血凝酶治疗神经外科手术出血的疗效和安全性系统评价

Systematic review of clinical researches of Baqutting(Reptilase) in neurosurgery hemorrhage

目的系统评价血凝酶在神经外科手术中应用效果和不良反应。方法采用系统评价方法,检索Pub Med、CBM、CNKI、万方等数据库的随机对照研究(RCT),使用Rev Man 5.2软件进行分析。结果涉及合并的9篇RCT文献的血浆凝血酶原时间(PT)、凝血酶时间(TT)和活化部分凝血活酶时间(APTT)的效应指标(MD,95%CI)分别为:-2.91(-3.79,-2.03),-1.20(-1.34,-1.07)和-1.55(-2.32,-0.78);术中出血量、术后引流量和输血量的效应指标为:-2.01(-3.08,-0.94)、-1.36(-2.23,-0.49)和-1.98(-2.94,-1.03)。文献分析未见报道过敏反应和深静脉血栓,亦未见明显全身及局部不良反应。结论神经外科手术中应用注射用血凝酶后,试验组与对照组相比多项凝血指标存在差异,并明显降低术中出血量、术后引流量和输血量;严重不良反应未见。

Objective To evaluate the efficacy and safety of Baqutting(Reptilase). Methods Retrieved Pub Med, CBM, CNKI, Wanfang database, collected RCT study, by the method of systematic review, and then analyzed the indicators with Rev Man 5.2 software. Results In the 9 screened RCT literatures, MD and 95% CI of plasma prothrombin time(PT), thrombin time(TT), activated partial coagulation time(APTT) were-2.91(-3.79,-2.03),-1.20(-1.34,-1.07) and-1.55(-2.32,-0.78); intraoperative blood loss, postoperative flow(24 hours) and transfusion volume’s effect size and 95% CI were-2.01(-3.08,-0.94),-3.08(-2.23,-0.49) and-1.98(-2.94,-1.03). No reports of allergic reactions and deep vein thrombosis in the literature analysis, also no obvious systemic and local ADR. Conclusions Baqutting(Reptilase) injection used in neurosurgery hemorrhage had been observed a significantly statistical difference of a number of blood coagulation indicators compared with control group, and apparently reduced intraoperative blood loss, postoperative flow and amount of blood transfusion as well. In addition, no serious adverse reactions was reported inapplication of neurosurgery.