藿香正气口服液治疗胃肠型感冒暑湿证的多中心、双盲随机对照临床研究  

Clinical Study on the Treatment of Gastrointestinal Flu of Summer-Dampness Syndrome with Huoxiang Zhengqi Oral Liquid (藿香正气口服液) : a Multicentered,Randomized,Placebo-Controlled,Double-Blind Clinical Trial

作　　者：张声生[1] 吴咏冬[2] 冯培民[3] 黄建伟 沈晨[1] 杨小军[5] 胡运莲[6] 金宇[7] 金小晶[8] 赵詹东 林海[10] 赵琦 郑亮[12] 肖惠珍 郭永泽[14] 李旭成[15] 刘爱民[16] 赵志英[17] 易琼[18] 陈峭[19] 张瑜[20] ZHANG Shengsheng;WU Yongdong;FENG Peimin;HUANG Jianwei;SHEN Chen;YANG Xiaojun;HU Yunlian;JIN Yu;JIN Xiaojing;ZHAO Zhandong;LIN Hai;ZHAO Qi;ZHENG Liang;XIAO Huizhen;GUO Yongze;LI Xucheng;Liu Aimin;ZHAO Zhiying;YI Qiong;CHEN Qiao;ZHANG Yu(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing,100010;Beijing Friendship Hospital,Capital Medical University;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine;The Fifth Hospital Affilia-ted to Guangzhou Medical University;Chongqing Traditional Chinese Medicine Hospital;Hubei Province Hospital of Traditional Chinese Medicince;Shenzhen Second People's Hospital;Nanjing Hospital of Chinese Medicine;Xiangyang First People's Hospital;People's Hospital of Quzhou City;The Second Affiliated Hospital of Guiyang University of Traditional Chinese Medicince;The Second Chinese Medicine Hospital of Jiangsu Province;The Guangzhou Hospital of Integrated Traditional Chinese and Western Medicine;Affiliated Hospital of Hebei University of Engineering;Wuhan Hospital of Traditional Chinese Medicine;Fuling Central Hospital of Chongqing;The Second Hospital of Baoding City;Hospital of Traditional Chinese Medicine of Meishan City;Traditional Chinese Medicine Hospital of Liuzhou City;Traditional Chinese Medicine Hos-pital of Handan City)

机构地区：[1]首都医科大学附属北京中医医院,北京市东城区100010 [2]首都医科大学附属北京友谊医院 [3]成都中医药大学附属医院 [4]广州医科大学附属第五医院 [5]重庆市中医院 [6]湖北省中医院 [7]深圳市第二人民医院 [8]南京市中医院 [9]襄阳市第一人民医院 [10]衢州市人民医院 [11]贵阳中医学院第二附属医院 [12]江苏省第二中医院 [13]广州市中西医结合医院 [14]河北工程大学附属医院 [15]武汉市中医医院 [16]重庆市涪陵中心医院 [17]保定市第二医院 [18]眉山市中医医院 [19]柳州市中医院 [20]邯郸市中医院

出　　处：《中医杂志》2020年第11期964-970,共7页Journal of Traditional Chinese Medicine

基　　金：国家“十三五”重大新药创制专项课题“创新药物全过程临床评价示范性技术平台建设”(2019ZX09734001)。

摘　　要：目的评价藿香正气口服液治疗胃肠型感冒暑湿证的有效性及安全性。方法采用前瞻性、随机、双盲、安慰剂对照的多中心临床研究方法,将全国20个中心确诊为胃肠型感冒暑湿证的240例患者,随机分为高剂量组、低剂量组及安慰剂组,每组80例。高剂量组口服藿香正气口服液,每次20ml,每日2次;低剂量组口服藿香正口服气液10ml/次+藿香正气口服液模拟剂10ml/次,每日2次;安慰剂组口服藿香正气口服液模拟剂,每次20ml,每日2次。各组疗程均为5天。观察主要疗效指标(第3天痊愈率及疾病痊愈时间)、次要疗效指标(胃肠型感冒症状总积分、中医症状总积分及证候有效率、中医单项症状消失率)及不良反应。结果高、低剂量组与安慰剂组第3天痊愈率分别为72.00%、37.33%、14.29%,组间比较差异有统计学意义(P<0.05),优效检验比较,组间痊愈率率差的95%CI下限均大于0,优效成立。各组中位疾病痊愈时间分别为2.0天、4.0天、5.0天;治疗3天后胃肠型感冒症状总积分分别为(1.04±1.70)分、(2.70±2.50)分、(3.69±2.65)分;治疗5天后中医症状总积分分别为(0.45±0.96)分、(0.69±1.46)分、(1.39±2.15)分;治疗5天后中医证候有效率分别为100.00%、100.00%、90.91%,以上指标组间比较差异均有统计学意义(P<0.05);同时,在中医单项症状恶心或/和呕吐、肢体困重消失率方面,组间比较差异有统计学意义(P<0.05)。治疗期间,各组均未出现与研究药物相关的不良反应。结论藿香正气口服液可改善胃肠型感冒暑湿证患者的临床症状,缩短病程,且安全性良好。Objective To evaluate the efficacy and safety of Huoxiang Zhengqi Oral Liquid(藿香正气口服液) in treatment of gastrointestinal flu of summer-dampness syndrome. Methods A prospective randomized, double blinded, placebo-controlled and multicentered clinical trial was conducted in 20 clinical centers in China. The 240 subjects confirmed of summer-dampness syndrome of stomach and intestine type enrolled were randomly divided into 3 groups, with 80 cases in each group. A high dose group treated with Huoxiang Zhengqi Oral Liquid 20 ml, twice a day;a low dose group treated with Huoxiang Zhengqi Oral Liquid 10 ml and Huoxiang Zhengqi Oral Liquid mimetic agent 10 ml, twice a day;and a placebo group treated with Huoxiang Zhengqi Oral Liquid mimetic agent 20 ml, twice a day. All the groups were treated for 5 days. The main efficacy indexes including recovery rate on the third day and the time of disease recovery, the secondary efficacy indexes including total score of gastrointestinal flu symptoms, total score of traditional Chinese medicine(TCM) symptoms and syndrome effectiveness, the disappearance rate of single symptoms of TCM and adverse reactions were observed. Results In the high dose group, low dose group and placebo group, the 3-day cure rates was 72.00%, 37.33% and 14.29% respectively. The differences are statistically significant(P<0.05). Compared with the superiority test, the 95% CI lower limit of the difference in recovery rate between the groups was greater than 0, and the superiority was established. The median illness cure-time were 2.0, 4.0 and 5.0 days respectively, and the total scores of symptoms after 3-day treatment were 1.04±1.70, 2.70±2.50 and 3.69±2.65 respectively;the total scores of TCM symptoms after 5-day treatment were 0.45±0.96, 0.69±1.46 and 1.39±2.15 respectively, and the effective rates of TCM symptoms after 5-day treatment were 100.00%, 100.00% and 90.91% respectively. The differences of the groups mentioned above were statistically significant(P<0.05). Meanwhile, there were

关 键 词：藿香正气口服液 胃肠型感冒 暑湿证 随机对照临床试验 

分 类 号：R254.9[医药卫生—中医内科学]