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首页> 外文期刊>Journal of studies on alcohol and drugs. >Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review.
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Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review.

机译：纳曲酮药物治疗试验中的依从性监测：系统评价。

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OBJECTIVE: The efficacy of naltrexone (Revia, Vivitrol) for the treatment of alcohol dependence exhibits a high degree of heterogeneity. The aim of the current study was to evaluate the extent to which variability in patient adherence to treatment contributed to the range of clinical responses observed during naltrexone treatment. METHOD: A systematic review was conducted of efficacy trials of naltrexone for the treatment of alcohol dependence to evaluate the level of adherence monitoring. RESULTS: Of 49 identified trials, 22 (49%) met the inclusion criteria of being randomized, double-blind, placebo-controlled trials that reported adherence. The "adherence-assurance score" of these trials was calculated as a function of the frequency with which "low," "moderate," or high randomized, controlled trials, only 3 (14%) met criteria for high levels of adherence assurance, 5 (23%) met medium adherenceassurance criteria, and 14 (64%) met low adherence criteria. Of the three high-assurance studies, one used direct supervision of thrice-weekly oral dosing of naltrexone, and two used extended-release injectable formulations of naltrexone administered once per month. The Spearman correlation between risk ratios for return to heavy drinking (for naltrexone vs. placebo) and the level of adherence assurance (low vs. medium vs. high) was significant (r = -.62, p = .025). CONCLUSIONS: These findings suggest that the modest effect sizes for naltrexone reported in systematic reviews and meta-analyses may be attributable, at least in part, to variability in naltrexone adherence rates. High-assurance adherence strategies should be standard practice in clinical trials of medications being evaluated for the treatment of alcohol dependence.
机译：目的：纳曲酮（Revia，Vivitrol）治疗酒精依赖的疗效表现出高度的异质性。当前研究的目的是评估患者对治疗依从性的差异程度在纳曲酮治疗期间观察到的临床反应范围。方法：对纳曲酮治疗酒精依赖的疗效试验进行了系统评价，以评估依从性监测水平。结果：在49项确定的试验中，有22项（49％）符合纳入标准的随机，双盲，安慰剂对照试验报告了依从性。这些试验的“依从性保证分数”是根据“低”，“中”或“高”随机对照试验的频率进行计算的，只有3（14％）个符合高水平依从性保证标准， 5个（23％）符合中等遵守保证标准，而14个（64％）符合低遵守标准。在三项高保证研究中，一项使用了纳曲酮每周三次口服给药的直接监督，另外两项使用了每月一次纳曲酮的缓释注射剂。重度饮酒的风险比（纳曲酮与安慰剂）与依从保证水平（低vs.中vs.高）之间的Spearman相关性很显着（r = -.62，p = .025）。结论：这些发现表明，在系统评价和荟萃分析中报道的纳曲酮适度的疗效大小可能至少部分归因于纳曲酮的依从性变化。在对酒精依赖治疗进行评估的药物的临床试验中，高放心依从性策略应成为标准实践。

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