摘 要：目的 評(píng)價(jià)小兒消積止咳口服液治療小兒痰熱咳嗽兼食積證（急性支氣管炎）的有效性，并觀察其安全性。方法 采用分層區(qū)組隨機(jī)、陽(yáng)性藥平行對(duì)照、多中心臨床研究的方法，將438例受試者分為試驗(yàn)組與對(duì)照組，分別服用小兒消積止咳口服液和兒童清肺口服液，療程5 d。結(jié)果 小兒消積止咳口服液治療小兒痰熱咳嗽兼食積證的證候療效總有效率為84.71%、對(duì)照組為55.96%，試驗(yàn)組的優(yōu)效性檢驗(yàn)優(yōu)于對(duì)照組。療后試驗(yàn)組與對(duì)照組中醫(yī)證候積分（主癥積分 ＋ 次癥積分）、主癥（痰熱）積分、次癥（食積）積分的組間比較，試驗(yàn)組均優(yōu)于對(duì)照組，差異顯著（P＜0.05）。治療前后差值的組間比較、協(xié)方差分析顯示，試驗(yàn)組3種積分的改善情況均優(yōu)于對(duì)照組（P＜0.05）。結(jié)論 小兒消積止咳口服液治療小兒痰熱咳嗽兼食積證（急性支氣管炎），療效優(yōu)于兒童清肺口服液，且無(wú)藥物不良反應(yīng)。

Abstract: Objective To assess the efficacy and safety of Xiao′er Xiaoji Zhike Oral Liquid for the treatment of children phlegm-heat cough combined with food accumulation syndrome（acute bronchitis）．Methods By the methods of stratified random，parallel control of positive drug，and multi-center clinical study，a total of 438 subjects were divided into experiment group and control group．Patients in the two groups were taken Xiao′er Xiaoji Zhike Oral Liquid and Ertong Qingfei Oral Liquid，for 5 d a course respectively．Results The total efficacy of experiment group and control group was 84.71% and 55.96%，respectively．TCM syndrome scores（main symptoms + secondary symptoms），main symptoms scores（phlegm-heat scores）and secondary symptoms scores（indigestion scores）in experiment group were obviously higher than those in control group（P＜0.05）．To compare the two groups between pre- and post-treatments and their analysis of covariance，the improvement of three scores in experiment groups is more obvious than those in control group（P＜0.05）．Conclusion For the treatment of children phlegm-heat cough combined with food accumulation syndrome（acute bronchitis），the efficacy of Xiao′er Xiaoji Zhike Oral Liquid is better than Ertong Qingfei Oral Liquid．In addition，there are no adverse reactions in treatment with Xiao′er Xiaoji Zhike Oral Liquid．