胆木浸膏糖浆治疗儿童流行性感冒多中心随机对照临床研究OA北大核心CSTPCD

Objective To evaluate the clinical efficacy and safety of Danmu extract syrup in the treatment of children with influenza.Methods A stratified block randomization,positive drug parallel control,and multicenter clinical trial design was used to enroll 480 children from 6 centers with influenza.They were randomly divided into a treatment group and a control group,with 240 cases in each group.The treatment group was treated with Danmu extract syrup,while the control group was treated with oseltamivir phosphate granules,both for 5 days.Observe the clinical recovery time,complete fever relief time,resolution time of main symptoms(pharyngalgia,cough,headache),Canadian Acute Respiratory Disease and Influenza Scale(CARIFS)score,traditional Chinese medicine syndrome efficacy,incidence rate of complications,severe and critical illness,and safety indicators of the two groups of children.Results The FAS results showed that the main efficacy indicators were as follows.The clinical recovery time of both groups was 4 days,and the complete fever relief time of both groups was 36 hours.After COX regression analysis,the inter-group HR and 95％CI were estimated,and after adjusting for the influence of central factors,0.67 was used as the non-inferiority standard.The treatment group was not inferior to the control group.Secondary efficacy indicators were as follows.The disappearance time of pharyngeal pain symptoms in the treatment group was 3 days,lower than that in the control group(4 days),with a statistically significant difference(P＜0.01).There was no statistically significant difference in the disappearance time of cough and headache symptoms between the two groups(P＞0.05).After medication,the CARIFS symptom dimension score in the treatment group was better than that in the control group,with a statistically significant difference(P＜0.01).The scores in CARIFS functional dimension and influencing parental dimension in the treatment group were better than those in the control group,but there was no statistically significant difference between the two groups(P＞0.05).The recovery rate of traditional Chinese medicine syndrome in the treatment group was 75.32％,higher than that in the control group,which was 60.50％,with a statistically significant difference(P＜0.01).There was no statistically significant difference in the total effective rate of traditional Chinese medicine syndrome between the two groups(P＞0.05).In addition,there was no statistically significant difference in the incidence of complications,severe and critical illnesses,or adverse events and reactions between the two groups(P＞0.05).Conclusion Danmu extract syrup has a significant effect on children's influenza,which is not inferior to oseltamivir phosphate granules,and helps to alleviate the symptoms of sore throat,shorten the course of influenza,and improve the health of children.Its clinical application is safe,and it is suitable for popularization.