小儿肺热清颗粒治疗小儿急性支气管炎痰热咳嗽证的有效性与安全性评价

Efficacy and safety of Xiao'er Feireqing granules for treating child acute bronchitis phlegm heat cough syndrome

目的:评价小儿肺热清颗粒治疗小儿急性支气管炎痰热咳嗽证的有效性与安全性。方法:采用区组随机、双盲、阳性药平行对照、多中心临床研究的方法。所选病证为小儿急性支气管炎(痰热咳嗽证),计划纳入受试者400例,按3∶1比例随机分为试验组和对照组,分别服用小儿肺热清颗粒和急支颗粒,疗程均为5 d。结果:疾病疗效愈显率,试验组为85.21%,对照组76.64%,组间比较差异有统计学意义;中医证候疗效愈显率,试验组为84.24%,对照组76.64%,组间比较差异无统计学意义;各项症状体征的单项计分组内前后对比,除对照组气息粗促外,差异均有统计学意义,组间治疗前后差值比较,差异无统计学意义;对于疗前白细胞计数水平异常升高、胸部X线异常、咽拭子细菌培养及鼻咽部分泌物病毒检测阳性患者,其复常率及转阴率的组间比较均无统计学差异。试验组不良反应发生率为0.31%,组间比较差异无统计学意义。实验室安全性指标及生命体征方面,未发现具有临床意义的改变。结论:小儿肺热清颗粒治疗小儿急性支气管炎(痰热咳嗽证)疗效好,且临床使用较为安全,临床应用前景可期。

Objective： To evaluate the effectiveness and safety of Xiao’er Feireqing granules for treating child acute bronchitis phlegm heat cough syndrome. Methods： A parallel control,double-blind,stratified randomization,multicenter clinical trial was conducted. Pediatric patients with acute bronchitis（ n = 400） were randomized to treatment group and control group at a ratio of 3∶ 1. Patients in the treatment group took Xiao’er Feireqing granules,while those in the control group used Jizhi granules,both for 5 days. Results： There was significant difference in disease cure rate between the treatment group（ 85. 21%） and control group（ 76. 64%）. The TCM syndrome cure rate in the treatment group（ 84. 24%） was similar with that in the control group（ 76. 64%）. The baseline scoresof the syndromes and signs had significant differences with the post-treatment scores except tachypnea. There was no significant difference in recovery rate of WBC count and chest X-ray,and negative conversion ratio of virus.Adverse reactions occurred in 0. 31% of patients in the treatment group,which was similar with the control group.There was no clinically significant change in laboratory examination and vital signs. Conclusion： Xiao’er Feireqing granules is effective and safe in treating child acute bronchitis phlegm heat cough syndrome.