目的 評(píng)價(jià)兒童清咽解熱口服液治療小兒急性咽炎（肺胃實(shí)熱證）的有效性和安全性。方法 采用隨機(jī)、雙盲、陽性藥對(duì)照、多中心臨床試驗(yàn)。12家研究中心共入選白細(xì)胞總數(shù)和中性粒細(xì)胞分類未超出參考值范圍上限的本病證受試者156例，隨機(jī)分為試驗(yàn)組（104例）、對(duì)照組（52例），分別服用兒童清咽解熱口服液、蒲地藍(lán)消炎口服液。療程5 d。結(jié)果 試驗(yàn)組和對(duì)照組的咽痛療效（愈顯率）分別為90.29%、78.85%（FAS），咽紅腫療效（愈顯率）分別為64.08%、59.62%。前者組間差異有統(tǒng)計(jì)學(xué)意義，試驗(yàn)組優(yōu)于對(duì)照組；后者組間差值的95%CI為4.46%（-11.68%、20.60%），提示試驗(yàn)組在非劣界值為-12%時(shí)，療效不劣于對(duì)照組。疾病療效（愈顯率）、中醫(yī)證候療效（愈顯率）的組間比較，差異均無統(tǒng)計(jì)學(xué)意義；單項(xiàng)癥狀中大便干消失率的組間比較，差異均有統(tǒng)計(jì)學(xué)意義，且試驗(yàn)組高于對(duì)照組。試驗(yàn)組發(fā)生“尿蛋白陽性”的不良事件1例，經(jīng)研究者判斷，與試驗(yàn)藥物無關(guān)。結(jié)論 兒童清咽解熱口服液對(duì)于小兒急性咽炎（肺胃實(shí)熱證）的咽痛、大便干、咽紅腫癥狀體征有效，且安全性較好，值得臨床推廣應(yīng)用。

Objective To evaluate the efficacy and safety of Ertong Qingyanjiere Oral Liquid in treatment of infantile acute pharyngitis with lung-stomach excess-heat syndrome. Methods A randomized controlled, double-blind, positive drug parallel controlled, multi-center clinical trial was conducted. Totally 156 children from 12 research centers whose total leucocyte amounts and neutrophil percentages were in normal ranges were included, 104 in experimental group, 52 in positive control group. The patients in experimental group were given Ertong Qingyanjiere Oral Liquid, and those in positive control group were given Pudilan Xiaoyanjiaoyan Oral Liquid, with 5 d in a course. Results The cured and markedly effective rates of experimental group and positive control group were 90.29% and 78.85% (FAS) respectively in pharyngalgia, with significant difference. The two groups' cured and markedly effective rates were 64.08% and 59.62% respectively in pharyngeal swelling. The 95% CI of difference between groups was 4.46% (-11.68%, 20.60%). It showed that the experimental group is non-inferior to the positive control group when non-inferiority margin was -12%. There was no significant difference between the two groups in the cured and markedly effective rate of the markedly effective rate of disease curative effect and the syndrome curative effect of traditional Chinese medicine. Experimental group's disappearance rate of dry stool was better than the positive control group's, with significant difference. In the safety evaluation, one case of children's urinary albumen was positive. The researchers determined that it had nothing to do with the experimental drug. Conclusion Qingyan Jiere Oral Liquid is effective for symptoms and signs such as pharyngalgia, pharyngeal swelling, and dry stool of children who suffer from acute pharyngitis, and is safe and worthy of clinical application.