小儿白贝止咳糖浆治疗小儿急性支气管炎痰火壅肺证的临床研究

Xiao'er Baibei Zhike Syrup for pediatric acute bronchitis characterized as phlegm and fire congesting the lung

目的评价小儿白贝止咳糖浆(白屈菜、瓜蒌、半夏、平贝母)治疗小儿急性支气管炎痰火壅肺证的有效性与安全性。方法采用阳性药平行对照、分层区组随机、双盲、多中心临床研究的方法。进入全分析数据集和安全性数据集的试验组339例、对照组113例。结果小儿白贝止咳糖浆对小儿急性支气管炎痰火壅肺证试验组的总有效率为93.22%,对照组为82.30%,经CMHχ2检验,试验组疗效优于对照组;对中医证候的总有效率为95.58%,对照组为84.07%,试验组也优于对照组。两组咳嗽、肺部体征、烦躁不安等单项症状与异常舌脉、指纹的改善情况比较,经秩和检验或χ2检验,差异均有显著性意义。实验中未发现临床不良事件。结论小儿白贝止咳糖浆对小儿急性支气管炎痰火壅肺证的治疗效果优于对照药金振口服液,且临床应用安全性良好。

AIM To assess the santhis Fructus , Pinelliae Rhizoma , efficacy and safety of Xiao＇er Baibei Zhike Syrup （ Chelidonii Herba, Tricho- Fritillariae ussuriensis Bulbus） for the treatment of pediatric acute bronchitis characteristic of the syndrome of phlegm and fire congesting the lung. METHODS To apply the methods of double blind parallel control of positive drug, stratified random, and multi-center clinical study. Three hundred and thirty nine patients in experiment group and one hundred and thirteen patients in control group included in full analysis set and safety set. RESULTS The total efficacy of experiment group and control group was 93.22% and 82.30% , respectively. By Cochran-Mantel-Haensel Statistics, the effectiveness of test drug was superior to the control one. The total efficacy of TCM syndrome was 95.58% and 84.07% , respectively. Experiment group were obviously higher than those in the control group （ P 〈 0.05 ）. The comparison was made between both groups in the improvement of cough and irritability, the sign of lung, abnormal tongue manifestation, pulse condition and finger venules. By Rank sum test or Chi-square test, there was significant difference in marked effective rate between control and treatment group. In addition, there was no clinical adverse reaction in the study. CONCLUSION The efficacy and safety of Xiao＇er Baibei Zhike Syrup are better than those of Jinzhen Oral Liquid .