仿制与原研利伐沙班预防髋膝关节置换术后深静脉血栓有效性与安全性比较

Comparison of Efficacy and Safety of Generic and Original - Patented Rivaroxaban in Prevention of Deep Vein Thrombosis After Total Hip and Total Knee Arthroplasties

目的 评估仿制与原研利伐沙班预防人工髋关节置换术(THA)或人工膝关节置换术(TKA)后深静脉血栓(DVT)的有效性与安全性。方法 收集医院关节外科2016年7月至2022年12月收治拟行THA(96例)或TKA(63例)的患者,按所用利伐沙班来源的不同分为原研组(91例)和仿制组(68例),并随访术后3个月内DVT与药品不良反应发生率。结果 原研组及仿制组术后DVT发生率分别为4.40%和5.88%,出血事件发生率分别为1.10%和0,其他不良反应(便秘、疼痛、下肢肿胀)发生率分别为3.30%和7.35%,组间比较均无统计学差异(P> 0.05)。结论 THA或TKA术后使用仿制与原研利伐沙班的有效性与安全性相当。

Objective To evaluate the efficacy and safety of generic and original-patented rivaroxaban in the prevention of deep vein thrombosis(DVT)after total hip arthroplasty(THA)or total knee arthroplasty(TKA).Methods The patients planned to undergo the THA(96 cases)or TKA(63 cases)in the joint surgery department of the hospital from July 2016 to December 2022 were collected and divided into the original-patented group(91 cases)and the generic group(68 cases)according to different sources of rivaroxaban.The incidences of DVT and adverse drug reactions within three months after surgery in the two groups were compared.Results The incidence of DVT after surgery in the original-patented group and the generic group was 4.40%and 5.88%,the incidence of bleeding event was 1.10%and 0,the incidence of other adverse reactions(constipation,pain,lower limb swelling)was 3.30%and 7.35%respectively,with no significant difference between the groups(P>0.05).Conclusion The efficacy and safety of generic and original-patented rivaroxaban are comparable in the postoperative use of THA or TKA.