尖吻蝮蛇凝血酶对腹部手术切口止血的有效性及安全性临床研究  

A clinical study of Haemocoagulase Acutus on wound hemostasis in abdominal operation

作　　者：谢舜峰[1] 杨填[1] 孙淑明[1] 卢晓峰[1] 

机构地区：[1]汕头大学医学院第一附属医院普外科,521000

出　　处：《中国医药》2010年第6期545-547,共3页China Medicine

摘　　要：目的 评价尖吻蝮蛇凝血酶在腹部手术切口的止血作用,以及对机体凝血功能的影响和凝血酶安全性.方法 本研究采用随机、双卣单模拟、安慰剂平行对照和多中心的研究方法,对腹部手术患者共120例进行研究,分为研究组及对照组各60例.2组分别应用尖吻蝮蛇凝血酶2 U和模拟尖吻蝮蛇凝血酶2 U,术前15 min静脉注射,对腹部手术切口出血的止血时间、出血量、单位面积出血鼍,以及机体凝血功能和安全性指标等方面进行观察.结果 2组患者应用药物后,注射凝血酶2U的研究组平均止血时间为97s,切口平均出血量为1.89 g,平均单位面积出血量0.048 g/cm^2,对照组结果分别为185 s、2.67 g、0.057 g/cm^2,2组比较,差异有统计学意义（P＜0.05）.在凝血功能及安全性指标等方面,2组结果相似（P＞0.05）.整个试验过程无不良事件.结论 尖吻蝮蛇凝血酶对腹部切口毛细血管有较好的止血作用和安全性.Objective To evaluate the hemostatic role of hemocoagulase Acutus in abdominal operation and its safety and effects on coagulation on surgical patients.Methods A total of 120 patients received abdominal operation were studied prospectively by randomized, double-blind controlled and multicenter design.They were divided into Study group（60 patients） and Control group（60 patients）.The Study group was given 2U Haemocoagulase and Control group was given 2U Haemocoagulase placebo 15 minutes before operation.Hemostatic time, hemorrhagic volume, hemorrhagic volume per square unit and body coagulation parameters （PT, APTT, TT, Fib and PLG） were recorded.Results The groups received different drugs.The average hemostatic time in the hemocoagulase group was 97 s, hemorrhagic volume was 1.89 g, and hemorrhagic volume per square unit was 0.048 g, significantly different （P 〈 0.05） from those in the Control group.Between the two groups, body coagulation parameters were not significantly different.There were no adverse events occurring.Conclusion Hemocoagulase is safe and plays a good hemostatic role in the hemorrhagic capillary in ＂abdominal operation.

关 键 词：尖吻蝮蛇凝血酶 手术切口 止血 出血 随机对照研究 

分 类 号：R605[医药卫生—外科学]