臺灣博碩士論文加值系統

中文摘要
研究背景
在台灣，心臟血管疾病在國人十大死因中不僅自2000年始至2003年，皆位居第三位，到2004年更躍升至第二位。冠狀動脈介入性治療術(Percutaneous Coronary Intervention；PCI)處置的技術與方法不斷進步，尤其是在冠狀動脈支架介入後，已大幅改善患冠狀動脈疾病(Coronary Artery Disease；CAD)病患的臨床結果。但是相較於塗藥型支架(Drug-eluting Stent；DES)，使用冠狀動脈支架(Bare Metal Stent；BMS)的再阻塞率仍是較高。然而，目前在台灣，使用塗藥型支架的臨床療效與資源耗用尚未有相關之研究結果。因此本研究之目的，在於探討使用裸露型支架與塗藥型支架之成本效果。
研究方法
本研究以回溯性研究方式評估在2003年7月至2005年2月間，接受PCI處置的個案，匹配塗藥型支架組(173人)與裸露型支架組(173人)之人口學變項。評估出院後一年內後續醫療結果和醫療資源利用，後續醫療結果含包死亡、急性心肌梗塞(Acute Myocardial Infarction；AMI)、鬱血性心衰竭(Congestive Heart Failure；CHF)和血管再重建(Target Lesion Revascularization；TLR)；醫療資源耗用則包含門診、住院次數和採行PCI處置的方式。
結　　果
在後續臨床結果中，整體心臟相關不良事件率在BMS組為30.63% (53/173)，DES組為18.49% (32/173)，其中血管再重建率在兩組間在統計上達顯著差異(p值為0.004)。在BMS組中，死亡為3人(1.73%)、AMI為2人(1.16%)、CHF為13人(7.51%)、TLR為35人(20.23%)；在DES組，死亡為1人(0.57%)、AMI為4人(2.31%)、CHF為11人(6.35%)、TLR為16人(9.25%)。醫療資源耗用中，在BMS組，其一年內門診利用為每人8.96次(SD=3.58)、再住院次數為每人0.61次(SD=0.65)，血管再重建所使用的方式中，採用氣球擴張術為每人0.16次(SD=0.41)、採用BMS為每人0.06次(SD=0.26)、採用DES則為每人0.02次(SD=0.13)；在DES組，其一年內門診利用為每人8.38次(SD=2.77)、再住院次數為每人0.61次(SD=0.62)，血管再重建所使用的方式中，採用氣球擴張術為每人0.08次(SD=0.35)、採用BMS為每人0.01次(SD=0.11)、採用DES則為每人0.05次(SD=0.24)。兩組間在血管再重建所使用的方式中，採用氣球擴張術(p = 0.05)和BMS(p = 0.03)方式是有顯著差異。透過迴歸模式分析，研究發現使用BMS和多條血管阻塞是影響TLR之預測因子。
結　　論
與裸露型支架比較的前提下，接受PCI處置的病人使用塗藥型支架後，確實能降低後續之血管再重建率，而由於DES的每支價格約為BMS的二至三倍。因此，接受PCI處置的病人，採用DES之成本效果仍是較低。
關鍵詞：冠狀動脈疾病、塗藥型支架、醫療資源利用、臨床療效

ABSTRACT
Background: Coronary artery disease (CAD) was the 3rd in top of ten death causes during 2000 to 2003 in Taiwan. However, it became the 2nd in 2004. Technology of percutaneous coronary intervention (PCI) is advancing very fast, and had improved the outcomes in treatment of patients with CAD, especially after using coronary stenting. However, the use of coronary stents was associated with unacceptable rates of restenosis, wich was improved significantely after the use of drug-eluting stents (DES). However, the overall clinical outcomes and resources utilization of DES are unknown in Taiwan. The purpse of the study is cost and effectiveness of BMS and DES.
Methods: This study retrospectively evaulated 173 DES patients and 173 BMS patients, with matched baseline clinical charatcteristics, in whome PCI were done during the period from Jul. 2003 to Feb. 2005. Clinical outcomes and resources utilization were assessed for all patients over a 1-year follow up period. Clinical outcomes indicators include all cause death, acute myocardial infarction (AMI), congestive heart failure (CHF) and target lesion revascularization (TLR). Resouces utilization indicators include out-patient visits, hospital re-admissions, device of PCI.
Results: The total clinical primary end point for the BMS group was 30.63% (53/173) and 18.49% (32/173), with the significant difference driven by the TLR (p value = 0.004). In the BMS group: death, AMI, CHF and TLR occurred in 3 (1.73%), 2 (1.16%), 13 (7.51%) and 35 (20.23%) patients respectively, while in the DES group: 1 (0.57%), 4 (2.31%), 11 (6.35%) and 16 (9.25%) respectively. In the BMS group there was 8.96(SD=3.58) out-patient visits, 0.61(SD=0.65) hospital re-admissions. Also; 0.16 (SD=0.41) balloons, 0.06 (SD=0.26) BMS, and 0.02 (SD=0.13) DES per patient were needed for revascularization in the BMS group. In the DES group there was 8.38 (SD=2.77) out-patient visits, 0.61 (SD=0.62) hospital re-admissions. Also; 0.08 (SD=0.35) balloons, 0.01 (SD=0.11) BMS, and 0.05 (SD=0.24) DES per patient were needed for revascularization in the DES group, (p value = 0.05 for balloons and p value = 0.03 for BMS needed for revascularization in the BMS versus DES group). Multivariate analysis demonstrated that BMS and multiple vessels disease were the strongest predictors of TLR.
Conclusion: As a real world practice, DES is effective at decreasing rates of TLR compared with BMS. However, the price of DES is two to three times than BMS. Therefore, the use of DES in Taiwan is less cost-effective in terms of collaborated clinical outcomes and resource use when compared to BMS for patients undergoing PCI.
Key Words: Coronary Artery Disease, Drug Eluting Stent, Medical Resource Utilization, Clinical Outcomes

目　　錄
致謝 I
中文摘要 II
英文摘要 IV
目錄 VI
圖目錄 VIII
表目錄 IX
附錄 X
第一章　緒論 1
第一節　研究背景與動機 1
第二節　研究目的 4
第三節　預期貢獻 5
第四節　名詞解釋 6
第二章　文獻探討 8
第一節　冠狀動脈疾病的發生、診斷及治療方式 8
第二節　探討接受裸露型支架與塗藥型支架病患之醫療結果實證研究 14
第三節　探討接受裸露型與塗藥型支架病患之醫療利用實證研究 26
第四節　探討影響CAD病患臨床療效之影響因子 30
第三章　研究方法 31
第一節　研究架構與假說 31
第二節　研究設計 34
第三節　研究對象與資料來源 35
第四節　研究工具之信效度檢測 37
第五節　研究變項與操作型定義 38
第六節　資料處理與統計分析方法 43
第四章　研究結果 45
第一節　個案醫院CAD病患所有接受PCI處置方式之利用現況 45
第二節　CAD病患接受不同PCI處置之基本資料結果 47
第三節　CAD病患接受不同PCI處置之臨床療效 51
第四節　CAD病患接受不同PCI處置之資源耗用結果 56
第五節　影響CAD病患臨床療效和醫療資源利用之影響因子 60
第五章　討論與建議 68
第一節　研究樣本之基本特質 68
第二節　研究結果討論 70
第三節　研究限制 82
第四節　結論與建議 84
參考文獻 86
中文文獻 86
英文文獻 87

圖目錄
圖2-1：心臟血管構造圖 8
圖2-2：冠狀動脈氣球擴張整型術 11
圖2-3：植入冠狀動脈內血管支架 12
圖3-1：研究架構 32
圖4-1：個案醫院使用不同PCI處置使用百分比 (2003年7月至2005年12月) 46
圖4-2：住院期間使用不同處置其MACE發生率 53
圖4-3：不同處置間出院後後續追蹤六個月之臨床結果 53
圖4-4：不同處置間出院後後續追蹤一年之臨床結果 54
圖4-5：不同處置間出院後一年內發生血管再重建率之情形 54
圖4-6：不同處置間住院中醫療資源使用 58
圖5-1：使用不同PCI處置逐月血管重建個案百分比 81

表目錄
表2-1：接受不同PCI處置病患之住院期間重大心臟血管不良事件實證研究 18
表2-2：接受不同PCI處置病患之後續追蹤醫療結果實證研究 20
表2-3：接受不同PCI處置病患之醫療資源利用實證研究 28
表3-1：研究變項一覽表 39
表4-1：個案醫院使用不同PCI處置使用量( 2003年7月至2005年12月) 46
表4-2：接受不同PCI處置之個人特質之差異 49
表4-3：接受不同PCI處置之危險因子和過去病史 49
表4-4：接受不同PCI處置之疾病嚴重程度 50
表4-5：檢定不同因子影響一年內血管再重建情形 55
表4-6：後續追蹤六個月及一年內之醫療資源耗用 59
表4-7：影響CAD病患住院中不良事件(MACE)影響因子 62
表4-8：影響CAD病患住院中死亡影響因子 63
表4-9：影響CAD病患出院後一年內不良事件影響因子 64
表4-10：影響CAD病患出院後一年內發生血管再重建影響因子 65
表4-11：影響CAD病患當次住院天數之影響因子 66
表4-12：影響CAD病患臨床療效和醫療資源利用之影響因子總表 67
表5-1：不同PCI處置間緊急處置分佈情形 79
表5-2：不同PCI處置間次族群住院中死亡率分佈情形 79
表5-3：研究假說之檢定結果總表 80

附　　錄
附錄3-1：冠狀動脈介入性治療術病歷摘錄表 91

參考文獻
中文文獻
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賴珊珊(2005)。接受經皮冠狀動脈介入性治療術病患之處置後三年醫療資源使用及臨床療效探討。未發表論文。高雄醫學大學健康科學院公共衛生研究所醫務管理學研究所碩士論文。
國際厚生健康園區　www.24drs.com
衛生署衛生統計網站　http://www.doh.gov.tw/cht/index.aspx


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