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研究生:葉憲宗
研究生(外文):Hsien-Tsung Yeh
論文名稱:第二型糖尿病人施行塗藥血管支架手術後服用Thiazolidinediones對其預後之影響
論文名稱(外文):Effects of Thiazolidinediones in Patients with Type 2 Diabetes Mellitus after Drug-Eluting Stent Implantation
指導教授:黃文鴻黃文鴻引用關係蔡憶文蔡憶文引用關係
指導教授(外文):Weng-Foung HuangYi-Wen Tsai
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:衛生福利研究所
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2010
畢業學年度:98
語文別:中文
論文頁數:156
中文關鍵詞:塗藥支架糖尿病血管再手術心肌梗塞
外文關鍵詞:Thiazolidinedionesdiabetesrevascularizationmyocardial infarctiondrug-eluting stent
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背景:
近來許多研究顯示,thiazolidinediones(TZDs)可降低非塗藥支架手術後血管支架內的再狹窄,進而減少血管再手術的發生。隨著塗藥支架的使用越來越普遍,但有關塗藥支架與TZDs的研究仍付之闕如。
目的:
探討第二型糖尿病患者置放塗藥支架手術後服用TZDs對其心肌梗塞、血管再手術與死亡之影響。
研究方法:
本研究採回溯性世代觀察研究之設計,以2005年到2008年之全民健保資料庫進行分析。研究對象為2006年12月1日到2007年12月31日第一次置放塗藥支架之第二型糖尿病患者,並依支架上所塗的藥物將塗藥支架分成limus類塗藥支架與paclitaxel塗藥支架兩組。以手術出院後90天內之降血糖藥用藥情形分成TZD組與non-TZD組,且其用藥需在發生不良反應前。並運用Cox proportional hazard model之統計方法,分別比較其出院後一年內之血管再手術、心肌梗塞、死亡預後情形。並以propensity score校正其結果。
結果:
個案數共1743人 (TZD組268人;non-TZD組1475人),其中limus類塗藥支架655人 (TZD組113人;non-TZD組542人),paclitaxel塗藥支架1088人 (TZD組155人;non-TZD組933人)。TZD組相較於non-TZD組,在血管再手術發生風險部分皆無顯著差異:未分支架種類(HR=0.853, 95%CI:0.575–1.267);limus類塗藥支架(HR=0.764, 95%CI:0.382–1.527);paclitaxel塗藥支架(HR=0.905, 95%CI: 0.554–1.480)。在心肌梗塞發生風險部分亦皆無顯著差異:未分支架種類(HR=1.228, 95%CI: 0.723–2.088);limus類塗藥支架(HR=0.930, 95%CI: 0.341–2.536);paclitaxel塗藥支架(HR=1.376, 95%CI: 0.728–2.599)。而在心肌梗塞或死亡的發生風險部分一樣皆無顯著差異:未分支架種類(HR=1.204, 95%CI: 0.73–1.985);limus類塗藥支架(HR=0.868, 95%CI: 0.320–2.35);paclitaxel塗藥支架(HR=1.344, 95%CI: 0.746–2.422)。最後在重大心血管事件(包括血管再手術、心肌梗塞、死亡)的發生風險部分亦皆無顯著差異:未分支架種類(HR=0.961, 95%CI: 0.682–1.355);limus類塗藥支架(HR=0.900, 95%CI:0.496–1.632);paclitaxel塗藥支架(HR=0.981, 95%CI: 0.637–1.509)。
進一步的分層分析中,置放limus類塗藥支架且有心肌梗塞病史之病患,術後服用TZDs似乎有較高心肌梗塞發生風險(HR= 5.292, 95%CI: 1.028 – 27.232),其它皆未有顯著差異。另在使用TZDs的族群中,limus類塗藥支架與paclitaxel塗藥支架的之預後亦未有顯著差異。
結論:
本研究之結果顯示,第二型糖尿病患無論是置放limus類塗藥支架或是paclitaxel塗藥支架,術後服用TZDs皆未發現其對血管在手術、心肌梗塞、死亡與重大心血管事件有顯著的改善。但有心肌梗塞病史且置放limus塗藥支架之病患,術後服用TZDs似乎有較高心肌梗塞發生風險。未來仍需較大型且長時間的研究來加以釐清。
Background
Recent studies have demonstrated that thiazolidinediones (TZDs) may reduce in-stent restenosis and improve clinical outcomes in patients with type 2 diabetes after bare-metal stent implantation. However, with the widespread use of drug-eluting stent(DES), it is still unknown whether diabetic patients with DES could also benefit from the treatment with TZDs.Our study focused on the effects of TZDs on clinical outcomes of diabetic patients after DES implantation.

Objectives
To compare clinical outcomes of type 2 diabetic patients with and without TZDs therapy after receiving DES.

Methods
We conducted a retrospective cohort study using the National Health Insurance Database (NHIRD) to identify 1,743 patients with type 2 diabetes mellitus and received the first limus-eluting stent or paclitaxel-eluting stent placement from December 1, 2006, through December 31, 2007. Follow-up data were available through December 31, 2008. Patients were classified into TZD group(n=268) or non-TZD group(n=1475) based on the antidiabetic agents they took from pharmacy records within 3 months after the index hospitalization . Our measure of effectiveness was the prevalence of death, myocardial infarction and repeat revascularization(percutaneous coronary intervention, coronary artery bypass surgery) within one year after index hospitalization. The Cox proportional hazards model and other analyses were performed in this study.

Results
Between TZD group and non-TZD group, there were no significant difference in adjusted hazard ratio of death, myocardial infarction and repeat revascularization, whether patients received limus-eluting stent or paclitaxel-eluting stent. In stratified analysis, patients who received limus-eluting stent with history of myocardial infarction and treated with TZDs were associated with a higher risk of myocardial infarction (HR= 5.292, 95%CI: 1.028 – 27.232). To Compare patients who received limus-eluting stent with those who received paclitaxel-eluting stent in TZD group, the adjusted hazard of adverse events within one year were no significant difference.

Conclusion
Our findings suggest that TZDs could not improve clinical outcomes in type 2 diabetes patients after drug-eluting stent implantation. TZDs may contribute to higher risk of myocardial infarction in patient with limus-eluting stent and history of myocardial infarction. Larger clinical trials are still needed to further clarify the clinical outcome of TZDs therapy after drug-eluting stent implantation .
目次
中文摘要 i
Abstract iii
目次 v
表次 vii
圖次 viii
第一章 緒論 1
第一節 研究背景與動機 1
第二節 研究目的 3
第三節 研究問題 3
第二章 文獻探討 4
第一節 冠狀動脈血管支架 4
第二節 糖尿病 15
第三節 Thiazolidinediones(TZDs) 20
第四節 Thiazolidinedione類藥物與血管支架 26
第三章 研究方法 37
第一節 研究設計 37
第二節 研究架構 39
第三節 研究假設 41
第四節 資料來源與個案選取 42
第五節 研究變項定義及測量 44
第六節 資料處理與統計分析 56
第四章 研究結果 60
第一節 置放塗藥支架術後有無使用thiazolidinediones之預後分析 61
第二節 置放limus類塗藥支架術後有無使用thiazolidinediones之預後分析 76
第三節 置放paclitaxel類塗藥支架術後有無使用thiazolidinediones之預後分析 92
第四節 Limus類塗藥支架與paclitaxel塗藥支架術後有無使用TZDs對其預後之分層分析 107
第五節 使用thiazolidinediones族群對置放limus類塗藥支架與paclitaxel塗藥支架之預後分析 110
第五章 討論 125
第一節 研究結果之討論 125
第二節 研究方法之討論 129
第三節 研究限制 132
第六章 結論與建議 133
第一節 結論 133
第二節 建議 134
參考文獻 135
附錄 146


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