Objective To observe the effect and safety of Qingfei Oral Liquid （Liquid for clearing lung） on children’s respiratory syncytial virus （RSV） pneumonia of TCM syndrome of phlegm-heat in the lung.Methods The 332 cases that met the criterion of phlegm-heat syndrome of children’s RSV pneumonia selected from 5 centers were divided randomly into experiment group （166 cases） and control group （166 cases）. The former was given Qingfei Oral Liquid and placebo by intravenous drip; the latter was given ribavirin intravenously plus placebo by oral taking. Single-blind parallel comparative study was conducted to observe the clinical effect and safety and the data was analyzed with SAS9.13 for statistical study.Results After treatment

the comparison of scores of dominant symptoms

secondary symptoms and total scores showed a significant difference （P<0.01）. The curative rate of experiment group was 80.00% and the effective rate 19.38%; while the curative rate of control group was 41.14% and the effective rate 41.14%. The comprehensive therapeutic effect of experiment group was much better than that of the control group. No adverse reaction was found in the experiment group in safety evaluation. Conclusion Qingfei Oral Liquid is effective and safe in treating the syndrome of phlegm-heat in the lung of children’s RSV pneumonia.