Objective To study the effect and safety of the combination of Qingkailing Injection with Ertong Qingfei Oral Liquid for the treatment of accumulation of phlegm-heat in lung in children respiratory syncytial virus pneumonia（RSVP）.Methods The involved children were randomized into Chinese medicine treatment group and control group which was treated by Ribavirin Injection plus Compound Guaiacol Potassium Sulfonale Oral Solution.The study was carried out simultaneously in five clinical centers in a duration of 10 days.Endpoint evaluation and effect onset evaluation were adopted to determine the therapeutic effect.Results The effect of Chinese medicine treatment group was evaluated safe and better than that of control group with a significant difference（P<0.05）.The effect onset of Chinese medicine was earlier than that of western medicine on relieving fever

cough

phlegm accumulation and on chest auscultation and X-ray manifestation（P<0.05）.Conclusion The combination of Qingkailing Injection with Ertong Qingfei Oral Liquid is a safe and effective therapy for the syndrome of accumulation of phlegm-heat in lung in children RSVP.