博文
埃博拉病毒（Ebola Virus)文献 药物 临床试验 分析
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自2014年2月至今，非洲几内亚、利比里亚、塞拉利昂和尼日利亚陆续暴发埃博拉出血热疫情，根据WHO实况报道，截至2014年8月13日确诊、可能和疑似累计病例数为1975例，其中死亡1069例，是自1976年以来最大的一次流行。
“新华网日内瓦８月１５日电（记者张淼 王昭）总部位于日内瓦的世界卫生组织１５日发布一份声明指出，某些产品与实践可预防或治愈埃博拉病毒是谣言”。为向大家提供科学的信息，破除谣言。
笔者通过调研国际科学文献、药品研究、临床试验数据库，通过开展计量分析，期望能为为埃博拉病毒病防控工作提供科技信息与情报支撑。
1. 研究论文
PuMed/Medline数据库共收录埃博拉病毒相关研究共计1228篇，其时间分布如图3所示。其中46.5%的研究（共626篇）为美国学者发表，中国学者论文8篇（如表1所示）。相关研究主要收录在J Virol, J Infect Dis, Virology,Lancet, Science等杂志。
图 埃博拉病毒相关研究论文时间分布（PubMed数据库收录）
2.药物研究
截至2014年8月13日，Thomson Cortellis数据库收录的埃博拉病毒感染（Ebola virusinfection）相关药物的有效研究记录35条，其中上市药物1个，处于Ⅰ期临床试验的药物3个，其余31个均处于临床前研发阶段。上市的药物为抗凝血酶药物，处于研究阶段的药物超过半数为疫苗（如表2所示）。
开展药物相关研究的机构超过30个，其中美国国立卫生院相关院所、美国陆军传染病医学研究所（USAMRIID）的在研药物数量达到了5个及以上。其中美国国立卫生院过敏和传染病研究所（NIAID）参与研发的2个疫苗已进入Ⅰ期临床试验。
3.临床试验
美国NIH的Clinicaltrial.gov显示迄今共有埃博拉病毒药物I期临床试验共9项，其中8项在美国进行，1项在乌干达（如表3所示）。
附件
表1 中国学者埃博拉病毒相关研究论文
编号 | 时间 | 研究论文 | 单位 |
1 | 2014 | Li YH, Chen SP. Evolutionary history of Ebola virus. Epidemiol Infect. 2014 Jun;142(6):1138-45. | 中国军事医学科学院 |
2 | 2012 | Luo M, Xiang X, Xiang D, Yang S, Ji X, He Z. A universal platform for amplified multiplexed DNA detection based on exonuclease III-coded magnetic microparticle probes. Chem Commun (Camb). 2012 Jul 28;48(59):7416-8. | 武汉大学 |
3 | 2012 | Wang X, Liu Y, Wang H, Shi Z, Zhao F, Wei J, et al. Generation and epitope mapping of a monoclonal antibody against nucleoprotein of Ebola virus. Sheng Wu Gong Cheng Xue Bao. 2012 Nov;28(11):1317-27. | 浙江农业林业大学 |
4 | 2012 | Huang Y, Wei H, Wang Y, Shi Z, Raoul H, Yuan Z. Rapid detection of filoviruses by real-time TaqMan polymerase chain reaction assays. Virol Sin. 2012 Oct;27(5):273-7. | 中科院武汉病毒所 |
5 | 2012 | Wu Y, Wu S, Hou L, Wei W, Zhou M, Su Z, et al. Novel thermal-sensitive hydrogel enhances both humoral and cell-mediated immune responses by intranasal vaccine delivery. Eur J Pharm Biopharm. 2012 Aug;81(3):486-97. | 中科院过程工程所 |
6 | 2011 | Wang YP, Zhang XE, Wei HP. Laboratory detection and diagnosis of filoviruses. Virol Sin. 2011 Apr;26(2):73-80. | 中科院武汉病毒所 |
7 | 2011 | Zhang N, Qi J, Feng S, Gao F, Liu J, Pan X, et al. Crystal structure of swine major histocompatibility complex class I SLA-1 0401 and identification of 2009 pandemic swine-origin influenza A H1N1 virus cytotoxic T lymphocyte epitope peptides. J Virol. 2011 Nov;85(22):11709-24. | 中国农业大学中国科学院 |
8 | 2008 | He M, Li K, Xiao J, Zhou Y. Rapid bio-barcode assay for multiplex DNA detection based on capillary DNA Analyzer. J Virol Methods. 2008 Jul;151(1):126-31. | 华东科技大学 |
数据来源：US NCBI PubMed/Medline数据库
表2 全球埃博拉病毒感染相关药物研发情况
Highest Status | No. | Drug Name | Target-based Actions | Active Indications | Active Companies |
Launched | 1 | antithrombin alfa | Antithrombin III |
| |
Phase 1 Clinical | 1 | -- | Ebola virus infection; Marburg virus infection | Crucell NV; National Institute of Allergy and Infectious Diseases; National Institutes of Health | |
2 | -- | Ebola virus infection | Tekmira Pharmaceuticals Corp | ||
3 | Ebola virus vaccine (recombinant adenoviral vector vaccine), Crucell/NIAID | -- | Ebola virus infection | ||
Discovery | 1 | bivalent vaccines (rabies/ebola virus infections), National Institute Of Allergy and Infectious Diseases/Thomas Jefferson University | -- | Rabies virus infection; Ebola virus infection | |
2 | BCX-4430 | RNA polymerase inhibitor | Marburg virus infection; Viral infection; Ebola virus infection | ||
3 | adenoviral vector vaccine (Ebola virus infection), Okairos/NIAID | -- | Ebola virus infection | Okairos; National Institute of Allergy and Infectious Diseases | |
4 | Ebola virus vaccine, SRC VB Vector | -- | Ebola virus infection | ||
5 | Ebola virus vaccine, BioProtection Systems | -- | Ebola virus infection | ||
6 | ZMapp | Viral envelope glycoprotein inhibitor | Ebola virus infection | ||
7 | DEF-201 + AdHu5-ZGP therapy (viral infection), Defyrus | Interferon alpha ligand | Ebola virus infection | ||
8 | DEF-201 | Interferon alpha ligand | Chikungunya virus infection; Yellow fever virus infection; SARS coronavirus infection; Vaccinia virus infection; Western equine encephalitis virus infection; Phlebovirus infection; Ebola virus infection | ||
9 | MB-2003 | -- | Ebola virus infection | ||
10 | Ebola and Dengue virus therapy (nanoparticle formulation), NanoViricides/US Army Medical Research Institute of Infectious Diseases | -- | Ebola virus infection; Dengue virus infection | ||
11 | ebola virus vaccine, Greffex | -- | Ebola virus infection | ||
12 | viral capsid assembly inhibitors (influenza/Ebola virus infections), Prosetta | -- | Influenza virus infection; Ebola virus infection | ||
13 | viral capsid assembly inhibitors (HCV/Ebola/VEEV infection), Prosetta | -- | Hepatitis C virus infection; Venezuelan equine encephalitis virus infection; Ebola virus infection | ||
14 | FiloVax | -- | Ebola virus infection; Marburg virus infection | ||
15 | viral uptake inhibitors (filoviruses), SIGA | -- | Marburg virus infection; Ebola virus infection | ||
16 | fully human monoclonal antibody therapy (ebola virus infection), Humabs BioMed | -- | Ebola virus infection | ||
17 | rVSV Ebola/Marburg vaccine, Profectus BioScience | -- | Ebola virus infection; Marburg virus infection | ||
18 | trimeric non-degradable protease-resistant D-peptide program (ebola virus infection), Navigen | -- | Ebola virus infection | ||
19 | ZMAb | Viral envelope glycoprotein inhibitor | Ebola virus infection | ||
20 | ARD-5 (ebola virus infection), University of Iowa |
| Ebola virus infection | ||
21 | small molecule ebola virus entry inhibitors, Harvard University/Harvard University Office of Technology Development | -- | Ebola virus infection | ||
22 | Antibody vaccine (ebola virus infection), US Army Medical Research and Materiel Command | -- | Ebola virus infection | ||
23 | ucleic acid vaccine (Ebola virus infection), NIAID | -- | Ebola virus infection | ||
24 | neutralizing antibody (Ebola virus infection), Scripps/USAMRIID | -- | Ebola virus infection | ||
25 | recombinant viral vector vaccine (ArV, VEE virus technology, filovirus/Marburg/Ebola virus infection), AlphaVax | -- | Marburg virus infection; Ebola virus infection; Filovirus infection | ||
26 | filoGP-Fc fusion protein subunit vaccine (ebola virus infection), USAMRIID | -- | Ebola virus infection | ||
27 | cyanovirin-N (HIV infection/influenza virus infection), NCI/NIDDK | -- | HIV infection; Influenza virus infection | National Institute of Diabetes, Digestive and Kidney Diseases; | |
28 | adenovirus vector 5-based ebola vaccine (oral/tablet), Vaxart | -- | Ebola virus infection | ||
29 | MVA-BN Filo | -- | Ebola virus infection; Marburg virus infection | ||
30 | Ebola virus entry inhibitors, Microbiotix | -- | Ebola virus infection; Marburg virus infection | ||
31 | Ebola vaccine, SKAU Vaccine | -- | Ebola virus infection |
数据来源：Thomson Cortellis数据库
表3 抗埃博拉病毒药物临床试验研究
编号 | 时间 | 名称 | 针对疾病 | 研究药物 | 状态 |
1 | 2009-2013 | Evaluating an Ebola and a Marburg Vaccine in Uganda | Ebola Virus Disease | Ebola DNA plasmid vaccine, VRC-EBODNA023-00-VP | 完成 |
2 | 2006-2009 | Experimental Vaccine for Prevention of Ebola Virus Infection | Ebola Hemorrhagic Fever | VRC-EBOADV018-00-VP | 完成 |
3 | 2008-2010 | Ebola and Marburg Virus Vaccines | Ebola Virus Disease | VRC-EBODNA023-00-VP VRC-MARDNA025-00-VP | 完成 |
4 | 2003-2007 | Experimental Ebola Vaccine Trial | Hemorrhagic Fever, Ebola | VRC-EBODNA012-00-VP | 完成 |
5 | 2011-2012 | Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus | Ebola Hemorrhagic Fever | AVI-6002 | 完成 |
6 | 2011-2014 | Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study of Intravenous (IV) TKM-100201 Infusion | Ebola Virus Infection | TKM-100201 | 完成 |
7 | 2014- | Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802 | Ebola Virus Infection | TKM-100802 for Injection | 暂停 |
8 | 2012-2013 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7537 in Healthy Adult Volunteers | Ebola Hemorrhagic Fever | AVI-7537 | 撤回 |
9 | 2008-2014 | Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study | Ebola | Poly-ICLC | 完成 |
数据来源：US Clinicaltrials.gov数据库
（文 贾晓峰 汪楠 严舒）
https://blog.sciencenet.cn/blog-786113-820116.html
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