消痔灵注射液联合经会阴手术疗法治疗直肠脱垂有效性和安全性的meta分析

Meta-analysis of efficacy and safety of Xiaozhiling Injection combined with meridian operation in the treatment of rectal prolapse

目的系统评价消痔灵注射液联合经会阴手术疗法治疗直肠脱垂的有效性及安全性。方法采用Rev Man5.4软件,系统检索中国知网、维普、万方(Wanfang)、中国生物医学文献服务系统、Cochrane Library、Pub Med、EMbase、Web of Science核心合集数据库,筛选出相关的随机对照试验(RCTs)。结果最终纳入11篇RCTs,包括710例患者。结果显示,与单纯采用经会阴手术比较,加用消痔灵注射液可提高治愈率[RR(95%CI)=1.49(1.16,1.91),P=0.002;RR(95%CI)=1.58(1.20,2.08),P=0.001],提高治疗总有效率[RR(95%CI)=1.17(1.09,1.26),P<0.0001],降低出血率[RR(95%CI)=0.16(0.05,0.47),P=0.0009],同时降低术后6个月、12个月复发率[RR(95%CI)=0.27(0.10,0.74),P=0.01;RR(95%CI)=0.10(0.02,0.53),P=0.007]。结论消痔灵注射液可提高经会阴手术治疗直肠脱垂临床效果,改善术后出血,减少复发,且在临床使用中尚未见严重不良反应,上述结论有待进一步论证。

Objective To evaluate the efficacy and safety of Xiaozhiling injection combined with meridian surg in the treatment of rectal prolapse.Methods Using RevMan 5.4 software,the databases of CNKI,VIP,Wanfang,China Biomedical Literature Service System,Cochrane Library,PubMed,EMbase,and Web of Science were systematically searched,and screened out relevant randomized controlled trial(RCT).Results Eleven RCTs were included,including 710 patients.The data showed that compared with perineal operation alone,Xiaozhiling Injection could improve the cure rate(RR[95%CI]=1.49[1.16,1.91],P=0.002;RR[95%CI]=1.58[1.20,2.08],P=0.001),improved the total response rate(RR[95%CI]=1.17[1.09,1.26],P<0.0001),reduced the bleeding rate(RR[95%CI]=0.16[0.05,0.47],P=0.0009),and decreased the recurrence rate at 6 and 12 months after surgery(RR[95%CI]=0.27[0.10,0.74],P=0.01;RR[95%CI]=0.10[0.02,0.53],P=0.007).Conclusion Xiaozhiling Injection can improve the clinical effect of meridian operation in the treatment of rectal prolapse,improve postoperative bleeding and reduce recurrence,and no serious adverse reactions have been seen in clinical use.The above conclusions need to be further demonstrated.