RESUMO
Objective: To evaluate the efficacy and safety of Qingfei Xiaoyan Pill (QXP) in the treatment of lung phlegm heat syndrome in children with acute bronchitis. Methods: Stratified random, open, parallel-group controlled, and multi-center clinical studies were applied. Totally 96 patients suffering from Xiao'er acute bronchitis were randomly divided into treatment group and the control group according to 2:1 ratio. The patients in treatment group were given QXP for application while the patients in control group were given Xiaoer Feire Kechuan Oral Liquid for application, 5 d in total. Results: The curative rates of treatment and control groups in disease efficacy were 76.92% and 50.00%, and the curative rates of both groups in traditional Chinese medicine syndrome effect were 78.85% and 60.76%. These of treatment group were better than those of control group, and there were significant differences between the two groups (P 0.05). Conclusion: QXP has a definite effect on lung phlegm heat syndrome in children with acute bronchitis with good safety and is better than Xiaoer Feire Kechuan Oral Liquid.