小儿清肺颗粒治疗小儿急性支气管炎痰热壅肺证的多中心、双盲、随机对照研究  

A Multi-center,Double-blind,Randomized Controlled Study on Xiao’er Qingfei Granules(小儿清肺颗粒) in Treating Children Acute Bronchitis with Syndrome of Phlegm-Heat Obstructing Lung

作　　者：刘昆[1] 冀晓华[1] 蔡建新[2] 贾艳红 张瑛[4] 韩选明 杨丽丽 易文龙[7] 鲁彩霞 冯自威 全惜春 王文丽[11] 高茉丽 郑颖超 冯焕琴 张惠娟 陈星竹 LIU Kun;JI Xiaohua;CAI Jianxin;JIA Yanhong;ZHANG Ying;HAN Xuanming;YANG Lili;YI Wenlong;LU Caixia;FENG Ziwei;QUAN Xichun;WANG Wenli;GAO Moli;ZHENG Yingchao;FENG Huanqin;ZHANG Huijuan;CHEN Xingzhu(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091;Wuhan Hospital of Chinese Medicine,Hubei Province;Fenyang Hospital of Shanxi Province;Heji Hospital Affiliated to Changzhi Medical College;Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine;Changzhi People′s Hospital,Shanxi Province;Tianyou Hospital Affiliated to Wuhan University of Science and Technology;Changji Hui Autonomous Prefecture Traditional Chinese Medicine Hospital,Xinjiang Uygur Autonomous Region;Luohe Traditional Chinese Medicine Hospital,Henan Province;Nanyang Traditional Chinese Medicine Hospital,Henan Province;Huangshi Traditional Chinese Medicine Hospital,Hubei Province;Qian′an Traditional Chinese Medicine Hospital,Hebei Province)

机构地区：[1]中国中医科学院西苑医院,北京市100091 [2]湖北省武汉市中医医院 [3]山西省汾阳医院 [4]长治医学院附属和济医院 [5]陕西中医药大学附属医院 [6]山西省长治市人民医院 [7]武汉科技大学附属天佑医院 [8]新疆维吾尔自治区昌吉回族自治州中医院 [9]河南省漯河市中医院 [10]河南省南阳市中医院 [11]湖北省黄石市中医院 [12]河北省迁安市中医院

出　　处：《中医杂志》2020年第17期1530-1535,1546,共7页Journal of Traditional Chinese Medicine

摘　　要：目的评价小儿清肺颗粒治疗小儿急性支气管炎痰热壅肺证的有效性与安全性。方法采用区组随机、阳性药平行对照、双盲双模拟、非劣效检验、多中心临床研究的方法,共观察病例240例,分为治疗组和对照组各120例。治疗组给予口服小儿清肺颗粒以及急支糖浆模拟剂,对照组给予急支糖浆以及小儿清肺颗粒模拟剂。两组疗程均为5天。疗程结束后评价主要症状(咳嗽、咯痰)基本消失时间、止咳起效时间、疾病疗效、中医证候疗效、完全退热时间及安全性。结果两组主要症状(咳嗽、咯痰)基本消失时间、止咳起效时间、完全退热时间比较,差异均无统计学意义(P>0.05)。经非劣效性检验,治疗组疾病疗效不劣于对照组,两组疗效相当。治疗5天后,治疗组、对照组两组中医证候有效率分别达到98.33%及92.37%,全分析数据集(FAS)中两组间比较差异有统计学意义(PFAS=0.0285),提示治疗组在症状改善方面优于对照组。两组不良反应比较差异无统计学意义(P>0.05)。结论小儿清肺颗粒对小儿急性支气管炎痰热壅肺证具有良好的治疗效果,其总体疗效与急支糖浆一致,在中医证候改善方面,小儿清肺颗粒更优,且安全性较好。Objective To evaluate the efficacy and safety of Xiao′er Qingfei Granules(小儿清肺颗粒) in treating children acute bronchitis with syndrome of phlegm-heat obstructing lung. Methods The stratified blocked randomization, positive drug parallel contrast, double blind, double dummy, non inferiority test, and multi-centered research were applied to this study. A total of 240 cases were divided into a treatment group and a control group, with 120 cases in each group. The treatment group was given oral Xiao′er Qingfei Granules and Jizhi Syrup(急支糖浆) simulator, and the control group was given Jizhi Syrup and Xiao′er Qingfei Granules Simulator. The course of treatment for both groups was 5 days. After treatment, the disappearance time of the main symptoms(cough, expectoration), the onset time of antitussive, the efficacy of the disease, the efficacy of traditional Chinese medicine(TCM) syndromes, the time for complete fever reduction and safety were evaluated. Results There was no statistically significant difference between groups in main symptoms(cough, expectoration) disappeared time, cough onset time and complete antipyretic time(P>0.05). After non-inferiority test, the therapeutic effects of the treatment group was not inferior to that of the control group, and the two groups had similar effects. After 5 days of treatment, the effective rates of TCM syndromes in the treatment group and the control group reached 98.33% and 92.37% respectively. The difference between groups in the full analysis data set(FAS) was statistically significant(PFAS=0.0285), suggesting the treatment group was better than the control group in improving symptoms. There was no significant difference in adverse reactions between groups(P>0.05). Conclusion Xiao′er Qingfei Granules has satisfactory effects on children acute bronchitis with syndrome of phlegm-heat obstructing lung, which is in line with those of Jizhi Syrup. In terms of TCM syndrome improving, Xiao′er Qingfei Granules is better, with good safety.

关 键 词：小儿急性支气管炎 小儿清肺颗粒 痰热壅肺证 随机对照试验 多中心临床研究 

分 类 号：R272[医药卫生—中医儿科学]