2013-08-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/659987摘要：研究背景：由於藥品上市後接受治療的病人數大幅增加，病情嚴重度與共病亦趨複雜，特別是國人之心腦血管風險較國外人種不同，藥品之有效性與安全性在上市後仍應持續監測。以大型健康照護資料做為安全性與有效性的評估其優點在於樣本數多、具代表性、能確實反應本土情況、以及花費低且具時效性。研究目的：比較個別斯達汀 (statins)類降血脂藥物、血管張力素受體阻斷劑(angiotensin receptor blockers)、以及選擇性血清素回收抑制劑(SSRI)與血清素-正腎上腺素再回收抑制劑 (SNRI)之心肌梗塞與腦中風發生率。研究方法：本研究為回溯性追蹤研究。將納入2000-2010 年 年齡30 歲以上，第一次接受上述藥物治療者為研究對象，排除於接受藥物治療時或之前，門診或住院記錄中已罹患心肌梗塞與腦中風者。將與內政部統計室全國生命資料串聯，追蹤研究對象中於 2000/1/1-2010/12/31 間死亡者，並以健保資料住院診斷中有心肌梗塞、缺血性腦中風、與出血性腦中風者，定義為endpoints。建立接受藥物治療者的baseline propensity-score 以作為控制干擾因子之工具，使用Cox regression model 計算接受不同藥物間、藥物治療與停藥時之相對風險。並以健康訪問調查資料中，接受藥物治療患者抽菸之比例，估計此一潛在干擾因子之可能影響。<br> Abstract: Background: Due to a tremendous number of patients with increasing severity of underlying disease and complexity of comorbidities will receive new drug treatments after they enter into the market, the comparative effectiveness and safety across a variety of active treatments should be continuously monitored. In particular, the cerebrovascular harm and benefit of statins, angiotensin receptor blockers, and new generation antidepressants need to be scrutinized in the Chinese population, in which higher incidence of stroke was noted as compared with western countries. Study goal: To conduct a comparative effectiveness and safety research of individual statins, angiotensin receptor blockers, serotonin-selective reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors for the incidence of myocardial infarction, ischemic and hemorrhagic stroke. Methods: A retrospective cohort study will be conducted by using National Health Insurance data in Taiwan. Participants will be age . 30 years old, who initiated the above medications during 2000-2010 without prior history of myocardial infarction and stroke. Vital status of each participant will be checked by linkage through National Death Registry. Patients will be followed from the date of insulin initiation to the earliest of myocardial infarction, ischemic stroke, hemorrhagic stroke, death, or December 31 2010. Propensity score model for individual drugs with demographics, comorbidities, concomitant medication use as the covariates will be build to control for potential confoundings. We will estimate adjusted hazard ratios and 95% confidence intervals (CIs) for individual medications as compared with reference drug by Cox proportional hazards models controlling for baseline propensity score. Sensitivity analysis using National Health Interview Survey data will be performed to estimate and control to control for unmeasured factors (such as smoking) in the claims database. Expected results: This study will examine the potential risk and benefit of ce rtain most commonly used medication in Taiwan. The result of the project will explore the feasibility of using large healthcare database to evaluate drug comparative effectiveness and safety that can provide evidence for policy making in Taiwan.建立我國以大型健康資料庫評估藥品比較性療效與安全性評估之方法Comparative effectiveness researchstatinsangiotensin receptorblockersserotonin-selective reuptake inhibitorsand serotonin-norepinephrine reuptakeinhibitorscerebrovascular disease