巴曲亭对低分子肝素抗凝全髋置换术患者出血量及凝血功能影响的研究

Effects of batroxobin on perioperative blood loss and coagulation in patients with low molecular weight heparin when undergoing the total hip replacement

目的：探讨巴曲亭与低分子肝素的相互作用，观察巴曲亭用于骨科低分子肝素抗凝全髋置换术患者的疗效和安全性。方法采用多中心、随机、双盲对照研究设计，按照1∶1比例纳入ASAⅠ～Ⅲ级单侧全髋置换术患者240例，试验组（低分子肝素＋巴曲亭组）120例，对照组（低分子肝素组）120例，比较两组患者的术中出血量、术后引流量，并检测术前、术中及术后24 h凝血酶原时间（PT）、部分凝血活酶时间（APTT）、纤维蛋白原（FIB）水平变化，两组患者均于术前及术后第3天行下肢静脉多普勒彩超检查，并记录术后住院时间。结果最终试验组119例、对照组120例纳入数据分析。试验组术中出血量（422.64 ml）明显低于对照组（667.67 ml）（P＜0.01），两组患者术毕PT、APTT均较给药前有所延长（P＜0.01），红细胞（RBC）、Hb、红细胞比容积（Hct）、血小板水平均较给药前明显下降（P＜0.01），组间比较差异无统计学意义（P＞0.05）。术后第3天下肢多普勒彩超检查均未发现下肢深静脉血栓。两组患者住院期间均无不良事件，且实际住院时间的差异无统计学意义（P＞0.05）。结论全髋置换术中使用巴曲亭不受低分子肝素的抑制，且安全有效，术前5～10 min静脉注射2 U可明显减少患者出（渗）血量。

Objective To investigate the interactive effects between batroxobin and low molecular weight heparin（LMWH）in reducing peri-operative blood loss and coagulation function in patients who undergone the total hip replacement surgery. Methods 240 ASA Ⅰ-Ⅲ patients received 4 000 IU LMWH 12 hours preoperatively before undergoing the total hip replacement operation,were randomly divided into two groups：testing group （Group A,n=120） and control group（Group B,n=120）receiving 2 U batroxobin or 50 mg mannitol 10 minutes before incision respectively. Perioperative blood loss,postoperative 24 hours drainage and blood routine test, prothrombin time （PT）,activated partial thromboplastin time（APTT） and fibrinogen（FIB） were measured respectively. Deep vein thrombosis （DVT） were measured through color Doppler B-ultrasound 3 days after the operation. Results The perioperative blood loss in Group A （422.64 ml）was less than that in Group B（667.67 ml）（P0.05）. There were no drug-related adverse effects found in the two groups,neither the difference in hospitalization between the two groups（P〉0.05）. Conclusion Batroxobin （2 U） could reduce the perioperative blood loss in patients with LMWH who had undergone the total hip replacement operation but did not show adverse effect on DVT.