儿童清咽解热口服液治疗小儿急性咽炎(肺胃实热证)的有效性和安全性的多中心临床评价

目的 评价儿童清咽解热口服液治疗小儿急性咽炎（肺胃实热证）的有效性和安全性。方法 采用随机、双盲、阳性药对照、多中心临床试验。12家研究中心共入选白细胞总数和中性粒细胞分类未超出参考值范围上限的本病证受试者156例，随机分为试验组（104例）、对照组（52例），分别服用儿童清咽解热口服液、蒲地蓝消炎口服液。疗程5 d。结果 试验组和对照组的咽痛疗效（愈显率）分别为90.29%、78.85%（FAS），咽红肿疗效（愈显率）分别为64.08%、59.62%。前者组间差异有统计学意义，试验组优于对照组；后者组间差值的95%CI为4.46%（-11.68%、20.60%），提示试验组在非劣界值为-12%时，疗效不劣于对照组。疾病疗效（愈显率）、中医证候疗效（愈显率）的组间比较，差异均无统计学意义；单项症状中大便干消失率的组间比较，差异均有统计学意义，且试验组高于对照组。试验组发生“尿蛋白阳性”的不良事件1例，经研究者判断，与试验药物无关。结论 儿童清咽解热口服液对于小儿急性咽炎（肺胃实热证）的咽痛、大便干、咽红肿症状体征有效，且安全性较好，值得临床推广应用。

A multi-center clinical trial:Evaluation on effectiveness and safety of Ertong Qingyanjiere Oral Liquid in treatment of infantile acute pharyngitis with lung-stomach excess-heat syndrome

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.