Kirchmayer U, Davoli M, Verster A
Agenzia di Sanità Pubblica Regione Lazio, Via di S. Costanza, 53, Rome, Lazio, Italy.
Cochrane Database Syst Rev. 2003(2):CD001333. doi: 10.1002/14651858.CD001367.
Despite widespread use of naltrexone maintenance in many countries for more than a decade, the evidence of its effects has not yet been systematically evaluated.
To evaluate the effects of naltrexone maintenance treatment in preventing relapse in opioid addicts after detoxification.
We searched MEDLINE (1973-first year of naltrexone use in humans-July 2000), EMBASE (1974-July 2000), Cochrane Controlled Trials Register (Cochrane Library issue 2001.4) and handsearched the "Bolletino per le Farmacodipendenze e l'Alcolismo" (1978 to 1997) and reference lists of relevant articles. We contacted pharmaceutical producers of naltrexone, authors and other Cochrane review groups. Date of most recent searches: February 2003.
All controlled studies of naltrexone; treatment of heroin addicts after detoxification.
Reviewers evaluated data independently and analysed outcome measures taking into consideration adherence to and success of the study intervention. Data were extracted and analysed stratifying for the three categories of study quality. Where possible, meta-analysis was performed.
Eleven studies met the criteria for inclusion in this review, even if not all of them were randomised. The methodological quality of the included studies varied, but was generally poor. Meta-analysis could be performed to a very low degree only, because the studies and their outcome measures were very heterogeneous. A statistically significant reduction of (re-)incarcerations was found for patients treated with naltrexone and behaviour therapy in respect to those treated with behaviour therapy only. The other outcomes considered in the meta-analysis did not yield any significant results. Final conclusions on whether naltrexone treatment may be considered effective in maintenance therapy cannot be drawn from the clinical trials available so far.
REVIEWER'S CONCLUSIONS: The available trials do not allow a final evaluation of naltrexone maintenance treatment yet. A trend in favour of treatment with naltrexone was observed for certain target groups (particularly people who are highly motivated), as has been previously described in the literature.
尽管纳曲酮维持疗法在许多国家已广泛应用了十多年,但其疗效证据尚未得到系统评估。
评估纳曲酮维持疗法对阿片类成瘾者脱毒后预防复吸的效果。
我们检索了MEDLINE(1973年——纳曲酮首次用于人体的年份——2000年7月)、EMBASE(1974年——2000年7月)、Cochrane对照试验注册库(Cochrane图书馆2001年第4期),并手工检索了《药物成瘾与酒精中毒通报》(1978年至1997年)以及相关文章的参考文献列表。我们联系了纳曲酮的制药生产商、作者及其他Cochrane综述小组。最近一次检索日期:2003年2月。
所有关于纳曲酮的对照研究;海洛因成瘾者脱毒后的治疗。
综述作者独立评估数据,并在考虑研究干预的依从性和成功率的基础上分析结果指标。数据按研究质量的三类进行提取和分析。在可能的情况下,进行荟萃分析。
11项研究符合纳入本综述的标准,尽管并非所有研究都是随机的。纳入研究的方法学质量各不相同,但总体较差。由于研究及其结果指标差异很大,只能进行非常有限的荟萃分析。发现接受纳曲酮和行为疗法治疗的患者与仅接受行为疗法治疗的患者相比,(再)监禁率有统计学意义的降低。荟萃分析中考虑的其他结果未产生任何显著结果。从目前可得的临床试验中无法得出纳曲酮治疗在维持治疗中是否有效的最终结论。
现有试验尚不能对纳曲酮维持疗法进行最终评估。如先前文献所述,在某些目标人群(特别是积极性高的人群)中观察到了支持纳曲酮治疗的趋势。