Amato L, Davoli M, Minozzi S, Ali R, Ferri M
Cochrane Drugs and Alcohol Group, Department of Epidemiology ASL RME, Via di Santa Costanza, 53, Roma, Italy, 00198.
Cochrane Database Syst Rev. 2005 Jul 20(3):CD003409. doi: 10.1002/14651858.CD003409.pub3.
Despite widespread use in many countries the evidence of tapered methadone's efficacy in managing opioid withdrawal has not been systematically evaluated.
To evaluate the effectiveness of tapered methadone compared with other detoxification treatments and placebo in managing opioid withdrawal on completion of detoxification and relapse rate.
We searched: Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE (January 1966 to December 2004), EMBASE (January 1988 to December 2004), PsycINFO (January 1985 to December 2004), and reference lists of articles. We also contacted manufacturers and researchers in the field.
All randomised controlled trials which focus on the use of tapered methadone versus all other pharmacological detoxification treatments or placebo for the treatment of opiate withdrawal.
Two reviewers assessed the included studies. Any doubt about how to rate the studies were resolved by discussion with a third reviewer. Study quality was assessed according to the criteria indicated in Cochrane Reviews Handbook 4.2. (Alderson 2004)
Sixteen trials involving 1187 people were included. Comparing methadone versus any other pharmacological treatment we observed no clinical difference between the two treatments in terms of completion of treatment, relative risk (RR) 1.12; 95% CI 0.94 to 1.34 and results at follow-up RR 1.17; 95% CI 0.72 to 1.92. It was impossible to pool data for the other outcomes but the results of the studies did not show significant differences between the considered treatments. These results were confirmed also when we considered the single comparisons: methadone with: adrenergic agonists (11 studies), other opioid agonists (four studies), chlordiazepoxide (study). Comparing methadone with placebo (one study) more severe withdrawal and more drop outs were found in the placebo group. The results indicate that the medications used in the included studies are similar in terms of overall effectiveness, although symptoms experienced by participants differed according to the medication used and the program adopted.
AUTHORS' CONCLUSIONS: Data from literature are hardly comparable; programs vary widely with regard to duration, design and treatment objectives, impairing the application of meta-analysis. The studies included in this review confirm that slow tapering with temporary substitution of long acting opioids, accompanied by medical supervision and ancillary medications can reduce withdrawal severity. Nevertheless the majority of patients relapsed to heroin use.
尽管美沙酮递减疗法在许多国家广泛使用,但尚未对其在管理阿片类药物戒断方面的疗效证据进行系统评估。
评估美沙酮递减疗法与其他戒毒治疗及安慰剂相比,在戒毒完成时管理阿片类药物戒断及复发率方面的有效性。
我们检索了:Cochrane对照试验中央注册库(《Cochrane图书馆》2005年第1期)、MEDLINE(1966年1月至2004年12月)、EMBASE(1988年1月至2004年12月)、PsycINFO(1985年1月至2004年12月)以及文章的参考文献列表。我们还联系了该领域的制造商和研究人员。
所有聚焦于使用美沙酮递减疗法与所有其他药物戒毒治疗或安慰剂治疗阿片类药物戒断的随机对照试验。
两名评审员评估纳入的研究。关于如何对研究进行评分的任何疑问,通过与第三名评审员讨论来解决。根据Cochrane综述手册4.2(Alderson 2004)中指出的标准评估研究质量。
纳入了16项涉及1187人的试验。比较美沙酮与任何其他药物治疗,我们观察到两种治疗在治疗完成方面无临床差异,相对风险(RR)为1.12;95%置信区间为0.94至1.34,随访结果RR为1.17;95%置信区间为0.72至1.92。无法汇总其他结局的数据,但研究结果未显示所考虑的治疗之间存在显著差异。当我们考虑单个比较时,这些结果也得到了证实:美沙酮与:肾上腺素能激动剂(11项研究)、其他阿片类激动剂(4项研究)、氯氮卓(1项研究)。比较美沙酮与安慰剂(1项研究),发现安慰剂组有更严重的戒断反应和更多的退出者。结果表明,纳入研究中使用的药物在总体有效性方面相似,尽管参与者经历的症状因使用的药物和采用的方案而异。
文献数据难以比较;方案在持续时间、设计和治疗目标方面差异很大,影响了荟萃分析的应用。本综述纳入的研究证实,缓慢递减并临时替代长效阿片类药物,同时进行医学监督和辅助药物治疗,可以减轻戒断严重程度。然而,大多数患者复发使用海洛因。