馥感啉口服液治疗小儿感冒气虚风热证的疗效观察

Clinical observation of Fuganlin Oral Liquid in treatment of common cold in children with qi deficiency and wind heat syndrome

目的观察馥感啉口服液治疗小儿感冒气虚风热证的临床疗效和安全性。方法采用区组随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法。467例患者随机分为对照组(117例)和治疗组(350例),对照组服用小儿解表口服液和馥感啉口服液模拟剂,治疗组服用小儿解表口服液模拟剂和馥感啉口服液,疗程为1周。观察两组的临床疗效、中医证候疗效、单项症状消失率,并对其依从性和安全性进行评价。结果对照组和治疗组临床疗效的总有效率分别为82.91%、98.29%,中医证候疗效的总有效率分别为84.62%、98.29%,两组比较差异均有统计学意义(P<0.01)。两组的发热、恶风、咽红肿痛、咳嗽的单项症状消失率比较差异均有统计学意义(P<0.05),两组鼻塞、流浊涕的单项症状消失率比较差异均无统计学意义。两组不良事件/不良反应发生率比较差异均无统计学意义。结论馥感啉口服液治疗小儿感冒气虚风热证具有较好疗效,且安全性较好,具有一定的临床推广应用价值。

Objective To evaluate the clinical efficacy and safety of Fuganlin Oral Liquid in treatment of common cold in children with qi deficiency and wind heat syndrome. Methods The stratified random, double blind, double dummy, parallel control of positive drugs, and multi-center clinical method were applied to this study. Patients（467 cases） were randomly divided into control group（117 cases） and treatment group（350 cases）. Patients in the control group were administered with Xiaoer Jiebiao Oral Liquid and simulation of Fuganlin Oral Liquid, while patients in the treatment group were administered with Fuganlin Oral Liquid and simulation of Xiaoer Jiebiao Oral Liquid. The patients in two groups were treated for one week. Clinical efficacy, traditional Chinese medicine syndrome, and single syndrome disappearance rate were observed. And the medication compliance and security were evaluated. Results The curative rates of treatment and control groups in clinical efficacy were 82.91% and 98.29%, and the clinical curative rates of both groups in traditional Chinese medicine syndrome effect were 84.62% and 98.29%. And there were differences between two groups（P〈 0.05）. The single syndrome disappearance rates of fever, aversion to wind, pharyngodynia, and cough in the treatment group were higher than those in the control group with significant differences（P〈 0.05）. There was no significant difference in single syndrome disappearance rate of rhinobyon and rhinorrhoea between two groups. And there was no significant difference in adverse event/reaction rate between two groups. Conclusion Fuganlin Oral Liquid has a good effect in treatment of common cold in children with qi deficiency and wind heat syndrome with good safety, which has a certain clinical application value.