OBJECTIVE： To evaluate the efficacy and safety of Bacterial lysates （hereinafter referred to as “Broncho-Vaxom”） for recurrent respiratory tract infections （RRTIs） of children，and to provide evidence-based reference for clinic. METHODS：Retrieved from PubMed， EMBase， Cochrane Library， CBM， CNKI， Wanfang database and VIP database， domestic and foreign published randomized controlled trials （RCTs） about Broncho-Vaxom （trail group） vs. placebo （control group） for RRTIs of children were collected during database establishment to Jan. 2018. After literature scanning and data extraction，the risk of bias of included trials were evaluated by using Cochrane 5.1.0 risk bias evaluation tool. Meta-analysis was performed by using Rev Man 5.3 software. RESULTS： A total of 13 RCTs involving 1 228 children were included. The results showed that the trial group was superior to control group in frequency of respiratory infection [MD＝－1.14，95％CI（－1.29，－0.99），P＜0.001]， total response rate [RR＝9.47，95％CI（2.33，38.54），P＝0.002]， the time of antibiotics use [MD＝－4.36， 95％CI（－6.52，－2.21），P＜0.001]， infection duration [MD＝－3.89，95％CI（－4.47，－3.04），P＜0.001]， febrile time [MD＝－1.81，95％CI（－3.40，－0.22），P＝0.03]， serum immunoglobulin （Ig）G level [MD＝1.25， 95％CI（0.13， 2.37）），P＝0.03]， IgA level [MD＝0.77， 95％CI（0.07， 1.46），P＝0.03] and the level of T cell subgroup CD4+ [MD＝1.33，95％CI（0.90， 1.76），P＜0.001] and CD8+ [MD＝0.64， 95％CI（0.24，1.04），P＝0.002]， there was statistical significance. Trail group was similar to control group in respect of cough time [MD＝－6.00， 95％CI（－13.86， 1.86），P＝0.13] and IgM level [MD＝－0.10， 95％CI（－0.32，0.12），P＝0.39] and the incidence of ADR [RR＝0.76，95％CI（0.43，1.35），P＝0.35]. CONCLUSIONS： The current evidence shows that Broncho-Vaxom could effectively prevent the RRTIs of children with good safety.