黄龙止咳颗粒治疗儿童咳嗽变异性哮喘多中心随机对照临床研究  

Randomized Controlled,Multi-center Clinical Study of Huanglong Zhike Granules for Treatment of Cough Variant Asthma in Children

作　　者：姜姝婷 胡思源[1] 李新民[1] 钟成梁[1] 王凯[2] 吴力群[3] 蔡栩栩[4] 丁樱[5] 徐勇胜[6] 薛征[7] 万力生[8] JIANG Shuting;HU Siyuan;LI Xinmin;ZHONG Chengliang;WANG Kai;WU Liqun;CAI Xuxu;DING Ying;XU Yongsheng;XUE Zheng;WAN Lisheng(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Shandong Provincial Qianfoshan Hospital,Jinan 250014,China;Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100078,China;Shengjing Hospital of China Medical University,Shenyang 117004,China;The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China;Tianjin Children’s Hospital,Tianjin 300134,China;Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai 200000,China;Shenzhen Children’s Hospital,Shenzhen 518038,China)

机构地区：[1]天津中医药大学第一附属医院/国家中医针灸临床医学研究中心,天津300381 [2]山东省千佛山医院,山东济南250014 [3]北京中医药大学东方医院,北京100078 [4]中国医科大学附属盛京医院,辽宁沈阳117004 [5]河南中医药大学第一附属医院,河南郑州450000 [6]天津市儿童医院,天津300134 [7]上海市中医医院,上海200000 [8]深圳市儿童医院,广东深圳518038

出　　处：《中国中医药信息杂志》2021年第5期104-109,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：国家科技重大专项(2020ZX09201-008)。

摘　　要：目的评价黄龙止咳颗粒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。方法计划纳入160例患儿,采用分层区组随机、双盲双模拟、平行对照、多中心临床研究方法,按随机分配表1∶1比例分为试验组和对照组各80例。试验组予黄龙止咳颗粒(3岁3 g/次,4~7岁6 g/次,8~13岁9 g/次,3次/d,开水冲服)及孟鲁司特钠咀嚼片模拟剂(1次/d,睡前口服);对照组予孟鲁司特钠咀嚼片(3~5岁4 mg/次,6~13岁5 mg/次)及黄龙止咳颗粒模拟剂,用法用量同试验组。2组均连续治疗4周。观察2组疾病控制情况及中医疗效,比较2组咳嗽症状严重程度评分、中医证候评分、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),147例进入符合方案数据集(PPS)。试验组治疗4周疾病总控制率为100.00%(72/72),对照组为98.67%(74/75),2组率差及可信区间为3.50%(-7.82%,14.82%)。考虑基线因素的Logistic回归分析结果显示,2组疾病总控制率比较差异无统计学意义(P>0.05);以-0.10为非劣界值,试验组非劣于对照组,PPS、FAS分析结论一致。治疗2、4周,2组中医疗效总有效率比较差异无统计学意义(P>0.05),PPS、FAS分析结论一致。2组治疗后咳嗽症状严重程度评分、中医证候评分、第1秒用力呼气量(FEV1)、用力肺活量(FVC)及FEV1/FVC比较,差异均无统计学意义(P>0.05)。对照组不良事件2例,无严重不良事件,1例判断为不良反应。2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)。结论黄龙止咳颗粒治疗儿童CVA肺肾气虚、痰热郁肺证疾病控制率非劣于孟鲁司特钠咀嚼片,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。Objective To evaluate the clinical efficacy and safety of Huanglong Zhike Granules for the treatment of cough variant asthma(CVA)in children with lung-kidney qi deficiency and phlegm-heat lung-stagnation syndrome.Methods Randomized layered block,double-blind,double-simulation,parallel control,multi-center clinical study method was conducted.160 children were planned to be included and randomly divided into the experimental group and the control group according to the ratio of 1:1.The experimental group and control group were respectively treated with Huanglong Zhike Granules(3 g/time for 3 years old,6 g/time for 4–7 years old,9 g/time for 8–13 years old,3 times/d,rinsed with boiling water)and montelukast sodium chewable tablets simulant(once daily,orally before going to bed).The control group was given montelukast sodium chewable tablets(4 mg/time for 3 to 5 years old,5 mg/time for 6 to 13 years old)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.Disease control and TCM clinical efficacy of the two groups were observed,and cough severity score,TCM syndrome score,lung function and safety indicators of the two groups were compared.Results Totally 160 cases entered the full analysis set(FAS)and safety set(SS),and 147 cases entered the per-protocol set(PPS).After 4 weeks of treatment,the overall disease control rate was 100.00%(72/72)in the experimental group and 98.67%(74/75)in the control group.The difference in rate and confidence interval between the 2 groups were 3.50%(-7.82%,14.82%).The results of Logistic regression analysis considering the baseline factors showed that there was no statistical significance in the overall disease control rates between the 2 groups(P>0.05).With-0.10 as the non-inferior boundary value,the experimental group was not inferior to the control group,and the PPS and FAS analysis results were consistent.There was no statistical significance between the two groups in the t

关 键 词：黄龙止咳颗粒 咳嗽变异性哮喘 儿童 随机对照试验 

分 类 号：R272.956[医药卫生—中医儿科学]