【摘要】 目的: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、双盲、阳性药平行对照、多中心临床研究的方法。结果:试验组、对照组疾病总有效率分别为92.5%、88.3%,证候疗效总有效率分别为95.0%、90.8%,两组比较差异均无统计学意义。非劣效检验结果显示,试验组疾病与证候疗效的总有效率均不劣于对照组(P=0.000)。本次试验共发生不良反应4例,两组发生率比较,差异无统计学意义。结论:芩香清解口服液在治疗小儿急性上呼吸道感染表里俱热证方面,疾病疗效、证候疗效均不劣于黄栀花口服液,临床应用需注意消化道反应。更多还原

【Abstract】 Objective:To evaluate the efficacy and safety of Qinxiang Qingjie Oral Liquid in treating acute upper respiratory infection children patient with the syndrome of heat in both exterior and interior.Methods:The randomized,doubleblind,positive drug parallel contrast and multi-center research methods were adopted in this research.Results:The total effective rate of disease in treatment and control groups was 92.5%and 88.3%,respectively,and the total effective rate of syndrome in treatment and control groups was 95.0%and 88.3%,respectively:The difference between the two groups was not significant,and the results of non-inferiority test showed that the total effective rate of disease and syndrome in treatment group was no inferior to that of control group(P=0.000).There were 4 cases of adverse reaction in this study,and the difference in adverse reactions between the two groups was not significant.Conclusion:The curative effect of Qinxiang Qingjie Oral Liquid is not inferior to Huangzhihua Oral Liquid in treating acute upper respiratory infection in pediatrics,and its gastrointestinal side effects need to be paid attention to when applied in the clinic.更多还原