尖吻蝮蛇凝血酶对手术切口止血有效性及安全性的临床研究  

A Clinical Research of Hemocoagulase Acutus on Hemostatic Effectiveness of Wound and Hemoagglutination Safety in Operation

作　　者：欧光武[1] 李威[1] 

机构地区：[1]汕头大学医学院第一附属医院普外科,广东汕头515041

出　　处：《现代生物医学进展》2010年第2期274-276,共3页Progress in Modern Biomedicine

基　　金：国家"十五"重大科技专项"创新药物和中药现代化"立项课题(2003AA223156;2004AA223B70)

摘　　要：目的:评价注射用尖吻蝮蛇凝血酶单次注射对外科手术切口止血的临床有效性及安全性。方法:采用随机、双盲单模拟、安慰剂平行对照的研究方法。将入选研究的82例随机分为研究组(61例,术前30分钟静注尖吻蝮蛇凝血酶2u)和对照组(21例,术前30分钟静注模拟尖吻蝮蛇凝血酶2u),并对手术切口、止血时间、出血量、单位面积出血量,以及机体凝血功能和安全性指标等进行观察。结果:研究组平均止血时间[(128.49±71.04)s]、切口平均出血量[(2.70±1.94)g]及平均单位面积出血量[(0.19±0.17)g.cm-2]较对照组[(177.19±77.31)s、(4.35±2.10)g、(0.35±0.17)g.cm-2]明显减少(P<0.05)。在凝血功能及安全性指标等方面,两组结果相似(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有较好的止血作用和安全性。Objective：To evaluate the hemostatic role of hemocoagulase acutus on wound in thoracic operation and its influence and safety on body coagulation. Methods：82 patients were divided into study group（61 cases,2 U haernocoagulase acutus iv. 30minutes before operation） and control group（21 cases,2 U haemocoagulase atutus placebo iv. 30 minutes before operation） . The operational wound,hemostatic time,amount of bleeding,amount of bleeding per square unit,body coagulation parameters and safety indexes were observed. The randomized,double-blind,parallel-controlled and multicenter design were used. Results：The hemostatic time [（128.49± 71.04） S],mean amount of bleeding for wound [（2.70±1.94） g]and mean amount of bleeding per square unit [0.19±0.17） g.cm-2]in the study group were obviously decreased,compared with those in the control group[（177.19±77.31） s,（4.35±2.10） g and（0.35±0.17） g. cm-2]. The body coagulation parameters and safety indexes were similar between two groups.There were no adverse events occurred. Conclusion：The hemocoagulase acutus has a good hemostatic role on wound,and shows its safety in thoracic operation.

关 键 词：尖吻蝮蛇凝血酶 手术切口 出血 止血 

分 类 号：R969[医药卫生—药理学] R973.1[医药卫生—药学]