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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 effectiveness and safety of pediatric Hyperactivity and Relieving Kechuan Granule in the treatment of acute pharynx-bronchitis in children. Methods Stratified group randomized, positive drug (emergency branch syrup) parallel control, double-blind double-dummy, non-inferiority test, multicenter clinical study. Results A total of 210 cases were collected, 105 cases in each group. The total effective rates of the disease and control groups were 96.04% and 96.08% (PPS), respectively. The total effective rates of TCM syndromes were 97.03% and 98.04% (PPS) respectively. The non-inferiority test showed that the curative effect Syndromes and efficacy are not inferior to the control group. The disappearance rates of the two groups were 57.43% and 43.14% (PPS) respectively, the experimental group was better than the control group, the difference was statistically significant (P <0.05), the other single symptom disappearance rate and complication rate, The difference was not significant. No adverse reactions occurred in both groups. Conclusion The overall therapeutic effect of Hyperactivity and Kechuan Granule in children is not inferior to that of emergency branch syrup. The disappearance rate of treatment for swollen or painful pharynx is higher than that of emergency branch syrup, and the safety of clinical application is good.