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小儿解表口服液治疗流行性感冒(风热犯卫证)多中心随机对照临床研究

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)
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摘要 目的评价小儿解表口服液治疗流行性感冒(风热犯卫证)的疗效及其安全性。方法采用分层区组随机、阳性药平行对照、多中心临床试验设计。计划纳入300例受试儿童,随机分为治疗组和对照组。治疗组予小儿解表口服液,对照组予磷酸奥司他韦颗粒,疗程5 d。比较两组疾病临床痊愈时间,完全退热时间,加拿大急性呼吸道疾病和流感量表(Canadian Acute Respiratory Illness and Flu Scale,CARIFS)评分,中医证候疗效,单项症状消失率,退热持续时间,并发症、重症及危重症发生率,和安全性指标。结果共纳入临床诊断患儿300例,其中297例进入全分析数据集(Full a⁃nalysis set,FAS),289例进入符合方案数据集(Per protocol set,PPS),297例进入安全性数据集(Safety set,SS)。治疗后,疾病临床痊愈中位时间,组间比较差异均无统计学意义(P>0.05),采用COX回归分析,按0.75的非劣标准,治疗组非劣效于对照组,PPS与FAS分析结论一致;完全退热中位时间,组间比较,FAS/PPS分析差异无统计学意义(P>0.05),采用COX回归分析,按0.75的非劣标准,治疗组非劣效于对照组;流涕消失率治疗组优于对照组,差异有统计学意义(P<0.05);PPS退热持续时间治疗组6(6~12)h,对照组6(6~7.5)h,经Log-rank检验,差异有统计学意义(P<0.05)。CARIFS评分,中医证候疗效,以及并发症、重症及危重症发生率组间比较差异均无统计学意义(P>0.05)。结论小儿解表口服液治疗儿童流行性感冒(风热犯卫证)具有缩短病程作用,疗效非劣于磷酸奥司他韦颗粒,临床应用的安全性较好。 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)h in 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.
作者 穆婧雯 王雪峰 王梅 崔振泽 王孟清 尚莉丽 刘英 尹庆锋 迟磊 张秀英 沈红岩 MU Jingwen;WANG Xuefeng;WANG Mei;CUI Zhenze;WANG Mengqing;SHANG Lili;LIU Ying;YIN Qingfeng;CHI Lei;ZHANG Xiuying;SHEN Hongyan(Liaoning University of Traditional Chinese Medicine,Shenyang 110847,Liaoning,China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,Liaoning,China;Dalian Children's Hospital,Dalian 116011,Liaoning,China;The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,Changsha 410007,Hunan,China;The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei 230031,Anhui,China;Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine,Nanchang 330006,Jiangxi,China;Jiangsu Famous Medicine Technology Co.Ltd.,Nanjing 210000,Jiangsu,China)
出处 《中华中医药学刊》 CAS 北大核心 2024年第5期131-136,共6页 Chinese Archives of Traditional Chinese Medicine
基金 国家中医药管理局中医药循证能力建设项目(2019XZZX-LG006)。
关键词 小儿解表口服液 儿童 流行性感冒 风热犯卫证 随机对照临床试验 Xiaoer Jiebiao Oral Liquid children influenza wind-heat invading Wei phase syndrome randomized controlled clinical trial
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