Ferri M, Davoli M, Perucci C A
Cochrane Drugs and Alcohol Group, Department of Epidemiology ASL RME, Via di Santa Costanza, 53, Roma, Italy.
Cochrane Database Syst Rev. 2003(3):CD003410. doi: 10.1002/14651858.CD003410.
Dependent heroin users are characterised by the persistence of use in spite of the difficulties they experience with health, law, social achievements and personal relationships. The present review will consider maintenance treatment in which the patients enter programs of pharmacological administration tailored to achieve patient stabilisation. Many medications have been used for this purpose such as: Methadone, Buprenorphine and LAAM. The present review will focus on maintenance treatment through the prescription of heroin.
To assess the efficacy and acceptability of heroin maintenance versus methadone or other substitution treatments for opioid dependence, in retaining patients in treatment; reducing the use of illicit substances and improving health and social functioning.
The Cochrane Central Register of Trials (CENTRAL) issue 4, 2002; MEDLINE (on Silver Platter) 1966-2002; EMBASE (on OVID) 1980-2000 and CINAHL till 2000 were searched. There was no language or publication year restrictions. Many researchers were contacted for information.
Randomised controlled trials of heroin (alone or combined with methadone) maintenance treatment compared with any other pharmacological treatments.
The trials were independently assessed for inclusion and methodological quality by the reviewers. Data were extracted independently and double checked. Studies were not pooled together because of heterogeneity.
2400 references were obtained and 20 studies were eligible, 4 met the inclusion criteria for a total of 577 patients. The studies included could not be analysed cumulatively because of heterogeneity of interventions and outcomes considered. Two studies compared injected heroin to oral methadone for 1 year (270 patients) but considered different outcomes; one study compared injected heroin and methadone to oral methadone for 6 months (51 patients); and one compared inhaled heroin and methadone to oral methadone for 1 year (235 patients). Retention in treatment: in two studies there was no statistical difference between groups; one study (N=90) had a RR=2.49 (95% CI 1.51-4.10) in favour of heroin; one study (N=235) had a RR 0.79 (95%CI 0.68-0.90) in favour of methadone. Relapse to illegal heroin use, based on self report: in one study the proportion of people still using heroin were 64% in the heroin group, 59% methadone group; in the other study the RR was 0.33 (95%CI 0.15-0.72) in favour of heroin. The remaining studies did not provide the data. Criminal offence: one of the two studies which provided details about this showed the potential of heroin prescription in reducing the risk of being charged RR 0.32 (95% CI 0.14-0.78). Social functioning: the two studies reporting this outcome did not show statistical difference between intervention groups. The two most recent studies considered criminal offence and social functioning as part of a multidomain outcome measure and showed higher improvement among those treated with heroin plus methadone over those on methadone only.
REVIEWER'S CONCLUSIONS: No definitive conclusions about the overall effectiveness of heroin prescription is possible because of non-comparability of the experimental studies available to be included in this review. Results favouring heroin treatment come from studies conducted in countries where the treatment system is comprehensive and easy accessible Methadone Maintenance Treatment at effective dosages is available. In those studies heroin prescription was addressed to patients who had failed previous methadone treatments.
依赖海洛因的使用者的特点是,尽管在健康、法律、社会成就和人际关系方面遭遇困难,但仍持续使用海洛因。本综述将探讨维持治疗,即患者进入为实现病情稳定而量身定制的药物管理项目。许多药物已被用于此目的,如:美沙酮、丁丙诺啡和左-α-乙酰美沙酮(LAAM)。本综述将聚焦于通过开具海洛因处方进行维持治疗。
评估海洛因维持治疗与美沙酮或其他阿片类药物依赖替代治疗相比,在使患者坚持治疗、减少非法物质使用以及改善健康和社会功能方面的疗效和可接受性。
检索了Cochrane临床试验中心注册库(CENTRAL)2002年第4期;MEDLINE(银盘数据库)1966年至2002年;EMBASE(OVID平台)1980年至2000年以及CINAHL截至2000年的数据。无语言或出版年份限制。还联系了许多研究人员以获取信息。
海洛因(单独或与美沙酮联合)维持治疗与任何其他药物治疗相比较的随机对照试验。
由评审人员独立评估试验是否符合纳入标准及方法学质量。数据独立提取并进行二次核对。由于存在异质性,未对研究进行合并分析。
共获取2400篇参考文献,20项研究符合条件,4项符合纳入标准,共计577名患者。由于所考虑的干预措施和结果存在异质性,纳入的研究无法进行累积分析。两项研究将注射用海洛因与口服美沙酮进行了1年的比较(270名患者),但考虑的结果不同;一项研究将注射用海洛因和美沙酮与口服美沙酮进行了6个月的比较(51名患者);另一项研究将吸入用海洛因和美沙酮与口服美沙酮进行了1年的比较(235名患者)。坚持治疗情况:两项研究中组间无统计学差异;一项研究(N = 90)中,相对危险度(RR)= 2.49(95%可信区间[CI] 1.51 - 4.10),支持海洛因治疗;一项研究(N = 235)中,RR为0.79(95%CI 0.68 - 0.90),支持美沙酮治疗。基于自我报告的非法海洛因复吸情况:一项研究中,海洛因组仍在使用海洛因的人群比例为64%,美沙酮组为59%;另一项研究中,RR为0.33(95%CI 0.15 - 0.72),支持海洛因治疗。其余研究未提供相关数据。刑事犯罪情况:两项提供此方面详细信息的研究之一显示,开具海洛因处方有降低被指控风险的可能性,RR为0.32(95%CI 0.14 - 0.78)。社会功能情况:报告此结果的两项研究未显示干预组间存在统计学差异。最近的两项研究将刑事犯罪和社会功能作为多领域结果指标的一部分进行考量,结果显示,接受海洛因加美沙酮治疗的患者比仅接受美沙酮治疗的患者改善程度更高。
由于本综述中纳入的实验研究缺乏可比性,因此无法就开具海洛因处方的总体有效性得出明确结论。支持海洛因治疗的结果来自于那些治疗体系全面且易于获得有效剂量美沙酮维持治疗的国家所开展的研究。在这些研究中,海洛因处方针对的是先前美沙酮治疗失败的患者。