Objective To systematically evaluate the clinical effect and safety of Bifidobacterium tetravaccine tablets in the treatment of antibiotic associated diarrhea (ADD) in infants in China. Methods Randomized controlled trials (RCTs) of treatment of AAD by Bifidobacterium tetravaccine in infants were searched by computer from China Knowledge Resource Integrated Database, VIP and Wanfang Data from their inception to November 2016. Meta-analysis of the data was carried out by RevMan 5.3 software. Results Twelve RCTs were chosen, which included 1 761 infant patients. The Meta analysis showed that the effects of treatment of ADD were significantly superior to those of the control group [OR=5.74, 95%CI (4.14, 7.96),P<0.000 01]. Among the 12 RCTs, 8 had no adverse reactions, while the rest4 articles did not mention adverse reactions. Conclusions Based on the present clinical evidences, treatment of ADD by Bifidobacterium tetravaccine in infants is effective and safe. But due to the small number and different quality of RCTs, this conclusion still needs to be confirmed by large sample, multicenter, and high-quality clinical RCTs.
