Objective:To assess the effectiveness of Jiuwei Zhuhuang Powder(JWZH),a Tibetan patent medicine in treating upper respiratory tract infection(URTI)associated cough in children.Methods:The study was a multicenter,rando...Objective:To assess the effectiveness of Jiuwei Zhuhuang Powder(JWZH),a Tibetan patent medicine in treating upper respiratory tract infection(URTI)associated cough in children.Methods:The study was a multicenter,randomized,open-label,controlled trial.A total of 142 children aged 2 to 14 years old,with URTIassociated cough within 48 h of onset,were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence.Children were treated with JWZH(1 to 1.5 g,twice to thrice daily)in the treatment group or conventional treatment(Pediatric Paracetamol,Artificial Cow-bezoar and Chlorphenamine Maleate Granules,0.25 to 1 g,thrice daily)in the control group for 5 days.The primary endpoints were the time to cough resolution and 4-day cough resolution rate.The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period.Results:A total of 138 children were included in the intention-to-treat analysis,with 71 cases in the treatment group and 67 cases in the control group.Compared with the conventional treatment,the children receiving JWZH had a shorter time to cough resolution[hazard ratio,2.10;95%confidence interval(CI),1.29-3.40;P=0.003].The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment(2 days vs.3 days;P<0.001).The 4-day cough resolution rate in the JWZH group was higher than that of the control group(94.4%vs.74.6%;risk difference:19.8%,95%CI:8.1%-31.5%;relative risk:1.265,95%CI:1.088-1.470;P=0.001).There were no statistically significant differences in the improvement of other symptoms caused by URTI(P>0.05).Adverse events was reported in 5.6%(4/71)and 4.5%(3/67)in participants of JWZH and PPACCM groups(P>0.05),respectively,which were all mild and resolved without treatment.Conclusion:JWZH seemed to be a safe and effective therapy for URTI-associated cough in children.(Trial registration No.Chi CTR2000039421)展开更多
基金Supported by the National Natural Science Foundation of China(No.81704197)。
文摘Objective:To assess the effectiveness of Jiuwei Zhuhuang Powder(JWZH),a Tibetan patent medicine in treating upper respiratory tract infection(URTI)associated cough in children.Methods:The study was a multicenter,randomized,open-label,controlled trial.A total of 142 children aged 2 to 14 years old,with URTIassociated cough within 48 h of onset,were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence.Children were treated with JWZH(1 to 1.5 g,twice to thrice daily)in the treatment group or conventional treatment(Pediatric Paracetamol,Artificial Cow-bezoar and Chlorphenamine Maleate Granules,0.25 to 1 g,thrice daily)in the control group for 5 days.The primary endpoints were the time to cough resolution and 4-day cough resolution rate.The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period.Results:A total of 138 children were included in the intention-to-treat analysis,with 71 cases in the treatment group and 67 cases in the control group.Compared with the conventional treatment,the children receiving JWZH had a shorter time to cough resolution[hazard ratio,2.10;95%confidence interval(CI),1.29-3.40;P=0.003].The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment(2 days vs.3 days;P<0.001).The 4-day cough resolution rate in the JWZH group was higher than that of the control group(94.4%vs.74.6%;risk difference:19.8%,95%CI:8.1%-31.5%;relative risk:1.265,95%CI:1.088-1.470;P=0.001).There were no statistically significant differences in the improvement of other symptoms caused by URTI(P>0.05).Adverse events was reported in 5.6%(4/71)and 4.5%(3/67)in participants of JWZH and PPACCM groups(P>0.05),respectively,which were all mild and resolved without treatment.Conclusion:JWZH seemed to be a safe and effective therapy for URTI-associated cough in children.(Trial registration No.Chi CTR2000039421)