摘要
为科学评价在新型冠状病毒肺炎(COVID-19)疫情下中药预防性给药(藿香正气口服液和金蒿解热颗粒联合使用)对社区人群干预效果,开展了大样本、前瞻性、随机、平行对照临床研究。对纳入22 065例受试者整群随机分为2组。非干预组只给予健康指导,中药干预组在健康指导基础上给予2种中药配合使用,藿香正气口服液:饭前口服,10 mL/次,每日2次。金蒿解热颗粒:饭后开水冲服,8 g/次,每日2次。疗程5 d,随访14 d。研究发现,随着用药时间的推进,中药干预组的不同时点发病率在入组后基本维持在一个较低且持续稳定的水平即0.01%~0.02%,而非干预组则在入组3~14 d整体呈持续增长的趋势即0.02%~0.18%。2组均未发生COVID-19疑似或确诊病例。中药干预组感冒发病2例,非干预组发病26例。2组感冒发病率差异有统计学意义(P<0.05),中药干预组感冒发病率小于非干预组。按年龄段分层分析,16~60岁人群,按发病率计算,中药干预组与非干预组分别为0.01%和0.25%,2组感冒发病率差异有统计学意义(P<0.05);≥60岁人群分别为0.04%和0.21%,2组感冒发病率差异无统计学意义,但非干预组的感冒发病率有高于干预组的趋势。中药对整体人群的保护率在91.8%,对16~60岁人群保护率尤为明显(95.0%)。提示藿香正气口服液和金蒿解热颗粒联合使用,可有效提高社区居民预防感冒等呼吸道疾病的保护率,值得在社区进行推广应用。另外,安全性方面中药干预组不良反应/事件发生率较低,与说明书基本相符。
To scientifically evaluate the intervention effect of Chinese medicine preventive administration(combined use of Huo-xiang Zhengqi Oral Liquid and Jinhao Jiere Granules)on community population in the case of coronavirus disease 2019(COVID-19),a large cohort,prospective,randomized,and parallel-controlled clinical study was conducted.Total 22065 subjects were included and randomly divided into 2 groups.The non-intervention group was given health guidance only,while the traditional Chinese medicine(TCM)intervention group was given two coordinated TCM in addition to health guidance.The medical instructions were as follows.Huoxiang Zhengqi Oral Liquid:oral before meals,10 mL/time,2 times/day,a course of 5 days.Jinhao Jiere Granules:dissolve in boiling water and take after meals,8 g/time,2 times/day,a course of 5 days,followed up for 14 days,respectively.The study found that with the intake of medication,the incidence rate of TCM intervention group was basically maintained at a low and continuous stable level(0.01%-0.02%),while the non-intervention group showed an overall trend of continuous growth(0.02%-0.18%)from 3 to 14 days.No suspected or confirmed COVID-19 case occurred in either group.There were 2 cases of colds in the TCM intervention group and 26 cases in the non-intervention group.The incidence of colds in the TCM intervention group was significantly lower(P<0.05)than that in the non-intervention group.In the population of 16-60 years old,the incidence rate of non-intervention and intervention groups were 0.01%and 0.25%,respectively.The difference of colds incidence between the two groups was statistically significant(P<0.05).In the population older than 60 years old,they were 0.04%and 0.21%,respectively.The incidence of colds in the non-intervention group was higher than that in the intervention group,but not reaching statistical difference.The protection rate of TCM for the whole population was 91.8%,especially for the population of age 16-60(95.0%).It was suggested that TCM intervention(combined use of Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules)could effectively protect community residents against respiratory diseases,such as colds,which was worthy of promotion in the community.In addition,in terms of safety,the incidence of adverse events and adverse reactions in the TCM intervention group was relatively low,which was basically consistent with the drug instructions.
作者
阎博华
蒋志伟
曾洁萍
唐健元
丁红
夏结来
秦少容
金思岑
卢云
张娜
王志虹
黎海燕
桑小雅
武丽娜
唐诗韵
李燕
陶孟瑶
王巧灵
王钧冬
谢红艳
陈其原
杨生文
胡念双
杨建琼
鲍晓霞
张琼
杨晓丽
江长勇
罗红艳
蔡正华
余曙光
YAN Bo-hua;JIANG Zhi-wei;ZENG Jie-ping;TANG Jian-yuan;DING Hong;XIA Jie-lai;QIN Shao-rong;JIN Si-cen;LU Yun;ZHANG Na;WANG Zhi-hong;LI Hai-yan;SANG Xiao-ya;WU Li-na;TANG Shi-yun;LI Yan;TAO Meng-yao;WANG Qiao-ling;WANG Jun-dong;XIE Hong-yan;CHEN Qi-yuan;YANG Sheng-wen;HU Nian-shuang;YANG Jian-qiong;BAO Xiao-xia;ZHANG Qiong;YANG Xiao-li;JIANG Chang-yong;LUO Hong-yan;CAI Zheng-hua;YU Shu-guang(Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China;Beijing Key Tech Statistical Consulting Co.,Ltd.,Beijing 100015,China;Air Force Military Medical University of People′s Liberation Army,Xi'an 710032,China;Taiji Group Co.,Ltd.,Chongqing 408000,China;Chengdu Zhongxiang Pharmaceutical Technology Co.,td.,Chengdu 610000,China;Yingmenkou Community Service Center,Chengdu 610036,China;Xi′anlu Community Service Center,Chengdu 610072,China;Jiangxijie Community Service Center,Chengdu 610041,China;Supo Community Service Center,Chengdu 610091,China;Caoshi Yuhe Community Service Center,Chengdu 610014,China;Shuangnan Community Service Center,Chengdu 610047,China;Yulin Community Service Center,Chengdu 610044,China;Jinyang Community Service Center,Chengdu 610045,China;Caotang Community Service Center,Chengdu 610072,China;Xinhua Shaocheng Community Service Center,Chengdu 610014,China;Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2020年第13期2993-3000,共8页
China Journal of Chinese Materia Medica
基金
四川省科技厅应对新型冠状病毒科技攻关应急项目(2020YFS0012,2020YFS0013)
成都市科技局重点研发支撑计划项目(2020-YF-00333-SN)
成都中医药大学校基金项目(XGZX2001,XGZX2002)。
