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马来西亚一项随机、参与者选择、开放性标签试验结果:出狱后,美沙酮预先发放对艾滋病毒和阿片类药物使用障碍者死亡率的影响。

Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia.

机构信息

Department of Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT, 06510-228, USA.

Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA.

出版信息

BMC Infect Dis. 2022 Nov 11;22(1):837. doi: 10.1186/s12879-022-07804-6.

Abstract

INTRODUCTION

Mortality is elevated after prison release and may be higher in people with HIV and opioid use disorder (OUD). Maintenance with opioid agonist therapy (OAT) like methadone or buprenorphine reduces mortality in people with OUD and may confer benefits to people with OUD and HIV leaving prison. Survival benefits of OAT, however, have not been evaluated prospectively in people with OUD and HIV leaving prison.

METHODS

This study prospectively evaluated mortality after prison release and whether methadone initiated before release increased survival after release in a sample of men with HIV and OUD (n = 291). We linked national death records to data from a controlled trial of prerelease methadone initiation conducted from 2010 to 2014 with men with HIV and OUD imprisoned in Malaysia. Vital statistics were collected through 2015. Allocation to prerelease methadone was by randomization (n = 64) and participant choice (n = 246). Cox proportional hazards models were used to estimate treatment effects of prerelease methadone on postrelease survival.

RESULTS

Overall, 62 deaths occurred over 872.5 person-years (PY) of postrelease follow-up, a crude mortality rate of 71.1 deaths per 1000 PY (95% confidence interval [CI] 54.5-89.4). Most deaths were of infectious etiology, mostly related to HIV. In a modified intention-to-treat analysis, the impact of prerelease methadone on postrelease mortality was consistent with a null effect in unadjusted (hazard ratio [HR] 1.3, 95% CI 0.6-3.1) and covariate-adjusted (HR 1.2, 95% CI 0.5-2.8) models. Predictors of mortality were educational level (HR 1.4, 95% CI 1.0-1.8), pre-incarceration alcohol use (HR 2.0, 95% CI 1.1-3.9), and lower CD4 T-lymphocyte count (HR 0.8 per 100-cell/mL increase, 95% CI 0.7-1.0).

CONCLUSIONS

Postrelease mortality in this sample of men with HIV and OUD was extraordinarily high, and most deaths were likely of infectious etiology. No effect of prerelease methadone on postrelease mortality was observed, which may be due to study limitations or an epidemiological context in which inadequately treated HIV, and not inadequately treated OUD, is the main cause of death after prison release.

TRIAL REGISTRATION

NCT02396979. Retrospectively registered 24/03/2015.

摘要

简介

出狱后死亡率升高,艾滋病毒和阿片类药物使用障碍(OUD)患者的死亡率可能更高。美沙酮或丁丙诺啡等阿片类激动剂维持治疗(OAT)可降低 OUD 患者的死亡率,并可能使出狱后 OUD 和 HIV 患者受益。然而,OAT 的生存获益尚未在出狱后 OUD 和 HIV 患者中进行前瞻性评估。

方法

本研究前瞻性评估了出狱后的死亡率,并评估了在 2010 年至 2014 年间,马来西亚监禁的 HIV 和 OUD 男性(n=291)中,出狱前开始美沙酮是否增加了出狱后的生存。我们将全国死亡记录与一项关于出狱前开始美沙酮的对照试验数据相联系,该试验对 HIV 和 OUD 男性进行了前瞻性评估。通过 2015 年的生命统计数据进行收集。随机分配(n=64)和参与者选择(n=246)来分配出狱前的美沙酮。使用 Cox 比例风险模型估计出狱前美沙酮对出狱后生存的治疗效果。

结果

总的来说,在 872.5 人年的随访中,共有 62 人死亡(872.5 人年),死亡率为每 1000 人年 71.1 例(95%置信区间为 54.5-89.4)。大多数死亡是传染病病因,主要与 HIV 有关。在改良的意向治疗分析中,出狱前美沙酮对出狱后死亡率的影响与未调整(风险比[HR] 1.3,95%CI 0.6-3.1)和调整协变量(HR 1.2,95%CI 0.5-2.8)模型中的无效效果一致。死亡率的预测因素是教育水平(HR 1.4,95%CI 1.0-1.8)、入狱前饮酒(HR 2.0,95%CI 1.1-3.9)和较低的 CD4 淋巴细胞计数(每增加 100 个细胞/ml,HR 0.8,95%CI 0.7-1.0)。

结论

本研究中 HIV 和 OUD 男性样本的出狱后死亡率非常高,大多数死亡可能是传染病引起的。没有观察到出狱前美沙酮对出狱后死亡率的影响,这可能是由于研究限制或流行病学背景所致,在这种背景下,未得到充分治疗的 HIV,而不是未得到充分治疗的 OUD,是出狱后死亡的主要原因。

试验注册

NCT02396979。2015 年 3 月 24 日回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51e9/9652918/aab2751ea606/12879_2022_7804_Fig1_HTML.jpg

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