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系統識別號 U0026-0408201501335800
論文名稱(中文) 運用實證為基礎之整合性藥物效益風險決策分析-以Statins類降血脂藥物為例
論文名稱(英文) Balancing Benefit and Risk to Select an Optimal Drug among a Series of Alternatives for Patients:An Evidence-Based Assessment of Statins
校院名稱 成功大學
系所名稱(中) 臨床藥學與藥物科技研究所
系所名稱(英) Institute of Clinical Pharmacy and Pharmaceutical sciences
學年度 103
學期 2
出版年 104
研究生(中文) 謝幸㚬
研究生(英文) Hsing-Chun Hsieh
學號 S66024034
學位類別 碩士
語文別 中文
論文頁數 209頁
口試委員 指導教授-徐之昇
口試委員-高淑敏
口試委員-高雅慧
口試委員-吳至行
召集委員-劉亞明
中文關鍵字 Statins 類降血脂藥  效益風險評估  療效  安全性  處方率 
英文關鍵字 statins  multi-criteria decision analysis  benefit-risk assessment  drug utilization 
學科別分類
中文摘要 背景:心血管疾病名列許多已開發國家死因排行的第一名,而高膽固醇是心血管疾病的重要危險因子之一,目前最常被用來治療高膽固醇血症的藥品為statin類降血脂藥物,雖然過去已有許多文獻確立statin類藥物的療效與安全性,然而,statin類降血脂藥物效益及風險的綜合性評估研究卻非常缺乏。

目的:本研究利用多準則決策分析方法,在同時考量藥物的效益及風險下,整合性地量化評估不同statin類降血脂藥物在一般血脂異常病患之療效與安全性。另外統計台灣於2002年至2011年間各statins及不同強度statins類藥物處方比率隨年份之變化趨勢,並針對有無特定臨床事件疾病史之新使用statins族群,探討statins類藥物處方比率之差異,呼應前半部決策分析結果進行討論。

方法:本研究利用多準則決策分析法(multiple criteria decision analysis, MCDA)評估atorvastatin、fluvastatin、lovastatin、pravastatin、rosuvastatin、simvastatin等六種statin。MCDA模型中包含五項評估準則,包括重大冠狀動脈事件之預防、重大腦血管事件之預防、肌痛或相關肌肉病變之風險、肝臟酵素上升之風險及新發生糖尿病之風險;其中,前兩項屬效益面評估準則,後三項屬風險面評估準則。藉由文獻回顧,本研究整理出各類statin在不同準則之間的表現能力及分數,並利用蒐集健康生活品質相關文獻及問卷設計與執行,分別收集代表病患以及南部某醫學中心醫師之偏好與意見,作為各準則權重分配之依據,最後,綜合各種statin於不同準則的表現分數及權重,為各類statin計算出總和分數,此外,本研究也進行了敏感度分析以評估準則權重的變化是否會影響研究結果。台灣每年度statins類使用族群之各statin處方比率統計部份,則透過2001-2011年之健保資料庫中百萬抽樣歸人檔資料進行分析。

結果:本研究結果顯示,不論是依據病患或醫師之立場評估所決定的準則權重,於所有statins中,fluvastatin有最高的總和分數(病患部分與醫師部分各得62.0分、54.9分),次高者為simvastatin (53.9分、54.6分),atorvastatin (53.1分、52.8分)與pravastatin (52.7分、53.8分)排名第三或四,而lovastatin (52.5分、52.2分)及rosuvastatin (51.9分、52.8分)之分數最低,整體而言,除病患部分評估結果中fluvastatin擁有顯著較高之分數,其他statins之間分數差距不大。以準則權重作為調整變數的敏感度分析結果發現,病患部分評估結果中,fluvastatin仍然擁有最高的總和分數,而其他statins的排名可能因準則權重之變動而有所變化;醫師部分評估結果則顯示fluvastatin的分數易受重大冠狀動脈事件及肝酵素上升等兩準則權重之變動而改變,反觀simvastatin的分數變化較不受準則權重變動之影響。在台灣各statin處方比率部份,研究期間以atorvastatin之處方比率為最高,而自2006年開始,強效statins如:rosuvastatin與simvastatin之處方比率有明顯的成長,在2010年後在處方占率上分別位居第二與第三。統計不同強度之statins處方趨勢,可觀察到低強度statins處方率隨年份下降,中高強度statins處方率則隨年份有明顯的成長。而在特定臨床事件疾病史的次族群分析部分,有冠狀動脈阻塞事件或腦血管事件疾病史的族群較無病史的患者有更高(>10%)的比例開立較強效的statins,包括atorvastatin及rosuvastatin,此開方情形在研究期間呈現一致之趨勢,亦可由發生特定臨床事件之族群有較高比例被開立中高強度之statins觀察而知。其他特定疾病史有無的次族群分析中則較無明顯藥物處方差異。

結論:本研究以statin類藥物為例,率先利用MCDA法之分析作為協助藥物在臨床上處方的決策參考,評估過程涵蓋病患或醫師兩方對不同準則之間的重要性評估,結果顯示,綜合考量藥物的效益與風險下,fluvastatin及simvastatin對一般血脂異常患者可作為較佳的藥物選擇。實際統計台灣本土之statins處方比率,可發現處方趨勢偏向以藥物療效為主,且曾經發生過重大心血管阻塞事件之患者有較高比例被開立強效之statins。
英文摘要 This study aims to synthetically evaluate the efficacy and safety of statins in general population and to investigate trends in use of statins among statin-users in Taiwan from 2002 to 2011 (10 years). We applied multi-criteria decision analysis (MCDA) methods to quantitatively assess different statins and made explicit the preferences and trade-offs between multiple criteria for patients and physicians, respectively. Criteria being assessed include benefits (prevention of major coronary events, and prevention of major cerebrovascular events) and risks (risk of myalgia/myopathy, risk of liver injury, and risk of incident diabetes) of statins. As for use of statins in Taiwan, the “Longitudinal Health Insurance dataset” derived from the National Health Insurance Research Database (NHIRD) was used for calculating prescribing rates of statins. Results form MCDA analysis suggested that fluvastatin might be preferred over other statins for general population. In Taiwan, atorvastatin has been the most commonly used statin (30-40% of market share by prescription volume) during the study period. Simvastatin and rosuvastatin also shared substantial prescription volume in recent years. Among statin new-users, patients with history of coronary or cerebrovascular events were more likely to be prescribed high-intensity statins (atorvastatin and rosuvastatin) than those without history of these events. To conclude, this study suggested use of fluvastatin based on risk-benefit balance of statins. However, prescription volume of statins in Taiwan indicated tendency towards drug efficacy.
論文目次 目錄
中文摘要 I
Extended Abstract IV
表目錄 XIII
圖目錄 XV
附件目錄 XVII
縮寫與全文對照表 XVIII

第一篇、Statin類降血脂藥物之治療決策分析與藥物利用趨勢分析 1
第1章 研究背景 1
第2章 研究目的與重要性 4
2.1 研究目的 4
2.2 研究重要性 5
第3章 文獻回顧 6
3.1 心血管疾病與高膽固醇 6
3.1.1 心血管疾病之簡介 6
3.1.2 高膽固醇與心血管疾病的關係 8
3.1.3 高膽固醇之流行病學 9
3.1.4 高膽固醇之簡介與治療 10
3.2 Statin類降血脂藥 14
3.2.1 Statin類降血脂藥物簡介 14
3.2.2 Statin類藥物之降血脂效果 15
3.2.3 Statin類降血脂藥物於心血管疾病之預防效果 18
3.2.4 Statin類降血脂藥物之安全性 27
3.3 醫療效益風險評估 (benefit-risk assessment of medicines) 30
3.3.1 醫療效益風險評估之緣起與簡介 30
3.3.2 醫療效益風險評估之類型與方法 32
3.3.3 運用效益風險評估於醫療決策分析 36
3.4 多準則決策分析 (multiple-criteria decision analysis, MCDA) 38
3.4.1 多準則決策分析法之簡介 38
3.4.2 運用多準則決策分析法於醫藥品評估 38
3.4.3 多準則決策分析模型應用於藥品決策之分析步驟 41
3.4.4 多準則決策分析模型之優勢與限制 45
3.5 層級分析法 (analytical hierarchy process, AHP) 47
3.5.1 層級分析法之簡介 47
3.5.2 層級分析法之目的與假設 48
3.5.3 層級分析法之分析步驟 49
3.5.4 層級分析法之應用 50
3.6 Statin類藥物利用 51
3.6.1 藥物利用研究 51
3.6.2 statin類藥物利用分析 52
3.6.3 國內statin類之藥物利用分析 54
3.7 文獻回顧總結 57
第4章 研究方法 58
4.1 研究架構與類型 58
4.2 MCDA:Statins類藥物多準則決策分析 59
4.2.1 建立決策內容 Establish the decision context 59
4.2.2 確立評估品項 Identify the options to be appraised 60
4.2.3 確立決策目標及評估準則 Identify objectives and criteria 60
4.2.4 評估不同準則之下各品項之表現 Assess the expected performance of each option against the criteria (‘scoring’) 63
4.2.5 為各評估準則設定權重 Assign weights for each criterion 69
4.3 台灣statins類藥物利用趨勢 72
4.3.1 研究設計 72
4.3.2 研究變項與操作定義 77
4.4 統計方法 80
4.4.1 統計軟體 80
4.4.2 資料分析 80
第5章 研究結果 81
5.1 MCDA:Statins類藥物多準則決策分析 81
5.1.1 計算各品項之加權總分 Calculate overall weighted scores 81
5.1.2 敏感性分析 Sensitivity analysis 86
5.2 台灣statins類藥物利用趨勢 89
5.2.1 每年度statins類藥物使用者(all users)之降血脂藥物處方比率趨勢 89
5.2.2 特定疾病史之statins類新使用者其第一筆statins處方分析 105
第6章 研究討論 128
6.1 MCDA:Statins類藥物多準則決策分析 128
6.1.1 研究之貢獻 128
6.1.2 研究結果之討論 128
6.1.3 多準則決策分析法之應用可能性 135
6.2 台灣statins類藥物利用趨勢 138
6.2.1 Statins類藥物使用者之人口特性 138
6.2.2 每年度statins類藥物使用者之各statin處方比率趨勢 138
6.2.3 特定疾病史之statins類新使用者處方分析 141
6.3 綜合討論 144
6.4 研究之限制 148
6.5 未來研究方向 149
第7章 結論與建議 150

第二篇、臨床藥事服務:Statins類藥物處方品質探討-著重潛在藥物交互作用之處方評估 151
第1章 緣起 151
第2章 目的與方法 157
2.1 研究目的 157
2.2 研究方法 157
第3章 結果 158
3.1 Statin類藥物基本處方量 158
3.2 潛在Statin類藥物交互作用之處方比例 159
3.3 常見Statin類藥物交互作用中之併用藥物 160
第4章 討論 164
第5章 未來建議 172

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