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Article(id=1220364302519816897, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1220364301731287745, articleNumber=null, orderNo=null, doi=10.16438/j.0513-4870.2020-0137, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1581955200000, receivedDateStr=2020-02-18, revisedDate=1582473600000, revisedDateStr=2020-02-24, acceptedDate=null, acceptedDateStr=null, onlineDate=1768887122993, onlineDateStr=2026-01-20, pubDate=1583942400000, pubDateStr=2020-03-12, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1768887122993, onlineIssueDateStr=2026-01-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1768887122993, creator=13701087609, updateTime=1768887122993, updator=13701087609, issue=Issue{id=1220364301731287745, tenantId=1146029695717560320, journalId=1189982191388893191, year='2020', volume='55', issue='3', pageStart='349', pageEnd='536', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1768887122805, creator=13701087609, updateTime=1768957149580, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1220658015389270676, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1220364301731287745, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1220658015389270677, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1220364301731287745, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=349, endPage=354, ext={EN=ArticleExt(id=1220364302976996036, articleId=1220364302519816897, tenantId=1146029695717560320, journalId=1189982191388893191, language=EN, title=Advances in research of novel coronavirus related drugs and biological products, columnId=1220364302905692867, journalTitle=Acta Pharmaceutica Sinica, columnName=Focus on Anti Novel Coronavirus Drugs Research, runingTitle=null, highlight=null, articleAbstract=

The novel coronavirus pneumonia was first discovered in December 2019. By February 21, 2020, the virus had spread to 27 countries, and the total number of patients were nearly 80 thousands. In order to effec-tively prevent and control the epidemic, countries around the world are organizing scientific research, especially in screening of therapeutic drugs, researching and developing of vaccine, which is the key point and difficulty of epidemic control. On the basis of a large number of relevantly collected information about drugs and biological products in the academia and the press of various countries, this paper focus on the research status and develop-ment of antiviral chemical drugs, Chinese traditional medicines and biological products, aiming to provide refer-ence for relevant departments, units and scientists.

, correspAuthors=He-ran WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2020 Acta Pharmaceutica Sinica. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=He-ran WANG, Xi WANG), CN=ArticleExt(id=1220364303568392905, articleId=1220364302519816897, tenantId=1146029695717560320, journalId=1189982191388893191, language=CN, title=新型冠状病毒有关药物和生物制品研究进展, columnId=1209792669673452292, journalTitle=药学学报, columnName=聚焦抗新冠病毒药物研究, runingTitle=null, highlight=null, articleAbstract=

自2019年12月发现新型冠状病毒肺炎患者起，至2020年2月21日新冠病毒肺炎疫情已扩散至27个国家，全球患者总数近8万人。此次疫情受到世界各国广泛关注，为了有效应对疫情，各国正组织科研攻关，特别是在治疗药物筛选和疫苗研发等方面加大攻关力度，这是控制疫情的重点和难点。本文收集整理了各国学术界和政府关于药物和生物制品的相关研究信息，主要围绕可能用于治疗新型冠状病毒肺炎的化学药、中药和生物制品的研究情况，供有关部门、单位和科技人员参考。

, correspAuthors=王赫然, authorNote=null, correspAuthorsNote=
*王赫然, Tel:86-10-88656258, E-mail:
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Drug name Organization Mechanism of action Phase
Remdesivir Gilead Nucleobindin-1 (NUCB1) inhibitors Phase III
Lopinavir/ritonavir King Abdullah International Med Res Cent HIV-1 protease inhibitors / HIV protease inhibitors /tumor necrosis factor receptor superfamily member 6 (CD95)/PLC-gamma-1 interaction inhibitors Phase II/ III
GLS-5300 Inovio Pharmaceuticals / GeneOne Life Science Spike glycoprotein (S) (MERS-CoV)-directed immunity inducers Phase I/II
ChAdOx1 MERS Vaccitech Ltd. / University of Oxford Spike glycoprotein (S) (MERS-CoV)-directed immunity inducers Phase I
MVA-MERS-S Ludwig-Maximilians-Univ. Muenchen Spike glycoprotein (S) (MERS-CoV)-directed immunity inducers Phase I
REGN-3048 Regeneron Anti-spike glycoprotein (MERS-CoV coronavirus) Phase I
REGN-3051 Regeneron Anti-spike glycoprotein (MERS-CoV coronavirus) Phase I
SAB-301 SAB Biotherapeutics Anti-spike glycoprotein (MERS-CoV coronavirus) Phase I
Darunavir/cobicistat Shanghai Public Health Clinical Center HIV protease inhibitors / cytochrome P450 CYP3A4 inhibitors Clinical
Oseltamivir phosphate Wuhan Tongji Hospital Neuraminidase (sialidase) (influenza virus) inhibitors Clinical
Umifenovir hydrochloride Wuhan Tongji Hospital Viral entry inhibitors / capsid assembly (hepatitis B virus) modulators Clinical
IFX-1 Staidson (Beijing) Biopharmaceuticals Anti-C5 (complement 5) IND Filed
GREVAX/MERS Greffex Recombinant adenoviral vector developed using GREVAX Universal Platform (GREVAX vector) encoding Middle East respiratory syndrome coronavirus (MERS-CoV) antigensPreclinical
Human leukocyte interferon alpha AIM ImmunoTech Interferon alpha proteins comprising approximately 166 amino acids ranging in molecular weights from 16 000 to 27 000 daltonsPreclinical
INO-4800 Inovio Pharmaceuticals Novel coronavirus strain 2019 (2019-nCoV) vaccine Preclinical
IR-101C Immune Response BioPharma Coronavirus vaccine consisting of depleted coronavirus spike glycoprotein without outter envelope inactivated with beta propiolactone and gamma irradiation; propagated in HUT78 cellsPreclinical
LCA-60 Vir Biotechnology Anti-spike glycoprotein (MERS-CoV coronavirus) Preclinical
MVA-MERS-S_DF1 Universitaetsklinikum Hamburg-Eppendorf Spike glycoprotein (S) (MERS-CoV)-directed immunity inducers Preclinical
), ArticleFig(id=1220394393442370005, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1220364302519816897, language=CN, label=Table 1, caption=

Drugs and biologics in development for the treatment and prevention of coronavirus infections

, figureFileSmall=null, figureFileBig=null, tableContent=
Drug name Organization Mechanism of action Phase
Remdesivir Gilead Nucleobindin-1 (NUCB1) inhibitors Phase III
Lopinavir/ritonavir King Abdullah International Med Res Cent HIV-1 protease inhibitors / HIV protease inhibitors /tumor necrosis factor receptor superfamily member 6 (CD95)/PLC-gamma-1 interaction inhibitors Phase II/ III
GLS-5300 Inovio Pharmaceuticals / GeneOne Life Science Spike glycoprotein (S) (MERS-CoV)-directed immunity inducers Phase I/II
ChAdOx1 MERS Vaccitech Ltd. / University of Oxford Spike glycoprotein (S) (MERS-CoV)-directed immunity inducers Phase I
MVA-MERS-S Ludwig-Maximilians-Univ. Muenchen Spike glycoprotein (S) (MERS-CoV)-directed immunity inducers Phase I
REGN-3048 Regeneron Anti-spike glycoprotein (MERS-CoV coronavirus) Phase I
REGN-3051 Regeneron Anti-spike glycoprotein (MERS-CoV coronavirus) Phase I
SAB-301 SAB Biotherapeutics Anti-spike glycoprotein (MERS-CoV coronavirus) Phase I
Darunavir/cobicistat Shanghai Public Health Clinical Center HIV protease inhibitors / cytochrome P450 CYP3A4 inhibitors Clinical
Oseltamivir phosphate Wuhan Tongji Hospital Neuraminidase (sialidase) (influenza virus) inhibitors Clinical
Umifenovir hydrochloride Wuhan Tongji Hospital Viral entry inhibitors / capsid assembly (hepatitis B virus) modulators Clinical
IFX-1 Staidson (Beijing) Biopharmaceuticals Anti-C5 (complement 5) IND Filed
GREVAX/MERS Greffex Recombinant adenoviral vector developed using GREVAX Universal Platform (GREVAX vector) encoding Middle East respiratory syndrome coronavirus (MERS-CoV) antigensPreclinical
Human leukocyte interferon alpha AIM ImmunoTech Interferon alpha proteins comprising approximately 166 amino acids ranging in molecular weights from 16 000 to 27 000 daltonsPreclinical
INO-4800 Inovio Pharmaceuticals Novel coronavirus strain 2019 (2019-nCoV) vaccine Preclinical
IR-101C Immune Response BioPharma Coronavirus vaccine consisting of depleted coronavirus spike glycoprotein without outter envelope inactivated with beta propiolactone and gamma irradiation; propagated in HUT78 cellsPreclinical
LCA-60 Vir Biotechnology Anti-spike glycoprotein (MERS-CoV coronavirus) Preclinical
MVA-MERS-S_DF1 Universitaetsklinikum Hamburg-Eppendorf Spike glycoprotein (S) (MERS-CoV)-directed immunity inducers Preclinical
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新型冠状病毒有关药物和生物制品研究进展
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王赫然 * , 王茜
药学学报 | 聚焦抗新冠病毒药物研究 2020,55(3): 349-354
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药学学报 | 聚焦抗新冠病毒药物研究 2020, 55(3): 349-354
新型冠状病毒有关药物和生物制品研究进展
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王赫然* , 王茜
作者信息
  • 科学技术部火炬高技术产业开发中心, 北京 100045

通讯作者:

*王赫然, Tel:86-10-88656258, E-mail:
Advances in research of novel coronavirus related drugs and biological products
He-ran WANG* , Xi WANG
Affiliations
  • Torch High Technology Industry Development Center, Ministry of Science and Technology, Beijing 100045, China
出版时间: 2020-03-12 doi: 10.16438/j.0513-4870.2020-0137
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摘要
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自2019年12月发现新型冠状病毒肺炎患者起，至2020年2月21日新冠病毒肺炎疫情已扩散至27个国家，全球患者总数近8万人。此次疫情受到世界各国广泛关注，为了有效应对疫情，各国正组织科研攻关，特别是在治疗药物筛选和疫苗研发等方面加大攻关力度，这是控制疫情的重点和难点。本文收集整理了各国学术界和政府关于药物和生物制品的相关研究信息，主要围绕可能用于治疗新型冠状病毒肺炎的化学药、中药和生物制品的研究情况，供有关部门、单位和科技人员参考。

新型冠状病毒  /  抗病毒药物  /  中药  /  疫苗

The novel coronavirus pneumonia was first discovered in December 2019. By February 21, 2020, the virus had spread to 27 countries, and the total number of patients were nearly 80 thousands. In order to effec-tively prevent and control the epidemic, countries around the world are organizing scientific research, especially in screening of therapeutic drugs, researching and developing of vaccine, which is the key point and difficulty of epidemic control. On the basis of a large number of relevantly collected information about drugs and biological products in the academia and the press of various countries, this paper focus on the research status and develop-ment of antiviral chemical drugs, Chinese traditional medicines and biological products, aiming to provide refer-ence for relevant departments, units and scientists.

novel coronavirus  /  antiviral drug  /  Chinese traditional medicine  /  vaccine
王赫然, 王茜. 新型冠状病毒有关药物和生物制品研究进展. 药学学报, 2020 , 55 (3) : 349 -354 . DOI: 10.16438/j.0513-4870.2020-0137
He-ran WANG, Xi WANG. Advances in research of novel coronavirus related drugs and biological products[J]. Acta Pharmaceutica Sinica, 2020 , 55 (3) : 349 -354 . DOI: 10.16438/j.0513-4870.2020-0137
正文
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2019年12月, 武汉发现新型冠状病毒肺炎患者[1]。该情况立即引起相关部门重视, 2020年1月5日, 复旦大学张永振教授完成了病毒测序, 并向美国国家生物技术信息中心GenBank数据库提交第一条新型冠状病毒基因组序列(Acc. No. MN908947)[2]。1月12日, 世界卫生组织(WHO)将新型冠状病毒暂时命名为“2019-nCoV”, 2月11日将其感染引起的疾病正式命名为“COVID-19”。截至2020年2月21日24时, 中国新冠病毒肺炎累计确诊病例达76 288人[3], 并且疫情已扩散至全球27个国家, 引发世界各国广泛关注。但目前尚未发现治疗新型冠状病毒疾病的特效药物。
新型冠状病毒(简称“新冠病毒”)是一种单链RNA冠状病毒, 其结构与引发非典型性肺炎(SARS)和中东呼吸综合征(MERS)的病毒结构极为相似, 同属β冠状病毒属, 与SARS病毒的基因组同源性为82%[4]。因此, 根据冠状病毒结构特点, 结合现有药物作用机制, 寻找和筛选针对该病毒引起疾病的靶向、高效、低毒的临床治疗方法, 显得尤为重要。据中国临床试验注册中心(Chinese Clinical Trial Registry, ChiCTR)官方网站数据, 截至2月21日, 中国有206个临床试验正在进行, 涉及化学药、中药和细胞疗法等。本文搜集整理了各国学术界、政府新闻发布会发布的相关信息, 主要围绕化学药物、中药和生物制品等研究进行综述, 供有关部门、单位和科技人员参考。
1 化学药物的研究
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新冠病毒由结构蛋白、非结构蛋白和辅助蛋白组成。这些蛋白参与病毒入侵细胞和病毒复制等过程[5], 因此它们被认为是开发抗病毒药物的重要靶点。
1.1 抑制病毒入侵细胞的药物
1.1.1 针对受体蛋白(ACE2)的药物
血管紧张素酶2 (angiotensin converting enzyme II, ACE2)是一种羧肽酶, 也是一种蛋白受体, 广泛分布于人体各器官。研究表明, 新冠病毒通过其刺突蛋白(spike glycoprotein, S蛋白)上的受体结合域(RBD)与ACE2相结合进入细胞, 其与宿主细胞ACE2蛋白结合具备很强的结合自由能(-50.6 kcal·mol-1)[6]。因此, 针对人细胞表面受体ACE2蛋白进行新药研发, 竞争性结合ACE2受体, 阻止病毒进入细胞, 有可能会得到理想的抗新冠病毒药物。
磷酸氯喹是一种上市多年的抗疟药物, 有文献[7]报道其能干扰ACE2受体的糖基化, 从而抑制重症急性呼吸综合征冠状病毒(SARS-CoV)与细胞的结合, 达到治疗目的。体外实验表明磷酸氯喹具有抑制新冠病毒的活性, 其半数有效浓度(EC50)为1.13 μmol[8]。目前, 该药物已列入《新型冠状病毒肺炎诊疗方案(试行第六版)》并开展临床试验, 截至2月21日, 已有8个机构开展的11项基于磷酸氯喹用于新冠肺炎的治疗方案在中国临床试验注册中心进行了临床试验注册。另外, 抗疟药硝唑尼特也显示了体外抑制新冠病毒的能力, 其EC50为2.12 μmol[8]。
1.1.2 针对病毒S蛋白的药物
S蛋白介导病毒识别宿主细胞受体, 促进其与细胞膜的融合。S蛋白由两个亚基S1与S2组成。依据上文所述机制, S1亚基的RBD可作为抗新冠病毒药物和疫苗研发的重要作用靶点。另有文献[9]报道, 来自于SARS-CoV S蛋白HR2区域的多肽SC可以阻断病毒进入细胞, 此外广谱抗S2药物可能有治疗效果, 需要进一步的研究证实。格瑞弗森(Griffithsin, GRFT)蛋白是从红藻中提取的对冠状病毒具有广谱抗性的凝集素。该凝集素通过直接结合病毒膜蛋白上的糖链, 抑制其与宿主细胞受体结合, 从而使病毒失活, 也具有潜在的应用价值[10]。
1.2 针对病毒复制相关蛋白的药物
冠状病毒的非结构蛋白对病毒的复制和组装等过程起非常重要的作用, 其中3-胰凝乳样蛋白酶(3-chymotrypsin-like protease, 3CLpro)、木瓜样蛋白酶(papain-like protease, PLpro)参与多肽翻译, RNA依赖的RNA聚合酶(RNA-dependent RNA polymerase, RdRp)参与病毒复制。因此, 这三种蛋白酶是抗病毒药物研发的重要靶点[11, 12]。潜在的相关药物如下。
1.2.1 RNA依赖的RNA聚合酶抑制剂
瑞德西韦(remdesivir)是一种核苷类似物。目前尚未在任何国家获得上市批准。在体外和动物模型中, 瑞德西韦被证实对非典型性肺炎和中东呼吸综合征的病毒病原体均有活性。体外细胞实验表明, 瑞德西韦对新冠病毒有较好抑制作用, EC50为0.77 μmol[8]。据报道, 美国首例新冠肺炎确诊病例接受瑞德西韦作为“同情给药”, 进行试验性治疗后病情出现迅速缓解[13]。目前瑞德西韦临床试验在我国已正式启动, 总计拟入组761例患者, 采用随机、双盲、安慰剂对照方法展开。
法匹拉韦(favipiravir)是一种核苷类似物, 2014年在日本批准上市, 用于甲型、乙型流感的抗病毒治疗, 并能有效抑制埃博拉病毒、黄热病病毒、诺如病毒和肠病毒等[14]。体外实验研究表明, 法匹拉韦对新冠病毒有效, 其EC50为61.88 μmol[8]。截至2月21日, 我国已开展4项有关法匹拉韦治疗新冠肺炎的临床试验。
利巴韦林(ribavirin)是一种广谱强效抗病毒药物, 对许多DNA和RNA病毒有抑制作用, 理论上应该具有一定的抗冠状病毒活性。但是, 体外实验结果已经证明利巴韦林对冠状病毒的抗病毒作用甚微[15]。
1.2.2 3-胰凝乳样蛋白酶抑制剂
洛匹那韦(lopinavir)是一种3CLpro抑制剂, 通常与利托那韦(ritonavir)联合使用增强效果。2000年在美国首度获批, 用于治疗艾滋病感染。体外研究表明, 洛匹那韦/利托那韦能够抑制中东呼吸综合征冠状病毒(MERS-CoV)及SARS-CoV的复制而发挥抗病毒作用[10, 16]。目前, 该药物作为推荐药物被《新型冠状病毒感染的肺炎诊疗方案(试行第三版)》收录, 已应用于新冠肺炎临床治疗并开展临床试验。但部分学者认为其对治疗新型冠状病毒感染的肺炎效果不佳, 且有毒副作用。因此, 其安全性和有效性需要进一步研究。
1.3 其他
阿比朵尔(arbidol)是一种抗病毒药物, 通过抑制病毒脂膜与宿主细胞的融合而阻断病毒的复制, 且具有干扰素诱导作用。1993年在俄罗斯首次上市, 主要用于流感病毒引起的流行性感冒, 同时对其他一些呼吸道病毒感染也有抗病毒活性。李兰娟团队发现在体外细胞实验中, 与药物未处理的对照组比较, 10~30 μmol阿比朵尔能有效抑制冠状病毒达到60倍, 并且显著抑制病毒对细胞的病变效应。目前, 该药已列入《新型冠状病毒肺炎诊疗方案(试行第六版)》, 已有部分患者接受阿比朵尔治疗后有效的报道[17]。
2 中药的研究
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中药曾在治疗SARS时发挥了重要作用, 针对此次疫情国家卫生健康委员会中医药专家根据中医辨证施治的原则, 在确诊患者临床治疗期的不同阶段提供了不同的中药处方和中成药等用于选择。如在医学观察期乏力伴有发热患者, 可使用金花清感颗粒、连花清瘟胶囊(颗粒)、疏风解毒胶囊(颗粒)和防风通圣丸(颗粒)等; 而对乏力伴有胃肠不适患者可使用中成药藿香正气胶囊(丸、水、口服液)等[18]。
姚开涛等[19]考察了中药连花清瘟在治疗新冠肺炎中的作用, 选取了42例诊断标准普通型患者。与对照组相比, 治疗组发热症状消失率从57.1%提升至85.7%, 咳嗽症状消失率从5.6%提升至46.7%, 发热持续时间缩短1.5天, 咳痰消失率从9.1%提升至64.3%, 气促症状消失率从0提升至77.8%。
张伯礼团队考察了中西医结合治疗新冠肺炎的临床效果。把52例新冠肺炎患者分成两组, 一组是中西医结合治疗, 接诊普通型27例、重型6例、危重型1例; 一组是纯西医治疗, 接诊普通型13例、重型4例、危重型1例。结果显示, 与纯西医组相比, 中西医结合治疗组平均治疗天数从7.15天缩短至5.15天, 体温恢复平均时间从4.38天缩短至2.64天, 平均住院天数从9.59天缩短至7.38天。CT影像好转率从68.8%提升至88.2%, 临床治愈率从61.1%提升至94.1%, 普通型转重型及危重型从35.3%降低至5.9%[20]。
除成方外, 部分中药成分也有一定的治疗新冠病毒的潜力。研究表明, 甘草素、黄芩苷等中药成分在之前的体外实验研究中具有抗SARS-CoV的效果[21, 22]; 人参皂苷有提高人体免疫力的效果, 对病毒感染具有一定疗效[23]。
3 生物制品的研究
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3.1 恢复期血浆
恢复期血浆治疗(convalescent plasma therapy, CPT), 其原理为利用康复者血浆中一定滴度的病毒特异性抗体, 使患者获得被动免疫, 中和特异性病原体, 最终清除血液循环中的病原体, 从而达到治疗预期。该方法已成功用于SARS的治疗, 是一项有效的治疗措施[24]。从临床病理发生过程看, 大部分新冠肺炎患者经过治疗康复后, 身体内会产生针对新冠病毒的特异性抗体, 可杀灭和清除病毒。在目前缺乏疫苗和特效治疗药物的前提下, 采用这种特免血浆制品治疗新冠病毒感染是比较可行的方法。
现在我国已将新冠病毒特免血浆投入临床救治部分重症患者, 患者接受治疗12~24 h后, 实验室检测主要指标、临床体征和症状明显好转。但是, 恢复期血浆的采集必须在合适的时机, 保证其具有较高的中和抗体滴度。恢复期血浆获取的数量有限也会在一定程度上限制其临床应用。目前, 正在进行临床试验, 进一步评估恢复期血浆治疗新冠病毒感染患者疗效和安全性。
3.2 免疫增强剂
3.2.1 细胞疗法
截至2月21日, 已有7项基于细胞疗法的新冠肺炎治疗方案在中国临床试验注册中心注册了临床试验, 涉及干细胞和自然杀伤(NK)细胞等。
干细胞治疗能够抑制免疫系统过度激活, 通过改善微环境促进内源性修复, 抑制肺部急性炎症进展, 缓解呼吸窘迫症状。已有研究表明间充质干细胞(MSCs)可有效用于MERS-CoV的治疗[25]。目前我国已开展干细胞技术在重症救治方面的临床研究, 经过严格的临床前安全性、有效性评价, 以及严格的质量检定, 干细胞产品在遵照当前干细胞临床应用规范和药物临床试验规定的前提下对若干重症患者进行了治疗, 也初步显示安全有效。
NK细胞, 源自胎盘, 具有良好的耐受性和安全性, 是一类独特的免疫细胞, 具有靶向癌细胞和与适应性免疫相互作用的能力, 并具有抗SARS-CoV的能力[26]。同种异体NK细胞疗法(CYNK-001)是一种冷冻保存的同种异体NK细胞治疗方法, 已有研究评估其作为治疗和预防冠状病毒的潜在疗法。
3.2.2 干扰素
干扰素是机体免疫细胞产生的一种细胞因子, 是一种糖蛋白。干扰素具有抗病毒、抑制细胞增殖、调节免疫及抗肿瘤作用, 临床可通过注射干扰素来增强机体免疫功能。在《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》中, 推荐了洛匹那韦/利托那韦和干扰素联合用于治疗新冠肺炎, 并已启动临床试验研究。该方案可用于治疗MERS-CoV, 并已成功治愈数名新冠肺炎患者[27]。
3.2.3 胸腺肽
胸腺肽是一种免疫调节药物, 能促使T-淋巴细胞成熟, 具有调节和增强人体细胞免疫功能的作用。目前已开启胸腺肽α1与其他药物联合治疗的临床试验研究。
3.3 单克隆抗体
单克隆抗体是由单一B细胞克隆产生的高度均一、仅针对某一特定抗原表位的抗体。据文献[28]报道, 单克隆抗体(mAbs) 4C2和2E6在体外能与MERS-CoV结合并有效地阻断病毒进入细胞。另有文献[29]报道, 一种SARS-CoV特异性的人单克隆抗体CR3022与新冠病毒具有较强的结合能力(Kd 6.3 nmol), 提示其具有治疗新冠肺炎的可能。然而, 病毒、细菌等病原体感染机体的机制复杂, 由于单克隆抗体只能识别单一抗原表位, 限制了单克隆抗体药物的抗感染效果。其次, 单克隆抗体的研发需要一定的时间周期, 对于新发病原体, 单克隆抗体是一种研究方向, 但可能短时间内难以实现临床应用。
3.4 疫苗
疫苗可用于预防感染或降低疾病严重程度, 从而有助于疫情的防控, 此前基于SARS和MERS病毒已设计了多种疫苗[30]。由于疫苗研发过程涉及病毒毒株分离和选取、体外实验、动物实验、临床试验和行政审批等程序, 因此所需时间较长。目前, 新冠病毒部分识别位点已经找到, 可用于疫苗研发[31, 32]。据专家估计疫苗成功研制需要至少3个月, 甚至可长达18个月。
科技部已组织全国优势单位进行联合攻关, 并安排了5条技术路线同步开展, 包括灭活疫苗、重组基因工程疫苗、腺病毒载体疫苗、核酸疫苗(mRNA疫苗和DNA疫苗)及减毒流感病毒疫苗载体制成的疫苗, 已有部分疫苗进入动物试验阶段。
3.4.1 重组蛋白疫苗
重组蛋白疫苗是将病毒的目的抗原基因构建在表达载体上, 将已构建的表达蛋白载体转化到细菌、酵母或哺乳动物或昆虫细胞中, 在一定的诱导条件下, 表达出大量的抗原蛋白并通过纯化制备的疫苗。之前有课题组成功将SARS特异的S蛋白重组到西红柿和烟草中, 并成功在小鼠体内表达特异性抗体[33]。
3.4.2 核酸疫苗
DNA疫苗是将编码某种蛋白质抗原的重组真核表达载体直接注射到动物体内, 使外源基因在活体内表达, 产生的抗原激活机体的免疫系统, 从而诱导特异性的体液免疫和细胞免疫应答。有课题组成功制备针对SARS的DNA疫苗, 并在动物模型中产生保护性免疫[34]。
mRNA疫苗是在体外合成翻译抗原的mRNA, 递送到体内由细胞翻译成抗原蛋白, 保持了DNA疫苗能够表达胞内抗原的优点, 同时克服其免疫原性低、可能产生抗载体的非特异免疫的缺点, 具备开发与生产周期短的优势。
3.4.3 病毒载体疫苗
腺病毒载体疫苗是指以病毒作为载体, 将保护性抗原基因重组到病毒基因组中, 使用能表达保护性抗原基因的重组病毒制成的疫苗。文献[35]报道, 利用狂犬病毒作为载体, 重组SARS病毒中特异性蛋白, 可在动物模型中产生保护性免疫。
此外, 分子夹(molecular clamp)技术、重组纳米颗粒技术也可能应用于制造及开发疫苗。
4 展望
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虽然目前已经获得了新冠病毒结构序列, 基本了解其传播方式, 但是该病毒具有潜伏期长、传染性强和重症率较高的特点, 依然给防治工作带来了极大的困难。由于暂时尚未发现特效药物及疫苗, 因此需要科研人员及医务工作者在实践中进行摸索, 通力合作, 不断改进治疗方案。本文将一些适用于新冠病毒预防和治疗的潜在药物和生物制品 (表1), 以及2019新型冠状病毒信息库 (2019nCoVR, https://bigd.big.ac.cn/ncov) 列出, 供相关人员参考[36,37]。
根据病毒结构预测并筛选可能药物, 虽然部分化学药物已进行体外实验并得到抗新冠病毒效果, 但是其在体内是否具有相当的活性仍然需要研究。因此需要尽快建立动物水平的模型以准确评价潜在药物, 并在体外有效的基础上小规模用于临床, 在实践中不断优化。同时, 对已有的中医方剂进行筛选, 着重考察前期治疗中效果明显的方案, 对患者进行中西医结合治疗, 尽可能提高救治率。此外, 进一步深入开展病毒结构和各蛋白功能及位点的研究, 以期尽快研制出特异性高的抗体及疫苗。
文献
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doi: 10.16438/j.0513-4870.2020-0137
  • 接收时间：2020-02-18
  • 首发时间：2026-01-20
  • 出版时间：2020-03-12
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  • 收稿日期：2020-02-18
  • 修回日期：2020-02-24
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    科学技术部火炬高技术产业开发中心, 北京 100045

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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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