To evaluate the efficacy and safety of Xiaoer Xuanfei Zhike Granule in the treatment of exogenous cough(external-contraction cold and phlegm-heat stagnation in lung).Methods:A total of 450 children with exogenous cough were selected as the research objects in the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine，Yunnan Provincial People's Hospital，the First Affiliated Hospital of Kunming Medical College，and Yunnan Red Cross Hospital from December 1993 to May 1994.They were randomly divided into an observation group and a control group.The observation group was given Xiaoer Xuanfei Zhike Granules，and the control group was treated with Tongxuan Lifei Granules.The courses were 3 days.The efficacy and safety of the two groups after medication were observed.Results:The total effective rate of the observation group was 93.33% and that of the control group was 76.67%(P<0.01).Compared with the control group，the observation group had a better curative effect on cough，phlegm，fever，aversion to cold，nasal obstruction，sneeze，anorexia，and other symptoms(P<0.05 or P<0.01).The average onset time of fever reduction and the average recovery time of body temperature in the observation group were significantly better than those in the control group(P<0.05 or P<0.01).There was no significant difference in the normal rate of leukocyte and neutrophil after treatment between the two groups(P>0.05).Xiaoer Xuanfei Zhike Granules had no selectivity on age and severity of disease，and no obvious adverse effects were observed.Conclusion:Xiaoer Xuanfei Zhike Granules have significant efficacy in the treatment of exogenous cough(external-contraction cold and phlegm-heat stagnation in lung)，which are convenient to take.In the course of clinical research，no obvious adverse reactions have been observed，and it is safe，reliable，and worthy of clinical promotion.