注射用尖吻蝮蛇血凝酶用于手术止血的安全性及有效性的系统评价和Meta分析

Efficacy and safety of hemocoagulase Agkistrodon injection for intraoperative hemostasis： a systematic review and Meta-analysis

目的系统评价注射用尖吻蝮蛇血凝酶在外科应用的安全性和有效性。方法计算机检索中文数据库中关于注射用尖吻蝮蛇血凝酶在外科手术应用的随机对照研究（RCT），检索时间自建库至2014年5月，并追溯纳入文献的参考文献。由2位研究者按照纳入标准筛选文献、提取资料和评价纳入研究的方法学质量后，采用RevMan 5．1．0软件进行Meta分析。结果初筛文献2358篇，最终纳入12个RCT，共1031例患者。Meta分析结果显示：注射用尖吻蝮蛇血凝酶与安慰剂（对照组）相比，切口平均止血时间缩短[OR=-40．29，95％CI（-71．13，-9．44），P=0．01]，切口出血量[OR=-1．38，95％CI（-1．90，-0．87），P〈0．00001]和切口单位面积出血量[OR=-0．05，95％cs（-0．06，-0．03），P〈0．00001]减少，术中出血量和术后24h引流量[OR=-18．52，95％CI（-25．50，-11．53），P〈0．00001]均减少。各研究中2组凝血功能、肝肾功能指标变化及不良事件均差异无统计学意义。结论注射用尖吻蝮蛇血凝酶可以明显缩短手术切口平均止血时间，减少切口出血量、术中出血量和术后24h引流量，并不影响凝血及肝肾功能，未增加不良事件发生率。

Objective To systematically evaluate the efficacy and safety of injected hemocoagulase Agkistrodon for intraoperative bleeding. Methods We electronically searched several Chinese database till May 2014 to identify randomized controlled trials （RCTs） about injected hemocoagulase Agkistrodon for operative hemorrhage. The methodological quality of included RCTs was assessed, and the data were extracted by two reviewers independently according to the Cochrane Handbook. The homogeneous RCTs were pooled using RevMan software （ Version 5. 1.0 ）. Results 2 358 articles were searched initially, and 12 RCTs involving 1 031 patients met the inclusion criteria. The results of Meta-analyses showed that： in the study groups,the average haemostatic time of the wound is shorter [ OR = -40.29, 95% CI（ -71.13, - 9.44） ,P = 0. 01 ] ,the hemorrhagic volume of the wound [ OR = - 1.38,95% CI（ - 1.90, - 0. 87 ） ,P 〈 0. 000 01 ] , hemorrhagic volume per unit area of the wound [ OR = - 0. 05,95 % CI（ - 0. 06, - 0. 03 ）, P 〈0. 1300 01 ] , introperative hemorrhagic volume and drainage volume on POD1 [ OR = - 18.52, 95% CI （ - 25.50, - 11.53） ,P 〈 0. 000 01 ] are lower than the placebo groups. In all studies, no difference was found in the variation of hemostatic function, liver and renal function and drug-induced adverse events. Conclusions The injection of hemocoagulase Agkistrodon can significantly reduce the average haemostatie time of the wound, the hemorrhagic volume of the wound, overall introperative hemorrhagic volume and drainage volume on POD1, and does not affect the hemostatic function, liver and renal function and not increase the incidence of adverse effects or postoperative complications.