最后审阅: 11 三月 2021
最后更新: 19 三月 2021
19 Mar 2021

欧洲药品管理局确认阿斯利康疫苗获益仍超过风险

欧洲药品管理局结束了对阿斯利康 COVID-19 疫苗接种人群血栓栓塞事件安全信号的初步审查。该机构安全委员会证实,此疫苗对于抵御仍在广泛传播的 COVID-19 威胁方面的获益,持续超过其副作用风险。[35] 进行该安全性审查之前,由于可疑血栓,阿斯利康疫苗在许多欧洲国家中止使用。

总体而言,在对其给予批准之前的研究中,以及接种运动开展之后的报告中,接种疫苗后报道的血栓栓塞事件总数均低于预期。基于此,委员会确认该疫苗与接种者血栓栓塞事件总体风险增加不具相关性。

他们还证实,无证据表明存在与特定批次疫苗或特定生产地点相关的问题。

但是,委员会确实发现该疫苗可能与极为罕见的血小板减少症相关性血栓病例有关,包括肠系膜静脉或脑静脉/脑静脉窦血栓形成等罕见病例。据报道,多数病例为 55 岁以下女性。报道的事件数量超过了预期,虽然因果关系尚未确定,但不能排除。关联强度尚不确定。

疫苗接种后,医疗卫生专业人士应警惕可能出现的血栓栓塞、弥散性血管内凝血或脑静脉窦血栓形成病例。应对接种者提出警告,若出现血栓栓塞和血小板减少症状,须立即就医,尤其是疫苗接种后三天内。

英国药品和医疗产品监管署亦确认,经过详细审查,阿斯利康疫苗获益超过风险。英国正在对报道的五例脑静脉窦血栓形成(与血小板减少症同时出现)进行审查。[36]

世界卫生组织认为阿斯利康疫苗获益超过风险,建议继续接种疫苗。[37]

根据约翰·霍普金斯大学系统科学与工程中心收集的数据,迄今为止,全球报道了超过 1.21 亿例 COVID-19 病例,超过 260 万例死亡。美国报道的感染和死亡数量为全世界最高。巴西报道的病例数量位居第二,此后为印度、俄罗斯、英国、法国、意大利、西班牙和土耳其。

Johns Hopkins University: coronavirus COVID-19 global cases external link opens in a new window

该专题基于当前可获得的最佳证据,但是由于形势正在迅速发生变化,因此证据有限,部分建议可能基于病例报道、观察性研究和回顾性分析以及随机对照试验和指南。

查看流行病学

更新原始来源external link opens in a new window

小结

定义

病史和体格检查

关键诊断因素

  • 发热
  • 咳嗽
  • 呼吸困难
  • 嗅觉/味觉改变

其他诊断因素

  • 乏力
  • 肌痛或关节痛
  • 痰液产生/排出
  • 胸闷
  • 胃肠道症状
  • 咽痛
  • 头痛
  • 头晕
  • 神经系统症状
  • 眼部症状
  • 流涕/鼻塞
  • 胸痛
  • 皮肤症状
  • 下尿路症状
  • 咯血
  • 支气管呼吸音
  • 呼吸急促
  • 心动过速
  • 紫绀
  • 听诊发现湿啰音/啰音

危险因素

  • 与可能或确诊病例产生接触
  • 居住/工作/旅行于传播高风险地区
  • 老年
  • 男性
  • 种族
  • 居住于长期照护机构
  • 合并症的发生
  • 肥胖
  • 心血管疾病
  • 糖尿病
  • 慢性呼吸系统疾病
  • 慢性肾病
  • 妊娠
  • 吸烟
  • 恶性肿瘤
  • 实质脏器移植
  • 唐氏综合征
  • 血红蛋白疾患
  • 高血压
  • 脑血管病
  • 痴呆
  • 慢性肝病
  • 免疫抑制
  • 伴有某些基础疾病的儿童
  • 维生素 D 缺乏
  • 质子泵抑制剂的使用
  • 自身免疫性疾病
  • HIV 感染
  • 血脂异常
  • 手术
  • A 型血和 B 型血
  • 消化道菌群失调
  • 环境因素

诊断性检查

首要检查

  • 实时逆转录聚合酶链反应 (RT-PCR)
  • 脉搏血氧测定
  • 动脉血气分析(ABG)
  • 全血细胞计数(FBC)
  • 生化全项
  • 血糖水平
  • 凝血筛查
  • 心脏生物标志物
  • 血清 C 反应蛋白
  • 血清红细胞沉降率
  • 血清乳酸脱氢酶
  • 血清白细胞介素-6 水平
  • 血清降钙素原
  • 血清铁蛋白水平
  • 血清淀粉样蛋白 A 水平
  • 血清肌酸激酶和肌红蛋白
  • 血液和痰液培养
  • 胸部 X 线检查

需考虑的检查

  • 胸部计算机体层成像(Computed Tomography, CT)
  • 血清学
  • 抗原检测

新兴检查

  • 逆转录环介导等温扩增(RT-LAMP)
  • 肺部超声
  • 钙卫蛋白

治疗流程

撰稿人

Consultant and Honorary Senior Lecturer in Infectious Diseases

Royal Liverpool University Hospital and Liverpool School of Tropical Medicine

Liverpool

UK

利益声明

NJB is partially supported by the National Institute of Health Research Health Protection Unit (NIHR HPRU) in Emerging and Zoonotic Infections at University of Liverpool in partnership with Public Health England (PHE), in collaboration with Liverpool School of Tropical Medicine. He is affiliated with Liverpool School of Tropical Medicine. The views expressed are those of the author and not necessarily those of the NHS, the NIHR, the Department of Health, or PHE.

Senior Clinical Lecturer and Defence Consultant in Infectious Diseases

Royal Liverpool University Hospital and Liverpool School of Tropical Medicine

Liverpool

UK

利益声明

TEF is a consultant/expert panel member to the World Health Organization, and is funded by the UK Surgeon General, the NHS, and Liverpool School of Tropical Medicine. TEF is partially supported by the National Institute of Health Research Health Protection Unit (NIHR HPRU) in Emerging and Zoonotic Infections at University of Liverpool in partnership with Public Health England (PHE), in collaboration with Liverpool School of Tropical Medicine. He is affiliated with Liverpool School of Tropical Medicine. He has received research grants from the Wellcome Trust, Medical Research Council, and the UK Public Health Rapid Support Team (UK-PHRST). The views expressed are those of the author and not necessarily those of the NHS, the NIHR, the Department of Health, or PHE.

H. Barrie Fairley Professor of Critical Care

University Health Network and Interdepartmental Division of Critical Care Medicine

Director

Clinical Epidemiology and Health Care Research

Institute of Health Policy, Management and Evaluation

Dalla Lana School of Public Health

University of Toronto

Chief

Tory Trauma Program

Sunnybrook Hospital

Toronto

Canada

利益声明

RF declares that he has no competing interests.

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Professor

Division of Infectious Diseases and International Health

University of Virginia

Charlottesville

VA

利益声明

WAP declares that he has no competing interests.

Attending Physician

The Fifth Medical Center of PLA General Hospital

Clinical Division and Research Center of Infectious Disease

Beijing

China 

利益声明

XZ declares that he has no competing interests.

Associate Professor in Medicine

Department of Clinical Microbiology and Infectious Diseases

Hadassah Hebrew University Medical Center

Jerusalem

Israel

利益声明

RNP has received research grants from US-Israel Binational Science Foundation, Hebrew University, Rosetrees Trust, and SpeeDx. He is chair of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Mycoplasma and Chlamydia Infections (ESGMAC). RNP is a consultant for and has stocks in eDAS Healthcare. He is also chairperson of the Israeli Society for Infectious Diseases guidelines committee.

Section Editor (Infectious Diseases)/Drug Editor, BMJ Best Practice

利益声明

AM declares that he has no competing interests.

Lead Section Editor, BMJ Best Practice

利益声明

IC declares that she has no competing interests.

Comorbidities Editor, BMJ Best Practice

利益声明

JC declares that she has no competing interests.

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Consultant, Older People's Medicine

Norfolk and Norwich University Hospitals

NHS Foundation Trust

Norwich

UK

利益声明

MP has accepted speaker fees and/or travel expenses to deliver lectures from: University of East Anglia, Leicester University (speaker fees only); Astellas Pharma Ltd (speaker fees and travel expenses). MP has accepted travel expenses from Newton Europe to present a joint project conducted by his main employer (Norfolk and Norwich University Hospitals NHS Trust) and Newton Europe at the NHS Confederation conference (Manchester 2018). MP has accepted sponsorship for travel expenses and accommodation costs from Astellas Pharma Ltd to attend the European Geriatric Society Meeting (Lisbon 2016).

Consultant Renal Physician

Honorary Associate Professor

Nephrology Department

Leeds Teaching Hospitals NHS Trust

Leeds

UK

利益声明

AL is Associate Clinical Director of NIHR Leeds In-Vitro Diagnostics Co-operative, Co-Chair of UK Kidney Research Consortium Renal Clinical Study Group, Member of Kidney Research UK Research Grant Committee, Committee Member of NICE Kidney Injury Clinical Guideline Update 2018-20, Committee Member of NICE Diagnostic Assessment for Point of Care Creatinine Testing 2018-19. AL attended the Acute Dialysis Quality Initiative Meeting in San Diego 2018 (accommodation expenses); AL was a speaker at the AKI & CRRT Conference in San Diego 2019 (travel and accommodation expenses), the AKI Conference in Coventry 2019 (travel expenses), and the NIHR AKI and Sepsis Meeting in Leeds 2019 (no expenses).

Professor of Cardiology

Imperial College London (Royal Brompton Hospital)

London

UK

利益声明

MC is a Non-Executive Director of NICE and Chair the Digital Health Committee of the European Society of Cardiology. MC’s university receives support for his research from Abbott, ResMed, Boston Scientific, and Medtronic. MC speaks at educational events and provides consultancy advice to a number of device, diagnostic, and pharmaceutical companies including Novartis, Servier, Bayer, Pfizer, AstraZeneca, Boehringer Ingelheim, Roche Diagnostics, Medtronic, Abbott, ResMed, and Boston Scientific. MC declares that none of these interests is directly related to topics advised on for this project.

Associate Professor (Clinical)

University of Leicester

Honorary Consultant Respiratory Physician

Glenfield Hospital

Leicester

UK

利益声明

RAE has been reimbursed for a GSK Advisory Board meeting on Physical Activity and Asthma in November 2016, and three Chiesi Education meetings for GPs on COPD care in 2019. RAE received a travel award for ERS 2017 from Chiesi and participated in the GSK clinical experience programme - respiratory in August 2018. RAE participated in the BTS/SIGN guidelines for asthma update 2016 (no fee).

Consultant Physician and Head of Service

Diabetes and Endocrine Centre and the Diabetes Research Unit

Ipswich Hospitals NHS Trust

Ipswich

UK

利益声明

GR has been paid for advisory board meetings with the following companies: Safoni Aventis, Abbott Diabetes UK, Lilly Diabetes, Bayer. GR has received lecture fees from Safoni Aventis, Abbott Diabetes UK, Lilly Diabetes, Novonordisk, Napp Pharmaceuticals Ltd.

Consultant Liaison Neuropsychiatrist

King’s College Hospital

South London and Maudsley NHS Foundation Trust

Honorary Senior Clinical Lecturer

Institute of Psychiatry, Psychology & Neuroscience

King’s College London

London

UK

利益声明

SP declares that he has no competing interests.

BMJ Best Practice would like to gratefully acknowledge Dr Matthew Jones for his advice on a section of the stroke comorbidity content.

Matthew Jones, MD, FRCP

Consultant Neurologist

Greater Manchester Neurosciences Centre

Salford Royal Foundation Trust

Honorary Senior Lecturer

University of Manchester

Manchester

UK

利益声明

AA and MJ declare that they have no competing interests.

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Consultant, Older People's Medicine

Norfolk and Norwich University Hospitals

NHS Foundation Trust

Norwich

UK

利益声明

MP has accepted speaker fees and/or travel expenses to deliver lectures from: University of East Anglia, Leicester University (speaker fees only); Astellas Pharma Ltd (speaker fees and travel expenses). MP has accepted travel expenses from Newton Europe to present a joint project conducted by his main employer (Norfolk and Norwich University Hospitals NHS Trust) and Newton Europe at the NHS Confederation conference (Manchester 2018). MP has accepted sponsorship for travel expenses and accommodation costs from Astellas Pharma Ltd to attend the European Geriatric Society Meeting (Lisbon 2016).

Consultant Geriatrician

Liverpool University Hospitals NHS Foundation Trust

Visiting Professor

University of Cumbria

Carlisle

Honorary Clinical Associate Professor

University of Liverpool

Liverpool

UK

利益声明

AA declares that he has no competing interests.

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