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| 如何利用观察性医药数据库进行药物流行病学的安全风险管理研究 |
| How to Use Observational Health Databases for Pharmacoepidemiology Research in Drug Safety Risk Management |
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| DOI： |
| 中文关键词: 数据库 医保数据 医疗记录（病历） 疾病随访注册登记 调查数据 自发性报告系统 风险管理 药品安全 |
| 英文关键词:Database Claims data Medical records Disease registry Survey data Spontaneous reporting systems Risk management Drug safety |
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| 中文摘要: |
| 摘 要 目的:回顾和比较观察性医药卫生数据库的特性，并讨论如何应用它们进行药物流行病学的药品安全风险管理研究。方法：通过美国医学索引Medline, PubMED, 国际药学文摘等公开出版物作为信息来源，检索相关信息和药物流行病学文献，查找其相关的观察性医药数据库，讨论和分析这些数据库的主要特性，回答如何利用观察性医药数据库来进行药物流行病学研究，为药品安全风险管理服务；介绍作者个人的独特研究经验。结果：通过本次回顾总结，从选择的公开发表文献中可找到几十种公众或机构专有的医药数据库。每种医药数据库都具有其特性、优势和局限性。将这些数据库分类为自发性报告系统数据、电子病历数据、医保数据、健康医疗相关的调查数据、疾病病种随访注册数据和其他数据等五大类。对如何应用医保数据进行特殊的药物流行病学研究进行了专项案例讨论，同时也阐述了常见的一些典型医保数据及其可链接性、数据有效性、患者隐私保护等问题。结论：本次回顾研究发现多种专业医药数据库均可用于药物流行病学研究，并为读者提供了针对特定研究目的选用和比较潜在数据库的多种有用信息。 |
| 英文摘要: |
| ABSTRACT Objective:To review and compare characteristics of observational health databases and discuss how to use them for pharmacoepidemiology research in drug safety risk management.Methods:Published information and phmarcoepidemiology literature related to observational health databases were searched using Medline, PubMED, International Pharmaceutical Abstracts and Internet. Some key characteristics about how to use observational health databases for pharmacoepidemiology research were reviewed and discussed. Author's personal research experiences were also described. Results:Several dozens of public or proprietary health data sources were identified from the published literature and selected for this review. Every health database has its characteristics, advantages, and limitations. These databases can be categorized as spontaneous reporting systems, electronic medical records, medical claims databases, disease follow up registries, health related survey data, and other. Application of health insurance claim database was discussed based on specific pharmacoepidemiologic examples. A typical medical claim database, its linkage capability, data validity, and health privacy issues were described.Conclusion:Many public and proprietary healthcare databases are available for research in pharmacoepidemiology. The present review provides useful information to compare and identify potential appropriate databases for specific research objectives. |
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