小儿肺热咳喘颗粒治疗小儿急性咽气管炎(感冒风热夹痰证)的多中心临床试验研究

Multi-center clinical trial of Xiao'er Feire Kechuan Granule on acute inflammation of pharynx and trachea with syndrome of pedo-anemopyretic cold with phlegm

目的评价小儿肺热咳喘颗粒治疗小儿急性咽-气管炎(感冒风热夹痰证)的有效性与安全性。方法采用分层区组随机、阳性药(急支糖浆)平行对照、双盲双模拟、非劣效检验、多中心临床研究的方法。结果共收集病例210例,两组各105例。试验组、对照组疾病疗效总有效率分别为96.04%、96.08%(PPS),中医证候疗效总有效率分别为97.03%、98.04%(PPS),经非劣效性检验,试验组疾病疗效及证候疗效均不劣于对照组。两组咽红肿或痛症状消失率分别为57.43%、43.14%(PPS),试验组优于对照组,差异有统计学意义(P<0.05),其他单项症状消失率及并发症发生率比较,差异不显著。两组均无不良反应发生。结论小儿肺热咳喘颗粒的总体治疗效果不劣于急支糖浆,对于咽红肿或痛的治疗消失率高于急支糖浆,且临床应用安全性良好。

Objective To evaluate the efficacy and safety of Xiao＇er Feire Kechuan Granule in treating on acute inflammation of the pharynx and the trachea with syndrome ofpedo-anemopyretic cold with phlegm. Methods The stratified blocked randomization, positive drug （Jizhi Syrup） parallel contrast, double blind, double dummy, non-inferiority test, and multi-center research were applied to this study. Results A total of 210 cases were collected, and each group with 105 cases. The total effective rates of disease in the treatment and control groups were 96.04% and 96.08%, respectively （per protocol analysis, PPS）, and the total effective rates of syndrome in the treatment and control groups were 97.03% and 98.04% （PPS）, respectively. The results of non-inferiority test indicated that the efficiency to the patients in the treatment group was no worse than that in the control group. The disappearance rate of sore red swollen throat in the two groups, respectively was 57.43% and 43.14% （PPS）; The treatment group was superior to the control group, the difference between the two groups was significant （P 〈 0.05）. Compared with the disappearance rate of other single syndromes and the incidence of complications, the difference between the two groups was not significant. There was no clinical adverse reaction in both groups. Conclusion The curative effect ofXiao＇er Feire Kechuan Granule is not inferior to Jizhi Syrup, and compared with the disappearance rate of sore red swollen throat, it is superior to Jizhi Syrup. In addition to, Xiao＇er Feire Kechuan Granule has high safety.