【摘要】 目的:评价尖吻蝮蛇血凝酶在腹部手术切口的止血作用及对凝血功能的影响及其安全性。方法:随机、盲法、平行对照的多中心研究。180例外科腹部择期中等手术患者分为高剂量组(A),低剂量组(B)和安慰剂组(C)三组,各60例。A组予尖吻蝮蛇血凝酶3U,B组予2U,C组给予0.8%右旋糖苷,术前15 m in静脉注射。观察腹部手术切口出血的止血时间、出血量、单位面积出血量及机体凝血功能和安全性。结果:A,B,C三组的平均止血时间分别为(37.5±21.4),(37.5±19.5),(59.7±25.1)s,切口出血量分别为(1.83±1.32),(1.86±1.03),(3.47±1.55)g,单位面积出血量分别为(0.030±0.017),(0.033±0.014),(0.077±0.033)g.cm-2。A和B组3方面结果相似(P>0.05);B组3方面的结果均明显少于C组(P<0.01),A和B组的止血效果明显优于C组。三组凝血指标和全血黏度结果相似。无不良事件。结论:尖吻蝮蛇血凝酶对腹部切口毛细血管出血有较好的止血作用和安全性,疗效不随药物剂量增加而增加。更多还原

【Abstract】 Objective: To evaluate the effects of agkistrodon hemocoagulase on its hemostatic and hemoagglutinant function and safety on the patients with abdominal operation.Methods: It is a randomized,double-blind,parallel controlled,multicenter study.Total 180 consented patients with abdominal surgery who met with inclusion/exclusion criteria were enrolled into the study,and then assigned to study group A(agkistrodon hemocoagulase 3 U, 60 cases),study group B(agkistrodon hemocoagulase 2 U,60 cases) and control group(0.8% Dextran,60 cases),received intravenous injection 15 minutes before operation.The hemostatic time,hemorrhagic volume,hemorrhagic volume per square unit,body hemoagglutination and safety were observed.Results: The average hemostatic time of study group A,B and C was(37.5+21.4),(37.5+19.5),(59.7+25.1)s respectively.The hemorrhagic volumes was(1.83+1.32),(1.86+1.03),(3.47+1.55) g in different groups,the hemorrhagic volume per square unit were(0.030+0.017),(0.033+0.014),(0.077+0.033) g.cm-2.Study group A had the similar results with study group B(P>0.05) in three aspects,but group B was much less than the control group(P<0.01).The hemostasis effects of group A and B are superior to that of group C.The results of hemoagglutination function and blood viscosity were similar in three groups.No adverse event was reported.Conclusion: Agkistrodon hmocoagulase has better hemostatic function and safety in the capillary hemorrhage in abdominal incision.The hemostatic effect is independent of drug dosage.更多还原