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目的系统评价双歧杆菌四联活菌对国内婴幼儿抗生素相关性腹泻(antibiotic associated diarrhea,ADD)的治疗作用及安全性。方法计算机联机检索中国知网、维普、万方数据库中关于双歧杆菌四联活菌治疗国内婴幼儿ADD的随机对照试验(randomized controlled trial,RCT),各数据库检索时间为创建至2016年11月。用Rev Man 5.3软件对数据进行Meta分析。结果共纳入12篇RCT,包括1 761例患儿。Meta分析结果显示,双歧杆菌四联活菌治疗ADD效果优于对照组[OR=5.74,95%CI(4.14,7.96),P<0.000 01]。纳入12篇RCT中8篇无不良反应发生,其余4篇未提及不良反应。结论基于现有临床证据,双歧杆菌四联活菌治疗ADD有效,安全性高。但由于纳入RCT数量较少,方法学质量不统一,该结论还需要更多大样本、多中心、高质量的临床RCT予以证实。
Objective To systematically evaluate the therapeutic effect and safety of antibiotic-associated diarrhea (ADD) in children with infantile antibiotic-associated diarrhea (ADD). Methods The computerized online randomized controlled trial (RCT) of China Unicom, VIP and Wanfang database for the treatment of infants and young children with Bifidobacterium viable in China was conducted on computer. The databases were searched from November 2016 to November 2016 . Meta-analysis of the data was performed using Rev Man 5.3 software. Results A total of 12 RCTs were included, including 1 761 children. The result of Meta analysis showed that Bifidobacterium quadriceps survivor was superior to control group [OR = 5.74,95% CI (4.14, 7.96), P <0.000 01]. No adverse reactions were found in 8 of 12 RCTs, and the remaining 4 articles did not mention adverse reactions. Conclusion Based on the available clinical evidence, Bifidobacterium quadriceps could effectively treat ADD with high safety. However, due to the small number of RCTs and the inconsistent methodological quality, this conclusion needs more large sample, multicenter and high-quality clinical RCTs.