基于Meta分析的消痔灵注射液联合自动套扎术治疗内痔或混合痔临床评价研究

Meta-analysis on the Efficacy of Xiaozhiling Injection Combined with Ruiyun Procedure for Hemorrhoid in the Treatment of Internal or Mixed Hemorrhoids

目的:系统评价消痔灵注射液联合自动套扎术治疗内痔或混合痔的临床疗效。方法:计算机检索CNKI、Wan Fang Data、VIP、Sino Med、PubMed、Embase、the Cochrane Library数据库,搜集消痔灵注射液联合自动套扎术治疗内痔或混合痔的随机对照试验(RCT),检索时限均为从建库至2020年4月15日,由两名研究者独立筛选文献、提取资料和评价纳入研究的偏倚风险后,通过Rev Man 5.3、Stata 12.0软件进行Meta分析和敏感性分析。结果:共纳入15个RCT,累计受试者1 630例。Meta分析结果显示,在自动套扎术的基础上联合使用消痔灵注射液,可提高内痔或混合痔患者的临床治愈率[RR=1.14,95%CI(1.02,1.27),P=0.02]、降低半年复发率[RR=0.28,95%CI(0.15,0.53),P<0.000 1]、缩短创面愈合时间[MD=-3.63,95%CI(-6.14,-1.12),P=0.005],并可缓解患者术后疼痛。结论:消痔灵注射液联合自动套扎术对内痔或混合痔有较好的治疗作用。受纳入研究质量的限制,上述结论尚需开展更多高质量的研究予以验证。

Objective: To systematically evaluate the clinical efficacy of Xiaozhiling injection combined with Ruiyun procedure for hemorrhoid(RPH) in the treatment of internal or mixed hemorrhoids. Methods: Embase,PubMed,the Cochrane Library,CNKI,Wan Fang Data,VIP and Sino Med database were searched to collect the randomized controlled trials(RCTs) of Xiaozhiling injection combined with RPH in the treatment of internal or mixed hemorrhoids from inception to April 15,2020. Two authors independently screened the literature,extracted the data and evaluated the risk of bias of included studies,and then Meta-analysis and sensitivity analysis was performed using Rev Man 5.3 and Stata 12.0 software. Results: A total of 15 RCTs with 1 630 patients were included. In the Meta-analysis,the combining use of Xiaozhiling injection and RPH could improve the cure rate of patients(RR = 1.14,95% CI1.02 to 1.27,P = 0.02),reduce the half-year recurrence rate(RR = 0.28,95%CI 0.15 to 0.53,P<0.000 1),shorten the wound healing time(MD =-3.63,95%CI-6.14 to-1.12,P = 0.005) and relieve the postoperative pain.Conclusion: Xiaozhiling injection combined with RPH in the treatment of internal or mixed of hemorrhoids has a certain adjuvant treatment effect in improving the efficacy and reducing the recurrence,while the conclusion still needs more large sample double blind RCTs with reasonable design and strict implementation.