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

蒲强红 ¹蒋兴 ¹李燕 ¹刘凯 ¹闫冰 ¹王永才¹

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作者信息

1. 四川省乐山市人民医院,四川乐山 614000
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摘要

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.

Abstract

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.

关键词

利伐沙班/深静脉血栓/人工髋关节置换术/人工膝关节置换术/原研药/仿制药/有效性/安全性

Key words

rivaroxaban/deep vein thrombosis/total hip arthroplasty/total knee arthroplasty/original-patented drug/generic drug/efficacy/safety

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基金项目

四川省医学会(恒瑞)科研基金专项科研课题(2021HR07)

出版年

2024

中国药业

重庆市食品药品监督管理局

中国药业

CSTPCD

影响因子：1.369

ISSN：1006-4931

参考文献量1

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