OBJECTIVETo evaluate the clinical efficacy of combined internal-external therapy of TCM on children pneumonia. Adopting multi-center, randomized, controlled, double blinded principle, children with pneumonia were divided into 2 groups. Besides the basic treatment of western medicine, to the 406 children in the treated group internal administering of Chinese recipe prescribed according to syndrome differentiation and external applying of Fuxiong plaster were given additionally, while to the 411 children in the control group simulative placeboes were given for instead. The clinical efficacy of treatment on disease and syndrome, improvement of TCM syndrome and physical signs of lung between the two groups were compared after treatment.RESULTSThe cured-markedly effective rate of treatment on disease and syndrome was 97.3%, 95.1% in the treated group and 89.8%, 86.6% in the control group, respectively, the differences of the two indexes between the two groups were significant (P < 0.05). The improvements on physical signs of lung, symptoms as cough, dyspnea and sputum expectorating in the treated group were significantly better than those in the control group (P < 0.05).CONCLUSIONIt was showed that the combined internal-external TCM treatment, which could significantly enhance the clinical efficacy, is an effective therapy for children pneumonia.