| 廖春晓,李立明,王岚,吕筠.流行病学方法在新型冠状病毒疫苗上市前后的应用[J].中华流行病学杂志,2022,43(1):7-13 |
| 流行病学方法在新型冠状病毒疫苗上市前后的应用 |
| Application of epidemiology research in evaluations of COVID-19 vaccines in both clinical trial and clinical use |
| 收稿日期:2021-09-02 出版日期:2022-01-26 |
| DOI：10.3760/cma.j.cn112338-20210902-00705 |
| 中文关键词: 疫苗 流行病学 效果 安全性 |
| 英文关键词: Vaccine Epidemiology Effectiveness Safety |
| 基金项目:国家自然科学基金（91846303）；北大百度基金——面向人群健康和重大疾病的大数据平台建设研究（2019BD010） |
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| 中文摘要: |
| 安全有效的疫苗是应对新型冠状病毒（新冠病毒）肺炎大流行的核心措施之一，从疫苗上市前安全性、保护效力的实验性研究到上市后安全性监测和人群保护效果的观察性研究，流行病学发挥了重要作用。本文通过列举国内外研究案例，系统介绍了临床试验、队列研究和病例对照研究设计在疫苗上市前后的应用及设计要素，以期丰富流行病学教学案例。另外，在新冠病毒疫苗上市后，国外多个国家在短时间内组织开展了规模数十万到千万人的人群观察性研究，得益于这些国家完善的公共卫生、医疗、医保等信息系统，通过不同数据系统的互联互通，实现整合分析。这对我国健康医疗大数据的发展具有重要启示。 |
| 英文摘要: |
| Safe and effective vaccines are essential for the prevention and control of COVID-19 pandemic. In the evaluations of COVID-19 vaccines' safety and efficiency in experimental research and the surveillance for COVID-19 vaccines' safety and population based effectiveness in observational study, epidemiology research has played a critical role. By analyzing research cases both at home and abroad, this paper systematically introduces the applications and design elements of clinical trial, cohort study and case-control study in the evaluations of COVID-19 vaccines' safety and efficiency in clinical trials and safety and population based effectiveness clinical use to enrich epidemiology teaching cases. After the marketing of COVID-19 vaccines, some foreign countries rapidly organized and carried out population based observational research for the clinical evaluation of the vaccines with sample size ranging from several hundred thousand to ten million. Benefiting from the developed public health, medical and medical insurance information systems in these countries, their data can be shared for integrated analysis, which would has important enlightenment for the development of medical big data in China. |
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