社團法人臺灣臨床藥學會

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【案例報告】新型口服抗凝血藥物於心房顫動併有慢性腎臟疾病病人使用建議:實證案例報告
Recommendations of Novel Oral Anticoagulants in Patients with Atrial Fibrillation and Chronic Kidney Diseases: Evidence-Based Case Report
口服抗凝血藥物,心房顫動,慢性腎臟疾病,實證醫學、Novel Oral Anticoagulants, Atrial Fibrillation, Chronic Kidney Diseases, Evidence-Based Medicine
邵時傑Shih-Chieh Shao1 、楊宗翰Chung-Han Yang2,3 、陳玉瑩Yuk-Ying Chan1,* 、洪明銳Ming-Jui Hung4
1長庚醫療財團法人基隆長庚紀念醫院藥劑科 、2長庚醫療財團法人林口長庚紀念醫院內科部風濕免疫科 、3壢新醫院內科部 、4長庚醫療財團法人基隆長庚紀念醫院內科部心臟血管科
  預防中風是照護心房顫動病人的首要之務,但此類病人常合併有慢性腎臟疾病,而腎功能不良除了與藥物劑量調整和安全性有關之外,研究更證實中度慢性腎臟疾病 (glomerular filtration rate, GFR: 30 ~ 59 mL/min/1.73 m2) 為心房顫動病人發生中風的獨立危險因子。因此,如何提供這群病人安全又有效中風預防藥物是臨床重要的議題。治療指引建議,非瓣膜性心房顫動病人CHA2DS2-VASc 分數大於2 分時,需接受口服抗凝血藥物來預防中風發生,中度腎功能不全病人(肌酸酐清除率30 ~ 49ml/min)雖需將dabigatran、rivaroxaban 或apixaban 減量使用,但療效與安全性仍未完全建立。因此,對於腎功能不良病人,臨床醫師常陷入應該選用warfarin 或新型口服抗凝血藥物的難題。本報告呈現一件藥物諮詢案例,描述藥師如何以實證醫學之手法,搜尋現有最佳研究證據,告知醫師根據系統性回顧研究顯示,針對中度慢性腎臟疾病併有心房顫動病人於抗凝血藥物的選擇中,新型抗凝血藥物無論是在療效或安全性考量均優於warfarin,個別藥物中dabigatran 可顯著減少栓塞事件發生以及apixaban 有顯著較低的重大出血發生率。此外,本文也同時呈現對此議題相關的文獻回顧,並簡介實證醫學執行步驟及臨床應用。

    Stroke preventions are the top priorities in the management of atrial fibrillation (AF), but these patients are commonly accompanied by the comorbidity of chronic kidney diseases (CKD). Impaired renal functions are related to the dose adjustment and drug safety, and studies proved that moderate CKD (glomerular filtration rate, GFR: 30 ~ 59 mL/min/1.73 m2) is the independent risk factor for the occurrence of stroke. According to practice guidelines, oral anticoagulants are recommended for patients with non-valvular AF and a CHA2DS2-VASc score of 2 or greater. For patients with moderate CKD, treatment with reduced doses of novel oral anticoagulants (NOACs) may be considered, but safety and efficacy have not been established. Thus, clinical physicians are confronted with the dilemma with regard to which drug should be prescribed.
  This drug consulting report demonstrated how the pharmacist adopts the method of evidence-based medicine (EBM) to search up-to-date evidence to tell clinical physicians that NOACs are superior to warfarin in efficacy and safety in nonvalvular AF patients with moderate CKD. Among different NOACs, dabigatran and apixaban are significantly associated with reduced risk of stroke or systemic embolism and major bleeding, respectively. Moreover, we performed the literature review and
introduced the procedure and clinical implications of EBM in this report. 
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