Efficacy and safety of the Chinese herbal medicine Xiao’er Niuhuangantipyretic plaster(小儿牛黄退热贴膏)for treating fever in childrenwith acute upper respiratory tract infection with wind-heat syndrome:a multicenter,randomized,double-blind,controlledOA

OBJECTIVE:To evaluate the efficacy and safety of Xiao''er Niuhuang antipyretic plaster(小儿牛黄退热贴膏)in treating fever associated with acute upper respiratory tract infection(AURI)accompanied by wind-heat syndrome in children.METHODS:A total of 464 pediatric patients diagnosed with AURI and wind-heat syndrome were enrolled.Participants were stratified into two age subgroups(1-2 years and 3-5 years)and then randomly assigned in a 3:1 ratio to receive either the Xiao''er Niuhuang antipyretic plaster or an extremely low-dose control plaster.The primary outcome was the time to onset of fever reduction.Safety assessments included monitoring of vital signs,laboratory tests(complete blood count,urinalysis,stool routine,and liver and kidney function),electrocardiogram,and local skin reactions.RESULTS:The median time to onset of antipyretic effect was significantly shorter in the Xiao''er Niuhuang antipyretic plaster group than in the control group(2.53 h vs 3.98 h).The complete antipyretic rates at the 4-h time point were 31.76%for the Xiao''er Niuhuang antipyretic plaster group and 17.70%for the control group;at the 8-h time point,the rates were 49.55%and 33.04%,respectively.No significant difference was observed in the incidence of adverse events between the two groups(P>0.05).No serious adverse events were reported.CONCLUSION:Xiao''er Niuhuang antipyretic plaster is an effective and safe treatment for fever in children with AURI and wind-heat syndrome.