Objective:To systematically evaluate the clinical efficacy and safety of Qingkailing (QKL) injection for pediatric acute upper respiratory infection (AURI).Methods:We searched for randomized controlled trials (RCTs) of pediatric AURI treated by QKL and west medicine (WM) in the China National Knowledge Infrastructure Database,China Science and Technology Joal Database,Wanfang,Chinese Biomedical Literature Database,PubMed and Cochrane Library from inception to August,2016.Two reviewers independently retrieved the RCTs and extracted information.The Cochrane Collaboration Risk of Bias Assessment Tool was used to evaluate the methodological quality of RCTs.The data were meta-analyzed by RevMan 5.3 software.Results:Ultimately,21 RCTs that involved 2364 participants were included,and the quality of RCTs was generally poor.According to the meta-analysis,the combined use of QKL and WM for treating AURI can be effective,with a higher total effective rate,less defervescence time and less recovery time of tonsil and throat inflammation.Twenty-five adverse drug reactions (ADRs) were reported in three RCTs,but there were no serious ADRs.Conclusion:The combination of QKL and WM for treating pediatric AURI can result in better effects,but no definitive conclusions can be made regarding its safety.More rigorous RCTs are needed to support the clinical application of QKL.