银翘清热片临床疗效观察  

Clinical efficacy observation of yinqiao qingre tablet

作　　者：吴圣贤[1] 樊钦华 苏文全 张立山[1] 张伟[2] 方邦江[3] 周凌[4] 龙友余[5] 张业清[6] 王檀[7] 熊旭东[8] 曲妮妮[9] 石克华[10] 肖伟[11] 商洪才[1] 王永炎[12] Wu Shengxian;Fan Qinhua;Su Wenquan;Zhang Lishan;Zhang Wei;Fang Bangjiang;Zhou Ling;Long Youyu;Zhang Yeqing;Wang Tan;Xiong Xudong;Qu Nini;Shi Kehua;Xiao Wei;Shang Hongcai;Wang Yongyan(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,Guangdong China;LongHua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;First Affiliated Hospital,Heilongjiang University of Chinese Medicine,Harbin 150040,Hei Longjiang,China;Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300150,China;Jiangsu Province Hospital on Integration of Chinese and Western Medicine,Nanjing 210000,Jiangsu,China;Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130000,Jilin,China;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200012,China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,Liaoning,China;Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai 200071,China;Jiangsu Kanion Pharmaceutical Co.,Ltd.,Lianyungang 222001,Jiangsu,China;China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]广州中医药大学第一附属医院,广东广州510405 [3]上海中医药大学附属龙华医院,上海200032 [4]黑龙江中医药大学附属第一医院,黑龙江哈尔滨150040 [5]天津中医药大学第二附属医院,天津300150 [6]江苏省中西医结合医院,江苏南京210000 [7]长春中医药大学附属医院,吉林长春130000 [8]上海中医药大学附属曙光医院,上海200012 [9]辽宁中医药大学附属医院,辽宁沈阳110032 [10]上海市中医医院,上海200071 [11]江苏康缘药业股份有限公司,江苏连云港222001 [12]中国中医科学院,北京100700

出　　处：《生物医学转化》2022年第3期82-92,共11页Biomedical transformation

摘　　要：目的评价银翘清热片治疗外感风热型普通感冒的有效性和安全性。方法采取随机、双盲、安慰剂、平行对照试验方法,将符合标准的受试者随机分为试验组、阳性药对照组和安慰剂对照组。试验药为银翘清热片,阳性对照药为银翘解毒片,安慰剂为银翘清热片模拟药和银翘解毒片模拟药。试验组口服银翘清热片和银翘解毒片模拟药,阳性药对照组口服银翘清热片模拟药和银翘解毒片,安慰剂对照组口服银翘清热片模拟药和银翘解毒片模拟药,疗程3天。评价治疗前后主要症状消失率、单项症状评分、中医证候疗效、体温变化、解热镇痛药使用情况和安全性。结果试验组主要症状消失率为62.12%,为三组中最高(P<0.01)。三组治疗后各单项症状评分均下降(P<0.01),试验组各单项症状评分下降最多,各单项症状消失率最高(P<0.01)。试验组中医证候有效率94.99%,为三组中最高(P<0.01)。三组治疗后体温均下降,试验组退热起效时间为8 h,体温复常时间为20 h,为三组中最快(P<0.01)。试验组解热镇痛药使用率为0.28%,为三组中最低(P<0.01)。三组治疗后未见严重不良事件和不良反应。结论银翘清热片治疗外感风热型感冒具有良好疗效和安全性。Objective To evaluate the efficacy and safety of yinqiao qingre tablet in treating common cold with wind-heat type.Methods The randomized,double-blind,placebo,parallel control research were applied to this study.The eligible subjects were divided into a experimental group,a positive control group and a placebo control group.The test drug was yinqiao qingre tablet,positive control drug was yinqiao jiedu tablet,and simulation drugs were yinqiao qingre simulation tablet and yinqiao jiedu simulation tablet.The experimental group was given yinqiao qingre tablet and yinqiao jiedu simulation tablet,the positive control group was given yinqiao qingre simulation tablet and yinqiao jiedu tablet,and the placebo control group was given yinqiao qingre simulation tablet and yinqiao jiedu simulation tablet.The course of treatment for each group was 3 days.Before and after treatment,the disappearance rate of major symptoms,individual symptom scores,efficacy of TCM syndrome,change of temperature,used of antipyretic analgesics and safety were evaluated.Results The disappearance rate of major symptoms was 62.12%in experimental group,was the highest among three groups(P<0.01).After treatment,individual symptom scores of the three groups all descended(P<0.01).In experimental group,the individual symptom scores decreased the most,and the disappearance rate was the highest(P<0.01).The efficacy rate of TCM syndrome was 94.99%,TCM efficacy rate of experimental group was the highest among three groups(P<0.01).Temperature of three groups all descended.In experimental group,the beginning drop time was 8 hours and the returning normal time was 20 hours,experimental group was was shortest among three groups(P<0.01).The use rate of antipyretic analgesics was 0.28%in experimental group,and was the least among three groups(P<0.01).There were no serious adverse events and reactions in the three groups.Conclusion Yinqiao qingre tablet has satisfactory effects and safety on common cold with wind-heat type.

关 键 词：银翘清热片 外感风热型 感冒 中药新药 临床试验 

分 类 号：R969.4[医药卫生—药理学]