注射用白眉蛇毒血凝酶对外科手术切口止血疗效和安全性的Meta分析  

Efficacy and safety of white-browed snake venom hemocoagulase for injection in surgical tresis vulnus:a Meta-analysis

作　　者：邵千航 刘雪梅 黄琳[1] 封宇飞 SHAO Qianhang;LIU Xuemei;HUANG Lin;FENG Yufei(Department of Pharmacy,People's Hospital,Peking University,Beijing 100044,China)

机构地区：[1]北京大学人民医院药学部,北京100044

出　　处：《中国药师》2024年第5期864-874,共11页China Pharmacist

基　　金：中国药品监督管理研究会立项课题项目(药监研[2021]043号)。

摘　　要：目的 探讨注射用白眉蛇毒血凝酶对外科手术切口止血的有效性和安全性。方法 计算机检索万方、VIP、CNKI,收集白眉蛇毒血凝酶在外科手术切口中止血的随机对照试验(RCT),检索时间为建库至2023年12月1日。采用RevMan 5.4软件进行Meta分析。结果 共纳入13项RCT,共1 027例患者。Meta分析结果显示,白眉蛇毒血凝酶组的平均止血时间、单位面积出血量、术中出血量和术后第1天的凝血酶时间(TT)均小于对照组(P <0.05);活化部分凝血活酶时间(APTT)、凝血酶原时间(PT)及纤维蛋白原(FIB)含量方面,两组差异无统计学意义(P>0.05)。亚组分析显示,不同类型的手术切口中,白眉蛇毒血凝酶组的止血时间、单位面积的出血量及术中出血量均减少(P <0.05)。神经外科手术切口术后第1天白眉蛇毒血凝酶组PT大于对照组(P<0.05),两组TT、APTT、FIB差异无统计学意义(P> 0.05);鼻内镜手术、普通外科手术切口术后第1天两组TT、APTT、PT、FIB差异均无统计学意义(P>0.05);妇科手术切口术后第1天白眉蛇毒血凝酶组TT、PT低于对照组(P<0.05),两组APTT、FIB差异无统计学意义(P>0.05)。共有6项研究对白眉蛇毒血凝酶使用后的不良反应进行报道,其中4项研究并未观察到任何不良反应。结论 与对照组相比,白眉蛇毒血凝酶对外科手术切口的止血疗效更佳,且对患者凝血功能影响较小,未增加不良反应事件的发生,安全性较好。Objective To evaluate the efficacy and safety of white-browed venom hemocoagulase for injection in surgical tresis vulnus.Methods Wanfang,VIP,and CNKI were computerized searched to collect randomized controlled trials(RCTs) of white-browed snake venom thrombin for hemostasis in surgical incisions from the construction of databases to December 1,2023.Meta-analysis was performed using RevMan 5.4 software.Results A total of 13 RCTs with 1027 patients were included.Meta-analysis showed that the mean hemostasis time,bleeding per unit area,intraoperative bleeding,and thrombin time(TT)on the first postoperative day in the white-browed snake venom hemocoagulase group were smaller than those in the control group(P<0.05);the activated partial thromboplastin time(APTT),prothrombin time(PT),and fibrinogen(FIB) content between the two groups were not statistically significant(P>0.05).Subgroup analysis showed that among different types of surgical incisions,the hemostasis time,bleeding per unit area and intraoperative bleeding were reduced in the white-browed snake venom hemocoagulase group(P<0.05).PT in the whitebrow snake venom hemocoagulase group was greater than that in the control group on the first postoperative day of neurosurgical incisions(P<0.05),and the differences in TT,APTT,and FIB between the two groups were not statistically significant(P>0.05);in the first postoperative day of nasal endoscopic surgery and general surgical incisions,there were no statistically significant differences between the two groups in terms of TT,APTT,PT,and FIB(P>0.05);and in the first postoperative day of gynecological incisions,the TT and PT of the white-browed snake venom hemocoagulase group were lower than those of the control group(P<0.05),and the differences in APTT and FIB between the two groups were not statistically significant(P>0.05).A total of six studies reported adverse reactions a?ter the use of white-browed snake venom hemocoagulase,of which four studies did not observe any adverse reactions.Conclusion Compared with the

关 键 词：白眉蛇毒血凝酶 外科手术切口 凝血酶时间 活化部分凝血活酶时间 凝血酶原时间 纤维蛋白原 安全性 META分析 

分 类 号：R969[医药卫生—药理学]