莫达非尼治疗苯丙胺类兴奋剂使用障碍的疗效和安全性:随机安慰剂对照试验的系统回顾和元分析》(Meta-Analysis of Randomized Placebo-Controlled Trials)。

IF 3.3 3区 医学 Q2 PSYCHIATRY
Laurent Elkrief, Heidar Sharafi, Hamzah Bakouni, Christina McAnulty, Gabriel Bastien, Simon Dubreucq, Nicolas Garel, Annie Trépanier, Daniela Ziegler, Didier Jutras-Aswad
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引用次数: 0

摘要

导言:苯丙胺类兴奋剂(ATS)在全球范围内造成了严重危害,而针对苯丙胺类兴奋剂使用障碍(ATSUD)的有效药物治疗却十分有限。莫达非尼被认为是治疗苯丙胺类兴奋剂使用障碍的潜在药物。本系统综述和荟萃分析(PROSPERO ID:CRD42023388487)旨在评估莫达非尼治疗ATSUD的有效性和安全性:于 2023 年 2 月 15 日对主要索引来源和试验登记进行了全面检索,检索时间从开始到检索日,并于 2023 年 10 月 31 日进行了更新。符合条件的研究均为莫达非尼对符合《精神疾病诊断与统计手册》第四版和第五版ATSUD诊断标准的个体进行的随机安慰剂对照试验(RCT)。采用科克伦偏倚风险工具对符合条件的研究进行了偏倚风险评估。主要结果包括莫达非尼对苯丙胺类兴奋剂使用的影响。次要结果包括治疗的保留率、对苯丙胺类兴奋剂的渴求、因不良事件(AEs)而中断治疗以及严重不良事件。根据莫达非尼剂量酌情进行分组分析。对二分变量的荟萃分析计算风险比(RR)或佩托几率比(OR),对连续变量的随机效应荟萃分析计算标准化平均差(SMD):结果:共纳入了五项研究性临床试验(N = 451 名参与者)。莫达非尼对苯丙胺类兴奋剂的使用(RR = 0.99; 95% CI, 0.97 to 1.02; p = 0.655)、治疗的持续时间(RR = 1.02; 95% CI, 0.91 to 1.14; p = 0.799)、对苯丙胺类兴奋剂的渴求(SMD = -0.36;95% CI,-1.19 至 0.47;p = 0.398),或因 AEs 而中断治疗(Peto's OR = 0.48;95% CI,0.20 至 1.14;p = 0.100)。这些结果在亚组分析中是一致的。与安慰剂组相比,莫达非尼组报告的严重AE更多,剂量更高(Peto's OR = 4.80; 95% CI, 1.18 to 19.56, p = 0.029):目前没有证据表明莫达非尼对 ATSUD 患者的疗效有显著的统计学影响。继续研究针对 ATSUD 的有效治疗方法和减少伤害策略至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and Safety of Modafinil for Treatment of Amphetamine-Type Stimulant Use Disorder: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials: Efficacité et innocuité du modafinil pour le traitement des troubles liés à l'usage de stimulants de type amphétamine : revue systématique et méta-analyse d'essais randomisés contrôlés par placebo.

Introduction: Amphetamine-type stimulants (ATSs) are related to significant harm worldwide, with limited effective pharmacological treatments for ATS use disorder (ATSUD). Modafinil has been explored as a potential treatment for ATSUD. This systematic review and meta-analysis (PROSPERO ID: CRD42023388487) aimed to evaluate the efficacy and safety of modafinil for the treatment of ATSUD.

Methods: A comprehensive search of major indexing sources and trial registries, from inception to search date, was conducted on February 15, 2023, and updated on October 31, 2023. Eligible studies were randomized placebo-controlled trials (RCTs) of modafinil in individuals meeting the criteria for the Diagnostic and Statistical Manual of Mental Disorders, fourth and fifth editions, diagnoses of ATSUD. Eligible studies were assessed for risk of bias, using the Cochrane Risk of Bias tool. The primary outcome included the effect of modafinil on ATS use. Secondary outcomes included retention in treatment, ATS craving, treatment discontinuation due to adverse events (AEs), and serious AEs. Subgroup analysis by modafinil dose was conducted where appropriate. Risk ratio (RR) or Peto's odds ratio (OR) was calculated for the meta-analysis of dichotomous variables and standardized mean difference (SMD) was calculated for the random-effect meta-analysis of continuous variables.

Results: Five RCTs (N = 451 participants) were included. Modafinil did not significantly impact ATS use (RR = 0.99; 95% CI, 0.97 to 1.02; p = 0.655), retention in treatment (RR = 1.02; 95% CI, 0.91 to 1.14; p = 0.799), ATS craving (SMD = -0.36; 95% CI, -1.19 to 0.47; p = 0.398), or treatment discontinuation due to AEs (Peto's OR = 0.48; 95% CI, 0.20 to 1.14; p = 0.100). These results were consistent across subgroup analyses. More episodes of serious AEs were reported in the modafinil group than in the placebo group, at higher doses (Peto's OR = 4.80; 95% CI, 1.18 to 19.56, p = 0.029).

Conclusion: There is currently no evidence suggesting that modafinil has a statistically significant effect on efficacy outcomes in populations with ATSUD. Continued research into effective treatments and harm reduction strategies for ATSUD is essential.

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来源期刊
CiteScore
7.00
自引率
2.50%
发文量
69
审稿时长
6-12 weeks
期刊介绍: Established in 1956, The Canadian Journal of Psychiatry (The CJP) has been keeping psychiatrists up-to-date on the latest research for nearly 60 years. The CJP provides a forum for psychiatry and mental health professionals to share their findings with researchers and clinicians. The CJP includes peer-reviewed scientific articles analyzing ongoing developments in Canadian and international psychiatry.
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