2012-12-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/646931摘要：動脈粥狀硬化是急性冠心症及腦中風之主要致病機轉,血脂異常又是動脈 粥狀硬化最重要的危險因子。為了找出在東方人血脂及動脈粥狀硬化之最 佳診斷及 治療戰略,實有必要進行多中心之大型臨床試驗,因多中心能快 速及有效的篩檢 及招收病案。本計畫之目的是 (1) 在台灣建立一血脂及動 脈粥狀硬化相關疾病 之臨床試驗聯盟,以進行標準化之重要血脂及動脈粥 狀硬化相關疾病之多中心 臨床試驗;(2) 經由多中心之大型臨床試驗來找 出最適宜之血脂及動脈粥狀硬化 相關疾病之治療方式;(3) 建立一血脂及 動脈粥狀硬化相關疾病患者及健康對照 者之生物樣本庫,以作為基礎研究、 臨床研究、及生物醫學工業之良好工作平 台。在台灣血脂及動脈粥狀硬化 學會之登錄研究小組推動下,我們已自 2009 年 10 月開始建立一台灣血脂 及動脈粥狀硬化臨床研究聯盟(TCLA),包含超過 10 家以上之醫學中心, 我們已登錄 4492 例具有冠心病、腦中風或周邊血管疾病之 患者。由此登 錄研究收集到的生物樣本庫及臨床資訊可做為進一步研究血脂及 動脈粥 狀硬化疾病之工作平台。因此經由此聯盟之運作,本計畫擬收集 5000 例 具動脈粥狀硬化血管疾病(AVD)之患者, 5000 位不具 AVD 但具有至少 一項心 血管危險因子者,及 5000 位健檢健康個體。臨床資料及樣本資訊 管理將利用由 陽明大學建立之 CSCI 系統。國衛院將負責統計資料分析及 生物樣本儲存及管 理。本計畫擬統計台灣具/不具動脈粥狀硬化疾病患者之 血脂控制狀況,利用 logistic 迴歸分析法,我們將找出控制血脂良好與否 之決定因子。我們將進行多 項觀察性試驗及隨機控制性大型臨床試驗，已達成上述目標。<br> Abstract: Atherosclerosis is the major contributor to the pathogenesis of acute coronarysyndrome and stroke. Dyslipidemia is the most important risk factor of atherosclerosis. To identify optimal diagnostic or therapeutic strategies for the lipid and atherosclerosis associated diseases in Oriental people, it is important to conduct multicenter trials that take the advantage of more efficient screening and enrollment of cases. The objectives of this proposal are (1) to establish a clinical consortium of lipid and atherosclerosis associated diseases in Taiwan that could standardize and conduct important multi-center trials in lipid and atherosclerosis associate diseases; (2) to identify optimal therapeutic strategies in the treatment of lipid and atherosclerosis associated diseases through multi-center clinical trials; (3) to establish a bio-specimen bank for the patients with lipid and atherosclerosis associated diseases and for healthy controls that could serve as platform for basic research, clinical research, and biomedical industry. Under the registry working group of Taiwan Society of Lipid and Atherosclerosis, we have established a Taiwan Consortium of Lipid and Atherosclerosis (TCLA) since October, 2009. We have had registered 4492 cases with coronary, cerebral, or peripheral vascular diseases. More than 10 hospitals have been included in this consortium. The bio-specimen bank and the clinical information collected from this study could provide a platform for further investigation of lipid and atherosclerosis associated diseases. 5,000 patients with atherosclerotic vascular diseases (AVD), 5,000 with no evidence of AVD but with at least 1 CV risk factor, and 5,000 apparent healthy persons have been or will be registered. The CSCI system, established by the Yang-Ming Medical University, will be used for management of clinical data and organization of data from multi-centers. And the National Health Research Institutes (NHRI) will provide the statistical and data analysis, and storage for the collected specimens. Distribution of lipids will be carried out for describing the control status of lipid levels in patients with/without atherosclerosis in Taiwan. Further, we will estimate the control rate and use the logistic regression to investigate the determinants for the well control in this lipid registry population. To achieve those objectives and several randomized controlled trials will be performed.