小儿热速清糖浆治疗小儿急性上呼吸道感染表里俱热证随机对照多中心研究  

A Randomized Controlled Multicenter Study on Xiaoer Resuqing Syrup(小儿热速清糖浆)in Treating Children Acute Upper Respiratory Tract Infection with Heat Syndrome of Both Exterior and Interior

作　　者：李梅芳[1] 胡思源[1] 李新民[1] 伍戈 蒋瑾瑾[2] 冯自威 韩选明 张雅梅[5] 贾艳红 洪丽军 李微微 杜永刚 田维政 董彩琴 罗红芳 高茉丽 马清平 李磊[15] LI Meifang;HU Siyuan;LI Xinmin;WU Ge;JIANG Jinjin;FENG Ziwei;HAN Xuanming;ZHANG Yamei;JIA Yanhong;HONG Lijun;LI Weiwei;DU Yonggang;TIAN Weizheng;DONG Caiqin;LUO Hongfang;GAO Moli;MA Qingping;LI Lei(The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,300381;Shanghai Changhai Hospital;Luohe Traditional Chinese Medicine Hospital,Henan Province;The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine;Jiamusi Traditional Chinese Medicine Hospital,Heilongjiang Province;Fenyang Hospital of Shanxi Province;Mudanjiang Traditional Chinese Medicine Hospital,Heilongjiang Province;Harbin Traditional Chinese Medicine Hospital,Heilongjiang Province;Changzhi People's Hospital of Shanxi Province;Meishan Traditional Chinese Medicine Hospital,Sichuan Province;Yuncheng Maternal and Child Health Hospital,Shanxi Province;The Second Affiliated Hospital of Guizhou Medical University;Qian'an Hospital of Traditional Chinese Medicine,Hebei Province;Affiliated Hospital of Hebei University of Engineering;Drug Evaluation and Research Technology Center,China Association of Traditional Chinese Medici)

机构地区：[1]天津中医药大学第一附属医院,天津市300381 [2]上海长海医院 [3]河南省漯河市中医院 [4]陕西中医药大学第二附属医院 [5]黑龙江省佳木斯市中医院 [6]山西省汾阳医院 [7]黑龙江省牡丹江市中医医院 [8]黑龙江省哈尔滨市中医医院 [9]山西省长治市人民医院 [10]四川省眉山市中医医院 [11]山西省运城市妇幼保健院 [12]贵州医科大学第二附属医院 [13]河北省迁安市中医医院 [14]河北工程大学附属医院 [15]中国中药协会药物研究评价技术中心

出　　处：《中医杂志》2020年第18期1617-1622,共6页Journal of Traditional Chinese Medicine

摘　　要：目的评价小儿热速清糖浆治疗小儿急性上呼吸道感染表里俱热证的有效性及安全性。方法采用区组随机、双盲双模拟、阳性药对照、多中心的临床研究方法。计划纳入480例,其中治疗组360例服用小儿热速清糖浆与小儿清热宁颗粒模拟剂,对照组120例服用小儿清热宁颗粒与小儿热速清糖浆模拟剂,两组疗程均为5天。比较两组完全退热时间、便秘疗效、中医证候疗效、单项症状消失率、即时退热时间与退热持续时间,安全性指标。结果共纳入468例,其中治疗组352例,对照组116例。全分析数据集(FAS)结果显示,治疗后治疗组与对照组的完全退热中位时间均为48 h,经COX回归模型估计组间风险比(HR)及95%可信区间,在校正中心因素的影响后,按0.67的非劣标准,治疗组非劣效于对照组。治疗后治疗组、对照组便秘总有效率分别为96.54%、88.70%,组间比较差异均有统计学意义(P<0.05);治疗组、对照组中医证候痊愈率分别为46.40%、31.30%(P<0.05)。本研究共发现7例不良事件,治疗组4例(1.15%),对照组3例(2.59%)。结论小儿热速清糖浆治疗小儿急性上呼吸道感染表里俱热证具有缩短热程作用,疗效不劣于小儿清热宁颗粒,且两药的安全性均良好。Objective To evaluate the effectiveness and safety of Xiaoer Resuqing Syrup(小儿热速清糖浆)in the treatment of children acute upper respiratory tract infection with heat syndrome of both exterior and interior.Method Block randomization,double blind double simulation,positive drug control,multi-center clinical research methods were used.It is planned to enroll 480 cases,including 360 cases in the treatment group and 120 cases in the control group.The treatment group was treated with Xiaoer Resuqing Syrup and Xiaoer Qingrening Granule(小儿清热宁颗粒)simulator,while the control group was treated with Xiaoer Qingrening Granules and Xiaoer Resuqing Syrup simulator.The course of treatment was 5 days.The time to complete antipyretics,the efficacy of constipation,the efficacy of traditional Chinese medicine(TCM)syndromes,the disappearance rate of single symptoms,the instantaneous antipyretic time and the duration of antipyretics,safety indicators were compared between the 2 groups.Results A total of 468 cases were included,including 352 cases in the treatment group and 116 cases in the control group.The results of the full analysis data set(FAS)showed that the median time to complete fever in the two groups were both 48 hours.The risk ratio(HR)and 95%confidence interval between the groups were estimated by the COX regression model.After adjusting the influence of central factors,according to the non-inferiority standard of 0.67,the treatment group was non-inferior to the control group.After treatment,the total effective rate of constipation in the treatment group and the control group was 96.54%and 88.70%,respectively.The differences between groups were statistically significant(P<0.05);the curative rate of TCM syndromes in the treatment group and the control group were respectively 46.40%,and 31.30%(P<0.05).A total of 7 cases of adverse events were found in this study including 4 cases(1.15%)in the treatment group and 3 cases(2.59%)in the control group.Conclusion Xiao'er Resuqing Syrup has the effect of sh

关 键 词：急性上呼吸道感染 表里俱热证 小儿热速清糖浆 便秘 退热 随机对照试验 

分 类 号：R272[医药卫生—中医儿科学]