注射用矛头蝮蛇血凝酶治疗消化系统疾病疗效的系统评价

Systematic review of clinical researches of Baqutting(Reptilase) in digestive system disease

目的系统评价注射用矛头蝮蛇血凝酶在消化系统疾病中应用效果和不良反应。方法采用系统评价方法,检索VIP、CNKI、万方等数据库的随机对照试验研究,应用Rev Man 5.3软件分析。结果根据不同疗效评价标准,对26篇文献合并分析有效率、显效率、显效+有效率的效应指标,4个亚组显效率效应指标OR(95%CI)分别为1.82(1.26,2.62)、2.79(1.74,4.48)、2.66(1.58,4.47)、3.53(2.35,5.30),有效率效应指标OR(95%CI)分别为1.03(0.63,1.54)、0.69(0.41,1.15)、0.80(0.51,1.51)、0.44(0.29,0.66),显效+有效率的效应指标OR(95%CI)分别为2.86(1.65,4.94),4.38(2.09,9.20),5.42(2.40,12.25),4.11(1.93,8.75);平均止血时间、平均输血量、术中出血量、术后引流量、活化部分凝血活酶时间(APTT)、血浆凝血酶原时间(PT)和纤维蛋白原浓度(FIB)的效应指标MD(95%CI)分别为-21.21(-22.50,-19.93),-263.50(-279.19,-247.80),-65.60(-80.57,-50.63),-113.69(-150.86,-76.52),1.04(-0.03,2.10),0.09(-0.06,0.24),-0.05(-0.14,0.04)。试验组与对照组不良反应发生频率没有差异,未见严重不良反应。结论消化系统疾病中应用注射用矛头蝮蛇血凝酶后,试验组与对照组相比凝血指标无差异、疗效明显、止血时间缩短,并明显降低术中出血量、术后引流量和输血量;未见严重不良反应。

Objective To evaluate the efficacy and safety of Baqutting (Reptilase) in digestive system disease.Methods Retrieved VIP, CNKI, Wanfang database, collecting RCT study, by the method of systematic review, and then analyzed the indicators with RevMan 5.3 software.Results Classified the 26 screened RCT literatures by different response evaluation criteria.OR and 95%CI of CR in four subgroup were 1.82 (1.26, 2.62), 2.79 (1.74, 4.48), 2.66 (1.58, 4.47) and 3.53 (2.35, 5.30);OR and 95%CI of PR in four subgroup were 1.03 (0.63, 1.54), 0.69 (0.41, 1.15), 0.80 (0.51, 1.51), 0.44 (0.29, 0.66);OR and 95%CI of CR+PR in four subgroup were 2.86 (1.65, 4.94), 4.38 (2.09, 9.20), 5.42 (2.40, 12.25), 4.11(1.93, 8.75);MD and 95%CI of average hemostasis time, mean blood transfusion volume, intraoperative blood loss, post operation flow were-21.21 (-22.50,-19.93),-263.50 (-279.19,-247.80),-65.60 (-80.57,-50.63),-113.69 (-150.86,-76.52).MD and 95%CI of activated partial coagulation time (APTT), plasma prothrombin in time (PT), plasma fibrinogen (FIB) were 1.04 (-0.03, 2.10), 0.09 (-0.06, 0.24),-0.05 (-0.14, 0.04). The frequency of ADR had a difference that was not statistically significant in both groups. Moreover, there was no obvious systemic and local ADR reported.Conclusion Baqutting (Reptilase) injection used in digestive system disease had been observed on statistical difference of a number of blood coagulation indicators compared with control group, and apparently improved curative effect as well as reduced average hemostasis time, mean blood transfusion volume, intraoperative blood loss and post operation flow. In addition, no serious adverse reactions was reported in application of digestive system disease.