目的 评价清肺消炎丸治疗小儿急性支气管炎(痰热壅肺证)的有效性和安全性。方法 采用随机、开放、平行对照、多中心临床研究的方法,将96例小儿急性支气管炎患者按2:1比例随机分为试验组和对照组。试验组用清肺消炎丸,对照组用小儿肺热咳喘口服液,疗程5 d。结果 试验组与对照组的疾病有效率分别为76.92%和50.00%,证候疗效的总有效率分别为78.85%和60.76%,差异显著(P<0.05),单项症状消失率的组间比较,咳痰黏稠,差异显著(P<0.05)。结论 清肺消炎丸治疗小儿急性支气管炎(痰热壅肺证)安全有效,疗效优于小儿肺热咳喘口服液。

Objective To evaluate the efficacy and safety of Qingfei Xiaoyan Pill (QXP) in the treatment of lung phlegm heat syndrome in children with acute bronchitis. Methods Stratified random, open, parallel-group controlled, and multi-center clinical studies were applied. Totally 96 patients suffering from Xiao'er acute bronchitis were randomly divided into treatment group and the control group according to 2:1 ratio. The patients in treatment group were given QXP for application while the patients in control group were given Xiaoer Feire Kechuan Oral Liquid for application, 5 d in total. Results The curative rates of treatment and control groups in disease efficacy were 76.92% and 50.00%, and the curative rates of both groups in traditional Chinese medicine syndrome effect were 78.85% and 60.76%. These of treatment group were better than those of control group, and there were significant differences between the two groups (P<0.05). Except ropy sputum, compared with same group before treatment, there were no significant differences between the two groups in single syndrome curative effect (P>0.05). Conclusion QXP has a definite effect on lung phlegm heat syndrome in children with acute bronchitis with good safety and is better than Xiaoer Feire Kechuan Oral Liquid.