芩香清解口服液治疗小儿急性上呼吸道感染表里俱热证的多中心Ⅲ期临床研究

发布时间：2018-12-15 08:54

【摘要】：目的:确证评价芩香清解口服液治疗小儿急性上呼吸道感染表里俱热证的有效性与安全性。方法:采用分层区组随机、阳性药(黄栀花口服液)平行对照、双盲、非劣效检验、多中心临床研究的方法。结果:共收集病例480例,其中试验组360例、对照组120例。试验组和对照组的疾病疗效总愈显率分别为77.8%和76.8%(PPS),中医证候疗效总愈显率分别为78.6%和77.5%(PPS),经非劣效性检验,试验组疾病疗效及证候疗效均不劣于对照组。试验中,试验组和对照组报告轻度腹泻3例、中度腹泻1例,轻度呕吐2例、轻度腹泻1例,不良反应发生率分别为1.1%和2.5%,两组比较,差异无统计学意义。结论:芩香清解口服液对小儿急性上呼吸道感染表里俱热证的总体治疗效果不劣于黄栀花口服液,临床应用安全性较好。
[Abstract]:Objective: to evaluate the efficacy and safety of Qinxiangqing oral liquid in treating acute upper respiratory tract infection in children. Methods: a multi-center clinical study was carried out with a randomized, stratified group of positive drugs (Huangzhihua Oral liquid), double blind, non-inferior test and multi-center clinical study. Results: a total of 480 cases were collected, including 360 cases in the experimental group and 120 cases in the control group. The total effective rate of TCM syndromes in the test group and the control group was 77.8% and 76.8%, respectively. The total effective rate of TCM syndromes in the test group and control group was 78.6% and 77.5% respectively. The curative effect of disease and syndrome in the test group was not inferior to that in the control group. In the trial group and control group, 3 cases of mild diarrhea, 1 case of moderate diarrhea, 2 cases of mild vomiting and 1 case of mild diarrhea were reported. The incidence of adverse reactions was 1.1% and 2.5%, respectively. There was no significant difference between the two groups. Conclusion: Qinxiangqingjie oral liquid is not inferior to Huangzhihua oral liquid in the treatment of acute upper respiratory tract infection in children.
【作者单位】：天津中医药大学第一附属医院;天津中医药大学;天津中医药大学第二附属医院;湖北省中医院;天津市儿童医院;山东中医药大学附属医院;
【分类号】：R272

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