安达卢西亚试验中处方注射用二乙酰吗啡的疗效：根据多领域结果指标对反应者和无反应者进行的贝叶斯分析。

Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index.

作者信息

Perea-Milla Emilio, Ayçaguer Luis Carlos Silva, Cerdà Joan Carles March, Saiz Francisco González, Rivas-Ruiz Francisco, Danet Alina, Vallecillo Manuel Romero, Oviedo-Joekes Eugenia

机构信息

Research Support Unit, Hospital Costa del Sol, Ctra Nacional 340, km 187, 29603 Marbella, Spain.

出版信息

Trials. 2009 Aug 14;10:70. doi: 10.1186/1745-6215-10-70.

DOI:10.1186/1745-6215-10-70

PMID:19682360

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2739523/

Abstract

BACKGROUND

The objective of this research was to evaluate data from a randomized clinical trial that tested injectable diacetylmorphine (DAM) and oral methadone (MMT) for substitution treatment, using a multi-domain dichotomous index, with a Bayesian approach.

METHODS

Sixty two long-term, socially-excluded heroin injectors, not benefiting from available treatments were randomized to receive either DAM or MMT for 9 months in Granada, Spain. Completers were 44 and data at the end of the study period was obtained for 50. Participants were determined to be responders or non responders using a multi-domain outcome index accounting for their physical and mental health and psychosocial integration, used in a previous trial. Data was analyzed with Bayesian methods, using information from a similar study conducted in The Netherlands to select a priori distributions. On adding the data from the present study to update the a priori information, the distribution of the difference in response rates were obtained and used to build credibility intervals and relevant probability computations.

RESULTS

In the experimental group (n = 27), the rate of responders to treatment was 70.4% (95% CI 53.287.6), and in the control group (n = 23), it was 34.8% (95% CI 15.354.3). The probability of success in the experimental group using the a posteriori distributions was higher after a proper sensitivity analysis. Almost the whole distribution of the rates difference (the one for diacetylmorphine minus methadone) was located to the right of the zero, indicating the superiority of the experimental treatment.

CONCLUSION

The present analysis suggests a clinical superiority of injectable diacetylmorphine compared to oral methadone in the treatment of severely affected heroin injectors not benefiting sufficiently from the available treatments.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN52023186.

摘要

背景

本研究的目的是使用多领域二分指数，采用贝叶斯方法，评估一项随机临床试验的数据，该试验测试了注射用二乙酰吗啡（DAM）和口服美沙酮（MMT）用于替代治疗的效果。

方法

62名长期被社会排斥的海洛因注射者，未从现有治疗中获益，在西班牙格拉纳达被随机分配接受DAM或MMT治疗9个月。完成治疗的有44人，研究期末获得了50人的数据。使用先前试验中使用的多领域结局指数，根据参与者的身心健康和社会心理融合情况，确定其为反应者或无反应者。采用贝叶斯方法进行数据分析，利用在荷兰进行的一项类似研究的信息来选择先验分布。在加入本研究的数据以更新先验信息后，获得反应率差异的分布，并用于构建可信度区间和相关概率计算。

结果

在实验组（n = 27）中，治疗反应者的比例为70.4%（95%可信区间53.2-87.6），在对照组（n = 23）中为34.8%（95%可信区间15.3-54.3）。经过适当的敏感性分析后，使用后验分布，实验组成功的概率更高。几乎整个率差分布（二乙酰吗啡减去美沙酮的分布）都位于零的右侧，表明实验治疗的优越性。