六神胶囊(丸)对新型冠状病毒体外抗病毒实验及核酸阳性大于14天患者的影响  

Effect of Liushen Capsules(Pill)on Antiviral Activity of COVID-19 in vitro and in Patients with Positive Nucleic Acid for More than 14 Days

作　　者：陶涛 刘义安[3,4] 冯彦军[5,6] 沈兴华 吴妹英[5,6] 黄建安 马钦海[8] 方邦江[9] 张建平[5,6] TAO Tao;LIU Yi-an;FENG Yan-jun;SHEN Xing-hua;WU Mei-ying;HUANG jian-an;MA Qin-hai;FANG Bang-jiang;ZHANG Jian-ping(Department of Respiratory and Critical Medicine,The Fifth People’s Hospital of Suzhou,Jiangsu215000;Department of Respiratory and Critical Medicine,The Affiliated Infectious Diseases Hospital of Soochow University,Jiangsu 215000;Department of Traditional Chinese Medicine,the Fifth People’s Hospital of Suzhou,Jiangsu 215000;Department of Traditional Chinese Medicine,The Affiliated Infectious Diseases Hospital of Soochow University,Jiangsu 215000;Department of Pulmonary,The Fifth People’s Hospital of Suzhou,Jiangsu215000;Department of Pulmonary,The Affiliated Infectious Diseases Hospital of Soochow University,Jiangsu215000;Department of Respiratory and Critical Care Medicine,The First Affiliated Hospital of Soochow University,Jiangsu 215000;State Key Laboratory of Respiratory Disease,National Clinical Research Center for Respiratory Disease,Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510000;Department of Emergency,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200000)

机构地区：[1]苏州市第五人民医院呼吸与危重症医学科,江苏215000 [2]苏州大学附属传染病医院呼吸与危重症医学科,江苏215000 [3]苏州市第五人民医院中医科,江苏215000 [4]苏州大学附属传染病医院中医科,江苏215000 [5]苏州市第五人民医院肺科,江苏215000 [6]苏州大学附属传染病医院肺科,江苏215000 [7]苏州大学附属第一医院呼吸与危重症医学科,江苏215000 [8]广州医科大学附属第一医院广州呼吸健康研究院呼吸疾病国家重点实验室/国家呼吸系统疾病临床医学研究中心,广州510000 [9]上海中医药大学附属龙华医院急诊医学科,上海200000

出　　处：《中国中西医结合杂志》2022年第9期1080-1086,共7页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的观察六神胶囊(丸)联合基础治疗对新型冠状(新冠)病毒核酸阳性大于14天患者病毒转阴的有效性和安全性及六神胶囊(丸)的体外抗病毒效应。方法通过细胞病变试验检测六神胶囊(丸)对新冠病毒(Omicron株)的半数有效抑制浓度(IC_(50))。临床研究方案在中国临床试验中心注册(No.ChiCTR2200057532)。选取50例新冠病毒核酸阳性的无症状、轻型、普通型患者,采用随机数法表分为试验组(26例)和对照组(24例)。对照组给予基础治疗,试验组在对照组基础上加用六神胶囊(丸)。比较两组患者入组后病毒平均转阴时间、转阴率、免疫学指标(IgG、IgM)水平以及治疗期间不良事件发生情况。结果六神胶囊(丸)抗SARS-CoV-2(Omicron株)的IC_(50)为0.1948μg/mL。试验组患者病毒平均转阴时间(5.03±2.41)d,显著低于对照组(6.46±2.32)d(P<0.05)。与对照组比较,入组第5天试验组的转阴率更高[57.36%(15/26)vs.29.17%(7/24),χ^(2)=4.12,P=0.042];治疗期间试验组的转阴率始终高于对照组(P<0.05)。与治疗前比较,两组IgM、IgG水平升高(P<0.05);与对照组比较,试验组治疗后IgM水平升高(P=0.022)。两组比较不良反应发生率差异无统计学意义(P>0.05)。结论六神胶囊(丸)具有体外抗病毒效应,六神胶囊(丸)联合基础治疗对新型冠状病毒核酸阳性大于14天的患者有一定疗效,可显著缩短患者核酸转阴时间、转阴率,改善患者免疫功能。Objective To observe the efficacy and safety Liushen Capsules(Pill,LSP)combined with basic therapy on patients with coronavirus disease 2019(COVID-19)and positive nucleic acid for more than 14 days,and to test the in vitro antiviral effect of LSP.Methods To test the in vitro antiviral effect against the omicron(B.1.1.529)variant,its half-maximal inhibitory concentration(IC50)was determined by cytopathic effect test.The protocol was registered in Chinese Clinical Trial Registry(No.ChiCTR2200057532).Totally 50 patients who tested positive for severe acute respiratory syndrome coronavirus 2(SARSCoV-2),who were asymptomatic or had mild symptoms,were randomly divided into experimental group(26 cases)and control group(24 cases).The control group was given a basic treatment,and the experimental group was given LSP in conjunction with the basis treatment.The average negative time,negative conversion rate,immunological indices(IgG,IgM),and adverse events during treatment were compared between the two groups.Results The IC50 of LSP against SARS-CoV-2(omicron strain)was 0.1948μg/mL.The average negative time of the virus in the experimental group[(5.03±2.41)d]was significantly lower than that in the control group[(6.46±2.32)d,P<0.05].After five days treatment,the negative conversion rate of the experimental group[57.36%(15/26)]was significantly lower than that of the control group[57.36%(15/26),P<0.05].During the treatment,the negative conversion rate of the experimental group was always higher than that of the control group(P<0.05).There was no significant difference in adverse reactions between the two groups(P>0.05).Conclusions LSP have an antiviral effect on SARS-CoV-2 in vitro,combined with basic therapy has certain curative effects on patients with positive nucleic acid for more than 14 days,and it can significantly shorten the negative conversion time of nucleic acid and negative rate,and improve the immune function of patients.

关 键 词：六神胶囊(丸) 基础治疗 核酸阳性 核酸转阴 免疫功能 

分 类 号：R259[医药卫生—中西医结合]