The Clinical Study On The Efficacy Of Xiaoer Resuqing Syrup In The Treatment Of Children With Acute Upper Respiratory Tract Infection(Biaoli Jure Syndrome)

Objective:To evaluate the efficacy of Xiaoer Resuqing Syrup in the treatment of children with acute upper respiratory tract infection(Biaoli Jure Syndrome)in shortening the duration of fever,improving constipation,improving TCM syndrome and effect of instant defervescence,and the safety.Methods:A randomized,double-blind,double simulation,positive-drug-controlled,multicenter clinical study was used.The trial intended to include 480 patients,who were randomly divided into treatment group and control group according to 3:1ratio.The treatment group was given Xiaoer Resuqing Syrup and the simulation of Xiaoer Qingrening granule for 5 days.And the control group was given Xiaoer Qingrening granule and the simulation of Xiaoer Resuqing Syrup.The two groups were compared for the fever resolution time,efficacy of constipation,efficacy of TCM syndrome,instant defervescence time and instant defervescence duration,and safety endpoints.Results:1.Baseline comparabilityA total of 468 patients were assigned to this study.6 patients were eliminated for violating the test protocol,of which 5 cases in the treatment group and 1 case in the control group.462 patients entered full analysis set,of which 347 cases in the treatment group and 115 case in the control group.433 patients were fitted in per-protocol set,of which324 cases in the treatment group and 109 case in the control group.And 463 in safety set,of which347 cases in the treatment group and 116 case in the control group.Patients' demographic data(age,height,weight,race,gender),disease related information(heat,family history,medical history,allergy history,complications before diagnosis,clinical drug combination before diagnosis),efficacy related endpoints(baseline temperature,primary symptom score,individual symptom score,and total score of TCM syndrome)in two groups,had no statistically differences(P>0.05),who entered full analysis set.The analysis results of FAS and PPS were consistent.2.Efficiency analysisThe median fever resolution time of the treatment group was 48 hours,and the control group was 48 hours.The COX regression model was used to estimate the intergroup HR and 95%CI.The intergroup HR was 1.08.And 98%CI was 0.87?1.342.After adjusting for the influence of center factor,the treatment group was not inferior to the control group according to the non-inferiority standard of 0.67.After 5 days of treatment,the rate of constipation disappearance was 88.47% in the treatment group and 80.00% in the control group(P<0.05).And the rate of constipation efficiency was 96.54% and 88.70%(P<0.05).The recovery rate of TCM syndromes were 46.40% and 31.30%(P<0.05).The disappearance rate of each single symptom in the two groups was higher.And the difference in constipation and pharyngalgiawas statistically significant between two groups(P<0.05).The medianinstant defervescence time of the treatment group was 2h and the control group was 2h(P>0.05).Theaverage instant defervescence duration of the treatment group was 4.20 h and the control group was 3.167h(P>0.05).The analysis results of FAS and PPSwere consistent.3.Security analysisIn this trial,there were 4 cases(1.15%)of adverse events in the treatment group and 3 cases(2.59%)in the control group.According to the judgment of the researchers,1 adverse event in the treatment group and 1 in the control group were judged to be an adverse drug reaction(P>0.05).Conclusion: Xiaoer Resuqing Syrup in the treatment of children with acute upper respiratory tract infection(Biaoli Jure Syndrome)can shorten the duration of fever,and improve constipation and TCM syndrome.And the security of Xiaoer Resuqing Syrup is good.It provides a new choice for the clinical treatment of acute upper respiratory tract infection(Biaoli Jure Syndrome)in children.