清宣止咳颗粒治疗儿童急性上呼吸道感染的临床观察  

Clinical Observation of Qingxuan Zhike Granule in the Treatment of Children With Acute Upper Respiratory Tract Infection

作　　者：郑媛[1] 唐玲[1] 李珊珊[1] 

机构地区：[1]山东大学附属济南市中心医院儿科,济南250013

出　　处：《中国医药导刊》2015年第1期76-77,79,共3页Chinese Journal of Medicinal Guide

摘　　要：目的:探讨清宣止咳颗粒治疗儿童急性上呼吸道感染的有效性和安全性。方法:选择我院在2013年11月至2014年5月上呼吸道感染治疗患儿138例,采用随机数表法分组,治疗组和对照组,分别给予清宣止咳颗粒和蒲地蓝消炎口服液治疗,比较总疗效、主要症状消失率及起效时间、不良事件发生率以及并发症发生率。结果:最终全数据分析集(FAS)134例,符合方案数据集(PPS)122例,安全数据集(SS)134例。FAS中,治疗组总有效率95.5%,愈显率85.1%;对照组总有效率80.6%,愈显率46.3%。两组间比较,差异有统计学意义(P<0.01)。PPS与FAS结果一致。治疗组咳嗽咳痰、鼻塞流涕、发热的消失率均高于对照组(P<0.05);咳嗽咳痰、发热的起效时间短于对照组(P<0.05);不良事件发生率低于对照组(1.5%vs.10.4%;P<0.05);并发症发生率低于对照组(1.5%vs.7.5%;P<0.05)。研究期间无严重不良事件发生。结论:清宣止咳颗粒治疗病程在48h内的儿童急性上呼吸道感染疗效确切,可显著改善患儿症状,效果优于蒲地蓝消炎口服液,且起效快,安全性好,还可减少并发症的发生。Objective： To evaluate the effectiveness and safety of Qingxuan Zhike granule in the treatmenl of acute upper respiratory tract infection of children.Methods：In our hospital in 2013 November to 2014 May,138 cases of children with upper respiratory tract infection treatment,using a random number table method group, the treatment group and the control group, were given anti-intlammatory oral liquid in the treatment of Qingxuan Zhike granule and Pudilan, comparing the total curative effect, the main symptom disappearance rate and time efficiency, the incidence of adverse events and complications rate.Results：The final analysis of full data set （FAS） in 134 cases, consistent with the scheme of data collection （PPS） in 122 cases,security data set （SS） of 134 cases. In FAS treatment group, the total efficiency of 95.5%, markedly effective rate 85.1%;control group,the total efficiency of 80,6%,markedly effective rate of 46.3%.The comparison between two groups,the difference was statistically significant （P〈0.01）.Results：PPS and FAS agree.In treatment group,cough and expectoration,nasal congestion and runny nose,fever disappearance rate was higher than that of control group （P〈.0.05）; the onset time of cough and expectoration,fever is shorter than the control group （P〈0.05）; the incidence of adverse events was lower than that of the control group （ 1.5% vs. 10.4%;P〈0.05）;the incidence of complications was lower than the control group （1.5% vs. 7.5%;P〈0.05）.No serious adverse events occurred during the study period. Conclusion：Qingxuan Zhike granule in the treatment of disease within the 48h in children with acute upper respiratory tract infection curative effect,can significantly improve the clinical symptoms,the effect is better than that of Pudilan Xiaoyan oral liquid, and has the advantages of quick response, good safety, and can reduce the occurrence of complications.

关 键 词：清宣止咳颗粒 儿童 急性上呼吸道感染 蒲地蓝消炎口服液 

分 类 号：R272[医药卫生—中医儿科学]