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研究生:何紀賢
研究生(外文):Chi-Hsien Ho
論文名稱:預測HMG-CoA還原酶抑制劑藥物治療期間糖尿病患發生肝毒性之預測量表建立
論文名稱(外文):Development of a Risk Score for Predicting Hepatotoxicity during HMG-CoA Reductase Inhibitors Therapy in Diabetic Patients
指導教授:陳香吟陳香吟引用關係
學位類別:碩士
校院名稱:臺北醫學大學
系所名稱:藥學研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2008
畢業學年度:96
語文別:中文
論文頁數:96
中文關鍵詞:HMG-CoA還原酶抑制劑肝毒性預測量表
外文關鍵詞:HMG-CoA Reductase InhibitorsHepatotoxicityRisk Score
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HMG-CoA還原酶抑制劑 (3-hydroxy-3-methyl-gutaryl-CoA reductase inhibitors, statins) 引起的肝毒性雖常見,但多數病人肝功能指數會自發性回復正常,因此臨床上糖尿病人使用時監測情形並不如藥品仿單建議的頻繁。但若嚴重肝毒性發生,就可能會降低病人的服藥配合度,甚至損害健康。糖尿病盛行率逐年增加,估計其中約有50%患者會同時併有血脂異常,因此常需併用statins治療。除了高血脂,肝臟疾病也是一個重要卻常被忽略的糖尿病合併症。在糖尿病病人接受statins治療時,應要有符合臨床需要和經濟效應的肝功能監測建議,以有效的進行肝功能檢測,並避免肝臟相關不良反應導致服藥依順性低而造成浪費。
本研究目的為利用糖尿病患者在statins 治療期間發生肝毒性的危險因子,建立一套預測量表,以輔助肝功能監測的安排。收案地點為台北醫學大學-市立萬芳醫院,共回溯219名糖尿病患之病歷,收集資料包括病人基本資料與合併疾病、生化檢驗數據,與使用藥物品項與劑量等。以univariate analysis評估潛在危險因子與statins使用期間發生的肝毒性之相關性。具有統計意義的危險因子再以logistic regression進行分析,並以危險因子進行配分,建立statins使用期間發生肝毒性的預測量表。量表之配適度以Hosmer-Lemeshow test評估,其檢測力則以receiver-operating characteristic (ROC) curve 下的面積(AUC)、sensitivity與specificity示之。
經過logistic regression分析並建立的量表總共包括五項危險因子:(1)男性,(2)三酸甘油脂的檢驗基準值,(3)糖尿病罹病期間,(4)合併疾病數,以及(5)病患所使用的angiotensin-converting enzyme inhibitors (ACEI)之每日處方劑量(Prescribed Daily Dose, PDD) 與每日定義劑量(Defined Daily Dose,DDD) 的比率。ROC 曲線下面積為0.864,Hosmer-Lemeshow test 的p 值為0.674,所得預測量最佳切點(cutoff point)為4.5分。大於50%以上的肝毒性發生在statins使用後半年內,因此建議STH預測量表得分大於4.5分的糖尿病患,應在statins開始使用的第三個月、第六個月、第十二個月,與第十八個月進行肝功能監測。
HMG-CoA reductase inhibitors (statins)-induced hepatotoxicity is a common adverse effect characterized by asymptomatic and transient elevations in liver enzymes. Due to the self-resolving nature, even without statin discontinuation, the frequency of monitoring of liver function tests (LFT) in patients receiving statin therapy is usually lower than the manifacturers’ recommendations. Although hepatotoxicity is rarely severe, once it occurs, patients are endangered directly by the event itself and indirectly from lowered patient compliance. Hyperlipidemia and liver diseases are important diabetic comorbidities. While statin is the most commonly prescribed lipid lowering agent, its hepatotoxicity in diabetic hyperlipidemic patients requires further evaluation. Current LFT monitoring recommendations should adjust to accommodate the clinical needs of diabetic patients during statins therapy.
This retrospective analysis was conducted to determine factors associated with hepatotoxicity among diabetic patients during statins therapy and to develop a risk score. Data of 219 patients were collected from the medical charts of Municipal Wan-Fang Hospital. Potential risk factors were assessed by univariate analysis for their association with hepatotoxicity during statin therapy. Factors significantly associated with the outcome were further evaluated in logistic regression analysis. A risk model was constructed by regression coefficients. Hosmer-Lemeshow test was performed to evaluate model fit. Discriminatory power was determined by area under receiver-operating characteristic curve (ROC curve).
Five risk factors were found significantly associated with hepatotoxicity during statin therapy and were incorporated to construct a risk model predicting hepatotoxicity. These factors included: (1) male gender, (2) baseline triglyceride level, (3) years since diabetes diagnosis, (4) number of diagnoses, and (5) PDD/DDD (Prescribed Daily Dose/Defined Daily Dose) ratio of angiotensin converting enzyme inhibitors. Area under ROC curve was 0.864 for the predictive model. Hosmer-Lemeshow test revealed a p-value of 0.674. Base on the findings in this study, it is advised that diabetic patients with STH score of 4.5 or above should monitor liver function at baseline, month 1, 3, 6, 9, 12, and 18 after initiation of statins.
中文摘要 3
英文摘要 4
目次 5
表目錄 7
圖目錄 9
第1章 緒論 1
第2章 文獻探討 2
2.1 HMG-COA REDUCTASE於糖尿病血脂異常之臨床用途與使用現況 2
2.1.1 糖尿病血脂異常 2
2.1.2 降血脂藥物在糖尿病合併血脂異常的治療 7
2.1.3 HMG-CoA Reducatse Inhibitors之臨床用途與使用現況 9
2.2 HMG-COA REDUCTASE INHIBITORS引起之藥物不良反應 12
2.3 藥物引起之肝毒性 15
2.3.1 藥物引起肝毒性之分類與機轉 15
2.3.2 藥物引起肝毒性的危險因子 17
2.3.3 HMG-CoA Reductase抑制劑引起之肝毒性 18
2.3.4 HMG-CoA Reductase 抑制劑引起肝毒性的危險因子 18
第3章 研究目的 20
第4章 研究方法 21
4.1 研究設計 21
4.2 研究對象 22
4.2.1 本研究納入之對象 22
4.2.2 本研究之排除標準 22
4.3 資料收集 23
4.3.1 資料收集之內容 23
4.3.2 研究相關定義 24
4.4 肝毒性判定與評估 30
4.4.1 藥物引起之肝毒性分類 30
4.4.2 肝毒性與Statins相關性之評估 30
4.5 資料統計與分析 32
4.5.1 基本資料分析 32
4.5.2 肝毒性相關因子分析 32
4.5.3 預測量表建立與驗證 33
第5章 研究結果 35
5.1 研究對象初步資料分析 35
5.1.1 研究對象納入狀況 35
5.1.2 基本資料分析 35
5.1.3 糖尿病患者Statins與併用藥物使用情形 36
5.1.4 研究對象檢驗基準值 38
5.2 糖尿病患者STATINS使用期間肝毒性發生率 41
5.2.1 肝毒性發生率 41
5.2.2 肝毒性發生時間點與檢驗值 41
5.2.3 肝毒性與不良反應的相關性評估 43
5.3 肝毒性相關危險因子分析 45
5.3.1 研究對象基本資料 45
5.3.2 生化檢測基準值 47
5.3.3 Statins與併用藥物 48
5.4 預測量表的建立 52
5.5 預測量表的驗證 55
第6章 討論 63
6.1 糖尿病患在STATINS治療期間發生之肝毒性 63
6.2 肝毒性的危險因子 65
6.2.1 性別 65
6.2.2 糖尿病罹病時間 67
6.2.3 三酸甘油酯檢驗基準值 68
6.2.4 合併疾病 69
6.2.5 Statins與合併藥物 70
6.3 使用STATINS期間之肝功能監測 76
第7章 研究限制 78
第8章 結論 79
參考文獻 80
附件 87
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