To objectively evaluate the clinical effect of traditional Chinese medicine in treating children’s respiratory syncytial viral pneumonia (RSVP) of phlegm-heat blocking Fei (럎) syndrome (PHBFS). A single-blinded multi-center

blocked

randomized and parallel-controlled method was adopted. The clinical study was carried out on 206 children with RSVP-PHBFS who were assigned to two groups

108 in the test group treated through intravenous dripping of Qingkailing Injection (쟥뾪쇩힢짤튺) in combination of oral intake of Er’tong Qingfei Oral Liquid (뛹춯쟥럎뿚럾튺) and 98 in the control group with intravenous dripping of ribavirin injection in combination with oral intake of potassium guaiacol sulfonate oral liquid

all for 10 days. The clinical efficacy was evaluated and compared at the end of the trial from various aspects by three methods including comprehensive efficacy

post-treatment main symptoms score difference and survival analysis of the main symptoms. After treatment

in the test group

60 patients were cured

36 markedly alleviated

and 12 improved. In the control group

41 were cured

38 markedly alleviated

18 improved and 1 unchanged. Comparison on the comprehensive efficacy between the two groups shows a better efficacy in the test group (χ2=4.4527

P=0.0348). Scores of the main symptoms were lowered after treatment in both groups

the difference was 22.41±4.99 scores in the test group and 17.61±6.34 scores in the control group

being more significant in the former (t=-5.99

P<0.01). Survival analysis shows that there was significant difference between the two groups in the effect initiating time on such symptoms as fever

cough

copious sputum

shortness of breath

and rales

which was earlier in the test group (P<0.01 or P<0.05). Evaluation of the efficacy of traditional Chinese medicine in treating children with RSVP-PHBFS by using the three methods jointly could better show the objectivity of the evaluation.