注射用尖吻蝮蛇血凝酶在手术创面止血中的有效性及安全性的系统评价  

Systematic Review on Efficacy and Safety of Haemocoagulase Agkistrodon for Injection for Surgical Wound Hemostasis

作　　者：高琰[1] 王品 黄飞[1] 张冰[3] GAO Yan;WANG Pin;HUANG Fei;ZHANG Bing(Dept.of Traditional Chinese Medicine,Beijing Hospital,National Center for Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Dept.of Outpatients,Hangzhou Yushou Traditional Chinese Medicine Clinic,Hangzhou 310000,China;School of Traditional Chinese Medicine,Beijing University of Traditional Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京医院中医科,国家老年医学中心,中国医学科学院老年医学研究院,北京100730 [2]杭州御寿中医诊所门诊部,杭州310000 [3]北京中医药大学中药学院,北京102488

出　　处：《中国医院用药评价与分析》2024年第2期232-236,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家中医药管理局区域中医(专科)诊疗中心建设项目。

摘　　要：目的:系统评价注射用尖吻蝮蛇血凝酶在手术创面止血中的有效性及安全性。方法:计算机检索PubMed、the Cochrane Library、Embase、中国知网、万方数据库和中国生物医学文献数据库,检索时间为建库至2023年3月,收集注射用尖吻蝮蛇血凝酶用于手术创面止血的随机对照试验(RCT,研究组干预措施为注射用尖吻蝮蛇血凝酶,对照组为安慰剂或空白对照),中文数据库中限定期刊为中国科技论文核心期刊,英文数据库中不限制期刊。由2名研究者对文献进行筛选、提取及偏倚风险评估,使用RevMan 5.3软件进行Meta分析。结果:共纳入19项RCT研究,包括1 384例患者,其中研究组患者716例,对照组患者668例。Meta分析结果显示,有效性方面,研究组方案降低术中出血量(MD=-65.71,95%CI=-81.99~-49.43,P<0.000 01)、缩短止血时间(MD=-27.25,95%CI=-36.73~-17.77,P<0.000 01)的效果优于对照组,差异均有统计学意义;在安全性方面,与对照组比较,研究组患者24 h后纤维蛋白原水平有一定的降低趋势,24 h后凝血酶原时间有一定的缩短趋势,但差异均无统计学意义(P>0.05)。结论:现有证据表明,注射用尖吻蝮蛇血凝酶针对手术创面止血具有良好的效果及安全性。因当前所掌握的研究数据在数量和质量方面存在限制,因此,需要未来开展更多高质量的RCT研究进一步验证上述结论。OBJECTIVE:To systematically review the efficacy and safety of hemocoagulase agkistrodon for injection for surgical wound hemostasis.METHODS:PubMed,the Cochrane Library,Embase,CNKI,Wanfang Data and CBM were retrieved for randomized controlled trials(RCT,the research group was treated with hemocoagulase agkistrodon for injection,the control group was given placebo or blank control)on hemocoagulase agkistrodon for injection for surgical wound hemostasis published on the Key Magazine of China Technology in Chinese database and un-limited magazines in English database from base-building to Mar.2023.Literature screening,data extracting and publication bias evaluation were performed by two researchers,and Meta-analysis was conducted by using RevMan 5.3 software.RESULTS:A total of 19 RCT were enrolled,including 1384 patients,with 716 cases in the research group and 668 cases in the control group.Results of Meta-analysis indicated that in terms of the efficacy,the effects of reducing intraoperative blood loss(MD=-65.71,95%CI=-81.99--49.43,P<0.00001)and shortening hemostasis time(MD=-27.25,95%CI=-36.73--17.77,P<0.00001)of the research group were better than those of the control group,with statistically significant differences;in terms of the safety,compared with the control group,the fibrinogen after 24 hours of the research group showed a certain decreasing trend,and the prothrombin time after 24 hours of the research group showed a certain shortening trend,while the differences were not statistically significant(P>0.05).CONCLUSIONS:Available evidence indicates that the hemocoagulase agkistrodon for injection has good efficacy and safety for surgical wound hemostasis.However,due to the quantitative and qualitative limitations of currently available research data,more high-quality RCT are needed in the future to further validate these findings.

关 键 词：注射用尖吻蝮蛇血凝酶 手术止血 META分析 有效性 安全性 系统评价 

分 类 号：R973.1[医药卫生—药品]