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研究生:魏漢源
研究生(外文):Han-Yuan Wei
論文名稱:B型肝炎和新發糖尿病對腎移植患者的影響:台灣健保資料庫研究
論文名稱(外文):The Impact of HBV and New Onset Diabetes in Renal Transplant Recipients:A Nationwide Cohort Study in Taiwan
指導教授:張浤榮張浤榮引用關係
學位類別:碩士
校院名稱:中山醫學大學
系所名稱:醫學研究所
學門:醫藥衛生學門
學類:醫學學類
論文種類:學術論文
論文出版年:2017
畢業學年度:105
語文別:中文
論文頁數:54
中文關鍵詞:臺灣健保險資料庫之特殊重大傷病醫療資源使用族群(LHID-CIP)移植術後的新發糖尿病B型肝炎肝癌腎臟移植
外文關鍵詞:Longitudinal Health Insurance Database for catastrophic illness patients(LHID-CIP)New-onset diabetes after transplantation(NODAT)hepatitis B virus(HBV)hepatocellular carcinoma(HCC)Kidney transplantation
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研究目的:
本研究的目的是探討B型肝炎與移植後新發糖尿病之間的關聯,了解這些對腎移植受者的影響,並為醫療服務及預防醫學提供參考。

研究資料及方法:
使用臺灣健保險資料庫之特殊重大傷病醫療資源使用族群(LHID-CIP)建立世代研究。其中新發糖尿病(NODAT)定義為腎臟移植後之新診斷,慢性B型肝炎(HBV)則設定為移植前已有之感染狀態。藉由此二變量,將腎移植受者構建成四組:1)A組具有NODAT(-)/ HBV(-)2,341人的世代;2)B組具有NODAT(+)/ HBV(-)432人的世代;3)C組具有NODAT(-)/ HBV(+)204人的世代;4)D組具有NODAT(+)/ HBV(+)34人的世代。所有腎移植受者總共3,011人均自2000年開始追蹤,終點評估(end point)則以發生透析依賴(dialysis dependent)失償性肝硬化或肝癌(cirrhosis, decompensation, or hepatocellular carcinoma)、病患死亡(death)或直至2011年底為止,以先到者為準。

研究結果:
在各組當中以多變量Cox模型分析,C組具有相對略高的透析依賴性風險(aHR = 1.43, 95% CI = 1.01-2.03);肝損害風險分別在D組為8.77倍,B組為5.66倍,C組為2.17倍(95% CI = 2.71-28.4, 3.34-9.58 和1.21-3.89);而較高的死亡風險呈現在C組和B組(aHR = 1.90和1.96, 95% CI = 1.39-2.59和1.29-2.99)。

結論與建議:
腎臟移植術後的新發糖尿病為失償性肝功能惡化、肝硬化或肝癌之風險因素,而慢性B型肝炎明顯會加重此危害;除追蹤移植腎患者之腎臟功能外,定期肝臟檢查應當作為腎移植患者之定期評估。而盡量減少新發糖尿病之形成與B型肝炎之防治,也應該是預防的一部份,將有助於提升腎臟移植術後的長期存活率。
Objective:
The objective of this study is to explore the connection between the hepatitis B carrier and new onset diabetes after kidney transplantation and to understand those influences on renal transplant recipients, designing and conduct with other dimensions to provide references for medical care.

Materials and Methods:
We conducted a nationwide cohort study by using Longitudinal Health Insurance Database for catastrophic illness patients(LHID-CIP). New-onset diabetes was defined by the diagnosis after kidney transplantation, and chronic hepatitis B was described as pre-transplantation infection status. Four cohorts were constructed from the renal transplant recipients by variables: 1)A cohort(n = 2,341), with NODAT(-)/ HBV(-); 2)B cohort(n = 432), with NODAT(+)/ HBV(-); 3)C cohort(n = 204), with NODAT(-)/ HBV(+); 4)D cohort(n = 34), with NODAT(+)/ HBV(+). All renal transplant recipients(n = 3,011)were followed up from the inception point of 2000 until the development of dialysis-dependent, cirrhosis, liver decompensation, hepatocellular carcinoma(HCC), withdrawal from insurance or December 2011.

Results:
Among the subgroups, the C cohort had a slightly higher risk with dialysis-dependent(aHR = 1.43, 95% CI = 1.01-2.03)compared to A cohort in multivariable Cox model. The risk of liver disease with cirrhosis, decompensation, or HCC respectively were 8.77-fold in D cohort, 5.66-fold in B cohort, and 2.17-fold in C cohort than A cohort(95% CI = 2.71-28.4, 3.34-9.58 and 1.21-3.89, separately). Contrast with A cohort, C and B cohorts had a significantly higher mortality risk(aHR = 1.90 and 1.96, 95% CI = 1.39-2.59 and 1.29-2.99, respectively).

Conclusions:
New-onset diabetic after renal transplantation is the risk factor for liver decompensation, cirrhosis or hepatocellular carcinoma. The chronic hepatitis B can exacerbate the above hazard risk. Regular liver examinations should be therefore considered on the renal transplant recipients. The approach to minimize the development of new-onset diabetes and the prevention of hepatitis B infection should be parts of the treatment and that will improve the long-term survival after renal transplantation.
目錄

第一章 緒論
第一節 研究背景與動機 -------------------------------------------------1
第二節 研究目的 ----------------------------------------------------------3
第三節 研究重要性 -------------------------------------------------------4
第二章 文獻探討
第一節 腎臟移植 ----------------------------------------------------------5
第二節 B型肝炎於腎移植患者 ---------------------------------------12
第三節 新發糖尿病於腎移植患者 -----------------------------------15
第四節 全民健康保險研究資料庫 -----------------------------------18
第五節 實證研究 --------------------------------------------------------21
第三章 研究方法
第一節 研究設計 ---------------------------------------------------------24
第二節 研究架構 ---------------------------------------------------------25
第三節 研究假說 ---------------------------------------------------------29
第四節 操作型定義與統計方法 ---------------------------------------30
第四章 研究結果
----------------------------------------------------------------------------31
第五章 討論
----------------------------------------------------------------------------36
第六章 結論與建議
第一節 結論 ---------------------------------------------------------------39
第二節 限制與建議 ------------------------------------------------------40

參考文獻
中文部分 -------------------------------------------------------------------42
英文部分 -------------------------------------------------------------------44


附錄一 國際疾病分類編碼(ICD9-CM)
--------------------------------------------------------------------------52
附錄二 臨床試驗計畫許可書
--------------------------------------------------------------------------54


表目錄

表2-1-1
2009年至2016年國內肝、腎臟活體捐贈移植例數 -------------------9

表4-1
新發糖尿病和B型肝炎患者於腎移植術後的統計分布以及相關合併症-----------------------------------------------------------------------------------32

表4-2
依Cox比例風險回歸與時間依賴性協變量,新發糖尿病和B型肝炎患者的終點評估(危害比與95%置信區間) ------------------------------35


圖目錄

圖2-1-1 實體器官移植後感染的時序參考表-----------------------------6

圖2-1-2 美國、歐洲與台灣透析病患五年存活率(依年齡別)-----8

圖2-1-3 透析病患與台閩地區一般民眾平均餘命 ----------------------8

圖2-2-1 感染B型肝炎或C型肝炎之腎移植患者10年存活率------12

圖2-3-1 無罹患糖尿病、糖尿病、腎移植術後新發糖尿病之存活曲線分析(Kaplan-Meier curve)-------------------------------------------------15

圖2-4-1 全民健康保險資料庫抽樣歸人檔年齡分布圖 --------------18

圖3-2 論文研究流程架構圖 -----------------------------------------------24
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