Lindblad Robert, Hu Lian, Oden Neal, Wakim Paul, Rosa Carmen, VanVeldhuisen Paul
The Emmes Corporation, Rockville, MD, United States.
Clinical Center, National Institutes of Health, Bethesda, MD, United States.
J Subst Abuse Treat. 2016 Nov;70:73-80. doi: 10.1016/j.jsat.2016.08.010. Epub 2016 Aug 15.
Most substance use disorders (SUD) treatment clinical trials are too short and small to reliably estimate the incidence of rare events like death.
The aim of this study is to estimate the overall mortality rates among a SUD treatment-seeking population by pooling participants from multiple clinical trials conducted through the National Institute on Drug Abuse (NIDA)-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN).
Drug and or alcohol users (N=9866) who sought treatment and participated in one of the twenty-two CTN trials.
Data were collected through randomized clinical trials in national community treatment programs for SUD. Pooled analysis was performed to assess age- and gender-standardized mortality rate(s) (SM rate(s)), and mortality ratio(s) (SM ratio(s)) of CTN trial participants compared to the U.S. general population.
The age- and gender-SM rate among CTN trials participants was 1403 (95% CI: 862-2074) per 100,000 person years (PY) compared to 542 (95% CI: 541-543) per 100,000 PY among the U.S. general population in 2005. By gender, age-adjusted SM ratio for female CTN trial participants was over five times (SM ratio=5.35, 95% CI: 3.31-8.19)), and for male CTN trial participants, it was over three times (SM ratio=3.39, 95% CI: 2.25-4.90) higher than their gender comparable peers in the U.S. general population.
Age and gender-standardized mortality rates and ratios among NIDA CTN SUD treatment-seeking clinical trial participants are higher than the age and gender comparable U.S. general population. The overall mortality rates of CTN trial participants are similar to in-treatment mortality reported in large U.S. and non-U.S. cohorts of opioid users. Future analysis with additional CTN trial participants and risk times will improve the stability of estimates, especially within subgroups based on primary substance of abuse. These SUD mortality rates can be used to facilitate safety monitoring within SUD clinical trials.
大多数物质使用障碍（SUD）治疗临床试验时间过短且规模过小，无法可靠地估计死亡等罕见事件的发生率。
本研究旨在通过汇总来自美国国立药物滥用研究所（NIDA）资助的国家药物滥用治疗临床试验网络（CTN）开展的多项临床试验的参与者，来估计寻求SUD治疗人群的总体死亡率。
寻求治疗并参与二十二项CTN试验之一的药物和/或酒精使用者（N = 9866）。
数据通过针对SUD的全国社区治疗项目中的随机临床试验收集。进行汇总分析以评估CTN试验参与者与美国普通人群相比的年龄和性别标准化死亡率（SM率）以及死亡率比（SM比）。
CTN试验参与者的年龄和性别标准化死亡率为每10万人年1403（95%可信区间：862 - 2074），而2005年美国普通人群为每10万人年542（95%可信区间：541 - 543）。按性别划分，女性CTN试验参与者的年龄调整后SM比是其在美国普通人群中性别匹配同龄人（SM比 = 5.35，95%可信区间：3.31 - 8.19）的五倍多，男性CTN试验参与者的年龄调整后SM比是其在美国普通人群中性别匹配同龄人（SM比 = 3.39，95%可信区间：2.25 - 4.90）的三倍多。
NIDA CTN寻求SUD治疗临床试验参与者的年龄和性别标准化死亡率及死亡率比高于美国年龄和性别匹配的普通人群。CTN试验参与者的总体死亡率与美国和非美国大型阿片类药物使用者队列中报告的治疗期间死亡率相似。纳入更多CTN试验参与者和风险时间进行的未来分析将提高估计的稳定性，尤其是在基于主要滥用物质的亚组内。这些SUD死亡率可用于促进SUD临床试验中的安全性监测。
