Department of Orthopedic Surgery, Osaka Koseinenkin Hospital, Fukushima-ku, Osaka, Japan.
J Arthroplasty. 2010 Dec;25(8):1267-74. doi: 10.1016/j.arth.2009.08.010. Epub 2009 Oct 25.
We assessed the efficacy, safety, and dose-response of dabigatran etexilate (DAB) in preventing venous thromboembolism (VTE) in Japanese patients undergoing total knee arthroplasty (TKA). Five hundred twelve patients received DAB (110, 150, or 220 mg) or placebo once daily for 11 to 14 days, starting the day after surgery. The primary efficacy end point was the incidence of total VTE and all-cause mortality; the primary safety end point was incidence of major, clinically relevant, and minor bleeding events. Total VTE and all-cause mortality were lower in patients receiving DAB (39.6%, 32.7%, and 24.0%) than placebo (56.4%). There was no difference in the incidence of major bleeding between the DAB and placebo groups. Overall, DAB reduced the incidence of VTE in Japanese patients undergoing TKA, with a comparable safety profile vs placebo.
我们评估了达比加群酯（DAB）在预防接受全膝关节置换术（TKA）的日本患者静脉血栓栓塞症（VTE）中的疗效、安全性和剂量反应。512 例患者接受 DAB（110、150 或 220mg）或安慰剂，每日一次，使用 11-14 天，术后第一天开始。主要疗效终点为总 VTE 和全因死亡率；主要安全性终点为主要、临床相关和轻微出血事件的发生率。接受 DAB（39.6%、32.7%和 24.0%）治疗的患者总 VTE 和全因死亡率低于安慰剂（56.4%）。DAB 组与安慰剂组之间主要出血的发生率无差异。总体而言，DAB 降低了接受 TKA 的日本患者 VTE 的发生率，安全性与安慰剂相当。
