目的系统评价布拉氏酵母菌预防儿童抗菌药物相关性腹泻(AAD)的疗效和安全性。方法计算机检索Cochrane图书馆、Pub Med、Cochrane对照试验数据库、EMBASE中国生物医学文献数据库(CBM)、中国期刊数据库(CNKI)、中国科技期刊全文数据库(VIP)、万方数据库,全面收集布拉氏酵母菌预防儿童AAD的随机对照试验(RCT),根据Cochrane协作网系统评价的方法进行评价。结果共纳入23项研究(患者3 939例),其中22项研究为空白对照,1项为安慰药。21项研究(患者3 534例)采用腹泻发生率作为结局指标进行评价,Meta分析结果显示,布拉氏酵母菌预防AAD发生率的疗效优于空白对照[RR=0.47,95%CI(0.42,0.53),I~2=0%]。7项研究(患者523例)采用有效率作为结局指标进行评价,Meta分析结果显示,布拉氏酵母菌预防AAD有效率优于空白对照[RR=1.34,95%CI(1.22,1.47),I2=0%]。共12项研究报道了不良反应(ADR),其中9项研究报道无ADR,3项报道了具体ADR,最常见的ADR为皮疹、口干、胃肠道不适和抗菌药物迟发型过敏。结论现有临床研究证据提示,布拉氏酵母菌能有效预防儿童AAD,且不良反应少。但因研究质量及研究样本的局限,其长期疗效和安全性尚需远期高质量的研究证实。
Objective To systematically evaluate the efficacy and safety of Saccharomyces boulardii in the prevention of antibiotic associated diarrhea (AAD) in children. Methods They searched the Cochrane library, PubMed, Cochrane, EMBASE, CBM, CNKI, VIP and Wanfang database for randomized controlled trial (RCTs) in evaluating the efficacy and safety of Saccharomyces boulardii in the prevention of AAD. Meta-analysis was conducted based on the methods recommended by the Cochrane Collaboration. Results Twenty-three studies (3 939 patients)were included, twenty-two RCTs used open control as control and one used placebo.Meta analysis of twenty-one studies (3 534 patients) showed Saccharomyces boulardii group could significantly reduced the diarrhea rate compared with open control group in the prevention of AAD (RR = 0.47, 95%CI (0.42, 0.53), 12 = 0%).Meta analysis of 7 studies (523 patients) showed that the efficacy rate of Saccharomyces boulardii group was significantly higher than open control group in the prevention of AAD (RR= 1.34, 95%CI (1.22,1.47) ,f2 =0%).Twelve studies reported adverse reactions, nine studies reported there was no ADR,three studies reported specific ADR.The most common AEs were rash, dry mouth, gastrointestinal discomfort and antibiotics delayed type hypersensitivity. Conclusion The available clinical evidence suggested that Saccharomyces boulardii was effective in the prevention of AAD and was well tolerant. However due to limited study sample and quality, the long-term efficacy and safety studies are required to confirmit.