Pearson Center for Alcoholism and Addiction Research, Committee on the Neurobiology of Addictive Disorders, The Scripps Research Institute, La Jolla, California 92037, USA.
Alcohol Clin Exp Res. 2012 Mar;36(3):497-508. doi: 10.1111/j.1530-0277.2011.01616.x. Epub 2011 Sep 6.
It is unknown whether women derive comparable benefits and have a similar safety and tolerability profile as men from acamprosate, a widely prescribed drug for the maintenance of abstinence in alcohol dependence. The objective of this study was to assess sex-specific differences in the efficacy, safety, and tolerability of acamprosate in the treatment of women and men with alcohol dependence.
A sex-specific meta-analysis was conducted based on individual patient data (IPD). Data were obtained from double-blind, randomized controlled trials with quantitative drinking measures in patients with alcohol dependence receiving oral acamprosate or placebo. Sources included PubMed, PsychInfo, and Cochrane electronic databases; reference lists from retrieved articles and presentations at professional meetings; and direct access to authors and companies who provided IPD.
Individual records were obtained from 1,317 women and 4,794 men who participated in 22 eligible studies conducted in 18 countries. IPD meta-analyses found a significant beneficial effect of acamprosate relative to placebo across all 4 efficacy end points: an incremental gain of 10.4% (95% CI 7.1 to 13.7, p < 0.001) in percentage of abstinent days, an incremental gain of 11.0% (7.4 to 14.6, p < 0.001) in percentage of no heavy drinking days, an odds ratio of 1.9 (1.6 to 2.2, p < 0.001) for rate of complete abstinence, and an odds ratio of 1.9 (1.6 to 2.3, p < 0.001) for rate of no heavy drinking, over the study duration. Acamprosate was also associated with significantly higher rates of treatment completion (p = 0.004) and medication compliance (p < 0.001) than placebo. Men and women did not differ on any measure of acamprosate efficacy, safety, or tolerability.
This sex-specific IPD meta-analysis provides evidence that acamprosate has a significant effect compared with placebo in improving rates of abstinence and no heavy drinking in both women and men with alcohol dependence. Further, acamprosate was associated with significantly higher rates of treatment completion and medication compliance than placebo among both women and men and had a comparable safety and tolerability profile.
安非他酮是一种广泛用于治疗酒精依赖患者戒酒维持的药物，但目前尚不清楚女性是否能像男性一样从安非他酮治疗中获得类似的疗效、安全性和耐受性获益。本研究旨在评估安非他酮治疗女性和男性酒精依赖患者的疗效、安全性和耐受性是否存在性别差异。
基于个体患者数据（IPD）进行了性别特异性荟萃分析。这些数据来自于 22 项随机双盲对照试验，试验中使用口服安非他酮或安慰剂治疗有定量饮酒行为的酒精依赖患者。数据来源包括 PubMed、PsychInfo 和 Cochrane 电子数据库、检索文章的参考文献列表和专业会议的演讲、以及直接联系提供 IPD 的作者和公司。
从参与了 18 个国家 22 项合格研究的 1317 名女性和 4794 名男性中获得了个体记录。IPD 荟萃分析发现，与安慰剂相比，安非他酮在所有 4 个疗效终点上均有显著的获益：无酗酒天数的百分比增加 11.0%（7.4 至 14.6，p < 0.001），完全戒酒的比例增加 10.4%（7.1 至 13.7，p < 0.001），完全戒酒的比值比为 1.9（1.6 至 2.2，p < 0.001），无重度饮酒的比值比为 1.9（1.6 至 2.3，p < 0.001），在研究期间。与安慰剂相比，安非他酮还与更高的治疗完成率（p = 0.004）和药物依从性（p < 0.001）相关。在安非他酮的疗效、安全性或耐受性方面，男性和女性之间没有差异。
这项基于个体患者数据的性别特异性荟萃分析提供了证据，表明与安慰剂相比，安非他酮可显著提高女性和男性酒精依赖患者的戒酒和无重度饮酒率。此外，与安慰剂相比，安非他酮在女性和男性中均与更高的治疗完成率和药物依从性相关，且安全性和耐受性相当。
