尖吻蝮蛇血凝酶对心肺转流术下心脏瓣膜置换术患者凝血功能的影响

Effects of agkistrodon hemocoagulase on coagulation function in patients undergoing cardiac valve replacement with cardiopulmonary bypass

目的：观察尖吻蝮蛇血凝酶对心肺转流术（CPB）下心脏瓣膜置换术患者凝血功能的影响和安全性。方法择期CPB下行心脏瓣膜置换术患者80例，随机分为对照组；H1组：手术开始前20 min给药；H2组：心肺转流开始后20 min给药；H3组：心肺转流结束肝素拮抗后给药，每组20例,H1-H3组均注射尖吻蝮蛇血凝酶2 U，对照组于手术前20 min注射等量0.9%氯化钠注射液。分别于术前20 min（T0）、术后即刻（T1）、术后24 h（T2）测定4组的凝血功能[凝血酶原时间（PT）、活化部分凝血酶时间（APTT）、凝血酶时间（TT）、血浆纤维蛋白原（Fib）]、血小板（PLT）；记录术后24 h内心包纵隔引流量、机械通气时间、重症加强护理病房（ICU）停留时间、实际住院天数及住院费用、输血量等各临床指标以及二次开胸、过敏、肝肾功能异常、深静脉血栓形成及精神神经症状等不良事件的发生情况。结果与对照组比较，T1、T2时H1、H2和H3组PT、APTT、TT降低（P〈0.05），与T0时比较，各组患者T1、T2时PT、APTT、TT升高；与H1组比较，H3组T1、T2时PT、TT降低（P〈0.05）。H1、H2和H3组术后24 h内心包纵隔引流量和机械通气时间低于对照组（P〈0.05），各组不良事件发生率无明显差异。结论应用尖吻蝮蛇血凝酶可改善心肺转流术下心脏瓣膜置换术患者的低凝状态，且使用安全。

Objective To investigate the efficiency and safety of agkistrodon hemocoagulase on coagulation function in pa？tients undergoing cardiac valve replacement with cardiopulmonary bypass （CPB）. Methods In this prospective,randomized controlled trial,80 eligible patients accepted valve replacement were assigned to control group （n=20） and agkistrodon hemoco？agulase groups （H1, H2, H3） according to the different timing of administration. Twenty patients were given treatment 20 minutes before anesthesia induction （H1 group）, 20 patients were given treatment 20 minutes after CBP （H2 group） and 20 patients were given treatment after CBP （H3 group）. Coagulation parameters including prothrombin time （PT）, activated partial thromboplas？tin time （APTT）, thrombin time （TT）, fibrinogen （Fib） and platelet （PLT） were detected 20 minutes before surgery （T0）, immedi？ately after surgery （T1） and 24 hours after surgery（T2）. Data of 24-h postoperative drainage of mediastinal and pericardial, dura？tion of mechanical ventilation, stay time of intensive care unit （ICU）, the actual days of hospitalization and hospital costs were recorded. The clinical parameters were also recorded including blood transfusion after surgery, secondary thoracotomy, aller？gies, liver and kidney dysfunction, deep vein thrombosis and neuropsychiatric symptoms. Results Compared with control group, values of PT, APTT and TT at T1 and T2 were significantly lower in H1, H2 and H3 groups （P〈0.05）. Compared with T0, values of PT, APTT and TT at T1 and T2 were significantly higher in all groups of patients （P〈0.05）. Values of PT and TT at T1 and T2 were significantly decreased in H3 group than those of H1 group （P〈0.05）. The pericardial and mediastinal drainage, the duration of ventilation support within 24-h after surgery were significantly lower in H1, H2 and H3 groups than those of control group （P〈0.05）. There was no significant difference in the incidence of adverse events between groups. Conclusion Agkis？trodon hemocoagulase is safe and effective in patients undergoing cardiac valve replacement with cardiopulmonary bypass.