摘要
目的:评价银翘败毒方治疗新型冠状病毒感染(coronavirus disease 2019,COVID-19)轻型患者的临床疗效及安全性。方法:采用随机、双盲、安慰剂对照试验设计,纳入250例COVID-19轻型患者,随机分为试验组和对照组各125例。试验组给予银翘败毒方,对照组给予安慰剂,两组疗程均为14 d。以核酸转阴时间为主要结局指标,以核酸转阴率、临床症状消失时间/率、转普通型/重型率、病死率、不良事件等为次要结局指标。结果:脱落5例(试验组2例、对照组3例),形成符合方案集245例(试验组123例、对照组122例)。试验组核酸转阴时间短于对照组(9.85 d vs 10.79 d,P<0.05)。治疗第14天,试验组核酸转阴率高于同期对照组(P<0.05);治疗第7天、10天,两组核酸转阴率比较,差异无统计学意义(P>0.05)。试验组发热、咳嗽、乏力、腹泻消失时间短于对照组(P<0.05)。两组其他症状消失时间比较,差异无统计学意义(P>0.05)。试验组治疗第4天、7天的发热消失率,治疗第7天、10天的咳嗽、乏力消失率均高于同期对照组(P<0.05)。两组均未发现转为普通型或重型病例,未出现死亡病例。两组不良事件发生率比较,差异无统计学意义(P>0.05)。结论:银翘败毒方能够缩短COVID-19轻型患者核酸转阴时间,提高患者核酸转阴率,加快发热、咳嗽、乏力等临床症状的消失。
Objective:To evaluate the clinical efficacy and safety of Yinqiao Baidu Decoction in the treatment of mild patients with COVID-19.Method:A randomized,double-blind,placebo-controlled trial design was adopted,involving 250 mild patients with COVID-19.They were randomly divided into the trial group and the control group with 125 patients each.The trial group was given Yinqiao Baidu Decoction,and the control group was given placebo for 14 days.The primary outcomes was the time of nucleic acid negative conversion.The secondary outcomes were the rate of nucleic acid negative conversion,the time/rate of clinical symptom disappearance,the rate of conversion to moderate/severe cases,mortality rate,and adverse events.Results:5 patients dropped out during the study(2 in the trial group and 3 in the control group),forming a per protocol set of 245 patients(123 in the trial group and 122 in the control group).The time of nucleic acid negative conversion in the trial group was shorter than that in the control group(9.85 d vs 10.79 d,P<0.05).At 14 days of treatment,the rate of nucleic acid negative conversion in the trial group was higher than that in the control group(P<0.05);At 7 and 10 days of treatment,there was no statistically significant difference in the rate of nucleic acid negative conversion between the two groups(P>0.05).The disappearance time of fever,cough,fatigue,and diarrhea in the trial group was shorter than that in the control group(P<0.05);and there was no statistically significant difference in the disappearance time of other symptoms(P>0.05).The fever disappearance rate at 4 and 7 days of treatment in the trial group and the cough and fatigue disappearance rate at 7 and 10 days of treatment,were higher than those in the control group(P<0.05).No moderate/severe cases or death cases occurred,and no statistically significant difference was found in the rate of adverse events between the two groups(P>0.05).Conclusion:In the treatment of mild patients with COVID-19,Yinqiao Baidu Decoction can shorten the time of nucleic acid negative conversion,improve the rate of nucleic acid negative conversion,and promote the disappearance of the main symptoms of patients such as fever,cough,fatigue,with good safety.
作者
李建生
赵敏
田曙光
李宁
王明航
赵虎雷
李素云
谢洋
韩瑞婷
杨建雅
史艳敏
LI Jiansheng;ZHAO Min;TIAN Shuguang;LI Ning;WANG Minghang;ZHAO Hulei;LI Suyun;XIE Yang;HAN Ruiting;YANG Jianya;SHI Yanmin(Henan University of Chinese Medicine,Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan&Education Ministry of P.R.China/Henan Key Laboratory of Chinese Medicine for Respiratory Disease,Zhengzhou Henan China 450046;The First Affiliated Hospital to Henan University of Chinese Medicine/Henan Province Clinical Research Center for Respiratory Diseases,Zhengzhou Henan China 450000)
出处
《中医学报》
CAS
2024年第11期2459-2464,共6页
Acta Chinese Medicine
基金
全国名老中医药专家传承工作室项目{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项目(ZYYCXTD-C-202206)
国家中医药管理局新型冠状病毒感染中医药应急专项资助项目(2023ZYLCYJ02-14)
河南省疫情防控应急科研攻关项目(221111312000,211100310500)。
