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

摘要： 目的    评价黄龙止咳颗粒联合孟鲁司特钠咀嚼片治疗儿童咳嗽变异性哮喘（CVA）肺肾气虚、痰热郁肺证的临床疗效及安全性。方法    采用分层区组随机、双盲、平行对照的临床研究方法，于2018年3月至2019年9月纳入8个研究中心（天津中医药大学第一附属医院、山东省千佛山医院、北京中医药大学东方医院、中国医科大学附属盛京医院、河南中医药大学第一附属医院、天津市儿童医院、上海市中医医院、深圳市儿童医院）160例病例，其中试验组和对照组各80例。试验组予黄龙止咳颗粒和孟鲁司特钠咀嚼片；对照组予孟鲁司特钠咀嚼片及黄龙止咳颗粒模拟剂，用法用量同试验组。两组均连续治疗4周。观察两组疾病控制情况及中医疗效，比较两组咳嗽症状严重程度评分、中医证候评分和、肺功能及安全性指标。结果    160例进入全分析集（FAS）、安全性数据集（SS）、152例进入符合方案数据集（PPS）。试验组治疗4周控制73例、部分控制3例、未控制1例，对照组控制63例、部分控制11例、未控制1例，试验组与对照组病情控制情况比较，差异有统计学意义（P<0.05），PPS、FAS分析结论一致。治疗4周，试验组中医证候疗效优于对照组，日间咳嗽症状严重评分、夜间咳嗽症状程度评分、中医证候积分和均低于对照组，两组比较差异有统计学意义（P<0.05），PPS、FAS分析结论一致。该研究发生不良事件2例，其中1例判断为不良反应。两组不良事件及不良反应发生率比较差异无统计学意义（P>0.05）。结论    黄龙止咳颗粒联合孟鲁司特钠咀嚼片治疗儿童CVA肺肾气虚、痰热郁肺证疾病控制情况、中医证候疗效优于单独使用孟鲁司特钠咀嚼片，并可减轻患儿咳嗽症状严重程度，改善相关症状，安全性较好。

关键词: 黄龙止咳颗粒, 咳嗽变异性哮喘, 儿童, 随机对照试验