慢性非癌痛患者中曲马多、短效氢可酮或短效羟考酮起始使用阿片类药物相关不良结局的比较研究。
Comparative Study of Opioid Initiation With Tramadol, Short-acting Hydrocodone, or Short-acting Oxycodone on Opioid-related Adverse Outcomes Among Chronic Noncancer Pain Patients.
机构信息
Division of Pharmaceutical Evaluation and Policy.
Department of Biomedical Informatics, College of Medicine.
出版信息
Clin J Pain. 2023 Mar 1;39(3):107-118. doi: 10.1097/AJP.0000000000001093.
OBJECTIVE
To compare the safety profiles of low and high-dose tramadol, short-acting hydrocodone, and short-acting oxycodone therapies among chronic noncancer pain individuals.
MATERIALS AND METHODS
A retrospective cohort study of individuals with back/neck pain/osteoarthritis with an initial opioid prescription for tramadol, hydrocodone, or oxycodone was conducted using IQVIA PharMetrics Plus claims for Academics database (2006 to 2020). Two cohorts were created for separately studying opioid-related adverse events (overdoses, accidents, self-inflicted injuries, and violence-related injuries) and substance use disorders (opioid and nonopioid). Patients were followed from the index date until an outcome event, end of enrollment, or data end. Time-varying exposure groups were constructed and Cox regression models were estimated.
RESULTS
A total of 1,062,167 (tramadol [16.5%], hydrocodone [61.1%], and oxycodone [22.4%]) and 986,809 (tramadol [16.5%], hydrocodone [61.3%], and oxycodone [22.2%]) individuals were in the adverse event and substance use disorder cohorts. All high-dose groups had elevated risk of nearly all outcomes, compared with low-dose hydrocodone. Compared with low-dose hydrocodone, low-dose oxycodone was associated with a higher risk of opioid overdose (hazard ratio: 1.79 [1.37 to 2.33]). No difference in risk was observed between low-dose tramadol and low-dose hydrocodone (hazard ratio: 0.85 [0.64 to 1.13]). Low-dose oxycodone had higher risks of an opioid use disorder, and low-dose tramadol had a lower risk of accidents, self-inflicted injuries, and opioid use disorder compared with low-dose hydrocodone.
DISCUSSION
Low-dose oxycodone had a higher risk of opioid-related adverse outcomes compared with low-dose tramadol and hydrocodone. This should be interpreted in conjunction with the benefits of pain control and functioning associated with oxycodone use in future research.
目的
比较低剂量曲马多、短效氢可酮和短效羟考酮治疗慢性非癌痛患者的安全性。
材料与方法
采用 IQVIA PharMetrics Plus 索赔学术数据库（2006 年至 2020 年）对接受曲马多、氢可酮或羟考酮初始阿片类药物处方的背痛/颈痛/骨关节炎患者进行回顾性队列研究。分别研究阿片类药物相关不良事件（过量、事故、自残和与暴力相关的伤害）和物质使用障碍（阿片类和非阿片类），创建了两个队列。患者从指数日期开始随访，直到发生结局事件、入组结束或数据结束。构建了时变暴露组，并估计了 Cox 回归模型。
结果
共有 1062167 例（曲马多[16.5%]、氢可酮[61.1%]和羟考酮[22.4%]）和 986809 例（曲马多[16.5%]、氢可酮[61.3%]和羟考酮[22.2%]）患者分别进入不良事件和物质使用障碍队列。与低剂量氢可酮相比，所有高剂量组几乎都有更高的所有结局风险。与低剂量氢可酮相比，低剂量羟考酮与阿片类药物过量风险较高相关（风险比：1.79[1.37 至 2.33]）。低剂量曲马多与低剂量氢可酮之间未观察到风险差异（风险比：0.85[0.64 至 1.13]）。与低剂量氢可酮相比，低剂量羟考酮发生阿片类药物使用障碍的风险较高，而低剂量曲马多发生事故、自残和阿片类药物使用障碍的风险较低。
讨论
与低剂量曲马多和氢可酮相比，低剂量羟考酮发生阿片类药物相关不良结局的风险更高。在未来的研究中，应结合曲马多和羟考酮使用与疼痛控制和功能改善相关的益处来解释这一点。
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