利伐沙班预防高龄骨科大手术后静脉血栓栓塞的临床研究

Rivaroxaban for Prevention of Venous Thromboembolism after Major Orthopedic Surgery in Elderly Patients

目的探讨利伐沙班预防高龄骨科大手术后静脉血栓栓塞(venous thromboembolism,VTE)的临床疗效和安全性。方法将65例采用股骨近端防旋髓内钉(proximal femoral nail anti-rotation,PFNA)固定的股骨转子间骨折患者按就诊顺序分为2组。治疗组32例,术后口服利伐沙班片;对照组33例,术后采用低分子肝素治疗。测定2组患者的术后出血量,术前及术后12 d血红蛋白量、血小板计数、凝血酶原时间(prothrombin time,PT)及活化部分凝血酶时间(activated partial thromboplastin time,APTT),并于术后12 d行血管彩色多普勒检察,观察患者是否有DVT形成;记录2组患者术后12 d内胃肠道出血和血肿等出血事件的发生情况。结果 2组患者手术前及术后12 d血红蛋白量、血小板计数、PT及APTT比较,差异均无统计学意义(均P>0.05)。治疗组患者术后出血量小于对照组(P=0.001),2组患者DVT发生率比较差异无统计学意义(P=0.628),治疗组发生胃肠道出血1例,对照组发生胃肠道出血1例、伤口局部血肿1例,2组患者不良反应发生率比较差异无统计学意义(P=1.000)。结论利伐沙班预防高龄股骨转子间骨折PFNA固定手术后VTE的临床疗效优于低分子肝素,安全性与其相当,并且简化了治疗过程,是预防骨科大手术后VTE的有效方法。

Objective To investigate the clinical efficacy and safety of rivaroxaban in the prevention of venous thromboembolism （ VTE ） after major orthopedic surgery in elderly patients . Methods Sixty-five patients who underwent proximal femoral nail anti-rotation （PFNA） fixation for intertrochanteric fracture were orally given either rivaroxaban （treatment group, n=32） or low molecular weight heparin （control group, n=33） after operation. The blood loss was detected before operation. The hemoglobin, platelet count, prothrombin time （PT） and activated partial thromboplastin time （APTT） were determined before and 12 days after operation. Furthermore, deep venous thrombosis （DVT） was observed by color Doppler sonography 12 days after operation. Moreover, gastrointestinal bleeding and hematoma were recorded within 12 days after operation. Results There were no statistical differences in hemoglobin, platelet count, PT and APTT between the two groups before and 12 days after operation （P〉0.05）. Compared with control group, postoperative blood loss reduced in treatment group（P=0.001）.No significant difference in the incidence of DVT was found between the two group （P=0.628）. In treatment group, 1 patient had gastrointestinal bleeding. In control group, 1 patient had gastrointestinal bleeding and 1 patient had local wound hematoma. The difference in the incidence of adverse reactions was not significant between the two groups （P=1.000）. Conclusion Rivaroxaban is superior to low molecular weight heparin for preventing VTE in elderly patients undergoing PFNA fixation for intertrochanteric fracture. In addition, rivaroxaban has the same safety as low molecular weight heparin. Therefore, rivaroxaban treatment is effective for the prevention of VTE after major orthopedic surgery.