【摘要】：目的:確證評價芩香清解口服液治療小兒急性上呼吸道感染表里俱熱證的有效性與安全性。方法:采用分層區(qū)組隨機(jī)、陽性藥(黃梔花口服液)平行對照、雙盲、非劣效檢驗(yàn)、多中心臨床研究的方法。結(jié)果:共收集病例480例,其中試驗(yàn)組360例、對照組120例。試驗(yàn)組和對照組的疾病療效總愈顯率分別為77.8%和76.8%(PPS),中醫(yī)證候療效總愈顯率分別為78.6%和77.5%(PPS),經(jīng)非劣效性檢驗(yàn),試驗(yàn)組疾病療效及證候療效均不劣于對照組。試驗(yàn)中,試驗(yàn)組和對照組報告輕度腹瀉3例、中度腹瀉1例,輕度嘔吐2例、輕度腹瀉1例,不良反應(yīng)發(fā)生率分別為1.1%和2.5%,兩組比較,差異無統(tǒng)計學(xué)意義。結(jié)論:芩香清解口服液對小兒急性上呼吸道感染表里俱熱證的總體治療效果不劣于黃梔花口服液,臨床應(yīng)用安全性較好。
[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.
【作者單位】： 天津中醫(yī)藥大學(xué)第一附屬醫(yī)院;天津中醫(yī)藥大學(xué);天津中醫(yī)藥大學(xué)第二附屬醫(yī)院;湖北省中醫(yī)院;天津市兒童醫(yī)院;山東中醫(yī)藥大學(xué)附屬醫(yī)院;
【分類號】：R272

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