Xiaoer Feire Kechuan Granules in treatment of children with influenza(heat toxin attacking lung syndrome):A multicenter randomized controlled clinical study
Objective To evaluate the efficacy and safety of Xiaoer Feire Kechuan Granules(小儿肺热咳喘颗粒,XFK)in the treatment of influenza(f heat toxin attacking lung syndrome).Methods Adopting a stratified block randomization,positive drug parallel control,and multicenter clinical trial design,240 enrolled children were randomly divided into a treatment group and a control group.The treatment group was given XFK,while the control group was given oseltamivir phosphate granules.The efficacy of two groups of traditional Chinese medicine syndromes,clinical recovery time,Canadian Acute Respiratory Disease and Flu Scale(CARIFS)score,complete fever reduction time,cough and expectoration relief time,cough and sputum pain digital evaluation scale(NRS-11)score,complication,severe and critical illness conversion rate,and safety indicators were observed.Results A total of 240 cases were included in the full analysis set(FAS),with 120 cases in the experimental group and 120 cases in the control group.The effective rate of traditional Chinese medicine syndrome in the treatment group was better than that in the control group(P＜0.05).The clinical recovery time of the treatment group was shorter than that of the control group after treatment(P＜0.05).The scores of the symptom dimension,functional dimension,and parental impact dimension of CARIFS of the two groups were significantly reduced compared to before treatment(P＜0.05),and the CARIFS scores of the treatment group were lower than those of the control group(P＜0.05).The complete fever reduction time,cough relief time,expectoration relief time of the treatment group were shorter than the control group(P＜0.05).The NRS-11 scores for cough and sputum in both groups decreased significantly compared to before treatment(P＜0.05),and the treatment group was lower than the control group(P＜0.05).There was no statistically significant difference in the incidence of complications,severe illness,and critical illness conversion rate between the two groups(P＞0.05).There was no statistically significant difference in safety indicators between the two groups(P＞0.05).Conclusion XFK can effectively relieve the symptoms of fever,cough and expectoration of children with influenza(heat toxin attacking lung syndrome),shorten the course of disease,and has good safety in clinical application.
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