A Multicenter Randomized Controlled Clinical Study of Xiaoer Jiebiao Oral Liquid(小儿解表口服液)in Treatment of Influenza(Wind-Heat Invading Wei Phase Syndrome)
Objective To evaluate the efficacy and safety of Xiaoer Jiebiao Oral Liquid(小儿解表口服液)in the treatment of influenza(wind-heat invading Wei phase syndrome).Methods A stratified randomized,positive drug parallel control,multi-center clinical trial design was adopted.A total of 300 children were planned to be included and randomly divided into treatment group and control group.The treatment group was given Xiaoer Jiebiao Oral Liquid(小儿解表口服液)in the treatment of influ-enza(wind-heat invading Wei phase syndrome)and the control group was given Oseltamivir Phosphate Granules for 5 days.It compared the clinical recovery time,complete fever relief time,Canadian acute respiratory illness and flu scale(CARIFS)score,traditional Chinese medicine syndrome efficacy,single symptom disappearance rate,defervescence duration,incidence of compli-cations,severe and critical illness and safety indicators between two groups of diseases.Results A total of 300 clinically diagnosed children were included,of which 297 were included in the Full analysis set(FAS),289 were included in the Per protocol set(PPS),and 297 were included in the Safety set(SS).After treatment,there was no statistically significant difference in the medi-an clinical recovery time between groups(P＞0.05).COX regression analysis was used.According to the non inferior standard of 0.75,the treatment group was not inferior to the control group,and the PPS and FAS analysis conclusions were consistent.There was no significant difference in the median time of complete defervescence between the groups by FAS/PPS analysis(P＞0.05).COX regression analysis was used.According to the non inferior standard of 0.75,the treatment group was not inferior to the control group.The disappearance rate of runny nose in the treatment group was better than that in the control group,with a statistically significant difference(P＜0.05).The antipyretic duration of PPS was 6(6～12)hin the treatment group and 6(6～7.5)h in the control group.The difference was statistically significant(P＜0.05)by Log rank test.There was no significant difference in CARIFS score,TCM syndrome effect,the incidence of complications,severe and critical diseases between groups(P＞0.05).Conclusion Xiaoer Jiebiao Oral Liquid has the effect of shortening the course of disease in treating children's influ-enza(wind-heat invading Wei phase syndrome),and its efficacy is not inferior to that of oseltamivir phosphate granules,and its clinical application is safe.
万方数据
维普
