利福昔明预防自发性细菌性腹膜炎有效性和安全性的Meta分析

Efficacy and safety of rifaximin in the prevention of spontaneous bacterial peritonitis:A Meta-analysis

目的评价利福昔明预防自发性细菌性腹膜炎(SBP)的有效性及安全性。方法通过计算机检索中国知网、万方数据、中国生物医学数据库、PubMed、Embase、Cochrane图书馆建库至2020年7月5日发表的有关利福昔明预防SBP的随机对照研究(RCT)、队列研究,根据纳入和排除标准对文献进行筛选,并对文献进行提取数据和质量评估,采用RevMan 5.3软件进行Meta分析。结果最终纳入13项研究,共2207例患者,其中6项为RCT,7项为队列研究。Meta分析结果显示,与无预防组相比,利福昔明组的SBP发病率(OR=0.36,95%CI:0.14~0.96,P=0.04)、死亡率(OR=0.59,95%CI:0.37~0.95,P=0.03)均明显下降;与诺氟沙星组相比,利福昔明组的SBP发病率(OR=0.39,95%CI:0.25~0.62,P<0.001)、死亡率(OR=0.55,95%CI:0.34~0.92,P=0.02)、不良反应(OR=0.36,95%CI:0.22~0.59,P<0.001)均明显降低,根据预防类型进行亚组分析,两组在初级预防无显著差异(OR=0.56,95%CI:0.23~1.35,P=0.20),二级预防时利福昔明组的SBP发病率(OR=0.18,95%CI:0.08~0.43,P<0.001)明显降低。此外,还发现利福昔明可以明显降低肝肾综合征(OR=0.34,95%CI:0.15~0.77,P=0.01)和肝性脑病(OR=0.55,95%CI:0.32~0.95,P=0.03)的发生风险。结论利福昔明对SBP初级预防和二级预防安全有效,在二级预防时,利福昔明优于诺氟沙星,但仍需高质量多中心RCT进行验证。

Objective To evaluate the efficacy and safety of rifaximin in the prevention of spontaneous bacterial peritonitis(SBP).Methods CNKI,Wanfang Data,CBM,PubMed,Embase,and Cochrane Library were searched for randomized controlled trials(RCTs)and cohort studies on rifaximin in the prevention of SBP published up to July 5,2020.The articles were screened according to the inclusion and exclusion criteria,and data extraction and quality assessment were performed.RevMan 5.3 software was used to conduct the meta-analysis.Results A total of 13 studies(with 2207 patients in total)were included,among which there were 6 RCTs and 7 cohort studies.The results of the meta-analysis showed that compared with the non-prevention group,the rifaximin group had significantly lower incidence rate of SBP(odds ratio[OR]=0.36,95%confidence interval[CI]:0.14-0.96,P=0.04)and mortality rate(OR=0.59,95%CI:0.37-0.95,P=0.03);compared with the norfloxacin group,the rifaximin group had significantly lower incidence rate of SBP(OR=0.39,95%CI:0.25-0.62,P<0.001),mortality rate(OR=0.55,95%CI:0.34-0.92,P=0.02),and adverse reactions(OR=0.36,95%CI:0.22-0.59,P<0.001).The subgroup analysis based on the type of prevention showed that there was no significant difference in primary prevention between the two groups(OR=0.56,95%CI:0.23-1.35,P=0.20),and in secondary prevention,the rifaximin group had a significantly lower incidence rate of SBP(OR=0.18,95%CI:0.08-0.43,P<0.001).In addition,it was also found that rifaximin significantly reduced the incidence rate of hepatorenal syndrome(OR=0.34,95%CI:0.15-0.77,P=0.01)and hepatic encephalopathy(OR=0.55,95%CI:0.32-0.95,P=0.03).Conclusion Rifaximin is safe and effective for the primary and secondary prevention of SBP.Rifaximin is superior to norfloxacin in secondary prevention,which still needs to be confirmed by high-quality multicenter RCTs.