三种抗凝药物在单侧全膝关节置换术后预防静脉血栓性疾病的病例对照研究

Case control study on three antithrombotic agents for the prevention of venous thromboembolism after unilateral total knee arthroplasty

目的 ：探讨3种不同抗凝药物在单侧全膝关节置换术后预防静脉血栓栓塞症的有效性和安全性。方法：收集2011年11月至2014年3月因膝关节骨性关节炎行单侧全膝关节置换术患者149例临床资料,其中男66例,女83例;年龄48~76岁。按抗凝药物不同分为阿司匹林组、低分子肝素组和利伐沙班组,阿司匹林组48例,男23例,女25例,平均年龄（61.52±13.42）岁;低分子肝素组54例,男20例,女34例,平均年龄（64.37±11.81）岁;利伐沙班组47例,男23例,女24例,平均年龄（63.83±12.04）岁。分别观察3组患者术后6、8、12周下肢深静脉血栓形成,肺栓塞及出血并发症（包括切口瘀斑、切口血肿等局部并发症,消化系统、心脑血管系统、泌尿系统出血等出血事件）。结果：阿司匹林组48例,下肢深静脉血栓形成4例,肺栓塞1例,出血并发症2例;低分子肝素组54例,下肢深静脉血栓形成3例,肺栓塞1例,出血并发症3例;利伐沙班组47例,下肢深静脉血栓形成3例,肺栓塞0例,出血并发症11例。3组下肢深静脉血栓形成、肺栓塞发生率差异无统计学意义（P〉0.05）,出血并发症发生率利伐沙班组高于阿司匹林、低分子肝素组。结论：阿司匹林、低分子肝素、利伐沙班均能有效预防全膝关节置换术后深静脉血栓的发生,且疗效相近。利伐沙班引起出血并发症发生率高,安全性须进一步研究。

Objective：To evaluate the efficacy and safety of three antithrombotic agents on venous thromboembolism（VTE） after unilateral total knee arthroplasty. Methods：From November 2011 to March 2014,149 patients undergoing unilateral total knee arthroplasty for knee osteoarthritis were reviewed. Among them,there were 66 males and 83 females,ranging in age from 48 to 76 years old. All the cases were randomly divided into three groups including Aspirin group,low molecular weight heparin（LMWH） group,and rivaroxaban group,according to antithrombotic agents. Deep vein thrombosis（DVT）,pulmonary embolism（PE）,and bleeding complication（including wound ecchymosis,hematoma and other local complications,gastrointestinal,cardiovascular,urinary hemorrhage and other major bleeding events） of antithrombotic agents were observed and analyzed statistically at the 6 week,8 week, and 12 week after operation. Results：Among patients who received Aspirin（48 cases）,4 patients had DVT,in 1 patient had PE,and 2 patients had bleeding complication. Among 54 patients in low molecular weight heparin group,3 patients had DVT,1 patient had PE,and 3 patients had bleeding complication. While among those patients received the rivaroxaban（47 cases）,3 patients had DVT,0 patient had PE,and 11 patients had bleeding complication. There were no statistically differences among three groups on DVT,and PE（P 〉0.05）. The incidence of bleeding complication in rivaroxaban group was higher than the other two antithrombotic agents,and the difference among the three groups was statistically significant（P〈0.05）. Conclusion：Aspirin,low molecular weight heparin,and rivaroxaban could effectively reduce the incidence of VTE after total knee arthroplasty,and their efficacy was similar. Rivaroxaban has a higher incidence of bleeding complication and further clinical trials are required to be conducted to assess the safety of rivaroxaban in clinical.