摘要
目的 评估布拉酵母菌(Saccharomyces boulardii,S. boulardii)制剂辅助治疗艰难拟梭菌相关腹泻(Clostridioides difficile associated diarrhea,CDAD)的有效性和安全性。方法 首先通过计算机检索中国知网、万方数据知识服务平台、中国生物医学文献服务系统、PubMed、Embase、Cochrane Library数据库中发表的有关布拉酵母菌治疗CDAD的临床随机对照试验;然后按照纳入及排除标准进行文献筛选、质量评价和数据提取,并根据干预措施的不同将纳入研究对象分为试验组(抗生素联合口服布拉酵母菌制剂治疗)和对照组(抗生素联用或不联用安慰剂治疗),利用Review Manager 5.4软件对符合纳入标准的文献进行Meta分析,最后利用Stata 12.0软件对纳入文献各结局指标的发表偏倚进行定量评估。结果 共纳入9篇文献,包含2 036例研究对象。Meta分析结果显示,与对照组相比,试验组患者CDAD的整体患病率降低,差异有统计学意义(RR=0.47,95%CI:0.27~0.81,P=0.007)。亚组分析发现,在儿童患者中,试验组患儿的CDAD患病率比对照组低,差异有统计学意义(RR=0.23,95%CI:0.08~0.68,P=0.008),两组患儿均无药物不良反应的病例报告;在成人患者中,试验组和对照组CDAD患病率(RR=0.67, 95%CI:0.35~1.31,P=0.240)和药物不良反应发生率(RR=0.94,95%CI:0.70~1.27,P=0.690)差异均无统计学意义,两组患者均无严重不良反应的病例报告。Begg和Egger检验均未发现纳入文献的各结局指标有显著发表偏倚。结论 布拉酵母菌制剂辅助治疗CDAD的策略表现出良好的临床安全性,有助于减少儿童患者的患病率,但对成人患者无效。由于受到纳入文献数量和质量的限制,以上结论仍需要更多高质量的研究进一步验证。
Objective To observe the efficacy and safety of Saccharomyces boulardii(S. boulardii) in treatment of Clostridioides difficile associated diarrhea(CDAD). Methods Randomized controlled trials(RCTs) about the treatment of CDAD with S. boulardii published on databases, including CNKI, WanFang Data, SinoMed, PubMed, Embase and Cochrane Library, were searched by computer. Then literature screening, quality evaluation and data extraction were accomplished in order based on the inclusion and exclusion criteria. The included subjects were divided into observation group(antibiotics combined with oral S. boulardii preparation) and control group(antibiotics combined with or without placebo treatment). Meta-analysis was conducted on the literatures that met the inclusion criteria by using Review Manager 5.4software. Finally, publication bias of outcomes from included studies was quantitatively assessed by using Stata 12.0 software. Results A total of 9 studies, including 2,036 subjects, were included. Meta-analysis showed that overall prevalence rate of CDAD in observation group was lower than that in control group(RR = 0.47, 95% CI: 0.27-0.81, P = 0.007). After subgroup analysis, we found that in pediatric patients, the prevalence rate of CDAD in the observation group was lower than that in the control group;the difference was statistically significant(RR = 0.23, 95% CI: 0.08-0.68, P = 0.008). No adverse event(AE) occurred in the two groups during the treatment. However, in adult patients, there was no significant difference in the prevalence rate of CDAD(RR = 0.67, 95% CI: 0.35-1.31, P = 0.240) and that of AE(RR = 0.94, 95% CI:0.70-1.27, P = 0.690) between groups. No case with serious AE was reported in both groups. There was no significant publication bias in the outcomes from included studies after Begg’s and Egger’s tests. Conclusion The strategy of using S.boulardii as adjuvant in treatment of CDAD showed good clinical safety and helped to reduce the prevalence rate of CDAD in children but was not effective in adults. Due to the restriction imposed by the number and quality of included literatures,the above conclusions still need to be further confirmed by more high-quality researches.
作者
刘一锋
苏建荣
LIU Yi-feng;SU Jian-rong(Clinical Laboratory Center,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)
出处
《中国微生态学杂志》
CAS
CSCD
2022年第11期1299-1305,共7页
Chinese Journal of Microecology
基金
首都卫生发展科研专项(首发2018-2-1114)。
关键词
布拉酵母菌
艰难拟梭菌
腹泻
系统评价
Saccharomyces boulardii
Clostridioides difficile
Diarrhea
Systematic review
