将研究设计与处方意图相匹配:用于研究阿片类药物的滥用威配方的流行新用户设计
Bethany L DiPrete1,2, GYeon Oh3,4,5,6, Daniela C Moga3,4,5,6
1Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.
Pharmacoepidemiology and drug safety
|May 9, 2024
概括
对滥用威制剂 (ADF) 类阿片类药物的营销后研究需要精心设计. 大多数开始使用ADF类阿片类药物的患者先前接触过ADF,与非ADF发起者相比,临床差异很大,因此需要考虑根据适用情况进行混.
科学领域:
- 药物监督和药物流行病学
- 片类止痛药 止痛药是一种阿片类止痛药.
- 药物安全和营销后监督
背景情况:
- 药物研究的研究设计可以限制对关键患者群体的访问.
- 在最初使用阿片类药物后,阿片类药物的滥用威配方 (ADF) 经常被处方.
- 对ADF阿片类药物的营销后研究需要仔细考虑研究设计,比较者选择和根据指示进行混.
研究的目的:
- 为了评估患者的特征和阿片类药物治疗史,对于那些开始使用滥用威剂 (ADF) 与非ADF延长释放/长效阿片类药物 (ER/LA) 的人来说.
- 为ADF阿片类药物的营销后研究的设计和解释提供信息.
- 强调在ADF阿片类药物研究中解决因适应症而引起的混的重要性.
主要方法:
- 使用来自北卡罗来纳州 (2006-2018) 和Merative MarketScan的索赔数据进行的回顾性队列研究.
- 确定18-64岁的患者开始使用ADF或非ADFER/LA类阿片类药物.
- 将患者分类为传统的新用户 (前6个月没有阿片类药物索赔) 或流行的新用户.
主要成果:
- 确定了ADF (n=147,978 MarketScan) 和非ADFER/LA阿片类药物启动剂 (n=232,028 MarketScan) 的大型队列.
- 大多数开始使用ADF和非ADFER/LA类阿片类药物的患者之前曾接触过阿片类药物 (64%-74%).
- 开始使用ADF类阿片类药物的患者显示最近疼痛,慢性疼痛和手术的患病率更高,同时立即释放的阿片类药物处方在流行新用户中更为常见.
结论:
- 仔细考虑研究设计对于ADF阿片类药物的营销后研究至关重要.
- 选择适当的比较对象对于减轻ADF阿片类药物研究中的偏见至关重要.
- 在检查与ADF阿片类药物使用相关的结果时,根据指示解决混至关重要.
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