清肺消炎丸治疗小儿急性支气管炎(痰热壅肺证)的临床观察

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(P0.05),单项症状消失率的组间比较,咳痰黏稠,差异显著(P0.05)。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。

Clinical observation of Qingfei Xiaoyan Pill in treatment of lung phlegm heat syndrome in children with acute bronchitis

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.