利伐沙班预防全膝关节置换术后静脉血栓栓塞症的临床研究  

Clinical investigation on rivaroxaban for thromboprophylaxis after total knee arthroplasty

作　　者：史占军[1] 严格[1] 肖军[1] 张赟[1] 王健[1] 李郅涵[1] 张洋[1] 

机构地区：[1]南方医科大学南方医院关节与骨病外科,广州510515

出　　处：《中华关节外科杂志（电子版）》2014年第6期14-18,共5页Chinese Journal of Joint Surgery(Electronic Edition)

基　　金：国家自然科学基金资助项目(81101389);广东省自然科学基金资助项目(S2011040003467)

摘　　要：目的探讨利伐沙班和那曲肝素在预防人工膝关节表面置换术(TKA)术后静脉血栓栓塞症(VTE)的疗效和抗凝并发症方面的差异。方法接受初始单侧膝关节表面置换手术的骨关节炎患者75例,随机分为利伐沙班组(n=50)和那曲肝素组(n=25)。监测术后1、3、5 d血常规并记录异体血输血率和输血量,测量术前和术后1、3和5 d大腿周径,了解肢体肿胀程度。观察切口愈合情况,记录切口并发症。同时,根据肢体肿胀程度查下肢血管超声诊断或排除VTE。结果利伐沙班组发生1例股深静脉血栓(2.00%),那曲肝素组无VTE发生,VTE发生率无组间统计学差异(P>0.05)。两组均无大出血事件发生。利伐沙班组5例发生小出血事件,那曲肝素组为2例,小出血事件发生率无组间统计学差异(P>0.05)。利伐沙班组2例切口乙级愈合,那曲肝素组全部甲级愈合,切口感染率无组间统计学差异(P>0.05)。利伐沙班异体输血率54.00%,输血量(286.00±302.38)ml,相对那曲肝素组无统计学差异(P>0.05)。利伐沙班组与那曲肝素组患者术后大腿周径变化总体无组间统计学差异(P>0.05)。结论本组数据显示利伐沙班预防TKA术后VTE的疗效和出血并发症与那曲肝素大致相当。Objective To investigate the thromboprophylaxis efficacy as well as the complication incidence given by rivaroxaban and nadroparin after total knee arthroplasty（TKA）.Methods Seventyfive patients undergone unilateral TKA with a primary diagnosis of osteoarthritis were randomly separated into a rivaroxaban group（n = 50） and a nadroparin group（n = 25）.The blood routine examination was monitored on the 1^st,3^rd,and 5^thday postoperatively.The amount and rate of allogeneic blood transfusion were recorded.The leg diameter was measured to understand the degree of swelling.The healing of the incision wound was observed and any incision complications were noted simultaneously.Venous thromboembolism（VTE） was diagnosed or excluded based on vascular color-ultrasound examination.Results One case（2.00%） of deep vein thrombosis was identified in the rivaroxaban group in contrast to the absent VTE occurrence in the nadroparin group,but no significant difference in VTE rate was discerned between the two groups（P〉0.05）.No major bleeding happened in either group.Five cases of minor bleeding in the rivaroxaban group and two cases in the nadroparin group were recorded,but that showed no intergroup difference（P〉0.05）.Two cases of class B healing in the rivaroxaban group were recorded and all the cases were healed excellently in the nadroparin group.These healing data again represented no intergroup difference（P〉0.05）.286.0 ± 302.4 ml allogeneic blood was transfused to 54% patients in the rivaroxaban group.However,both the rate and the volume of blood transfusion presented no significant difference in contrast to those of the nadroparin group（P〉0.05）.The overall change about the leg diameter of the patients in the rivaroxaban group and the nadroparin group showed no significant difference between the two groups（P〉0.05）.Conclusion The results of current investigation suggests equivalent thromboprophylaxis efficacy and hemorrhagic complications rate between rivaroxaban and nadroparin.

关 键 词：关节成形术 置换 膝 静脉血栓形成 利伐沙班 那曲肝素 

分 类 号：R687.4[医药卫生—骨科学]