利伐沙班与低分子肝素钙预防髋部骨折术后下肢深静脉血栓形成的有效性与安全性

The effectiveness and safety of rivaroxaban versus low molecular weight heparin calcium on preventing postoperative lower extremity deep vein thrombosis in elderly patients with hip fracture

目的比较利伐沙班及低分子肝素钙(LMWH)对于下肢深静脉血栓形成(DVT)的预防作用,评价二者对于老年髋部骨折术后患者预防下肢DVT的安全性及有效性。方法 2009年12月到2011年8月选取老年髋部手术病例128例,随机分为性别、年龄、手术类型均衡的2组。利伐沙班组64例,术后6h开始口服利伐沙班10mg/d;LMWH组64例,术后6h开始皮下注射LMWH4100U,每天1次;疗程均为3周。比较2组患者下肢DVT、肺栓塞(PE)的发生率,以及术后负压引流量、出血等情况。结果 AO动力髋螺钉(DHS)、人工股骨头置换、全髋关节置换术后下肢DVT的发生率在利立伐沙班组分别为16.1%、11.1%和20.0%;在LMWH组分别为12.9%、15.0%和26.1%;组间差异均无统计学意义(P均>0.05)。术后2组均无PE发生。2组不同手术类型患者围手术期内负压引流量比较,差异无统计学意义(P均>0.05)。仅利伐沙班组出现1例髋关节置换术后第8天切口处大血肿,余均无明显异常。结论利伐沙班及LMWH均可有效预防老年患者髋骨骨折手术后下肢DVT,二者安全性及有效性相当,于术后6h应用安全;利伐沙班口服更方便、患者依从性高。

Objective To compare the preventive effect of rivaroxaban versus low molecular weight heparin calcium（LMWH）for lower extremity deep vein thrombosis（DVT）and evaluate the effectiveness and safety in the prevention post operative DVT in elderly patients with hip fracture.Methods From December 2009 to August 2011,128 elderly patients with hip fracture receiving hip operation were selected and randomized to gender-,age-,and operation type-matched two groups（n=64,each）：rivaroxaban group and LMWH group.Beginning at 6 h post operation,anticoagulants were used in both two groups：rivaroxaban（in rivaroxaban group）10 mg once a day for three weeks by oral medication;LMWH（in LMWH group）4 100 U once a day for three weeks by hypodermic injection.The incidence of DVT and pulmonary embolism（PE）,the postoperative drainage volume and bleeding volume were compared between two groups.Results The incidences of postoperative DVT in the operation of dynamic hip screw（DHS）,artificial head replacement and total hip arthroplasty were 16.1%,11.1% and 20.0% respectively in rivaroxaban group,and that of the LMWH group were 12.9%,15.0% and 26.1%,respectively.There was no significant difference between two groups（all P0.05）.No PE occurred after operation in all the patients.There was no significant difference in the drainage volume and bleeding volume of perioperative period between two groups.At the eighth day after artificial head replacement,big hematoma at wound place occurred only in one case in rivaroxaban group,and no other abnormalities were found.Conclusion Both rivaroxaban and LMWH can effectively prevent lower extremity DVT after hip fractures operation,which show an equivalent efficacy and have a similar safety at 6 h post operation,but oral rivaroxaban is more convenient and has a good patient compliance.