双歧杆菌四联活菌片联合氨基水杨酸治疗溃疡性结肠炎的系统评价及Meta分析

Systematic review and meta-analysis of tetragenous viable bifidobacterium tablets plus aminosalicy acids on ulcerative colitis

目的系统评价双歧杆菌四联活菌片联合氨基水杨酸治疗轻中度活动期溃疡性结肠炎的有效性和安全性。方法计算机检索PubMed、EMbase、Cochrane Library、SinoMed、CNKI、VIP、WanFang、Clinicaltrials数据库及谷歌学术搜寻,检索收集有关双歧杆菌四联活菌片联合氨基水杨酸治疗溃疡性结肠炎的随机对照试验,筛选、提取资料,采用Cochrane风险评估工具评价纳入研究质量,采用RevMan 5.3软件进行Meta分析。结果纳入14项研究,共1123名受试者。试验组改善Mayo评分[RR=-1.47,95%CI=(-2.60,-0.34),P=0.01],提高临床总有效率,降低TNF-α、IL-8、hsCRP、ox-LDL、LPO水平,增加CD4^(+)、CD4^(+)/CD8^(+)水平的效果优于对照组,两组不良反应发生率无统计学差异[RR=0.58,95%CI=(0.33,1.04),P=0.07]。结论双歧杆菌四联活菌片联合氨基水杨酸治疗轻中度活动期溃疡性结肠炎的临床疗效可能优于单独使用氨基水杨酸,可改善患者Mayo评分,提高临床总有效率,降低炎症因子、脂质过氧化损伤水平,平衡外周T淋巴细胞亚群,且不良反应发生率趋于降低,具有良好的有效性和安全性。双歧杆菌四联活菌片使用剂量为1.5 g/次tid po可能取得更好的疗效,针对年龄<45岁或病程时间较长的患者治疗效果可能更明显。

Objective To evaluate the clinical efficacy and safety of tetragenous viable bifidobacterium tablets plus aminosalicy acids for mildly and moderately active ulcerative colitis.Methods PubMed,Embase,Cochrane Library,SinoMed,CNKI,VIP,WanFang,Clinicaltrials databases and Google Scholar were searched to collect randomized controlled trials using the medication by tetragenous viable bifidobacterium tablets in the treatment of ulcerative colitis.Data were screened.The quality of the included studies was evaluated with the Cochrane risk-of-bias tool.Meta analysis was conducted with RevMan 5.3.Results Totally 14 articles were included,involving 1123 participants.Meta analysis demonstrated that the improvement of Mayo score[RR=-1.47,95%CI=(-2.60,-0.34),P=0.01],the clinical effect rate,and decrease of levels of TNF-α,IL-8,hs-CRP,ox-LDL,and LPO,and the increase of levels of CD4^(+),and CD4^(+)/CD8^(+)in the treatment group,were all better than those in the control group.There was no significant difference was observed in the incidence of adverse events[RR=0.58,95%CI=(0.33,1.04),P=0.07].Conclusion Tetragenous viable bifidobacterium tablets plus aminosalicy acids may improve the Mayo score and clinical effect rate,decrease the level of inflammatory factors and damage of lipid peroxidation injury level,balance peripheral T lymphocyte subsets,and decrease the incidence of adverse events,indicating better efficacy and safety in the combination therapy.Better efficacy is seen in the patients<45 years old with long course of disease at the tetragenous viable bifidobacterium tablet dose of 1.5 g/day tid,orally.