OBJECTIVE： To investigate the time of clinical symptom disappearance， therapeutic efficacy and safety of Pudilan xiaoyan oral liquid and its effects on immune factors in the treatment of pediatric acute upper respiratory tract infection. METHODS： A total of 142 children aged 3-17 with acute upper respiratory tract infection selected from Chongqing Jiulongpo District Second People’s Hospital during May 2015-May 2016 were divided into observation group （72 cases） and control group （70 cases） according to random number tablet. Both groups received symptomatic treatment as antivirus， antipyretic. Observation group was additionally given Pudilan xiaoyan oral liquid 10 mL each time， 3 times a day， treated for consecutive 7 d. The defervescence time， the disappearance time of rhinobyon， coughing， diarrhea and pharynx swelling were compared between 2 groups. The levels of TNF-α， IL-6 and immune factors （CD3+， CD4+ and CD4+/CD8+） were determined in 2 groups before and after treatment. Clinical efficacies and the occurrences of ADR were observed in 2 groups. RESULTS： Compared to control group， the defervescence time， the disappearance time of rhinobyon， coughing， diarrhea， pharynx red and swelling were significantly shortened in observation group （P＜0.05）. Before treatment， there was no statistical significance in the serum levels of TNF-α， IL-6 or immune factors between 2 groups （P＞0.05）. After treatment， the serum levels of TNF-α and IL-6 in 2 groups were significantly lower than before treatment （P＜0.05）. The serum levels of CD3+， CD4+ and CD4+/CD8+ were significantly higher than before treatment of each group（P＜0.05）， while the improvement of observation group was significantly better than that of control group （P＜0.05）. Total response rate of observation group was significantly higher than that of control group （P＜0.05）， but there was no statistical significance in the incidence of ADR between 2 groups （P＞0.05）. CONCLUSIONS： Pudilan xiaoyan oral liquid can shorten the time of acute upper respiratory tract infection disapperance as defervescence， nasal congestion and cough. It combined with antiviral drug is better than antiviral drug alone， but antiviral drug combined with it or alone have same safety.