摘要
目的评价银翘败毒方治疗新型冠状病毒(新冠病毒)无症状感染者的疗效和安全性。方法采用随机、双盲、安慰剂对照试验设计方法。选择2022年10月至12月由河南中医药大学第一附属医院驻会展中心医学观察点收治的新冠病毒无症状感染者250例作为研究对象,采用分层随机区组法将受试者随机分为试验组和对照组,每组125例。共有5例患者未完成研究,其中试验组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)。试验组给予银翘败毒合剂(由金银花、连翘、青蒿、射干、虎杖、薏苡仁等13味中药组成),对照组给予银翘败毒安慰剂(由5%的中药及调味剂等组成),试验药物均由河南中医药大学第一附属医院制剂室统一煎煮提供,每日1剂,分2次口服,连续治疗14 d。以核酸转阴时间为主要结局指标,以核酸转阴率、转型率、转型时间、症状发生率、症状发生时间、不良事件累积发生率为次要结局指标,比较不同治疗方法两组主要结局指标和次要结局指标的差异。结果试验组核酸转阴时间较对照组明显缩短(d:8.93±2.13比10.47±3.95,P<0.05)。治疗7、10和14 d,试验组核酸转阴率均明显高于对照组〔分别为44.7%(55/123)比27.9%(34/122)、91.9%(113/123)比72.1%(88/122)、98.4%(121/123)比88.5%(108/122),均P<0.05〕。治疗4 d和7 d,试验组转型率均明显低于对照组〔分别为4.9%(6/123)比12.3%(15/122)、5.7%(7/123)比13.1%(16/122),均P<0.05〕,转型时间较对照组明显延后(d:7.82±2.99比6.15±1.39,P<0.05)。治疗4 d,试验组发热、咳嗽、乏力症状的发生率均明显低于对照组〔分别为4.9%(6/123)比17.2%(21/122)、8.9%(11/123)比18.0%(22/122)、14.6%(18/123)比26.2%(32/122),均P<0.05〕,到治疗10 d两组发热症状发生率差异仍有统计学意义〔9.8%(12/123)比18.9%(23/122),P<0.05〕,治疗14 d两组发热症状发生率无明显差异,治疗7 d两组对乏力症状的改善程度相当,治疗10 d开始试验组对乏力的改善程度明显优于对照组〔25.2%(31/123)比37.7%(46/122),P<0.05〕,持续到治疗14 d〔26.8%(33/123)比39.3%(48/122),P<0.05〕。两组各时间点胸闷、气短、腹胀、腹泻发生率比较差异均无统计学意义,说明银翘败毒方在改善上述症状方面的疗效相当。试验组发热、咳嗽、乏力症状发生的时间较对照组明显延后(d:6.62±1.50比5.30±1.22、8.48±3.34比6.54±1.45、7.97±3.21比6.11±0.98,均P<0.05),两组其他症状发生时间比较差异均无统计学意义。试验组和对照组不良事件发生率比较差异无统计学意义〔10.6%(13/123)比11.5%(14/122),P>0.05〕。结论银翘败毒方治疗新冠病毒无症状感染者在缩短核酸转阴时间、提高核酸转阴率、降低转型率、延后转型时间等方面均有较好的临床疗效,且不良反应少,安全性好。
Objective To evaluate the efficacy and safety of Yinqiao Baidu decoction in the treatment of asymptomatic patients with coronavirus disease 2019(COVID-19).Methods A randomized,double-blind,placebo-controlled trial design was used in this study,250 patients of COVID-19 asymptomatic who were admitted by the Medical Observation Point of the First Affiliated Hospital of Henan University of Chinese Medicine in the Convention and Exhibition Center from October to December 2022 were randomly divided into the experimental group and the control group by stratified block randomization method,125 cases in each group.A total of 5 patients did not complete the study,including 2 in the experimental group and 3 in the control group,forming a protocol set of 245 cases(123 in the experimental group and 122 in the control group).The experimental group was given Yinqiao Baidu decoction(composed of 13 traditional Chinese medicines including Honeysuckle,Forsythia suspensa,Artemisia annua,Blackberry Lili Rhizome,Polygonum cuspidatum,Coix seed,etc.),and the control group was given placebo Yinqiao Baidu decoction(composed of 5%traditional Chinese medicine and seasoning agents).All the test drugs were provided by the preparation room of the First Affiliated Hospital of Henan University of Chinese Medicine through unified decoction,one dose per day,twice orally,for 14 consecutive days.The time of negative nucleic acid conversion was taken as the primary outcome,the negative nucleic acid conversion rate,the conversion rate and the time of conversion,the incidence of symptoms,the occurrence time of symptoms,and the cumulative incidence of adverse events were taken as the secondary outcomes.Compare the differences in primary and secondary outcome indicators between two groups of different treatment methods.Results The average time of negative nucleic acid conversion time in the experimental group was significantly shorter than that in the control group(days:8.93±2.13 vs.10.47±3.95,P<0.05).At 7,10 and 14 days of treatment,the negative nucleic acid conversion rate of the experimental group was higher than that of the control group[44.7%(55/123)vs.27.9%(34/122),91.9%(113/123)vs.72.1%(88/122),98.4%(121/123)vs.88.5%(108/122),all P<0.05].At 4 days and 7 days of treatment,the conversion rate of the experimental group was lower than that of the control group[4.9%(6/123)vs.12.3%(15/122),5.7%(7/123)vs.13.1%(16/122),respectively,both P<0.05].The average conversion time of the experimental group was significantly delayed compared with the control group(days:7.82±2.99 vs.6.15±1.39,P<0.05).Afer 4 days of treatment,the incidence of fever,cough and fatigue in experimental group was significantly lower than that in control group[4.9%(6/123)vs.17.2%(21/122),8.9%(11/123)vs.18.0%(22/122),14.6%(18/123)vs.26.2%(32/122),respectively,all P<0.05].After 10 days of treatment,there was still a statistically significant difference in the incidence of fever symptoms between the two groups[9.8%(12/123)vs.18.9%(23/122),P<0.05j.However,there was no significant difference between the two groups after 14 days of treatment.After 7 days of treatment,the improvement of fatigue symptoms in both groups was comparable.The improvement degree of fatigue symptoms in the experimental group was significantly better than that in the control group at the beginning of 10 days of treatment[25.2%(31/123)vs.37.7%(46/122),P<0.05],and continued to 14 days of treatment[26.8%(33/123)vs.39.3%(48/122),P<0.05.There was no statistically significant difference in the incidence of chest tightness,shortness of breath,abdominal distension,and diarrhea between the two groups at every time points,which indicated that the efficacy of Yinqiao Baidu decoction is equivalent in improving the above symptoms.The occurrence time of the fever,cough and fatigue symptoms in the experimental group was significantly delayed compared with that of the control group(days:6.62±1.50 vs.5.30±1.22,8.48±3.34 vs.6.54±1.45,7.97±3.21 vs.6.11±0.98,respectively,all P<0.05),but there was no statistical difference in the occurrence time of other symptoms between the two groups.There was no statistically significant difference in the incidence of adverse events between the experimental group and the control group[10.6%(13/123)vs.11.5%(14/122),P>0.05].Conclusion In the treatment of asymptomatic patients with COVID-19,Yinqiao Baidu decoction can shorten the time of negative nucleic acid conversion,improve the rate of negative nucleic acid conversion,reduce the rate of transition,and delay the transition time,with fewer adverse reactions and safety.
作者
赵虎雷
王明航
李建生
赵敏
田曙光
李宁
谢洋
韩瑞婷
杨建雅
史艳敏
李素云
Zhao Hulei;Wang Minghang;Li Jiansheng;Zhao Min;Tian Shuguang;Li Ning;Xie Yang;Han Ruiting;Yang Jianya;Shi Yanmin;Li Suyun(Department of Respiratory,the First Affiliated Hospital of Henan University of Chinese Medicine,Henan Province Clinical Research Center for Respiratory Diseases,Zhengzhou 450000,Henan,China;Co-Construction Collaborative Innovation Center for Respiratory Disease Diagnosis and Treatment&Chinese Medicine Development of Henan Province/Henan Key Laboratory of Chinese Medicine for Respiratory Disease,Henan University of Chinese Medicine,Zhengzhou 450046,Henan,China)
出处
《中国中西医结合急救杂志》
CAS
CSCD
北大核心
2023年第4期402-407,共6页
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care
基金
全国名老中医药专家传承工作室(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)
河南省疫情防控应急科研攻关项目(211100310500,221111312000)
河南省新冠肺炎中医药科研专项课题(2022ZYFY01)
国家中医药管理局新型冠状病毒感染中医药应急专项(2023ZYLCYJ02-14)。
关键词
新型冠状病毒感染
无症状
银翘败毒方
疗效评价
Coronavirus disease 2019
Asymptomatic
Yinqiao Baidu decoction
Clinical efficacy
