芍倍注射液治疗混合痔及内痔疗效和安全性的Meta分析

Meta- analysis on efficacy and safety of Shaobei injection in treatment of mixed hemorrhoids and internal hemorrhoids

目的系统评价芍倍注射液治疗混合痔及内痔的疗效及安全性。方法计算机检索国内外相关数据库,收集以消痔灵注射液为对照,观察芍倍注射液治疗混合痔及内痔的临床随机对照试验文献,检索时限为建库至2018年12月。采用RevMan 5.2软件进行Meta分析。结果共纳入15篇随机对照研究(涉及4 018例患者)。Meta分析结果显示,与消痔灵注射液相比,芍倍注射液治疗混合痔及内痔有更好的综合疗效[RR=1.19,95%CI(1.12,1.25),Z=6.17,P<0.01],并且可以降低术后不良反应总发生率[RR=0.04,95%CI(0.02,0.07),Z=9.56,P<0.0I]、术后直肠硬结发生率[RR=0.01,95%CI(0.01,0.03),Z=10.14,P<0.01]、术后出血发生率[SR=0.09,95%CI(0.02,0.30),Z=3.80,P<0.01]及术后肛门直肠狭窄发生率[RR=0.07,95%C/(0.02,0.21),Z=4.56,P<0.01)]。结论与消痔灵注射液相比,芍倍注射液治疗混合痔及内痔有更好的综合疗效,并能减少术后不良反应的发生;但由于文献质量偏低,上述结论有待后续研究结果验证。

Objective To systematically evaluate the efficacy and safety of Shaobei Injection in the treatment of mixed hemorrhoids and internal hemorrhoids.Methods The related databases at home and abroad were searched by computer,and literature on clinical randomized controlled trials of Shaobai Injection in the treatment of mixed hemorrhoids and internal hemorrtioids using Xiaozhiling Injection as control were collected.The search time limit was from establishment of the database to December 2018.Meta-analysis was performed using RevMan5.2.Results A total of 15 randomized controlled trials involving 4,018 patients were included.The meta-analysis results showed that compared with Xiaozhiling Injection,Shaobai Injection had better comprehensive effect on mixed hemorrhoids and internal hemorrhoids[RR=1.19,95%C/(1.12,1.25),Z=6.17,PvO.Ol],and could significantly reduce the overall incidence of postoperative adverse reactions[RR=0.04,95%CI(0.02,0.07),Z=9.56,P<0.01],the incidence of postoperative rectal induration[RR=0.01,95%CI(0.01,0.03),Z=10.14,P<O.Ol],the incidence of postoperative bleeding[RR=0.09,95%CI(0.02,0.30),Z=3.80,P<0.01],and the incidence of postoperative anorectal stenosis[RR=0.07,95%CI(0.02,0.21),Z=4.56,P<0.01].Conclusion Compared with Xiaozhiling Injection,Shaobai Injection has better overall efficacy in the treatment of mixed hemorrhoids and internal hemorrhoids,and can reduce the incidence of adverse reactions after operation.However,due to the low quality of literature,the above conclusion needs to be verified by follow?up study results.