double-blind and double-dummy. Another 49 heroin addicts with severe withdrawal symptoms were recruited into an open trial, receiving buprenorphine treatment for 10-14 days. Results : Buprenorphine could relieve withdrawal symptoms and the anxiety caused by heroin withdrawal, showing no significant difference compared with methadone. The single dose of buprenorphine reached 6 mg, and maximum daily dose was 18 mg in the first 3 days. The most common adverse drug reaction was constipation. There was no significant rebound of withdrawal symptoms after cessation of medication. Conclusion : Sufficient dose of buprenorphine was effective and safe in detoxification treatment for heroin addicts.