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曲马多与其他阿片类药物在全髋关节和膝关节置换术后的安全性比较。

Comparative safety of tramadol and other opioids following total hip and knee arthroplasty.

机构信息

Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, RI, USA.

Center for Gerontology and Healthcare Research, Brown University School of Public Health, Providence, RI, USA.

出版信息

BMC Geriatr. 2024 Apr 5;24(1):319. doi: 10.1186/s12877-024-04933-2.

Abstract

BACKGROUND

Tramadol is increasingly used to treat acute postoperative pain among older adults following total hip and knee arthroplasty (THA/TKA). However, tramadol has a complex pharmacology and may be no safer than full opioid agonists. We compared the safety of tramadol, oxycodone, and hydrocodone among opioid-naïve older adults following elective THA/TKA.

METHODS

This retrospective cohort included Medicare Fee-for-Service beneficiaries ≥ 65 years with elective THA/TKA between January 1, 2010 and September 30, 2015, 12 months of continuous Parts A and B enrollment, 6 months of continuous Part D enrollment, and no opioid use in the 6 months prior to THA/TKA. Participants initiated single-opioid therapy with tramadol, oxycodone, or hydrocodone within 7 days of discharge from THA/TKA hospitalization, regardless of concurrently administered nonopioid analgesics. Outcomes of interest included all-cause hospitalizations or emergency department visits (serious adverse events (SAEs)) and a composite of 10 surgical- and opioid-related SAEs within 90-days of THA/TKA. The intention-to-treat (ITT) and per-protocol (PP) hazard ratios (HRs) for tramadol versus other opioids were estimated using inverse-probability-of-treatment-weighted pooled logistic regression models.

RESULTS

The study population included 2,697 tramadol, 11,407 oxycodone, and 14,665 hydrocodone initiators. Compared to oxycodone, tramadol increased the rate of all-cause SAEs in ITT analyses only (ITT HR 1.19, 95%CLs, 1.02, 1.41; PP HR 1.05, 95%CLs, 0.86, 1.29). Rates of composite SAEs were not significant across comparisons. Compared to hydrocodone, tramadol increased the rate of all-cause SAEs in the ITT and PP analyses (ITT HR 1.40, 95%CLs, 1.10, 1.76; PP HR 1.34, 95%CLs, 1.03, 1.75), but rates of composite SAEs were not significant across comparisons.

CONCLUSIONS

Postoperative tramadol was associated with increased rates of all-cause SAEs, but not composite SAEs, compared to oxycodone and hydrocodone. Tramadol does not appear to have a superior safety profile and should not be preferentially prescribed to opioid-naïve older adults following THA/TKA.

摘要

背景

曲马多在全髋关节和膝关节置换术(THA/TKA)后越来越多地被用于治疗老年患者的急性术后疼痛。然而,曲马多的药理学复杂,其安全性可能并不优于完全阿片类激动剂。我们比较了曲马多、羟考酮和氢可酮在接受择期 THA/TKA 的阿片类药物初治老年患者中的安全性。

方法

这是一项回顾性队列研究,纳入了 2010 年 1 月 1 日至 2015 年 9 月 30 日期间接受择期 THA/TKA 的 Medicare 按服务项目付费的受益人群(年龄≥65 岁)。参与者需要满足以下条件:THA/TKA 术后 12 个月内连续参加 Medicare 部分 A 和 B,6 个月内连续参加 Medicare 部分 D,并且在 THA/TKA 前 6 个月内没有使用过阿片类药物。参与者在 THA/TKA 住院出院后 7 天内开始单一阿片类药物治疗,无论是否同时给予非阿片类镇痛药。主要结局包括全因住院或急诊就诊(严重不良事件(SAEs))和 THA/TKA 后 90 天内的 10 种手术和阿片类药物相关的 SAE 复合事件。使用逆概率治疗加权的多变量逻辑回归模型估计曲马多与其他阿片类药物相比的全因 SAE 的意向治疗(ITT)和符合方案(PP)风险比(HR)。

结果

研究人群包括 2697 例曲马多、11407 例羟考酮和 14665 例氢可酮使用者。与羟考酮相比,仅在 ITT 分析中,曲马多增加了全因 SAE 的发生率(ITT HR 1.19,95%置信区间(CI)为 1.02,1.41;PP HR 1.05,95%CI 为 0.86,1.29)。在所有比较中,复合 SAE 的发生率均无统计学意义。与氢可酮相比,曲马多在 ITT 和 PP 分析中增加了全因 SAE 的发生率(ITT HR 1.40,95%CI 为 1.10,1.76;PP HR 1.34,95%CI 为 1.03,1.75),但复合 SAE 的发生率在所有比较中均无统计学意义。

结论

与羟考酮和氢可酮相比,术后曲马多与全因 SAE 发生率增加相关,但复合 SAE 发生率无差异。曲马多的安全性似乎没有优势,不应该优先用于 THA/TKA 后的阿片类药物初治老年患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d49e/10996118/011b164ccb93/12877_2024_4933_Fig1_HTML.jpg

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