关键词: 黄龙止咳颗粒, 咳嗽变异性哮喘, 儿童, 随机对照试验

Abstract: Objective    To evaluate the clinical efficacy and safety of Huanglong Zhike Granules combined with montelukast sodium chewable tablets for the treatment of cough variant asthma （CVA） in children with lung-kidney qi deficiency and phlegm-heat lung-stagnation syndrome. Methods    From March 2018 to September 2019，160 cases in 8 research centers were included for research by stratified，randomied，paralleled controlled method（First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine，Qianfoshan Hospital of Shandong Province，Dongfang Hospital of Beijing University of Traditional Chinese Medicine，Shengjing Hospital of China Medical University，The First Affiliated Hospital of Henan University of Chinese Medicine，Tianjin Children's Hospital，Shanghai Municipal Hospital of Traditional Chinese Medicine，Shenzhen Children 's Hospital ），including 80 cases in the experimental group and 80 cases in the control group. The experimental group were treated with Huanglong Zhike Granules and montelukast sodium chewable tablets；the control group was given montelukast sodium chewable tablets and Huanglong Zhike Granule simulant，and the usage and dosage were the same as those in the experimental group. Both groups were treated continuously for 4 weeks. The disease control and TCM efficacy of the two groups were observed. The cough symptom severity score，TCM syndrome score，lung function and safety index were compared between the two groups. Results    All the 160 cases entered the full analysis set （FAS），safety data set （SS），and 152 cases entered the compliance scheme data set （PPS）. In the experimental group，73 cases were controlled，3 cases were partially controlled，and 1 case was not controlled after 4 weeks of treatment. In the control group，63 cases were controlled，11 cases were partially controlled，and 1 case was not controlled. The disease control in the experimental group was better than that in the control group. The difference between the two groups was statistically significant （P<0.05）. The conclusion of PPS and FAS analysis was consistent with this. After 4 weeks of treatment，the efficacy of TCM syndromes in the experimental group was better than that in the control group. The scores of daytime cough symptom severity，nighttime cough symptom severity，and TCM syndrome scores were lower than those in the control group. The difference between the two groups was statistically significant （P<0.05）. The results of PPS and FAS analysis were consistent  with this. There was no significant difference in FEV1，FVC and FEV1/FVC between the two groups （P>0.05）. There were 2 cases of adverse events，and 1 case was judged as adverse reaction. There was no significant difference in the incidence of adverse events or rate of adverse reactions between the two groups （P>0.05）. Conclusion    Huanglong Zhike Granules combined with montelukast sodium chewable tablets is superior to montelukast sodium chewable tablets alone in the treatment of children with CVA of lung and kidney qi deficiency and phlegm-heat stagnation regarding lung syndrome disease control and TCM syndrome. It can reduce the severity of cough symptoms in children，improve related symptoms，and has good safety.

Key words: Huanglong Zhike Granules, cough variant asthma, child, randomized controlled trial