热感糖浆治疗普通感冒(风热证)有效性和安全性的多中心、随机、双盲双模拟、安慰剂与阳性药平行对照Ⅱb期临床试验  

Efficacy and safety of Regan Syrup in treatment of common cold(wind-heat syndrome):a multicenter,randomized,double-blind,double-dummy,placebo and positive drug-controlled,parallel,phaseⅡb clinical trial

作　　者：胡薏敏 刘清泉[3] 陈生[2] 陈叶洋 王兰[5] 刘南[6] 陈宁[7] 龙友余[8] 董辉[9] HU Yi-min;LIU Qing-quan;CHEN Sheng;CHEN Ye-yang;WANG Lan;LIU Nan;CHEN Ning;LONG You-yu;DONG Hui(the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine,Shenzhen 518033,China;Shenzhen Traditional Chinese Medicine Hospital,Shenzhen 518033,China;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Bejing 100010,China;Clinical College of Chinese Medicine,Gansu University of Chinese Medicine,Lanzhou 730000,China;Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China1;the First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China;Guangdong Second Traditional Chinese Medicine Hospital,Guangzhou 510095,China;Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300150,China;Taian Traditional Chinese Medicine Hospital,Taian 271000,China)

机构地区：[1]广州中医药大学第四临床医学院,广东深圳518033 [2]深圳市中医院,广东深圳518033 [3]首都医科大学附属北京中医医院,北京100010 [4]甘肃中医药大学中医临床学院,甘肃兰州730000 [5]北京中医药大学东直门医院,北京100700 [6]广州中医药大学第一附属医院,广东广州510405 [7]广东省第二中医院,广东广州510095 [8]天津中医药大学第二附属医院,天津300150 [9]泰安市中医医院,山东泰安271000

出　　处：《中国中药杂志》2023年第8期2233-2240,共8页China Journal of Chinese Materia Medica

基　　金：深圳市科技计划项目创新创业专项(JSGG20220226090203006);深圳市“医疗卫生三名工程”项目(SZSM201812063)。

摘　　要：热感糖浆具有清热解表、利咽止咳之功效。前期的Ⅱ期临床试验结果表明,热感糖浆大剂量组及小剂量组疗效优于安慰剂组,安全性指标组间差异无统计学意义。现为进一步探索推荐剂量(20 mL)的热感糖浆治疗普通感冒(风热证)的有效性和安全性,开展该试验。选取符合纳入、排除标准的患者,采用区组随机化方法,按照1∶1∶1随机分为试验组、阳性药组和安慰剂组。试验组予热感糖浆+疏风解毒胶囊模拟剂,阳性药组予热感糖浆模拟剂+疏风解毒胶囊,安慰剂组予热感糖浆模拟剂+疏风解毒胶囊模拟剂,3组疗程均为3 d,在治疗后第4天进行随访,主要疗效指标为退热起效时间和解热时间。6家研究中心共纳入119例受试者,试验组39例、阳性药组和安慰剂组各40例。结果显示,试验组退热起效时间比安慰剂组短(P≤0.01),虽较阳性药组短,但组间差异无统计学意义;试验组解热时间优于阳性药组(P<0.05),虽较安慰剂组短,但组间差异无统计学意义;试验组相比阳性药组能够有效缩短全部症状的消失时间(P≤0.0001);试验组在改善咽痛、发热症状方面优于阳性药组和安慰剂组(P<0.05);临床疗效方面,试验组相比安慰剂组能够提高普通感冒(风热证)的痊愈率(P<0.05);治疗后第4天,试验组和阳性药组中医证候积分均比安慰剂组显著降低(P<0.05)。3组不良事件发生率组间差异无统计学意义,均未发生与研究药物相关的严重不良事件。结果表明,热感糖浆能够缩短退热起效时间和解热时间,改善风热感冒引起的咽痛、发热等症状,降低中医证候总积分,提高临床痊愈率,安全性良好。Regan Syrup has the effect of clearing heat,releasing exterior,benefiting pharynx and relieving cough,and previous phaseⅡclinical trial showed that the efficacy of Regan Syrup high-dose and low-dose groups was better than that of the placebo group,and there was no statistically significant difference in the safety between the three groups.The present study was conducted to further investigate the efficacy and safety of the recommended dose(20 mL)of Regan Syrup in the treatment of common cold(wind-heat syndrome).Patients who met the inclusion and exclusion criteria were selected and divided into the test group(Regan Syrup+Shufeng Jiedu Capsules placebo),positive drug group(Regan Syrup placebo+Shufeng Jiedu Capsules)and placebo group(Regan Syrup placebo+Shufeng Jiedu Capsules placebo)at a 1∶1∶1 using a block randomization method.The course of treatment was 3 days.A total of 119 subjects were included from six study centers,39 in the test group,40 in the positive drug group and 40 in the placebo group.The onset time of antipyretic effect was shorter in the test group than in the placebo group(P≤0.01)and the positive drug group,but the difference between the test group and the positive drug group was not significant.The test group was superior to the positive drug group in terms of fever resolution(P<0.05),and had a shorter onset time of fever resolution than the placebo group,but without obvious difference between the two groups.Compared to the positive drug group,the test group had shortened disappearance time of all symptoms(P≤0.0001).In addition,the test group was better than the positive drug group and the placebo group in relieving symptoms of sore throat and fever(P<0.05),and in terms of clinical efficacy,the recovery rate of common cold(wind-heat syndrome)was improved in the test group compared to that in the placebo group(P<0.05).On the fourth day after treatment,the total TCM syndrome score in both test group and positive drug group was lower than that in the placebo group(P<0.05).There was no sig

关 键 词：普通感冒(风热证) 热感糖浆 临床试验 安全性 有效性 

分 类 号：R254.1[医药卫生—中医内科学]