Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients
Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients
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DOI：
10.1046/j.1360-0443.2003.00335.x
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发表时间：
2003-04-01
期刊：
影响因子：
6
通讯作者：
Danz, C
中科院分区：
文献类型：
--
作者：
Mattick, RP;Ali, R;Danz, C
目的使用灵活的给药方案和市场上销售的丁丙诺啡片剂，在大样本中评估丁丙诺啡和美沙酮维持疗法治疗阿片依赖的疗效。设计患者在双盲、双模拟试验中随机接受丁丙诺啡或美沙酮治疗13周。在澳大利亚设立三家美沙酮诊所。参与者405名阿片依赖患者寻求治疗。干预患者接受临床指示的丁丙诺啡或美沙酮，使用灵活的剂量方案。在第1-6周，患者每天服药。从第7周到第13周，丁丙诺啡患者每隔一天接受两倍于第6周的剂量。测量治疗中的滞留，并通过尿检确定非法阿片类药物的使用。自我报告的药物使用、心理功能、艾滋病毒风险行为、一般健康和主观评级是次要结果。发现意向治疗分析显示，13周的完成率没有显著差异。在13周内，美沙酮在停药时间上优于丁丙诺啡(Wald chi(2)=4.371，df=1，P=0.037)，但在单日和隔日给药阶段没有分开。在吗啡阳性尿液、自我报告的海洛因或其他非法药物使用方面，两组之间没有显著差异。大多数(85%)的丁丙诺啡患者被转移到隔日给药中。结论丁丙诺啡与美沙酮在抑制海洛因使用方面没有区别，但患者数量减少了约10%。这种较差的保留率可能是由于丁丙诺啡诱导太慢。对于大多数患者，丁丙诺啡可以隔天给药。
Aims To assess the efficacy of buprenorphine compared with methadone maintenance therapy for opioid dependence in a large sample using a flexible dosing regime and the marketed buprenorphine tablet.Design Patients were randomized to receive buprenorphine or methadone over a 13-week treatment period in a double-blind, double-dummy trial. Setting Three methadone clinics in Australia.Participants Four hundred and five opioid-dependent patients seeking treatment.Intervention Patients received buprenorphine or methadone as indicated clinically using a flexible dosage regime. During weeks 1-6, patients were dosed daily. From weeks 7-13, buprenorphine patients received double their week 6 dose on alternate days.Measurements Retention in treatment, and illicit opioid use as determined by urinalysis. Self-reported drug use, psychological functioning, HIV-risk behaviour, general health and subjective ratings were secondary outcomes.Findings Intention-to-treat analyses revealed no significant difference in completion rates at 13 weeks. Methadone was superior to buprenorphine in time to termination over the 13-week period (Wald chi(2) = 4.371, df = 1, P = 0.037), but not separately for the single-day or alternate-day dosing phases. There were no significant between-group differences in morphine-positive urines, or in self-reported heroin or other illicit drug use. The majority (85%) of the buprenorphine patients transferred to alternate-day dosing were maintained in alternate-day dosing.Conclusions Buprenorphine did not differ from methadone in its ability to suppress heroin use, but retained approximately 10% fewer patients. This poorer retention was due possibly to too-slow induction onto buprenorphine. For the majority of patients, buprenorphine can be administered on alternate days.