Larney Sarah, Gowing Linda, Mattick Richard P, Farrell Michael, Hall Wayne, Degenhardt Louisa
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia; Alpert Medical School, Brown University, Sydney, Australia.
Drug Alcohol Rev. 2014 Mar;33(2):115-28. doi: 10.1111/dar.12095. Epub 2013 Dec 3.
Naltrexone implants are used to treat opioid dependence, but their safety and efficacy remain poorly understood. We systematically reviewed the literature to assess the safety and efficacy of naltrexone implants for treating opioid dependence.
Studies were eligible if they compared naltrexone implants with another intervention or placebo. Examined outcomes were induction to treatment, retention in treatment, opioid and non-opioid use, adverse events, non-fatal overdose and mortality. Quality of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach. Data from randomised studies were combined using meta-analysis. Data from non-randomised studies were presented narratively.
Five randomised trials (n = 576) and four non-randomised studies (n = 8358) were eligible for review. The quality of the evidence ranged from moderate to very low. Naltrexone implants were superior to placebo implants [risk ratio (RR): 0.57; 95% confidence interval (CI) 0.48, 0.68; k = 2] and oral naltrexone (RR: 0.57; 95% CI 0.47, 0.70; k = 2) in suppressing opioid use. No difference in opioid use was observed between naltrexone implants and methadone maintenance (standardised mean difference: -0.33; 95% CI -0.93, 0.26; k = 1); however, this finding was based on low-quality evidence from one study.
The evidence on safety and efficacy of naltrexone implants is limited in quantity and quality, and the evidence has little clinical utility in settings where effective treatments for opioid dependence are used.
Better designed research is needed to establish the safety and efficacy of naltrexone implants. Until such time, their use should be limited to clinical trials. [Larney S, Gowing L, Mattick RP, Farrell M, Hall W, Degenhardt L. A systematic review and meta-analysis of naltrexone implants for the treatment of opioid dependence.
纳曲酮植入剂用于治疗阿片类药物依赖,但其安全性和有效性仍知之甚少。我们系统回顾了相关文献,以评估纳曲酮植入剂治疗阿片类药物依赖的安全性和有效性。
若研究将纳曲酮植入剂与另一种干预措施或安慰剂进行比较,则该研究符合纳入标准。所考察的结果包括治疗诱导、治疗维持、阿片类药物和非阿片类药物使用、不良事件、非致命性过量用药和死亡率。使用推荐分级的评估、制定与评价方法对证据质量进行评估。随机研究的数据采用荟萃分析进行合并。非随机研究的数据以叙述形式呈现。
五项随机试验(n = 576)和四项非随机研究(n = 8358)符合纳入综述的标准。证据质量从中等到极低不等。在抑制阿片类药物使用方面,纳曲酮植入剂优于安慰剂植入剂[风险比(RR):0.57;95%置信区间(CI)0.48,0.68;k = 2]和口服纳曲酮(RR:0.57;95% CI 0.47,0.70;k = 2)。在纳曲酮植入剂与美沙酮维持治疗之间未观察到阿片类药物使用方面的差异(标准化均差:-0.33;95% CI -0.93,0.26;k = 1);然而,这一发现基于一项研究的低质量证据。
关于纳曲酮植入剂安全性和有效性的证据在数量和质量上都很有限,且在使用阿片类药物依赖有效治疗方法的环境中,这些证据几乎没有临床实用性。
需要开展设计更优的研究来确定纳曲酮植入剂的安全性和有效性。在此之前,其使用应仅限于临床试验。[拉尼 S,高英 L,马蒂克 RP,法雷尔 M,霍尔 W,德根哈特 L。纳曲酮植入剂治疗阿片类药物依赖的系统评价与荟萃分析。