- 期刊
Rivaroxaban用於關節置換術後之藥物使用評估
Drug Utilization Evaluation of Rivaroxaban for Thromboprophylaxis After Hip or Knee Arthroplasty
摘要
目的：為探討口服抗凝血藥rivaroxaban用於膝關節（total knee replacement, TKR）或髖關節置換（total hip replacement, THR）術後預防靜脈栓塞症（venous thromboembolism, VTE）之療效與安全性，並與warfarin及未用藥組做比較。方法：採回溯性世代研究，收集2011年至2014年接受關節置換術病人，並追蹤6個月。排除年齡小於18歲、住院前3個月內發生血栓栓塞症、術前1年有心房纖維顫動病史或曾接受心臟瓣膜置換手術，及術後warfarin與rivaroxaban互換的病人等。病人資料以Kaplan-Meier analysis及log-ranktest進行分析。結果：共1,928人納入分析，平均年齡67歲，女性居多（65.5%）。接受TKR手術占大部分（68.4%）。術後多數病人並未使用抗凝血藥（55.8%），而有用藥者以warfarin居多（68.5%）。未用藥組病人的肝臟疾病（1.8 vs. 0.4%, p=0.007）及腫瘤疾病（5.9 vs. 3.5%, p=0.023）比例皆明顯高於用藥組。使用抗凝血藥組之VTE發生率明顯高於未用藥組（1.3 vs. 0.0%, p=0.002），使用warfarin組VTE發生率雖高於rivaroxaban組（1.5 vs. 0.7%, p=0.339），但未達統計差異性。未用抗凝血藥者其出血事件發生率明顯較用藥組高（2.8 vs. 1.3%, p=0.024），使用warfarin組出血事件發生率雖高於rivaroxaban組，但亦無統計差異性（1.4 vs. 1.1%, p=0.759）。結論：相較於其他文獻，本研究並未發現rivaroxaban在療效與安全性方面有優於warfarin之處。但本研究局限於單一醫學中心、醫師用藥習慣與加上病人出血風險高等因素，可能影響結果；因此rivaroxaban用於關節術後栓塞的預防，值得進一步以大型資料庫探討。
並列摘要
Objective: We investigated the efficacy and safety of rivaroxaban, warfarin, and no-medication groups for venous thromboembolism (VTE) prophylaxis after hip or knee arthroplasty. Methods: A total of 1,928 patients with arthroplastic surgery of the knee (TKR) or hip (THR) during a 3-year period (2011 to 2014) with 6 months follow-up were enrolled in this retrospective cohort study. Those excluded were of ages ＜ 18 years, with a history of thrombosis, atrial fibrillation, valve replacement, or with drugs switched between warfarin and rivaroxaban. The Kaplan-Meier analysis and log-rank test were used for statistical analyses. Results: The mean age was 67.0 years old (65.5% female) with 68.4% received the TKR. More than half (55.7%) received no anticoagulant treatments (anticoagulants [ACs], or the ACs-free group), while the rest (44.2%, or the ACs group) received either warfarin or rivaroxaban. The ACs-free group, had higher rates of liver and cancer-related diseases (liver: 1.8 vs. 0.4%, p = 0.007; cancer: 5.9 vs. 3.5%, p = 0.023). More VTE occurred in the ACs group (1.3 vs. 0.0%, p ＜ 0.001). The warfarin subgroup had similar VTE incidences, comparing with the rivaroxaban subgroup (1.5 vs. 0.7%, p = 0.339). Bleeding incidences occurred more in the ACs-free group (2.8 vs. 1.3%, p = 0.024), and with slightly more bleedings in the warfarin subgroup (1.4 vs. 1.1%, p = 0.759). Conclusion: This study was not able to demonstrate any significant difference in rivaroxaban and warfarin for thromboprophylaxis after arthroplasty. The results might due to limitations of this study. However, a large population study is needed to confirm the efficacy of rivaroxaban in Taiwan.
延伸閱讀
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