Abstract: Objective：To evaluate the effect superiority of TCM on children′s pneumonia with“wind and heat blocking the lung syndrome”and“phlegm-heat-obstructing-the-lung syndrome”objectively.Methods：Multi-center,randomized controlled study was done on 640 cases of pneumonia with“wind and heat blocking the lung syndrome”and“phlegm-heat obstructing the lung syndrome”in thirteen hospitals by TCM clinical validation scheme.Children with pneumonia were randomly divided into 3 groups.Besides the basic treatment of Chinese patent drug by intravenous injections,children in group A were treated with TCM decoction according to syndrome;in group B,the patients were treated by external application of Fubei plaster,while the children in group C were treated by internal administration and external application of Fubei plaster.The course of therapy was 14 days for each group.The children′s clinical symptoms were recorded at the 1,7,14 days of admission.To all these groups,the general effect and syndrome score of TCM were analyzed.Results：In these three groups,the score of clinical symptoms obviously decreased after treatment,indicateding that three therapies all let patients′ condition ameliorate,and the clinical outcome time corresponds with course of children′s pneumonia.On the 7th day,in group C,the score diminishing rates were better than the other groups (P<0.05),especially in the group of“wind and heat blocking the lung syndrome”.The score diminishing rates in the group of“phlegm-heat obstructing the lung syndrome”and on 14th day were of no differences among the three groups (P>0.05).There was no difference among the three groups on the symptom in fever,sputum,cough,breathlessness and auscultation on the lung recovered (P>0.05).On the 7th day, the effective rates were 59.9% in group A, 56.69% in group B and 70.2% in group C respectively.There was significant difference among the three groups (P<0.05), which meant clinical effect of group C was superior than the other groups. At the same points for the “wind and heat blocking the lung syndrome”,the effective rates were 58.1% in group A,54.8% in group B and 74.0% in group C respectively.There was significant difference among the three groups (P<0.05);and for the“phlegm-heat obstructing the lung syndrome”on the 14th day,there was no significant difference among the three groups (P>0.05).Conclusions：TCM has marked clinical effect on children′s pneumonia,whether by internal administration of Chinese recipe prescribed according to syndrome differentiation,external application of Fubei plaster,or combining both methods,especially in the early stage of pneumonia.Besides,application therapy is more handy simpler and more convenient,so we could popularize this method.

Key words: pneumonia with dyspnea and cough, wind and heat blocking the lung syndrome, phlegm-heat obstructing the lung syndrome, internal therapy, external therapy；children