摘 要：目的 评价小儿消积止咳口服液治疗小儿痰热咳嗽兼食积证（急性支气管炎）的有效性，并观察其安全性。方法 采用分层区组随机、阳性药平行对照、多中心临床研究的方法，将438例受试者分为试验组与对照组，分别服用小儿消积止咳口服液和儿童清肺口服液，疗程5 d。结果 小儿消积止咳口服液治疗小儿痰热咳嗽兼食积证的证候疗效总有效率为84.71%、对照组为55.96%，试验组的优效性检验优于对照组。疗后试验组与对照组中医证候积分（主症积分 ＋ 次症积分）、主症（痰热）积分、次症（食积）积分的组间比较，试验组均优于对照组，差异显著（P＜0.05）。治疗前后差值的组间比较、协方差分析显示，试验组3种积分的改善情况均优于对照组（P＜0.05）。结论 小儿消积止咳口服液治疗小儿痰热咳嗽兼食积证（急性支气管炎），疗效优于儿童清肺口服液，且无药物不良反应。

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．