Minozzi Silvia, Amato Laura, Bellisario Cristina, Davoli Marina
Department of Epidemiology, Lazio Regional Health Service, Via di Santa Costanza, 53, Rome, Italy, 00198.
Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD007210. doi: 10.1002/14651858.CD007210.pub3.
The scientific literature examining effective treatments for opioid-dependent adults clearly indicates that pharmacotherapy is a necessary and acceptable component. Nevertheless, no reviews have been published that systematically assess the effectiveness of pharmacological maintenance treatment in adolescents.
To assess the effectiveness of any maintenance treatment alone or in combination with psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions for retaining adolescents in treatment, reducing the use of substances and improving health and social status.
We searched the Cochrane Drugs and Alcohol Group's Trials Register (January 2014), the Cochrane Central Register of Controlled Trials (2014, Issue 1), PubMed (January 1966 to January 2014), EMBASE (January 1980 to January 2014), CINAHL (January 1982 to January 2014), Web of Science (1991 to January 2014) and reference lists of articles.
Randomised and controlled clinical trials of any maintenance pharmacological interventions either alone or associated with psychosocial intervention compared with no intervention, placebo, other pharmacological intervention, pharmacological detoxification or psychosocial intervention in adolescents (13 to 18 years).
We used the standard methodological procedures expected by The Cochrane Collaboration.
We included two trials involving 189 participants. One study, with 35 participants, compared methadone with levo-alpha-acetylmethadol (LAAM) for maintenance treatment lasting 16 weeks, after which patients were detoxified. The other study, with 154 participants, compared maintenance treatment with buprenorphine-naloxone and detoxification with buprenorphine. We did not perform meta-analysis because the two studies assessed different comparisons.In the study comparing methadone and LAAM, the authors declared that there was no difference in the use of a substance of abuse or social functioning (data not shown). The quality of the evidence was very low. No side effects, such as nausea, vomiting, constipation, weakness or fatigue, were reported by study participants.In the comparison between buprenorphine maintenance and buprenorphine detoxification, maintenance treatment appeared to be more efficacious in retaining patients in treatment (drop-out risk ratio (RR) 0.37; 95% confidence interval (CI) 0.26 to 0.54), but not in reducing the number of patients with a positive urine test at the end of the study (RR 0.97; 95% CI 0.78 to 1.22). Self reported opioid use at one-year follow-up was significantly lower in the maintenance group, even though both groups reported a high level of opioid use (RR 0.73; 95% CI 0.57 to 0.95). More patients in the maintenance group were enrolled in other addiction treatment programmes at 12-month follow-up (RR 1.33; 95% CI 0.94 to 1.88). The quality of the evidence was low. No serious side effects attributable to buprenorphine-naloxone were reported by study participants and no patients were removed from the study due to side effects. The most common side effect was headache, which was reported by 16% to 21% of patients in both groups
AUTHORS' CONCLUSIONS: It is difficult to draft conclusions on the basis of only two trials. One of the possible reasons for the lack of evidence could be the difficulty of conducting trials with young people for practical and ethical reasons.There is an urgent need for further randomised controlled trials comparing maintenance treatment with detoxification treatment or psychosocial treatment alone before carrying out studies that compare different pharmacological maintenance treatments. These studies should have long follow-up and measure relapse rates after the end of treatment and social functioning (integration at school or at work, family relationships).
研究阿片类药物依赖成年人有效治疗方法的科学文献明确表明,药物治疗是必要且可接受的组成部分。然而,尚未发表系统评估青少年药物维持治疗有效性的综述。
评估任何维持治疗单独使用或与心理社会干预联合使用相比于无干预、其他药物干预或心理社会干预,在使青少年持续接受治疗、减少物质使用以及改善健康和社会状况方面的有效性。
我们检索了Cochrane药物与酒精组试验注册库(2014年1月)、Cochrane对照试验中央注册库(2014年第1期)、PubMed(1966年1月至2014年1月)、EMBASE(1980年1月至2014年1月)、CINAHL(1982年1月至2014年1月)、科学引文索引(1991年至2014年1月)以及文章的参考文献列表。
针对青少年(13至18岁),比较任何单独的维持性药物干预或与心理社会干预联合使用与无干预、安慰剂、其他药物干预、药物脱毒或心理社会干预的随机对照临床试验。
我们采用了Cochrane协作网期望的标准方法程序。
我们纳入了两项涉及189名参与者的试验。一项有35名参与者的研究,比较了美沙酮与左-α-乙酰美沙醇(LAAM)进行为期16周的维持治疗,之后患者进行脱毒。另一项有154名参与者的研究,比较了丁丙诺啡-纳洛酮维持治疗与丁丙诺啡脱毒治疗。我们未进行荟萃分析,因为两项研究评估的是不同的比较。在比较美沙酮和LAAM的研究中,作者宣称在滥用物质的使用或社会功能方面无差异(数据未显示)。证据质量非常低。研究参与者未报告恶心、呕吐、便秘、虚弱或疲劳等副作用。在丁丙诺啡维持治疗与丁丙诺啡脱毒治疗的比较中,维持治疗在使患者持续接受治疗方面似乎更有效(退出风险比(RR)0.37;95%置信区间(CI)0.26至0.54),但在研究结束时减少尿检测阳性患者数量方面效果不明显(RR 0.97;95%CI 0.78至1.22)。在一年随访时,维持治疗组自我报告的阿片类药物使用显著更低,尽管两组报告的阿片类药物使用水平都很高(RR 0.73;95%CI 0.57至0.95)。在12个月随访时,维持治疗组有更多患者参加了其他成瘾治疗项目(RR 1.33;95%CI 0.94至1.88)。证据质量低。研究参与者未报告丁丙诺啡-纳洛酮所致的严重副作用,也没有患者因副作用退出研究。最常见的副作用是头痛,两组中16%至21%的患者报告有头痛。
仅依据两项试验很难得出结论。缺乏证据的一个可能原因是出于实际和伦理原因,对年轻人进行试验存在困难。在开展比较不同药物维持治疗的研究之前,迫切需要进一步的随机对照试验,比较维持治疗与脱毒治疗或单独的心理社会治疗。这些研究应进行长期随访,并测量治疗结束后的复发率以及社会功能(在学校或工作中的融入情况、家庭关系)。