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系統識別號 U0026-0708201420483300
論文名稱(中文) 臺灣慢性透析合併心房顫動患者使用warfarin之成效與風險分析
論文名稱(英文) Effectiveness and risk of warfarin in chronic dialysis patients with atrial fibrillation in Taiwan
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 102
學期 2
出版年 103
研究生(中文) 陳秋縈
研究生(英文) Chiu-Ying Chen
學號 s66011049
學位類別 碩士
語文別 中文
論文頁數 170頁
口試委員 指導教授-高雅慧
口試委員-陳志弘
口試委員-王明誠
口試委員-林嘉音
中文關鍵字 透析  心房顫動  warfarin  中風  死亡 
英文關鍵字 dialysis  atrial fibrillation  warfarin  stroke  mortality 
學科別分類
中文摘要 研究背景
心房顫動對於慢性透析病患是很常見的共病症,而罹患心房顫動也會顯著增加慢性透析病人中風栓塞與死亡的風險。雖然許多大型臨床試驗已證實warfarin於心房顫動患者預防中風栓塞的效果,也被列入臨床指引的建議當中;但透析患者因有較高的中風栓塞與出血風險,故多排除在試驗條件之外,且目前相關研究證據並不多也沒有定論。因此,本研究欲探討於臺灣慢性透析合併心房顫動患者使用warfarin之成效與風險。

研究方法
本研究為一回溯性世代研究,以全民健康保險研究資料庫為研究材料,納入2001年至2007年間,首次申請永久重大傷病卡慢性腎衰竭必須定期透析的病患,並於重大傷病卡申請後,門診出現兩次心房顫動診斷碼且間隔90天內或住院出現一次心房顫動診斷紀錄者為研究對象。由於warfarin的使用會隨時間更動,故於追蹤期間以依time-dependent之方式分析warfarin之曝露情形。主要研究終點為發生腦中風或死亡之複合終點,次要研究終點為任何腦中風、缺血性腦中風、出血性腦中風以及死亡。採取time-dependent Cox proportional hazard model與利用傾向分數配對,來探討warfarin的曝露與各研究終點的相關性。

研究結果
本研究最終收入3,463位慢性透析合併心房顫動患者,其中有522人(15.07%)於追蹤期間內曾使用warfarin。校正可能之干擾因子後,本研究發現接受warfarin治療並不能顯著降低發生腦中風或死亡的風險(HR 0.88; 95% CI 0.69 to 1.14);而warfarin使用與發生任何腦中風(HR 0.75; 95% CI 0.40 to 1.41)、缺血性腦中風(HR 0.71; 95% CI 0.34 to 1.49)、出血性腦中風(HR 0.93; 95% CI 0.27 to 3.20),以及死亡(HR 0.92; 95% CI 0.70 to 1.22)皆無顯著相關性。此外,在經過傾向分數配對後分析,也得到一致的研究結果。

研究結論
本研究結果顯示,在臺灣慢性透析合併心房顫動患者當中,使用warfarin並不能顯著降低腦中風或死亡的風險。因此,目前缺乏強烈的證據支持在這些患者當中使用warfarin來預防腦中風,在下結論前還需證據等級更高的嚴謹研究以獲得更明確的結果。
英文摘要 Although warfarin is generally recommended for stroke prevention in atrial fibrillation (AF) patients, the effectiveness and safety of warfarin in dialysis patients remains controversial. In order to investigate the associations between warfarin use and risk of stroke or mortality, we conducted a retrospective cohort study of chronic dialysis patients aged 18 years and older with diagnosis of AF by using Taiwan’s National Health Insurance claims database. The exposure of warfarin was treated as a time-dependent variable during follow-up period. Time-dependent COX proportional modeling and propensity score matching were used to study the association among warfarin exposure and risk of stroke or mortality. Among 3,463 dialysis patients with AF, 522 (15.07%) filled a prescription for warfarin. Compared to warfarin non-exposure, warfarin exposure was not associated with statistically significant reduction in risk for stroke or mortality (HR 0.88; 95% CI 0.69 to 1.14). Similar results were obtained after propensity score matching. These results suggest that warfarin use is not beneficial in reducing risk of stroke or mortality in Taiwanese chronic dialysis patients with AF. Further analyses with adequately controlled confounders are needed to determine the risk and benefit of warfarin therapy in these patients.
論文目次 中文摘要 I
英文摘要 III
誌謝 VI
目錄 VIII
表目錄 XI
圖目錄 XIII
第一篇 臺灣慢性透析合併心房顫動患者使用warfarin之成效與風險分析 1
第一章 研究背景 1
第二章 文獻回顧 2
第一節 臺灣末期腎臟病與透析醫療之現況 2
第二節 末期腎臟病與心房顫動 4
2.2.1 透析病患罹患心房顫動之流行病學 4
2.2.2 透析病患罹患心房顫動的相關危險因子 6
2.2.3 透析患者合併心房顫動對預後的影響 7
第三節 透析病患之栓塞風險 10
2.3.1 透析病患之栓塞風險 10
2.3.2 透析病患發生栓塞之病理機轉與相關因素 12
第四節 透析病患之出血風險 13
2.4.1 透析病患之出血風險 13
2.4.2 導致透析病患出血之病理機轉與相關因素 15
第五節 透析合併心房顫動患者抗血栓藥物的選擇 17
2.5.1 抗血栓藥物與治療證據 17
2.5.2 透析病患合併心房顫動之臨床治療指引之建議 19
第六節 Warfarin於透析合併心房顫動患者的使用 24
2.6.1 中風風險層級評估 24
2.6.2 出血風險層級評估 25
2.6.3 Warfarin與血管鈣化 29
第七節 慢性透析合併心房顫動患者使用warfarin之處方型態 31
第三章 研究目的 32
第四章 研究方法 33
第一節 研究設計 33
4.1.1 研究類型 33
4.1.2 研究材料與工具 33
4.1.3 研究對象 34
4.1.4 研究藥品與分組 35
4.1.5 研究事件與追蹤期間 36
第二節 研究名詞、研究變項與操作定義 38
4.2.1 研究名詞及操作定義 38
第三節 資料處理流程 44
4.3.1 檔案串聯 44
4.3.2 研究流程 45
第四節 統計分析 46
4.4.1 統計工具 46
4.4.2 統計模式設定 46
4.4.3 資料分析方法 46
4.4.4 敏感性分析與次組分析 50
第五章 研究結果 52
第一節 病患基本特性分佈 52
第二節 Warfarin曝露情形與研究事件發生率 60
第三節 Warfarin曝露與研究事件風險之相關性 64
5.3.1 任何腦中風或死亡之複合終點 64
5.3.2 任何腦中風 70
5.3.3 缺血性腦中風 71
5.3.4 出血性腦中風 72
5.3.5 全死因死亡 73
第四節 Warfarin曝露與研究事件風險之次分析 77
5.4.1 敏感性分析 77
5.4.2 次組分析 77
第六章 研究討論 79
第一節 研究族群臨床特性與warfarin使用情形 79
第二節 腦中風與死亡發生率 83
6.2.1 慢性透析合併心房顫動病患之腦中風發生率 83
6.2.2 慢性透析合併心房顫動病患之死亡率 86
第三節 慢性透析合併心房顫動患者使用warfarin之成效與風險 88
第四節 研究限制 101
第七章 結論與建議 103
第二篇 臨床藥事服務-製作抗腫瘤藥物須知 104
第一章 背景 104
第二章 目的 106
第三章 方法 108
第四章 結果 113
第五章 未來展望與建議 113
參考文獻 158
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