蛇毒类血凝酶用于外科手术切口有效性和安全性的系统评价

Efficacy and Safety of Hemocoagulase on Surgical Incision: A Systematic Review

目的系统评价蛇毒血凝酶应用于外科手术切口的有效性和安全性。方法计算机检索Web of Science、MEDLINE、EMbase、EBSCO、PubMed、CNKI、WanFang Data和VIP数据库,检索时限均为从建库至2015年6月20日,搜集蛇毒血凝酶应用于外科手术切口的相关随机对照试验(RCT)。由两位研究者独立进行文献筛选、资料提取并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果共纳入16个RCT,包括1 867例患者。Meta分析结果显示,与对照组相比,蛇毒血凝酶组的平均止血时间[MD=–38.58,95%CI(–55.75,–21.41),P<0.000 1]、单位面积出血量[MD=–0.09,95%CI(–0.11,–0.07),P<0.000 01]和术后第一天的凝血酶原时间(PT)[MD=–0.41,95%CI(–0.70,–0.11),P=0.007]均更小。但两组在活化部分凝血活酶时间(APTT)、凝血酶时间(TT)及纤维蛋白原含量(FIB)方面,差异无统计学意义。结论蛇毒血凝酶可缩短外科手术切口的出血时间,减少单位面积出血量。受纳入研究的数量和质量限制,上述结论尚需开展更多高质量研究进行验证。

Objective To evaluate the efficacy and safety of all kinds of hemocoagulase on operative incisions. Methods Databases including Web of Science, MEDLINE, EMbase, EBSCO, PubMed, CNKI, WanFang Data and VIP were electronically searched to collect randomized controlled trials （RCTs） about hemocoagulase on operative incisions from the inception to June 20th, 2015. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by RevMan 5.2 software. Results A total of 16 RCTs involving 1 867 patients were included. The results of meta-analysis showed that, compared with the control group, the hemostatic time （MD= -37.84, 95%CI -52.72 to -22.96, P〈0.000 01）, blood loss volume per unit area （MD= -0.09, 95%CI -0.10 to -0.07, P〈0.000 01）, PT of the first postoperative day （MD= -0.37, 95%CI -0.65 to -0.09, P=0.009） were significantly shorter in the hemocoagulase group. However, no significant differences were found in APTT, TT and FIB between two groups. Conclusion Hemocoagulase can reduce hemostatic time and blood loss volume in surgical incisions. Due to the limited quantity and quality of the included studies, the above condusion needs to be further verified by more high quality studies.