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研究生： 陳品慈
Chen, Pin-Tzu
論文名稱： 血液透析患者使用萬古黴素治療oxacillin抗藥性金黃色葡萄球菌血流感染的藥效動力學指標與臨床療效之相關性
Pharmacodynamic Target and Treatment Outcome of Vancomycin in Hemodialysis Patients with Oxacillin-resistant Staphylococcus aureus Bloodstream Infection
指導教授： 林文亮
Lin, Wen-Liang
鄭靜蘭
Cheng, Ching-Lan
李南瑤
Lee, Nan-Yao
學位類別： 碩士
Master
系所名稱： 醫學院 - 臨床藥學與藥物科技研究所
Institute of Clinical Pharmacy and Pharmaceutical sciences
論文出版年： 2022
畢業學年度： 110
語文別： 中文
論文頁數： 130
中文關鍵詞： 萬古黴素 、血液透析 、藥物血中濃度監測 、族群藥物動力學 、臨床療效
外文關鍵詞： vancomycin, hemodialysis, therapeutic drug monitoring, population pharmacokinetics, clinical outcome
相關次數： 點閱：127  下載：0 
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    • 背景
    血液透析的患者需要長時間使用血液透析導管，再加上本身免疫功能較差的因素，使他們感染的風險較非透析患者高上許多，過去許多研究都發現最常導致透析患者血流感染的菌種為金黃色葡萄球菌（Staphylococcus aureus），其中又以抗藥性金黃色葡萄球菌（oxacillin-resistant Staphylococcus aureus, ORSA）佔多數，因此臨床上常以萬古黴素為此類患者感染時的首選抗生素。近年來，研究發現在腎功能正常的患者若以給藥前波谷濃度作為藥效動力學監測指標，發生急性腎損傷的風險較高，故2020年美國感染症醫學會指引不再建議腎功能正常的患者以給藥前波谷濃度作為替代24小時區間血中濃度曲線下面積與最低抑菌濃度比值（AUC24/MIC）的監測指標，應該直接監測AUC24/MIC。而對於透析患者的監測指標因研究相對缺乏，故仍以給藥前波谷濃度在15~20 mg/L作為監測目標，不過透析患者的給藥前波谷濃度是否能與臨床療效有較好相關性，或是否有其他藥效動力學指標與療效的相關性更佳而可作為監測的目標，目前仍值得研究與探討。
    目的
    本研究將以真實透析患者的抽血濃度數據建立族群藥物動力學模型，進而以模型模擬出個別患者的藥效動力學參數，並以所得之藥效動力學數值連結患者的臨床療效，找出與療效相關性較佳的藥效動力學指標作為治療監測目標。
    方法
    本研究為單中心回溯性世代研究，以病歷回顧方式納入2014年7月1日至2021年6月30日於成大醫院感染抗藥性金黃色葡萄球菌血流感染之年齡20歲以上的住院透析患者，且在研究期間若同一患者有兩次以上的ORSA血流感染則僅納入第一次感染事件。患者基本特徵及濃度數據等資料以成大醫院院內電子病歷收集，族群藥物動力學模型以Monolix®軟體建置，個別患者的藥效動力學參數值以Simulx®模擬而得，各藥效動力學參數的最適切點採用ROC曲線及決策樹分析，最後以羅吉斯回歸模型分析與臨床療效相關之危險因子。
    結果
    本研究共納入94位透析患者的平均年齡為67歲，其中男性比例為59%。242筆vancomycin濃度資料建立族群藥物動力學模型，以二室模式作為架構模型，並額外加入透析時vancomycin清除率之參數，當真實體重作為中央室分布體積及非透析時之vancomycin清除率的影響共變項時，中央室分布體積的個體間變異可從60%下降至26%，非透析時之vancomycin清除率則可從17%下降至15%，且以第二型混合誤差模式作為誤差模型可得表現較佳之族群藥動學模型，最終模型所估計之群體周邊室分布體積約為31.55 ± 3.38（L），透析時vancomycin的移除率約為1.91 ± 0.34（L/hr），模型計算之藥效動力學參數Ctr為16.4 ± 3.1（L/hr）、AUC0-24為472 ± 199、AUC24-48為304 ± 100、AUC0-48為707 ± 183、AUCpre-tr24為400 ± 88、AUCmean為618 ± 310（mg*L/hr）。
    在治療效果的部分，則納入90位符合收案條件的患者進入分析，其中30天全因死亡人數共9人（10%），治療失敗共27人（30%），30天全因死亡及治療失敗的最佳監測指標皆為AUC0-24/MIC，而最適切點則分別為403及398。在風險因子分析方面，PBS為影響30天全因死亡的重要危險因子，而治療失敗的危險因子則為AUC0-24/MIC小於398。
    結論
    對ORSA血流感染的血液透析患者，30天死亡與治療失敗的指標及最適切點為起始劑量給藥後24小時內的AUC0-24/MIC，且目標分別應高於403及398。此外，依據羅吉斯回歸的分析結果，AUC0-24/MIC ≥398為影響治療成功的重要因子，因此建議AUC0-24/MIC ≥398可以做為ORSA血流感染的透析患者使用vancomycin時之監測指標。

    Vancomycin, a glycopeptide antibiotic, is the first-line therapy for hemodialysis (HD) patients due to high prevalence of oxacillin-resistant Staphylococcus aureus (ORSA) infections. However, the outcome studies investigating the pharmacodynamic targets of vancomycin in HD patients with ORSA bloodstream infection are scarce. This study was designed to establish a population pharmacokinetic model and to explore the pharmacodynamic targets of vancomycin in these population. A retrospective observational study was conducted in a medical center. Inpatients from July 1, 2014 to June 30, 2021 were included and relevant data retrieved from electronic medical record. Vancomycin population pharmacokinetic (PPK) model was constructed using Monolix® software and the appropriate structural model and initial estimated value was selected from PPK literatures. The cut-off points of Ctr and different AUC/MIC ratio associated with 30-day all-cause mortality and treatment failure were identified by receiver operating characteristic curve (ROCc) and classification and regression tree (CART). A total of 94 patients and 242 vancomycin concentration data were included for PK model construction. The mean body weight was 58.7 kilogram. The PPK of vancomycin was best described by two-compartment model with covariate model included the effects of normalized body weight on clearance of residual renal function and central volume distribution. The final model showed the population clearance of hemodialysis and peripheral volume distribution were 1.9 L/h and 31.6 L, respectively. Overall, 90 patients were included for therapeutic outcome analysis. The mortality rate was 10% and the treatment failure rate was 30%. ROC curve found cut-off points of AUC0-24/MIC <403 for 30-day mortality, and AUC0-24/MIC <398 was identified by CART and ROC curve. In logistic regression, PBS was associated with 30-day mortality, and AUC0-24/MIC <398 was significant risk factor for treatment failure.

    中文摘要 i Abstract iii 致謝 vi 表目錄 x 圖目錄 xii 縮寫與全名對照表 xiii 第一篇 血液透析患者使用萬古黴素治療oxacillin抗藥性金黃色葡萄球菌血流感染的藥效動力學指標與臨床療效之相關性 1 第一章 研究背景 1 第二章 文獻回顧 4 第一節 抗藥性金黃色葡萄球菌 4 2.1.1 流行病學 4 第二節 Vancomycin 基本特性 5 2.2.1 臨床使用 6 2.2.2 不良反應 6 2.2.3 藥效學 7 2.2.4 藥物動力學 12 第三節 間歇性血液透析簡介與對vancomycin清除率的影響 15 2.3.1 血液透析 15 2.3.2 血液透析器 16 2.3.3 間歇性透析對vancomycin清除率的影響 17 第三章 研究目的與重要性 19 第四章 研究方法 20 第一節 研究設計 20 4.1.1 研究地點與研究類型 20 4.1.2 研究期間 20 第二節 研究對象 20 4.2.1 納入條件 20 4.2.2 排除條件 20 第三節 研究流程 21 第四節 資料收集 23 4.4.1 資料來源 23 4.4.2 相關變項 23 4.4.3 研究操作型定義 23 4.4.4 族群藥物動力學模型 34 4.4.5 藥效動力學參數的取得與計算 35 第五節 統計方法 36 第五章 研究結果 39 第一節 收案對象 39 第二節 基本資料、特性及治療結果分析 41 第三節 藥物動力學模型 50 5.3.1 給藥療程、頻次及濃度資料 50 5.3.2 族群藥物動力學建模過程 54 5.3.3 各藥效學指標數值估算結果及分布狀況 66 5.3.4 Ctr與AUCpre-tr24之線性相關性 71 第四節 臨床療效與藥效學參數指標切點 72 5.4.1 30天死亡在各藥效學參數指標之切點預測 72 5.4.2 治療失敗在各藥效學指標之切點預測 75 5.4.3 治療指標參數的選擇 80 第五節 危險因子分析 83 5.5.1 30天死亡的危險因子 83 5.5.2 治療失敗的危險因子 85 第六章 討論 87 第一節 流行病學與研究族群的臨床特徵 87 第二節 血液透析患者的vancomycin藥物動態學分析 89 6.2.1 藥物動力學參數分析 89 6.2.2 藥效動力學參數分析 93 第三節 藥效學指標與臨床療效的關係 101 6.3.1 各治療結果之切點分析 101 6.3.2 危險因子分析 103 第四節 研究優勢與侷限 105 6.4.1 優勢 105 6.4.2 侷限 105 第五節 未來研究方向 107 第七章 結論與建議 108 第二篇 臨床藥事服務 109 第一章 服務動機 109 第二章 服務目的與方法 111 第一節 目的 111 第二節 方法 111 2.2.1 研究流程 111 2.2.2 研究區間、地點與對象 112 2.2.3 問卷調查 112 第三章 結果 117 第一節 第一階段研究結果 117 第二節 第二階段研究結果 118 第四章 結論與建議 119 參考文獻 120 附錄 130 附錄一 人體試驗委員會同意計畫證明書 130

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