目的 评价清降片治疗7～14岁学龄儿童肺胃蕴热证咽喉肿痛的有效性和安全性。方法 采用分层区组随机、双盲双模拟、阳性药平行对照、多中心临床研究,非劣效性检验的方法。选取7～14岁学龄儿童肺胃蕴热证240例,按1:1分为治疗组和对照组。两组分别给予清降片和小儿咽扁颗粒,疗程为5 d。结果 PP分析中,中医病证疗效的愈显率(即总有效率)对照组为79.63%,治疗组为81.82%,疾病疗效的愈显率对照组为77.78%,治疗组为77.27%。采用按中心分层的CMHX2法统计,两组在各访视点的中医病证疗效、疾病疗效比较,差异均无统计学意义,且PP分析、ITT分析的结论一致。同时对于中医病证疗效的非劣效性检验结果显示,清降片组愈显率不低于小儿咽扁颗粒组(P< 0.05),且PP分析、ITT分析的结论一致。结论 清降片在治疗儿童肺胃蕴热证咽喉肿痛方面不仅适用于1～6岁儿童,同样适用于7～14岁学龄儿童;且具有较好的疗效性和安全性,其疗效不劣于对照药小儿咽扁颗粒。

Objective To evaluate the efficacy and safety of Qingjiang Tablets in treatment of lung and stomach heat syndrome in sore throat in children aged 7-14 years old. Methods Randomized, double-blind, positive drug parallel controlled, and multi center clinical study were adopted, and the method of non inferiority was also used. Children (240 cases) aged 7-14 years old with lung and stomach heat syndrome in sore throat were randomly divided into experimental and control groups. Each group had 120 cases. Children in two groups were po administered with Qinjiang Tablets and Xiaoer Yanbian Granules. The patients in two groups were treated for 5 d as a course. Results Through PP analysis, effective rate of TCM syndrome curative effect (ie total efficiency) in the control and experimental groups were 79.63% and 81.82%, respectively, and curative effects were 77.78% and 77.27%. CMHX2 statistics in the center layer indicated that there was no significant difference in visit the therapeutic effect of TCM diseases and disease curative effect between two groups. The conclusion was in accord with results of PP analysis and ITT analysis. At the same time, the noninferiority test for efficacy of TCM syndromes showed that markedly effective rate of Qingjiang Tablets group was not lower than that of Xiaoer Yanbian Granules group (P < 0.05). The conclusion was also in accord with the results of PP analysis and ITT analysis. Conclusion Qingjiang Tablets has good clinical efficacy in treatment of lung and stomach heat syndrome in sore throat of children aged not only 1-6 years old, but also 7-14 years old. And Qingjiang Tablets have better efficacy and safety which is not inferior to those of Xiaoer Yanbian Granules.

国家科技重大专项重大新药创制项目(2011ZX09302-006)