OBJECTIVE： To systematically review the efficacy and safety of the aerosol inhalation of Yanhuning for injection in adjuvant treatment of children respiratory system infections， and provide evidence-based basis for the administration way of off-label drug use in clinic. METHODS： Retrieved from PubMed， Science direct， EMBase， CHKD， VIP and Wanfang Database， randomized controlled trials （RCT） or quasi-randomized controlled trials （qRCT） about the aerosol inhalation of Yanhuning for injection in adjuvant treatment of children respiratory system infections were collected. Meta-analysis was performed by using Rev Man 5.3 software after data extraction and quality evaluation. RESULTS： Totally 11 RCTs were enrolled， involving 982 patients. Results of Meta-analysis showed， the aerosol inhalation of Yanhuning for injection in adjuvant treatment of children respiratory system infections can significantly improve the clinical total effective rate [OR＝4.47，95％CI（2.80，7.16），P＜0.001]， shorten breath shortness duration [MD＝－2.05， 95％CI（－2.86，－1.24），P＜0.001]， cough duration [MD＝－1.73，95％CI（－2.34，－1.13），P＜0.001] and pulmonary rales duration [MD＝－2.13，95％ CI（－3.38，－0.89），P＜0.001]， reduce the hospitalization days [MD＝－2.38，95％CI（－2.86，－1.89）， P＜0.001]， and not increase the incidence of adverse reactions [OR＝0.65，95％CI（0.21，2.00），P＝0.45]， nor shorten the fever duration[MD＝－1.18，95％CI（－2.58，0.22），P＝0.10]. CONCLUSIONS： The aerosol inhalation of Yanhuning for injection can improve the clinical efficacy in adjuvant treatment of children respiratory system infection， it helps to improve respiratory symptoms in children and does not increase the incidence of adverse reactions.