Effectiveness And Safety Of Xiaoer Jinqiao Granules For Influenza(Wind Heat Syndrome) In Children:A Randomized Controlled Trial

Objective:To evaluate the effectiveness in shortening course and improve the clinical effect,and observe the safety of Xiaoer Jinqiao Granules for Influenza(Wind Heat Syndrome)of children.Methods:This randomized,controlled,multicenter clinical trial planed to enroll 240 children who had Influenza(Wind Heat Syndrome).All of them were randomly assigned to received either Xiaoer Jinqiao Granules or Oseltamivir Phosphate Granules for5 days.Results:A total of 240 children were enrolled,half for the test group and half for the control group.Among of them,the FAS included 229 cases(113 in test group,116 in control group),PPS included 200 cases(95 in test group,105 in control group),and SS included 233cases(115 in test group,118 in control group).After 5 days of treatment and 2 days of follow-up,the median time of clinical recovery duration in the test group and the control group were both 3 days.There was no significant difference between the two groups(P>0.05).Using the accelerated failure time model,according to the non-inferior standard of 0.75,the test group was not inferior to the control group,and the confirmed cases were consistent with the analysis results of clinical diagnosis cases.The fever resolution time of the test group was42(42)hours and in the control group was 36(42)hours.There was significantly difference in FAS(P<0.05),but there was no significantly difference in PPS(P>0.05).The conclusions of the analysis are consistent among different groups.The results of confirmed cases were similar with clinical diagnosis cases.Among the AUC of CARIFS symptom dimension score,as well as the incidence of complications,severe cases and critical illness,there was no significant difference between the groups(P>0.05).The FAS(PPS)results of clinical diagnosis of traditional Chinese medicine syndrome(recovery rate)showed that the test group was 48.67%(47.37%)and the control group was 56.03%(52.38%).There was no statistically significant difference between the groups(P>0.05),FAS,PPS analysis conclusions are consistent,and the analysis results between different populations are consistent.In this trial,23 cases in the test group and 18 cases in the control group were regarded as AE.Among of them,9 cases inthe test group and 10 cases in the control group were judged as adverse reactions by the researchers.There was no significant differences between the groups in the incidence of adverse events and adverse reactions and serious adverse events(P>0.05).Conclusions:Xiaoer Jinqiao Granules can reduce the course of influenza in children,and its effectiveness was not inferior to Oseltamivir Granules.It can be used to treat influenza of children effectively and Safely.From this trial,we think the Xiaoer Jinqiao Granules can be a new option for the treatment of influenza in child with effectiveness and safety.