Mattick R P, Kimber J, Breen C, Davoli M
National Drug and Alcohol Research Centre, University of New South Wales, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.
Cochrane Database Syst Rev. 2003(2):CD002207. doi: 10.1002/14651858.CD002207.
Buprenorphine has recently been reported to be an alternative to methadone and LAAM for maintenance treatment of opioid dependent individuals, differing results are reported concerning its relative effectiveness indicating the need for an integrative review.
To evaluate the effects of buprenorphine maintenance against placebo and methadone maintenance in retaining patients in treatment and in suppressing illicit drug use.
We searched the following databases up to 2001, inclusive: Cochrane Drugs and Alcohol Review Group Register, the Cochrane Controlled Trials Register, MEDLINE, EMBASE, Current Contents, Psychlit, CORK [www. state.vt.su/adap/cork], Alcohol and Drug Council of Australia (ADCA) [www.adca.org.au], Australian Drug Foundation (ADF -VIC) [www.adf.org.au], Centre for Education and Information on Drugs and Alcohol (CEIDA) [www.ceida.net.au], Australian Bibliographic Network (ABN), and Library of Congress databases, available NIDA monographs and the College on Problems of Drug Dependence Inc. proceedings, the reference lists of all identified studies and published reviews and authors of identified RCT's were asked about any other published or unpublished relevant RCT.
Randomised clinical trials of buprenorphine maintenance compared with either placebo or methadone maintenance for opioid dependence.
Reviewers evaluated the papers separately and independently, rating methodological quality of concealment of allocation; data were extracted independently for meta-analysis and double-entered.
Thirteen studies met the inclusion criteria, all were randomised clinical trials, all but one were double-blind. The method of concealment of allocation was not clearly described in 11 of the studies, otherwise methodological quality was good. Buprenorphine given in flexible doses appeared statistically significantly less effective than methadone in retaining patient in treatment (RR= 0.82; 95% CI: 0.69-0.96). Low dose buprenorphine is not superior to low dose methadone. High dose buprenorphine does not retain more patients than low dose methadone, but may suppress heroin use better. There was no advantage for high dose buprenorphine over high dose methadone in retention (RR=0.79; 95% CI:0.62-1.01), and high dose buprenorphine was inferior in suppression of heroin use. Buprenorphine was statistically significantly superior to placebo medication in retention of patients in treatment at low doses (RR=1.24; 95% CI: 1.06-1.45), high doses (RR=1.21; 95% CI: 1.02-1.44), and very high doses (RR=1.52; 95% CI: 1.23-1.88). However, only high and very high dose buprenorphine suppressed heroin use significantly above placebo.
REVIEWER'S CONCLUSIONS: Buprenorphine is an effective intervention for use in the maintenance treatment of heroin dependence, but it is not more effective than methadone at adequate dosages.
最近有报道称丁丙诺啡可替代美沙酮和长效美沙酮用于阿片类药物依赖者的维持治疗,但关于其相对疗效的报道结果不一,这表明需要进行一项综合评价。
评估丁丙诺啡维持治疗与安慰剂及美沙酮维持治疗相比,在使患者坚持治疗和抑制非法药物使用方面的效果。
截至2001年(含2001年),我们检索了以下数据库:Cochrane药物与酒精综述组注册库、Cochrane对照试验注册库、医学索引数据库、荷兰医学文摘数据库、《现刊目次》、心理学文摘数据库、CORK[www.state.vt.su/adap/cork]、澳大利亚酒精与药物理事会(ADCA)[www.adca.org.au]、澳大利亚药物基金会(ADF - 维多利亚州)[www.adf.org.au]、酒精与药物教育与信息中心(CEIDA)[www.ceida.net.au]、澳大利亚书目网络(ABN)以及美国国会图书馆数据库、已获取的美国国立药物滥用研究所专论和药物依赖问题学会会议论文集,向所有已识别研究的参考文献列表以及已发表综述和已识别随机对照试验的作者询问任何其他已发表或未发表的相关随机对照试验。
丁丙诺啡维持治疗与安慰剂或美沙酮维持治疗用于阿片类药物依赖的随机临床试验。
综述作者分别独立评估论文,对分配隐藏的方法学质量进行评分;数据独立提取用于荟萃分析并进行二次录入。
13项研究符合纳入标准,均为随机临床试验,除1项外均为双盲试验。11项研究未明确描述分配隐藏方法,其他方面方法学质量良好。灵活剂量的丁丙诺啡在使患者坚持治疗方面的效果在统计学上显著低于美沙酮(相对危险度=0.82;95%可信区间:0.69 - 0.96)。低剂量丁丙诺啡并不优于低剂量美沙酮。高剂量丁丙诺啡在使患者坚持治疗方面不比低剂量美沙酮更多,但可能在抑制海洛因使用方面更好。高剂量丁丙诺啡在使患者坚持治疗方面并不优于高剂量美沙酮(相对危险度=0.79;95%可信区间:0.62 - 1.01),且在抑制海洛因使用方面不如高剂量美沙酮。低剂量(相对危险度=1.24;95%可信区间:1.06 - 1.45)、高剂量(相对危险度=1.21;95%可信区间:1.02 - 1.44)和极高剂量(相对危险度=1.52;95%可信区间:1.23 - 1.88)的丁丙诺啡在使患者坚持治疗方面在统计学上显著优于安慰剂。然而,只有高剂量和极高剂量的丁丙诺啡在抑制海洛因使用方面显著优于安慰剂。
丁丙诺啡是用于海洛因依赖维持治疗的有效干预措施,但在适当剂量下并不比美沙酮更有效。