背景:曲马多越来越多地用于治疗老年人全髋和膝关节置换术(THA/TKA)后的急性术后疼痛。然而,曲马多具有复杂的药理学,可能不比完全阿片类激动剂更安全。我们比较了曲马多的安全性,羟考酮,选择性THA/TKA术后阿片类药物未治疗的老年人和氢可酮。
方法:该回顾性队列包括在2010年1月1日至2015年9月30日期间选择THA/TKA的≥65岁的Medicare按服务收费受益人,连续12个月的A和B部分参加,连续6个月的D部分注册,并且在THA/TKA之前的6个月内没有使用阿片类药物。参与者开始使用曲马多进行单阿片类药物治疗,羟考酮,或氢可酮从THA/TKA住院出院后7天内,无论同时使用非阿片类镇痛药。感兴趣的结果包括全因住院或急诊就诊(严重不良事件(SAE))以及THA/TKA90天内10个与手术和阿片类药物相关的SAE的复合。曲马多与其他阿片类药物的意向治疗(ITT)和符合方案(PP)风险比(HR)使用逆治疗概率加权合并逻辑回归模型进行估计。
结果:研究人群包括2,697曲马多,11,407羟考酮,和14,665个氢可酮引发剂。与羟考酮相比,曲马多仅在ITT分析中增加了全因严重不良事件的发生率(ITTHR1.19,95%CLs,1.02,1.41;PPHR1.05,95%CLs,0.86,1.29)。复合SAE的比率在比较中不显著。与氢可酮相比,曲马多增加了ITT和PP分析中所有原因严重不良事件的发生率(ITTHR1.40,95%CLs,1.10,1.76;PPHR1.34,95%CLS,1.03,1.75),但复合SAE的发生率在比较中并不显著.
结论:术后曲马多与全因SAE的发生率增加有关,但不是复合SAE,与羟考酮和氢可酮相比。曲马多似乎没有更好的安全性,不应在THA/TKA后优先用于阿片类药物初治的老年人。
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.