目的 評價清降片治療7～14歲學齡兒童肺胃蘊熱證咽喉腫痛的有效性和安全性。方法 采用分層區(qū)組隨機、雙盲雙模擬、陽性藥平行對照、多中心臨床研究,非劣效性檢驗的方法。選取7～14歲學齡兒童肺胃蘊熱證240例,按1:1分為治療組和對照組。兩組分別給予清降片和小兒咽扁顆粒,療程為5 d。結果 PP分析中,中醫(yī)病證療效的愈顯率(即總有效率)對照組為79.63%,治療組為81.82%,疾病療效的愈顯率對照組為77.78%,治療組為77.27%。采用按中心分層的CMHX2法統(tǒng)計,兩組在各訪視點的中醫(yī)病證療效、疾病療效比較,差異均無統(tǒng)計學意義,且PP分析、ITT分析的結論一致。同時對于中醫(yī)病證療效的非劣效性檢驗結果顯示,清降片組愈顯率不低于小兒咽扁顆粒組(P< 0.05),且PP分析、ITT分析的結論一致。結論 清降片在治療兒童肺胃蘊熱證咽喉腫痛方面不僅適用于1～6歲兒童,同樣適用于7～14歲學齡兒童;且具有較好的療效性和安全性,其療效不劣于對照藥小兒咽扁顆粒。

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.

國家科技重大專項重大新藥創(chuàng)制項目(2011ZX09302-006)