天津中医药大学学报2025，Vol.44Issue(4)：303-308,6.DOI:10.11656/j.issn.1673-9043.2025.04.04
玉叶解毒颗粒治疗儿童流行性感冒临床观察
Clinical observation on the treatment of influenza in children with Yuye Jiedu Granules
摘要
Abstract
[Objective]Exploring the efficacy and safety of Yuye Jiedu Granules in the treatment of influenza in children.[Methods]A prospective,single-arm,open,positive drug external control,multicentre design was used.Cases of oseltamivir granules with the same design(similar population,same key indicators and measurements,and similar study duration)were selected as external controls in the clinical research database.The duration of treatment was 5 days with 2 days of follow-up.The population after propensity score matching(PSM)was used as the primary analysis set to compare the two groups in terms of clinical recovery rate,time to clinical recovery,time to complete fever reduction,Canadian Acute Respiratory Illness and Flu Scale(CARIFS)total and dimensional scores,single symptom disappearance rate,complication rate,and adverse events rate.[Results]A total of 334 cases were included,133 cases in the test group and 201 cases in the control group,69 cases in each group after 1∶1 matching.After PSM,the between-group comparisons of baseline demographic information,disease and efficacy-related conditions were not statistically significant and well-balanced.After PSM,the study endpoints,the clinical cure rate was 92.75%in the experimental group and 91.30%in the control group,with no statistically significant difference in the between-group comparisons(P＞0.05),and the difference in the rates between the two groups was 1.45%[(95CI%(-8.35%,11.35%)],the test group was not inferior to the control group by the non-inferiority test(Δ=-12%),and the conclusions of the analysis before and after matching were consistent.The mean time to clinical recovery estimated using Restricted mean survival time(RMST)was 4.754 days in the experimental group and 4.594 days in the control group,and the difference between the groups was not statistically significant(P＞0.05).The time to complete fever reduction,the value of change from baseline in CARIFS total score and scores of each dimension,the rate of disappearance of single symptom,and the rate of complications were not statistically significant when compared between groups(P＞0.05).In terms of safety,intergroup comparisons of the incidence of adverse events/adverse reactions between the two groups showed no statistically significant differences(P＞0.05).[Conclusion]The efficacy of Yuye Jiedu Granules in the treatment of influenza in children is not inferior to that of oseltamivir phosphate granules,and the safety of clinical application is better,which has clinical promotion value.关键词
玉叶解毒颗粒/儿童流行性感冒/外部对照/倾向性评分匹配Key words
Yuye Jiedu Granule/childhood influenza/external control/propensity score matching分类
医药卫生引用本文复制引用
郭圣璇,张梦也,胡思源,李妙媛,沈晓明..玉叶解毒颗粒治疗儿童流行性感冒临床观察[J].天津中医药大学学报,2025,44(4):303-308,6.基金项目
中国人口福利基金会妇女儿童关爱工程计划资助项目(GNB-6-20210304-68). （GNB-6-20210304-68）
