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系統識別號 U0026-0307201315483400
論文名稱(中文) 台灣慢性透析病患罹患心房顫動之盛行率及抗血栓劑處方型態分析
論文名稱(英文) Prevalence and prescribing pattern of antithrombotic therapy for atrial fibrillation in chronic dialysis patients 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 101
學期 2
出版年 102
研究生(中文) 顏家拓
研究生(英文) Chia-Tu Yen
學號 s66004026
學位類別 碩士
語文別 中文
論文頁數 117頁
口試委員 指導教授-高雅慧
指導教授-歐凰姿
口試委員-王明誠
口試委員-林立人
口試委員-吳宗軒
口試委員-林嘉音
中文關鍵字 透析病患  心房顫動  抗血栓劑  warfarin 
英文關鍵字 Dialysis  atrial fibrillation  antithrombotic therapy  warfarin 
學科別分類
中文摘要 研究背景
美國曾在2010年度報告指出「心房顫動是造成透析病患死亡率提高的主因之一」;臨床上也確實缺乏相關的研究及證據,而無法改善病患存活。
截至目前,治療指引即使已建議心房顫動病患使用抗血栓劑在栓塞之預防,卻尚未針對透析病患提出相關的使用證據。故本研究旨在探討台灣慢性透析病患發生心房顫動的盛行率及發生率,同時分析抗血栓劑之處方型態及其處方影響因子,以提供醫師醫療決策之參考。

研究方法
本研究納入全民健康保險研究資料庫2002年至2008年間首次申請慢性透析重大傷病卡,並在申請日3年內曾出現門診兩次或住院一次心房顫動診斷碼者為研究對象,觀察其診斷後180天內所使用之抗血栓劑情形。另外以單變項分析及邏輯式多變項複回歸分析影響醫師處方抗血栓劑及warfarin相關因子。

研究結果
研究最終收入64,383為穩定慢性透析病患,平均年齡62.9歲; 約91.2%病患選擇以血液透析模式為其腎臟替代療法。進一步分析其中心房顫動的盛行率及發生率分別為6.95%及每百人年1.12位病患。
在抗血栓劑方面,處方比例最高為aspirin達66.88%,依序為clopidogrel/ ticlopidine (41.67%)、 warfarin (11.54%)。另外則有22.97%未使用任何抗血栓劑。影響warfarin處方的因素,除了年齡增加外,高血壓、糖尿病都會降低病患接受warfarin治療的機會,而高收入或居住地之都市化程度較高的病患則提高醫師處方warfarin之頻率。

研究結論
本研究結果顯示,台灣穩定透析病患發生心房顫動的盛行率及發生率,因年齡、性別及心血管共病症之影響,而高於一般病患。在抗血栓劑的使用上,雖透析病患具有較高之栓塞風險,但受到病患臨床特性及醫療使用狀況之影響,而造成醫師的warfarin處方率偏低。
英文摘要 Background
Cardiovascular events are the most serious diseases that lead the dialysis patients to death, especially atrial fibrillation (AF) in both Taiwan (TWRDS) and United Stated (USRDS). Therefore, in USRDS 2010 annual report emphasized that AF is a neglected cardiovascular problem in dialysis patients and is supposed to pay more attention on it.
Antithrombotic therapy is widely prescribed for the patients with AF to prevent the stroke. And, warfarin has proven efficacy in reducing re-hospitalization and mortality risk. However, due to the higher bleeding risk of the dialysis patients, randomized trials would less likely to include them into the studies.
The objectives of this study were to investigate the prevalence of AF and the prescribing pattern of antithrombotic therapy among Taiwan chronic dialysis patients and to identify factors affecting the antithrombotic therapy.

Method
We retrieved chronic renal failure patients with regular dialysis, whose disease status were confirmed through registry for catastrophic illness from the National Health Insurance Research Database (NHIRD) during 2002 to 2008. Then patients with claims of ICD9-CM code of “AF” twice in outpatients and once in inpatients were regarded as AF cases. Utilization of antithrombotic therapy among these patients within 180 days after AF diagnosis was analyzed. Univarate and multiple logistic regressions were performed to identify factors associated with antithrombotic therapy.

Result
There were 64,383 chronic dialysis patients with average age of 62.9 years old met the inclusion and exclusion criteria. 91.18% of target population received hemodialysis. After we examined whether patients had AF diagnosis before dialysis initiation, and found the prevalence in Taiwan chronic dialysis patients was about 6.95%, the incidence was 1.12/ 100-patient-years.
As for the antithrombotic therapy prescribing pattern among incident AF patients, aspirin (66.88%) was the most widely used antiplatelet, followed by clopidogrel/ ticlopidne (41.67%) and warfarin (11.54%). In this study, there were 22.97% patients did not receive any antithrombotic therapies to prevent the stroke.
Other than age, cardiovascular comorbidities presented an inverse association with warfarin use. Otherwise, patients’ income, urbanization increased the probability of warfarin prescribed by physicians.

Conclusion
Compared with other countries, lower prevalence and incidence of AF were found in chronic dialysis population in Taiwan. Moreover, the proportion of dialysis patients receiving antithrombotic therapy after AF diagnosed was low, especially warfarin.
論文目次 中文摘要 I
Abstract III
誌謝 V
目錄 VII
表目錄 XI
圖目錄 XIII
縮寫與全名對照表 XIV

第一篇 台灣慢性透析病患罹患心房顫動之盛行率及抗血栓劑處方型態分析 1
第一章 研究背景 1
第二章 文獻回顧 3
第一節 台灣透析人口之流行病學 3
第二節 透析病患共病症、死亡風險及存活分析 4
2.2.1 透析病患之共病症 4
2.2.2 透析病患之死亡風險及死因分析 4
第三節 透析病患罹患心房顫動情形與心血管事件發生及死亡之影響 5
2.3.1 透析病患罹患心房顫動之機轉 5
2.3.2 透析病患罹患心房顫動之流行病學 5
2.3.3 透析病患罹患心房顫動之共病症分析 6
第四節 透析病患罹患心房顫動之抗血栓劑選擇比較 8
2.4.1 心房顫動之抗血栓劑藥品 8
2.4.1.1 口服維他命K拮抗劑(oral vitamin K antagonists) 8
2.4.1.2 口服非維他命K拮抗劑(oral non-vitamin K antagonists ) 9
2.4.1.3 抗血小板劑(antiplatelet agents) 9
2.4.2 治療指引對於抗血栓劑於透析病患之建議 10
第五節 抗血栓劑於透析患者罹患心房顫動之相關研究 13
2.5.1 抗血栓劑於透析病患罹患心房顫動之臨床試驗及核准適應症 13
2.5.2 透析病患罹患心房顫動使用抗血栓劑之處方型態 13
第六節 缺血性栓塞風險評估 16
第七節 Warfarin出血風險評估 18
2.7.1 常見出血風險評估方式 18
2.7.2 透析病患之出血風險評估建議 21
第八節 透析病患使用抗血栓劑之臨床建議 22
第九節 醫療使用狀況與醫師處方抗血栓劑之影響 23
2.9.1 居住地之都市化程度之影響性 23
2.9.2 醫院層級之影響性 23
2.9.3 醫師專科之影響性 24
第三章 研究目的 25
第四章 研究方法 26
第一節 研究設計 26
4.1.1 研究類型 26
4.1.2 研究材料及工具 26
4.1.2.1 全民健康保險研究資料庫2000年至2011年全人口承保資料檔 26
4.1.2.2. 國衛院發行之重大傷病證明明細檔 26
4.1.2.3 健保給付藥品Anatomical Therapeutic Chemical (ATC)代碼對照檔 27
4.1.2.4 國際疾病分類代碼ICD-9-CM 2001年版 27
4.1.3 研究對象 27
4.1.3.1 納入條件 27
4.1.3.2 排除條件 27
4.1.3.3 分組條件 27
第二節 研究名詞、研究變項與操作定義說明 29
4.2.1 研究名詞及操作定義 29
第三節 資料處理流程 33
第四節 統計分析 34
4.4.1 統計工具 34
4.4.2 統計模式設定 34
4.4.3 資料分析方法 34
4.4.3.1 描述性統計 34
4.4.3.2 推論性統計 34
第五章 研究結果 36
第一節 研究族群篩選流程 36
第二節 研究族群之臨床特性分布 37
第三節 慢性透析病患新發生心房顫動之發生率及盛行率 37
第四節 慢性透析病患新發生心房顫動之抗血栓劑處方型態 40
5.4.1 觀察期間抗血栓劑處方型態分析 40
5.4.2 栓塞風險評估(CHADS2)與抗血栓劑之使用 40
第五節 影響抗血栓劑與抗凝血劑處方相關預測因子 42
5.5.1 病患特性與抗血栓劑處方相關性探討 42
5.5.2 病患特性與warfarin處方相關性探討 47
第六章 研究討論 52
第一節 研究族群之臨床特性分布 52
第二節 慢性透析病患新發生心房顫動之盛行率及發生率 55
6.2.1 慢性透析病患新發生心房顫動之盛行率 55
6.2.2 慢性透析病患新發生心房顫動之發生率 55
第三節 慢性透析病患新發生心房顫動之抗血栓劑處方型態分布 58
6.3.1 各國之處方型態分布 58
6.3.2 台灣之處方型態分布 59
6.3.3 栓塞風險評估(CHADS2)與抗血栓劑之使用 60
第四節 研究對象臨床特性與處方抗血栓劑相關性探討 63
6.4.1 抗血栓劑處方預測因子 63
6.4.1.1 年齡 63
6.4.1.2 透析模式 63
6.4.1.3 相關危險因子 64
6.4.1.4 醫療使用狀況 64
6.4.2 Warfarin處方預測因子 65
6.4.2.1 年齡 65
6.4.2.2 性別 65
6.4.2.3 投保薪資 65
6.4.2.4 相關危險因子 66
6.4.2.5 醫療使用狀況 67
第五節 研究限制 68
第七章 結論與建議 69
第八章 未來研究方向 70
參考文獻 71

第二篇 臨床藥事服務- 臨床處方抗凝血劑(warfarin)之影響因素探討 83
第一章 服務背景 83
第二章 服務方法 86
第一節 服務對象 86
2.1.1 臨床處方warfarin影響因素之收集對象 86
2.1.2 臨床處方warfarin影響因素問卷之回饋對象 86
第二節 服務材料 86
2.2.1 受訪問卷 86
2.2.2 調查訪問之前準備 87
2.2.3 醫師處方抗凝血劑(warfarin)之臨床考量分析簡報 87
2.2.4 藥師認知程度調查表 87
第三節 服務流程 88
第三章 服務結果 89
第一節 受訪問卷翻譯及信、效度評估 89
3.1.1 臨床處方抗凝血劑之影響因素探討之中文版翻譯 89
3.1.2 臨床處方抗凝血劑之影響因素探討之信度及效度評估 89
3.1.2.1 效度分析 89
3.1.2.2 信度分析 90
第二節 多醫療院所(multi-centers)資料收集分析 92
3.2.1 臨床處方抗凝血劑影響因素之收集問卷對象來源 92
3.2.2 醫師處方抗凝血劑之考量順序 92
3.2.3 醫師背景對醫師處方抗凝血劑之影響 92
3.2.3.1 醫療層級對醫師處方抗凝血劑之影響 92
3.2.3.2 專科別對醫師處方抗凝血劑之影響 93
3.2.3.3 執業年資對醫師處方抗凝血劑之影響 93
3.2.3.4 處方及調整抗凝血劑之頻率對醫師處方抗凝血劑之影響 93
3.2.4 醫師背景對評估病患情形之影響 93
第三節 院內藥師認知程度調查 96
第四章 服務討論 98
第一節 中文版問卷與英文原版結果比較 98
第二節 醫師背景對醫師處方抗凝血劑之影響 100
第三節 醫師背景對評估病患情形之影響 103
第四節 院內藥師認知程度調查 104
第五章 未來展望之臨床實際運用 105
參考文獻 106
附錄2.1-臨床處方抗凝血劑(Warfarin)之影響因素探討 108
附錄2.2-調查訪問之前準備 112
附錄2.3-醫師處方抗凝血劑(Warfarin)之臨床考量分析簡報 113
附錄2.4-藥師認知程度調查表 117

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