口炎清颗粒(无糖)治疗慢性咽炎的多中心、随机、开放、阳性平行对照临床研究  

A Multicenter,Randomized,Open-Label,Parallel Active-Controlled Clinical Trial of Kouyanqing Granule(口炎清颗粒)(Sugar-Free)on Chronic Pharyngitis

作　　者：张孝文[1] 马兆鑫[2] 霍红[3] 江萍[4] 何培杰[5] 谢景华[6] 任理[7] 林娟[7] 刘旻[7] 魏春生[5] ZHANG Xiaowen;MA Zhaoxin;HUO Hong;JIANG Ping;HE Peijie;XIE Jinghua;REN Li;LIN Juan;LIU Min;WEI Chunsheng(First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,Guangdong,China;Shanghai East Hospital,Shanghai 200120,China;Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China;Nanjing Stomatological Hospital,Medical School of Nanjing University,Nanjing 210008,Jiangsu,China;Eye&ENT Hospital of Fudan University,Shanghai 200031,China;The First People’s Hospital of Guangzhou,Guangzhou 510180,Guangdong,China;Modern Chinese Medicine Research Institute,Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Limited Company,Guangzhou 510515,Guangdong,China)

机构地区：[1]广州医科大学附属第一医院,广东广州510120 [2]上海市东方医院,上海200120 [3]中国医学科学院,北京协和医学院,北京协和医院,北京100730 [4]南京大学医学院附属口腔医院,江苏南京210008 [5]复旦大学附属眼耳鼻喉科医院,上海200031 [6]广州市第一人民医院,广东广州510180 [7]广州白云山和记黄埔中药有限公司现代中药研究院,广东广州510515

出　　处：《中华中医药学刊》2024年第9期1-4,共4页Chinese Archives of Traditional Chinese Medicine

基　　金：国家重点研发计划项目(2018YFC1707300);广州市科技创新委员会民生科技攻关计划项目(201803010082)。

摘　　要：目的评价口炎清颗粒(无糖)治疗慢性咽炎的有效性和安全性。方法采用多中心、随机、开放、阳性平行对照方法,将纳入的186例慢性咽炎患者按1∶1比例随机分为试验组与对照组,分别给予口炎清颗粒(无糖)、慢严舒柠?清喉利咽颗粒,服用方法为口炎清颗粒(无糖)一次2袋,2次/d,慢严舒柠?清喉利咽颗粒一次1袋,3次/d,两组疗程均为4周。观察慢性咽炎患者的咽痛、咽痒、咽干等临床症状。结果调整意向治疗患者,试验组92例,对照组88例。主要有效性指标第28天的临床症状与总有效率,试验组为76.7%,对照组为71.8%,两组差异无统计学意义(P>0.05),总有效率试验组非劣效于对照组。次要有效性指标第7天的临床症状与体征总有效率,试验组为32.6%,对照组为19.3%,两组比较差异有统计学意义(P<0.05)。治疗第28天单项临床症状与体征咽痛消失率,试验组为58.0%,对照组为34.0%,两组比较差异有统计学意义(P<0.05)。其他次要有效性评价指标,两组差异均无统计学意义,但试验组的点估计值高于对照组。试验中,不良事件发生率试验组为30.4%,对照组为27.3%。严重不良事件,试验组1例,对照组2例。与试验药物相关的治疗期不良事件试验组和对照组均有2例。两组不良事件发生率比较,差异无统计学意义(P>0.05)。结论口炎清颗粒(无糖)治疗慢性咽炎,可有效改善临床症状,且临床应用安全性较好。Objective To evaluate the efficacy and safety of Kouyanqing Granule(口炎清颗粒)(sugar-free)on chronic pharyngitis.Methods A total of 186 patients were randomly divided into experimental group[Kouyanqing Granule(sugar-free),2 bags for each time,twice a day]and control group[Manyanshuning Qingyanlihou Granule(慢严舒柠清喉利咽颗粒),1 bag for each time,3 times a day]with 1∶1 ratio by multicenter,randomized,open-label and parallel active-controlled method.The treatment of both groups lasted 4 weeks.The clinical symptoms of chronic pharyngitis in patients,such as pharyngeal pain,pha-ryngeal itch and pharyngeal dryness were observed.Results There were 92 patients in the experimental group and 88 patients in the control group.The clinical symptoms and total effective rate at day 28 which was the main effectiveness indicator was 76.7%in the experimental group and 71.8%in the control group,and there was no statistical significance between the two groups(P>0.05).The total effective rate of the experimental group was not inferior to that of the control group.The clinical symptoms and total effective rate at day 7 which was the secondary effectiveness indicators was 32.6%in the experimental group and 16.3%in the control group,and there were statistical differences between the two groups(P<0.05).The single clinical symptoms and the disappearance rate of pharyngeal pain at day 28 was 58.0%in the experimental group and 34.0%in the control group,and the difference between the two groups was statistically significant(P<0.05).For other secondary effectiveness indicators,there was no statistical significance between the two groups,but the points estimated of the experimental group were higher than that of the control group.The incidence of adverse events was 30.4%in the experimental group and 27.3%in the control group.There was 1 case with serious adverse events in the experimental group and 2 cases in the control group.There were 2 cases of adverse e-vents related to the experimental drug in both the experimental g

关 键 词：口炎清颗粒(无糖) 慢性咽炎 随机开放试验 

分 类 号：R246.81[医药卫生—针灸推拿学]