臺灣博碩士論文加值系統

研究動機與目的：2009年衛生福利部核准二肽基肽酶-4 抑制劑(Dipeptidyl peptidase-4 inhibitors, DPP-4 inhibitors)作為第二型糖尿病治療二線用藥。DPP-4 inhibitors類藥品可改善傳統口服降血糖藥物之副作用，但有國外研究發現其與骨折風險具相關性，因此本研究目的為探討台灣第二型糖尿病患使用DPP-4 inhibitors類藥品與骨折風險之相關性。
研究方法：本研究資料來源為國家衛生研究院「全民健康保險學術研究資料庫」之「承保抽樣歸人檔」(LHID2010)，研究對象為2009年至2013年間新發生之第二型糖尿病患者。排除2008年1月至12月間曾罹患第二型糖尿病及骨折之對象，另排除2013年新發生第二型糖尿病之個案，以確保樣本確診後追蹤時間至少有一年。另使用傾向分數配對法，以增加實驗組與對照組樣本之可比較性；利用卡方檢定(Chi-squared test)分析第二型糖尿病患有無使用DPP-4 inhibitors類藥品與骨折之相關性；採用邏輯斯迴歸模型探討DPP-4 inhibitors類藥品與骨折之相關因素。
研究結果：本研究以1:4配對得到使用DPP-4 inhibitors類藥品之799人，未使用DPP-4 inhibitors類藥品之3,196人。發現DPP-4 inhibitors類藥品與骨折並未有顯著相關性，糖尿病患發生骨折之顯著影響因素包含性別、年齡、疾病嚴重度及都市化程度等變項。其中，女性相較男性有1.34倍骨折風險（95% C.I.：1.153-1.555），而大於70歲以上之糖尿病患，骨折風險隨著年齡增加而上升，糖尿病患疾病嚴重度中度至重度，骨折風險為輕度之1.64倍及2.70倍(95% C.I.：1.223-2.207及1.819-3.998)。都市化程度高者，相較低者有1.98倍的骨折風險(95% C.I.：1.107-3.548)。
結論：本研究驗證DPP-4 inhibitors類藥品與骨折風險並未有顯著相關性，目前做為糖尿病二線治療用藥，尚屬安全。而糖尿病患之女性、年齡較高者、疾病嚴重度中度以上及都市化程度高者，皆為骨折發生之影響因素。本研究結果可提供醫藥衛生相關單位研擬相關用藥安全政策之參考。

Background and Objectives: Dipeptidyl peptidase-4 inhibitors(DPP-4 inhibitors) were second-line drug for the treatment of diabetes mellitus which have been approved by Ministry of Health and Welfare in 2009. DPP-4 Inhibitors can improve the side effects of traditional oral hypoglycemic agents, but foreign studies have found a correlation with fracture risk, so the purpose of this study is to explore the correlation between the use of DPP-4 Inhibitors and the risk of fracture in type II diabetes mellitus in Taiwan.
Methods: The data source is using the 2009 to 2013 Longitudinal Health Insurance Database (LHID2010), a nationally representative database established by National Health Research Institutes. All patients who have type II diabetes mellitus and fractures before 2009 will be excluded, and another case of new type II diabetes in 2013 will be excluded to ensure that the tracking time is at least one years. Use the Propensity Score to increase the comparability between the experimental group and the control group, using the Chi Squared test to analyze the correlation between the DPP-4 Inhibitors and the fracture of the second type diabetes mellitus, and to discuss the related factors of the DPP-4 Inhibitors drug and fracture with the logistic regression model.
Results: In this study, were used in the experimental group of DPP-4 Inhibitors drugs, 799 were not used DPP-4 Inhibitors drug control group 3,196. It was found that there was no significant correlation between DPP-4 Inhibitors and fracture, and the significant factors of fracture were the gender, age, severity of disease and degree of urbanization of the patients. Among them, women were 1.34 times more likely to fracture risk (95% C. I.：1.153-1.555) than men, and the risk of fracture increased with age as compared to those with diabetes over 70 years old. Moderate to severe degree of disease, the risk of fracture is 2.7 times the severity of mild disease (95% C.I.：1.82-4.00). The high degree of urbanization is 1.98 times the risk of fracture(95% C.I.：1.107-3.548) compared with those with low urbanization.
Conclusions: This study verified that there was no significant correlation between DPP-4 Inhibitors and the risk of fracture, and it was safe to use the second-line therapy for diabetes. The factors affecting the occurrence of the fracture were the women of diabetes mellitus, the higher age, the moderate degree of disease severity and the high degree of urbanization. The results of this study can provide a reference for the relevant drug safety policy.

目錄
中 文 摘 要 i
Abstract iii
謝誌 v
表目錄 viii
第一章 緒論 1
第一節、研究動機 1
第二節、研究目的 3
第二章、文獻探討 4
第一節、糖尿病流行病學 4
第二節、糖尿病之診斷、分類與治療 5
第三節、骨折之影響因素 8
第四節、口服降血糖藥物與骨折之相關性 10
第五節、文獻小結 13
第三章、研究方法 14
第一節、研究架構 14
第二節、研究對象與資料來源 15
第三節、研究設計與資料處理 18
第四節、研究工具 20
第五節、研究變項與操作型定義 21
第六節、分析方法 24
第四章、研究結果 25
第一節、糖尿病患基本特性之描述性統計 25
第二節、糖尿病患是否使用DPP-4 inhibitors與骨折之影響因素 28
第三節、糖尿病患是否使用DPP-4 inhibitors與骨折之相對風險 33
第五章、討論 39
第一節、DPP-4 inhibitors類藥品與骨折之相關性 39
第二節、骨折之影響因素 40
第六章、結論與建議 42
第一節、結論 42
第二節、建議 43
第三節、研究限制 44
參考文獻 45

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