荆花解毒方治疗新型冠状病毒感染轻型患者的疗效评价  

Efficacy evaluation of Jinghua Jiedu Formula for patients with mild COVID-19

作　　者：李建生[1] 王明航[2] 张海龙[2] 崔青荣[2] 李素云[2] 赵虎雷 谢洋[2] 韩瑞婷[2] 杨建雅[2] 史艳敏 LI Jiansheng;WANG Minghang;ZHANG Hailong;CUI Qingrong;LI Suyun;ZHAO Hulei;XIE Yang;HAN Ruiting;YANG Jianya;SHI Yanmin(Henan University of Chinese Medicine,Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province&Education Ministry of P.R.China/Henan Key Laboratory of Chinese Medicine for Respiratory Disease,Zhengzhou 450046,China;The First Affiliated Hospital to Henan University of CM,Henan Province Clinical Research Center for Respiratory Diseases,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学,呼吸疾病中医药防治省部共建协同创新中心/河南省中医药防治呼吸病重点实验室,郑州450046 [2]河南中医药大学第一附属医院,河南省呼吸疾病临床医学研究中心,郑州450000

出　　处：《中华中医药杂志》2024年第7期3818-3823,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：全国名老中医药专家传承工作室(No.国中医药人教函[2022]75号);呼吸疾病中医药防治国家中医药传承创新团队(No.ZYYCXTD-C-202206);河南省疫情防控应急科研攻关项目(No.221111312000)。

摘　　要：目的:评价荆花解毒方治疗新型冠状病毒感染轻型患者的有效性及安全性。方法:采用随机、双盲、安慰剂对照试验设计,收集2022年10月20日一12月5日在郑州市航空港区方舱医院治疗的新型冠状病毒感染轻型患者,随机分为试验组和对照组,各125例,试验组给予荆花解毒方合剂,对照组给予安慰剂,每日1剂,疗程14d,以核酸转阴时间为主要结局指标,符合解除隔离管理标准即可停止用药。以临床症状(发热、咳嗽、胸闷、气短等)消失时间/率、转为普通型/重型率、病死率、不良事件等为次要结局指标。结果:脱落12例(试验组5例、对照组7例),形成符合方案集238例(试验组120例、对照组118例)。两组在年龄、身高、体重、入院间隔、合并疾病、疫苗接种等基线资料间差异无统计学意义。试验组核酸转阴时间显著短于对照组(P<0.01);治疗7、10、14d时,试验组核酸转阴率均显著高于对照组(P<0.05,P<0.01)。试验组发热、咳嗽、气短消失时间显著短于对照组(P<0.01,P<0.05)。试验组治疗4d时发热消失率和7d时咳嗽消失率均高于对照组(P<0.05,P<0.01)。两组患者均未发现转为普通型/重型及死亡病例。结论:荆花解毒方治疗新型冠状病毒感染轻型患者,能够缩短核酸转阴时间,提高核酸转阴率,促进发热、咳嗽症状的消失,且安全性较好。Objective:To evaluate the efficacy and safety of Jinghua Jiedu Formula(JHJD)for patients with mild COVID-19.Methods:A randomized,double-blind,placebo-controlled trial was conducted,and patients with mild COVID-19 treated in Fang-Cang Hospital of Zhengzhou Airport District from October 20 to December 5,2022 were randomly divided into experimental group and control group,with 125 patients in each group.The experimental group was given JHJD prescription mixture and the control group was given placebo,one dose a day for 14 days.The time of nucleic acid turning negative was used as the primary outcome,and the medication could be stopped if the isolation management standard was met.The time/rate of disappearance of clinical symptoms(fever,cough,chest tightness,shortness of breath,etc.),rate of conversion to moderate/severe type,mortality,adverse events,etc.,were used as secondary outcomes.Results:Twelve cases(5 cases in experimental group and 7 cases in control group)fell off,forming 238 cases(120 cases in experimental group and 118 cases in control group)conforming to the protocol set.There were no significant differences between the two groups in age,height,weight,hospitalization interval,co-morbidity and vaccination.The nucleic acid conversion time of experimental group was shorter than that of control group(P<0.01),and the rate of nucleic acid negative conversion in the experimental group was significantly higher than that of the control group at 7-,10-and 14-days during treatment(P<0.05,P<0.01).The disappearance time of fever,cough and shortness of breath in experimental group was shorter than that in control group(P<0.01,P<0.05).The disappearance rate of fever in the experimental group at 4-days and the disappearance rate of cough at 7-days during treatment were higher than those in the control group(P<0.05,P<0.01).No cases conversion to moderate/severe or death in the two groups.Conclusion:JHJD can effectively shorten the negative conversion time of nucleic acid,improve the negative conversion rate of nucleic ac

关 键 词：新型冠状病毒感染 荆花解毒方 轻型 疗效评价 

分 类 号：R259[医药卫生—中西医结合]