目的 本研究通过对尖吻蝮蛇血凝酶(haemocoagulase agkistrodon,HCA)在外科手术止血进行快速卫生技术评估(health technology assessment,HTA),评价HCA在外科手术止血临床应用的有效性、安全性和经济性,为临床用药决策提供循证医学证据。方法 计算机检索PubMed、Embase、Cochrane Library、中国知网、万方数据库、中国生物医学文献数据库和HTA机构官方网站,收集HCA在外科手术止血的系统评价(SR)/Meta分析、经济学评价和HTA报告,检索时限均为建库至2023年5月。由两位研究者独立根据纳入排除标准进行文章筛选、质量评价及数据提取,并对数据结果进行分析。结果 共纳入28项研究,包括2项SR/Meta分析、22项随机对照试验(RCTs)和4项经济学研究,未检索到HTA报告。在有效性方面,所纳入的研究结果基本一致:HCA在降低创面出血量、降低术后创面引流量、减少切口平均止血时间及切口单位面积出血量方面对比安慰剂或空白实验均表现出明显优势,对比其他阳性药物无统计学意义;安全性良好,对血凝指标、血常规及肝肾功能无影响,不会导致血栓的发生;就目前价格而言经济学具有一定优势。结论 HCA在围手术期渗出血防治方面对比安慰剂有明显效果,安全性良好,经济性具有一定优势。
Abstract
OBJECTIVE To evaluate the effectiveness, safety and economy of haemocoagulase agkistrodon(HCA) in the clinical application of hemostasis in surgical operations by conducting a rapid health technology assessment (HTA) for hemostatic action, and provides a basis for clinical drug decision-making. corroborating medical evidence. METHODS The study were searched PubMed, Embase, Cochrane Library, CNKI, Wanfang Database, China Biomedical Literature Database and the official website of the HTA institution to collect the systematic review (SR)/Meta-analysis, economic evaluation and HTA report of HCA in surgical hemostasis,the retrieval time limit is from the establishment of the database to May 2023. Two researchers independently screened articles, evaluated quality, and extracted data according to the inclusion and exclusion criteria, and analyzed the data results. RESULTS A total of 28 studies were included, including 2 SR/Meta-analyses, 22 randomized controlled trials (RCTs) and 4 economic studies, and no HTA report was retrieved. In terms of effectiveness, the results of the included studies are basically the same:HCA has obvious advantages over placebo or blank experiment in reducing the amount of wound bleeding, reducing postoperative wound drainage, reducing the average hemostasis time of the incision and the blood loss per unit area of the incision. Compared with other positive drugs there is no statistical significance; good safety, no effect on blood coagulation indicators, blood routine, liver and kidney function, and will not lead to the occurrence of thrombosis; economical at the current price Learning has certain advantages. CONCLUSION HCA is more effective than placebo in the prevention and treatment of perioperative bleeding, with good safety and certain economic advantages.
关键词
尖吻蝮蛇血凝酶 /
外科手术止血 /
有效性 /
安全性 /
经济性 /
快速卫生技术评估
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Key words
haemocoagulase agkistrodon /
surgical hemostasis /
efficacy /
safety /
economy /
rapid HTA
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参考文献
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脚注
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基金
国家重点研发计划资助(课题编号:2020YFC2008305)
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