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  

Multi-center phase Ⅲ clinical trial of Qinxiang Qingjie Oral Liquid for treating pediatric patients of acute upper respiratory infection with syndrome of heat in both exterior and interior

作　　者：胡思源[1] 马融[1] 陈馨雨 魏小维[1] 程燕[3] 齐铮[4] 黄文玉[5] 李燕宁[6] 

机构地区：[1]天津中医药大学第一附属医院,天津300193 [2]天津中医药大学,天津300193 [3]天津中医药大学第二附属医院,天津300150 [4]湖北省中医院,武汉430073 [5]天津市儿童医院,天津300074 [6]山东中医药大学附属医院,济南250011

出　　处：《中国新药杂志》2017年第10期1152-1156,共5页Chinese Journal of New Drugs

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。Objective： To confirm the efficacy and safety of Qinxiang Qingjie Oral Liquid in treating pediatric patients of acute upper respiratory infection with the syndrome of heat in both exterior and interior. Methods： A multi-center, stratified blocked randomization, positive drug （Huangzhihua Oral Liquid） parallel control, double- blind, non-inferiority design was adopted to this study. Results： A total of 480 cases were enrolled, with 360 in the treatment group and 180 in the control group. The total cure-remarkable-effectiveness rates of disease in the treatment and control groups were 77.8% and 76.8% , respectively （ per protocol analysis, PPS）, and the total cure-remarkable-effectiveness rates of syndrome in the treatment and control groups were 78. 6% and 77. 5% （PPS） , respectively. The results of non-inferiority analysis showed that the efficacy for either disease or syndrome in the treatment group was non-lnferior to that of the control group. During the study, the treatment group reported 3 eases of mild diarrhea, 1 ease of moderate diarrhea, and the control group reported 2 eases of mild vomiting, 1 ease of mild diarrhea. The incidences of adverse reactions in the treatment and eontrol groups were 1. 1% and 2.5%, respectively, and the difference between the two groups was not significant. Conclusion： The eurative effect of Qinxiang Qingjie Oral Liquid is not inferior to Huangzhihua Oral Liquid in treating acute upper respiratory infection in pediatrics. In addition, Qinxiang Qingjie Oral Liquid has good safety.

关 键 词：芩香清解口服液 急性上呼吸道感染 儿童 表里俱热证 多中心 临床研究 

分 类 号：R969.4[医药卫生—药理学]