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研究生： 王郁文
Wang, Yu-Wen
論文名稱： 臺灣機械性心臟瓣膜置換病患之抗血栓劑使用評估
Utilization of Antithrombotic Agents in Patients with Mechanical Heart Valves in Taiwan
指導教授： 高雅慧
Yang, Yea-Huei Kao
葉鳳英
Liu Yeh, Pheng-Ying
學位類別： 碩士
Master
系所名稱： 醫學院 - 臨床藥學研究所
Institute of Clinical Pharmacy
論文出版年： 2011
畢業學年度： 99
語文別： 中文
論文頁數： 174
中文關鍵詞： 機械性心臟瓣膜 、心臟瓣膜置換 、抗血栓劑 、處方型態
外文關鍵詞： mechanical heart valve, heart valve replacement, antithrombotic, prescribing patterns
相關次數： 點閱：113  下載：2 
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    • 研究背景
    數十年來，學界一致認為置換過機械性心臟瓣膜的病人必須終身使用口服抗凝血劑。然而，在抗凝血劑的使用之下，每年仍然有1‐3%的病人發生嚴重栓塞事件，因此開始有人提倡加上抗血小板製劑來預防。經眾多臨床試驗證實，併用抗血小板製劑確實可以顯著降低血栓栓塞風險，但也伴隨著出血風險的提高。在風險與效益難以清楚斷定之下，美國三大相關學會（ACC、AHA、ACCP）及歐洲心臟學會（ESC）對於機械性心臟瓣膜置換病患，是否需併用抗凝血劑和抗血小板製劑，十多年來一直處於意見分歧的情況。本研究之目的即在於檢視臺灣病患置換機械性心臟瓣膜後，抗血栓劑的使用情況，並且探討其接受口服抗凝血劑和抗血小板藥品合併治療的影響因子。

    研究方法
    利用未抽樣的全民健康保險資料申報檔，找出在2001年1月1日至2004年6月30日之間置換機械性心臟瓣膜之病患。手術出院後30天內在門診曾被處方任一口服抗血栓劑（warfarin、aspirin、ticlopidine、clopidogrel或 dipyridamole）者始納入研究。追蹤所有研究對象在指標日期後30天內五種抗血栓劑的使用情況，並使用羅吉斯複迴歸找出臺灣機械性心瓣置換病患接受抗凝血劑與抗血小板製劑合併療法的影響因子。

    結果
    共2,830人納入抗血栓劑使用型態的分析，平均年齡為55.4歲，其中2,818人（99.6%）在追蹤期間曾使用warfarin。追蹤期間（30天）內併用warfarin與任一抗血小板製劑達15天以上者共223人（7.9%），之中有95%的病患是由同一位醫師同時處方warfarin和抗血小板製劑。進一步分析影響病人接受到合併療法的因素，置換瓣膜同時施行冠狀動脈繞道手術（OR: 8.12, 95% CI: 5.70-11.57, p<0.0001）和有心肌梗塞病史（OR: 2.02, 95% CI: 1.21-3.40, p=0.0077）會顯著增加合併療法處方率。

    結論
    臺灣機械性心臟瓣膜置換者服用口服抗凝血劑的比例接近百分之百，此外，確實有少部分的病患使用口服抗凝血劑與抗血小板製劑合併療法，顯著影響合併療法處方率的因素僅有「同時施行冠狀動脈繞道手術」和「心肌梗塞」。

    Background
    Lifelong oral anticoagulant treatment has been recommended for all patients with mechanical heart valves for several decades. However, even with the use of oral anticoagulants, major systemic embolism still occurs at a rate of 1-3% per year. To further reduce the risk, addition of an antiplatelet agent has been evaluated and advocated. According to the results of several clinical trials, adding antiplatelet to oral anticoagulation decreased the risk of systemic embolism, but slightly increased the risk of bleeding. Because there is no definitive benefit of adding antiplatelet, recommendations of combining anticoagulant and antiplatelet for patients with mechanical valves are inconsistent between ACC/AHA, ACCP and ESC guidelines. The aim of this study was to survey the utilization patterns of antithrombotic agents in patients after mechanical heart valve replacement in Taiwan and identify factors associated with receiving combination therapy of anticoagulant and antiplatelet.

    Methods
    We identified patients undergoing mechanical heart valve replacement between 1 January 2001 and 30 June 2004 from non-sampled National Health Insurance claims database. Patients were eligible if having prescriptions of any antithrombotics (warfarin, aspirin, ticlopidine, clopidogrel or dipyridamole) within 30 days after discharge. We investigated the utilization of antithrombotic agents for 30 days after valve replacement. Combination therapy was defined as receiving warfarin and any antiplatelet both for 15 days and over during follow-up. Logistic regression was performed to identify factors associated with combination therapy by using SAS version 9.2.

    Results
    2,830 patients were identified and met the inclusion and exclusion criteria (mean age 55.4 years). 2,818 patients (99.6%) had received warfarin during 30 days follow-up. 223 patients (7.9%) received combination of warfarin and antiplatelets at least 15 days, and 95% of them had been prescribed warfarin and antiplatelets by the same doctor. Concomitant coronary artery bypass grafting (OR: 8.12, 95% CI: 5.70-11.57, p<0.0001) and a history of myocardial infarction (OR: 2.02, 95% CI: 1.21-3.40, p=0.0077) significantly increased the probability of receiving combination therapy.

    Conclusions
    Nearly 100% of patients received oral anticoagulant after mechanical heart valve replacement in Taiwan. Besides, some of them received combination therapy of anticoagulant and antiplatelet. Independent predictors of combination therapy were concomitant CABG and history of myocardial infarction.

    第一篇、臺灣機械性心臟瓣膜置換病患之抗血栓劑使用評估 1 第一章、研究背景 1 第二章、文獻回顧 3 第一節、機械性心臟瓣膜之簡介 3 一、機械性心臟瓣膜之發展 3 二、機械性瓣膜與生物性瓣膜（bioprosthetic valves）之比較 6 第二節、瓣膜性心臟病與瓣膜置換手術 8 一、簡介與流行病學 8 二、風濕熱與風濕性心臟病 9 第三節、機械性心臟瓣膜引起血栓之理論機制 11 第四節、機械性心臟瓣膜置換病人之抗血栓劑療法 16 一、人工瓣膜相關的血栓栓塞風險 16 二、抗血栓劑個論 17 三、機械性心臟瓣膜置換病人之抗血栓劑治療發展 22 第五節、抗凝血劑與抗血小板製劑合併療法應用在機械性心臟瓣膜置換病人之臨床試驗 26 一、Aspirin與抗凝血劑合併療法 28 二、Dipyridamole與抗凝血劑合併療法 29 三、Ticlopidine與抗凝血劑合併療法 31 四、Clopidogrel與抗凝血劑合併療法 32 五、總結 33 第六節、國際準則建議之抗血栓劑療法 35 一、準則所建議的目標INR範圍 36 二、準則建議須併用OAC與抗血小板製劑的時機 37 三、準則所列出之血栓栓塞風險因子 38 四、準則建議併用的抗血小板製劑 39 五、總結 40 第三章、研究目的 46 第四章、研究方法 47 第一節、研究設計 47 一、研究類型 47 二、研究材料與工具 47 三、研究對象 49 四、研究名詞定義 51 五、觀察時間與觀察內容 52 六、影響研究對象是否接受合併療法的因子 52 七、分組 53 八、研究流程 54 第二節、研究變項與研究事件之操作定義 55 一、研究變項定義 55 二、研究事件定義 59 第三節、研究變項校正與每日劑量的計算 60 一、年齡校正 60 二、性別校正 60 三、藥品每日劑量計算 61 四、給藥天數校正 61 第四節、統計方法 62 一、統計工具 62 二、統計模式設定 62 三、資料分析方法 62 第五章、研究結果 64 第一節、研究對象納入、排除與分組 64 第二節、研究對象之特性分佈 67 第三節、置換瓣膜之廠牌與住院死亡率 75 一、置換瓣膜之廠牌 75 二、機械性心臟瓣膜置換手術之住院死亡率 76 第四節、追蹤期間抗血栓劑使用型態 78 一、機械性心臟瓣膜置換手術後口服抗凝血劑之使用率 78 二、追蹤期間（指標日期後30天內）抗血栓劑使用型態 78 第五節、OAC與抗血小板製劑合併療法預測因子 86 一、主要分析結果：併用OAC與任一種抗血小板製劑之預測因子 86 二、次分析結果：併用OAC與Aspirin之預測因子 91 第六章、研究討論 96 第一節、納入、排除條件與結果之探討 96 一、出院後30天內有門診處方的抗血栓劑為納入條件 96 二、排除年齡小於18歲者 97 三、排除懷孕者 98 第二節、研究族群人口特性 99 第三節、住院死亡率 100 一、與國內外研究之比較 100 二、瓣膜置換手術合併冠狀動脈繞道手術 101 第四節、抗血栓劑使用型態 105 一、抗血栓劑使用率 105 二、Warfarin之使用劑量 106 三、Dipyridamole之使用劑量 108 四、併用Aspirin或Dipyridamole之比較 109 第五節、OAC與抗血小板製劑合併療法預測因子 111 一、心肌梗塞 111 二、同時施行冠狀動脈繞道手術 113 第六節、研究限制 115 第七章、結論與建議 116 第八章、未來研究方向 117 第二篇、臨床藥事服務-Warfarin 與富含維生素K食物交互作用之文獻回顧與建議處置 118 第一章、服務背景 118 第二章、文獻回顧 119 第一節、維生素K簡介 119 第二節、Warfarin與維生素K交互作用之機轉 121 第三節、烹調造成的維生素K含量變動 123 第四節、不同食物來源的維生素K生體可用率差異 124 第五節、每日維生素K攝取量的安全變動範圍 125 第三章、建構臺灣常見富含維生素K食物的含量換算 133 第一節、參考資料與換算流程 133 第二節、臺灣常見富含維生素K食物之維生素K含量表 135 第三節、臺灣常見富含維生素K食物的含量換算表 139 第四章、Warfarin使用者日常食用富含維生素K食物之建議處置 140 第一節、相關文獻探討 140 第二節、建議處置 144 第三節、每日可容許的額外蔬果攝取量 146 第五章、結論 148 參考文獻 149 附錄一、各準則建議的抗血栓劑療法 161 附錄二、Warfarin與其他食物之交互作用 167 表目錄 表1、建議置換機械性心臟瓣膜的情況 7 表2、建議置換生物性心臟瓣膜的情況 7 表3、人工瓣膜相關的血栓栓塞風險 16 表4、抗血栓劑治療與否之血栓栓塞事件發生率 24 表5、血栓栓塞事件的多變項分析 25 表6、2007年ESC準則所訂定的目標INR 37 表7、1998年ACC/AHA準則建議之抗血栓劑療法 41 表8、2008年ACC/AHA準則建議之抗血栓劑療法 42 表9、1998年ACCP準則建議之抗血栓劑療法 43 表10、2001年ACCP準則建議之抗血栓劑療法 44 表11、2008年ACCP準則建議之抗血栓劑療法 45 表12、第一階段四項排除條件的排除人數 66 表13、分組的定義與人數 66 表14、研究對象之人口特性 70 表15、研究對象置換機械性心臟瓣膜的廠牌比例 75 表16、本研究之住院死亡率 77 表17、追蹤期間（30天）各個抗血栓劑的使用人數與每日劑量 80 表18、追蹤期間（30天）抗凝血劑與各個抗血小板製劑併用之型態 81 表19、Warfarin在兩組之間的每日劑量比較 83 表20、合併療法組的處方開立分析 84 表21、不同瓣膜置換部位之warfarin劑量 85 表22、OAC與抗血小板製劑合併療法之預測因子 87 表23、OAC與Aspirin合併療法之預測因子 92 表24、機械性心臟瓣膜置換手術之住院死亡率 103 表25、Warfarin平均劑量與INR測量值之華人（Chinese）研究 107 表26、2004年Schurgers等人之試驗流程 126 表27、口服抗凝血劑與維生素K交互作用之臨床試驗 131 表28、臺灣常見富含維生素K食物之維生素K含量表 135 表29、臺灣常見富含維生素K食物的含量換算表 139 表30、各種蔬菜每份之維生素K得分對照表 145 表31、每日可容許的額外蔬果攝取量 146 表32、凝血因子名稱與其半衰期 147 圖目錄 圖1、籠球型瓣膜 3 圖2、籠盤型瓣膜 3 圖3、傾斜圓盤型瓣膜 4 圖4、雙葉型瓣膜 5 圖5、心臟瓣膜 8 圖6、凝血路徑 14 圖7、血小板與凝血系統共同形成血栓之流程 15 圖8、Warfarin之作用機轉 18 圖9、Dipyridamole之作用機轉 20 圖10、合併療法組範例 53 圖11、研究對象納入與排除情況 65 圖12、在各年齡分層中合併療法病患佔全部族群比例 67 圖13、在各年齡分層中單一療法病患佔全部族群比例 67 圖14、追蹤期間warfarin與抗血小板製劑併用天數的比例分佈 82 圖15、納入病患的指標日期與指標出院日期之天數差距 97 圖16、實驗所用的碗 134

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