黄酮类静脉活性药物治疗痔急性发作的系统评价和Meta分析

Systematic review and Meta-analysis of flavonoid venoactive drug for the treatment of acute hemorrhoids

目的:系统评价黄酮类静脉活性药物在成人痔急性发作治疗中的有效性和安全性。方法:计算机检索Embase、PubMed、The Cochrane Library、中国知网、万方数据库等文献资料,纳入黄酮类静脉活性药物在成人痔急性发作治疗中有效性和安全性的随机对照试验,检索时间从建库截至2023年12月。由2名研究者按照纳入与排除标准筛选文献、提取资料并评价纳入研究的方法学质量后,采用Stata 16.0软件进行直接比较和间接比较的Meta分析。结果:共纳入文献6篇,包括668例患者。直接比较Meta分析结果显示,黄酮类静脉活性药物联合常规治疗组的总有效率显著优于常规治疗组,差异有统计学意义[OR=4.86,95%CI(2.86,8.27),P<0.05];微粒化纯化黄酮(MPFF)联合常规治疗组的出血改善率显著优于常规治疗组,差异有统计学意义[OR=3.13,95%CI(2.06,4.77),P<0.05]。间接比较Meta分析结果显示,MPFF联合常规治疗组的总有效率可能优于地奥司明联合常规治疗组,但差异不显著(P>0.05)。累积排序概率图下面积(SUCRA)结果显示,痔急性发作总有效率最佳的是MPFF联合常规治疗组(SUCRA=81.7%)、其次为地奥司明联合常规治疗组(SUCRA=68.2%),二者显著优于常规治疗组(SUCRA=0.1%)。黄酮类静脉活性药物的不良事件发生情况与常规治疗组相当。结论:当前证据提示黄酮类静脉活性药物在痔急性发作的治疗中安全、有效,其中MPFF的疗效可能更佳。但受纳入研究数量和样本量的限制,上述结论尚需要更多大样本多中心临床试验予以验证。

Objective:To systematically evaluate the efficacy and safety of flavonoid venoactive drugs in the treatment of acute hemorrhoids in adults.Methods:EMbase,PubMed,the Cochrane Library,CNKI,and WanFang database were searched systematically,and randomized controlled trials(RCTs)related to the efficacy and safety of flavonoid venoactive drugs in the treatment of acute hemorrhoids were included up to December 2023.Meta-analysis was performed using Stata 16.O software after two researchers screened the literature according to inclusion and exclusion criteria,extracted data,and evaluated the methodological quality of the included studies.Results:A total of 6 articles(6 RCTs)were enrolled,including 668 patients.The results of direct comparison Meta-analysis showed that the overall effective rate of flavonoid venoactive drugs combined with the conventional treatment group was significantly better than that of the conventional treatment group[OR=4.86,95%CI(2.86,8.27),P<0.05].The bleeding improvement rate in the MPFF combined with the conventional treatment group was significantly better than that in the conventional treatment group[0R=3.13,95%CI(2.06,4.77),P<O.05].Indirect comparison Meta-analysis showed that the total effective rate of MPFF with conventional treatment may be better than that of Diosmin combined with conventional treatment,but the difference was not significant(P>0.05).SUCRA results showed that the total effective rate of MPFF was the best in the flavonoid venoactive drugs combined with the conventional treatment group(SUCRA=81.7%),followed by the Diosmin combined with the conventional treatment group(SUCRA=68.2%),both of which were significantly better than the conventional treatment group(SUCRA=0.1%).The incidence of adverse events of flavonoid venoactive drugs was comparable to that of the conventional treatment group.Conclusion:Existing evidence suggests that flavonoid venoactive drugs are safe and effective in the treatment of acute hemorrhoids,and the MPFF may be more effective.However,due to the limitations of the number and sample size,the above conclusions still need to be verified by more large-sample multi-center clinical trials.