2014-08-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/701466摘要：藥品的上市需要經過前臨床試驗及臨床試驗研究結果的詳細評估，但是因為臨床試驗在病人數，及臨床情境如共病、藥品交互作用以及藥品疾病交互作用的限制，因此藥品上市後的安全性仍須嚴格監視。自發性通報系統(adverse event reporting system, AERS)為目前上市後藥品監視(post-marketing pharmacovigilance)的主要方式，而主動積極偵測創新藥品的安全訊號(novel drug safety signals)應是藥品監視的核心做法，但全世界目前對於主動積極偵測創新藥品的安全訊號，尚無具體的解決方案。臺灣健康保險申報資料庫，納入臺灣超過 99%的族群，且有追蹤超過 10 年的連續資料，包括於門、住、急診之就診相關資料，如疾病診斷及藥品使用，過去已利用此資料庫，進行許多藥物流行病學之相關研究，且有許多國際論文發表。本研究團隊自 2012開始，由臺灣大學臨床藥學研究所與資訊管理學系進行跨領域合作，已開始著手建立一個能藉由分析健保申報資料庫，將有可能之藥品及不良反應事件配對，而偵測早期的藥品安全訊號之藥品主動監視分析系統。在此提出之三年計畫中，利用臺灣健保資料庫，分別將就藥品所引起的心臟血管疾病、肝毒性、腎毒性等三方面進行研究，利用世代(cohort)或病例對照(case-control)研究方法來進行獨立研究，來確效我們開發出的藥品主動監視分析系統所偵測出的創新藥品安全訊號，並釐清其相關風險因子如種族、共病以及同時使用的藥品等；除此之外，也將進一步利用美國的大型醫療申報資料庫來進行對照研究，明瞭該特定藥品流行病學與人種之關聯性。預期此三年計畫完成後，我們將可以針對這些藥品提供適當的規範以及政策建議，並更進一步發展出實證臨床決策研究來改善臨床使用藥品的有效性及安全性。我們將利用這個重要的計畫，建立未來的研究成果在以實證為基礎的臨床輔助支援研究之影響與角色。 <br> Abstract: Medications are approved by extensive evaluation according to the evidence from pre-clinical and clinical studies, but the safety of the medications in patients remains a concern due to the limited number of patients and restricted scenario, e.g. comorbidity and drug-drug interaction of drug-disease and drug-drug, in clinical trials. The spontaneous adverse event reporting system (AERS) is currently the mainstay in post-marketing pharmacovigilance. An active detection system of novel drug safety signals is the core of post-marketing pharmacovigilance, but it remains further efforts all over the world. We are developing a pharmacovigilance analytics system which can comprehensively identify the possible drug-event pairs associated with early drug safety signals during via the interdisciplinary collaboration of Graduate Institute of Clinical Pharmacy and Department of Information Management at National Taiwan University since 2012. In our next 3-year proposal, we would like to confirm the novel safety signaling by each independent study using population-based health claimed database from two different countries, Taiwan and United States, in order to validate the safety signals and elucidate the risk factors, such as ethnicity, comorbidity, and concurrent medications, etc. Retrospective Cohort and case-control study designs are used as the methods in this grant. After this 3-year study, we are able to address the global or Chinese specific medication issues to provide appropriate medication regulation and policy for the populations. And generate an evidence-based clinical decision research to improve the effectiveness and safety of medication use in practice. This is a great opportunity to establish our research plays a central role in the evidenced-based clinical decision support research.藥品主動監視藥品安全訊號藥品不良反應醫療申報資料庫pharmacovigilancesafety signalsadverse drug reaction (ADR)health claimed database