基于随机对照试验对粪菌移植治疗功能性便秘的系统评价

Systematic Review of Fecal Microbiota Transplantation for Functional Constipation Based on Randomized Controlled Trials

目的:通过粪便微生物菌群移植(FMT fecal microbiota transplantation)或联合多种治疗来调节肠道微生态正成为治疗功能性便秘的一种新方法,系统评价FMT与药物联合治疗功能性便秘的临床疗效,为临床治疗提供循证医学依据。方法:对国内外6个数据库进行系统文献检索,筛选FMT治疗功能性便秘的随机对照试验(RCT)或观察性试验,由两名研究人员独立进行筛选、数据提取和偏倚评估。并采用Cochrane偏倚风险评估工具和StataSE 15.0软件进行质量评价和统计分析。结果:最终纳入11项RCT研究,共958例患者。Meta分析结果显示,与单纯药物治疗功能性便秘相比,FMT联合药物治疗可以显著提高临床疗效[RR=1.39,95%CI(1.23,1.58),P<0.001];明显改善大便性状(BSFS评分)[WMD=0.81,95%CI(0.53,1.08),P<0.001];降低便秘症状自评(KESS评分)[WMD=-4.58,95%CI(-6.41,-2.74),P<0.001];降低便秘生活质量(PAC-QOL评分)[WMD=-13.47,95%CI(-15.24,-11.7),P<0.001];降低Wexner便秘评分WMD=-2.78,95%CI(-3.02,-2.53),P<0.001];同时显著改善胃肠功能[WMD=-30.99,95%CI(-38.26,-23.72),P<0.001];调节血清胃肠激素水平的平衡[WMD=3.78,95%CI(0.30,7.26),P<0.001]。在调节肠道菌群方面可以显著降低致病菌的含量以及增加有益菌;在不良反应事件发生[RR=0.49,95%CI(0.20,1.25),P<0.001]上的差异没有统计学意义。结论:FMT联合药物治疗功能性便秘相比单纯常规治疗具有更好的疗效。

Objective:To evaluate the clinical efficacy of FMT combined with drugs in the treatment of functional constipation and to provide evidence-based medical basis for clinical treatment.Methods:A systematic literature search of six domestic and international databases was conducted to screen randomised controlled trials(RCTs)or observational trials of FMT for functional constipation,with screening,data extraction and bias assessment carried out independently by two researchers.The Cochrane Risk of Bias Assessment Tool and StataSE 15.0 software were used for quality assessment and statistical analysis.Results:Eleven RCT studies with a total of 958 patients were eventually included.Meta-analysis showed that FMT combined with pharmacological treatment significantly improved clinical outcomes compared with pharmacological treatment alone for functional constipation[RR=1.39,95%CI(1.23,1.58),P<0.001];significantly improved stool properties(BSFS score)[WMD=0.81,95%CI(0.53,1.08),P<0.001];reduced quality of life in constipation(PAC-QOL score)[WMD=-13.47,95%CI(-15.24,-11.7),P<0.001];reduced Wexner constipation score WMD=-2.78,95%CI(-3.02,-2.53),P<0.001];while significantly improving gastrointestinal function[WMD=-30.99,95%CI(-38.26,-23.72),P<0.001];and regulating the balance of serum gastrointestinal hormone levels[WMD=3.78,95%CI(0.30,7.26),P<0.001].The difference in the regulation of intestinal flora was statistically significant in reducing the level of pathogenic bacteria as well as increasing beneficial bacteria;the difference in the occurrence of adverse events[RR=0.49,95%CI(0.20,1.25),P<0.001]was not statistically significant.Conclusion:FMT combined with medication has better efficacy in the treatment of functional constipation than conventional treatment alone.