摘要
目的:评价“清感冬饮”对流行性感冒的预防效果及安全性。方法:通过医院信息系统检索2020年小雪至大雪节气期间符合纳入和排除标准的医院门诊就诊患者。将受试者分为中药组和对照组,每组384例,中药组给予“清感冬饮”随访观察10周,分别记录两组受试者流感事件发生情况、上呼吸道感染事件发生情况、因上呼吸道感染医疗机构就诊情况、平素不适症状改善情况,以及不良反应发生情况,运用生存分析方法评价“清感冬饮”预防流感的临床疗效及安全性。结果:中药组在流感事件与上呼吸道感染事件方面的K-M生存曲线均优于对照组(P<0.05,P<0.01),多因素COX比例风险回归分析显示“清感冬饮”可使流感事件与上呼吸道感染事件发生风险分别降低80.3%和74.2%。另外,中药组受试者因上呼吸感染医疗机构就诊率显著低于对照组(P<0.05)。“清感冬饮”对受试者平素不适症状治疗的有效率为68.2%,所改善的症状中以咽喉、鼻和气管等上呼吸道部位症状为主。观察期间对照组受试者未发生药物所致的不良反应,中药组受试者不良反应的发生率为2.3%。结论:“清感冬饮”可有效预防冬季流行性感冒,临床使用安全性良好;并且可改善受试者上呼吸道不适症状,降低受试者因上呼吸道感染医疗机构就诊需求。
Objective:To evaluate the preventive effect and safety of‘Qinggandong Decoction’on influenza.Methods:To search hospital outpatients who met the inclusion and exclusion criteria during the period of minor snow to major snow in 2020 by using the hospital information system.The subjects were divided into traditional Chinese medicine(TCM)group and control group,384 cases in each group.‘Qinggandong Decoction’were given to TCM group and followed up for 10 weeks.The occurrence of influenza and upper respiratory tract infectious(URTI),the member of people who went to medical institutions due to URTI,and the improvement of past discomfort symptoms,and the occurrence of adverse reactions were recorded respectively.To evaluation of clinical efficacy and safety of‘Qinggandong Decoction’in preventing influenza by survival analysis.Results:The K-M survival curves of influenza events and URTI events in TCM group were better than those in the control group(P<0.05,P<0.01).Multivariate COX proportional hazard regression analysis showed that Qinggandong Decoction could reduce the risk of influenza events and URTI events by 80.3%and 74.2%,respectively.In addition,the rate of visiting medical institutions for URTI in the TCM group was significantly lower than that in the control group(P<0.05).The effective rate of‘Qinggandong Decoction’in the treatment of past discomfort symptoms of the subjects was 68.2%,and the symptoms of upper respiratory tract such as throat,nose and trachea were mainly improved.During the observation period,no adverse reactions caused by drugs occurred in the control group,and the incidence of adverse reactions in TCM group was 2.3%.Conclusion:‘Qinggandong Decoction’can effectively prevent winter influenza and is safe for clinical use.Moreover,it can improve the symptoms of upper respiratory tract discomfort of subjects and reduce their medical demand due to URTI.
作者
昝树杰
王凯
张硕
付鲲
周胜元
封继宏
倪道艳
雒明池
张伯礼
ZAN Shu-jie;WANG Kai;ZHANG Shuo;FU Kun;ZHOU Sheng-yuan;FENG Ji-hong;NI Dao-yan;LUO Ming-chi;ZHANG Bo-li(Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Second Teaching Hospital of Tianjin University ofTraditional Chinese Medicine,Tianjin 300250,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2023年第5期1960-1966,共7页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
天津市中医药重点领域科研项目(No.2021009,No.2022002)。
关键词
清感冬饮
中药
流行性感冒
预防
队列研究
生存分析
Qinggandong Decoction
Traditional Chinese medicine
Influenza
Prevention
Cohort study
Analysis of survival