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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 何?芳 | |
dc.contributor.author | Jun-Hong Ye | en |
dc.contributor.author | 葉俊宏 | zh_TW |
dc.date.accessioned | 2021-06-08T02:27:21Z | - |
dc.date.copyright | 2015-09-24 | |
dc.date.issued | 2015 | |
dc.date.submitted | 2015-08-17 | |
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dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/19923 | - |
dc.description.abstract | 研究背景 藥物引致肝損傷的監測之於台灣等肝炎盛行區域格外重要。文獻顯示amiodarone在藥物引致肝損傷致死的排行中居前十名內,或許與其獨特的藥效學及藥動學特性有關,值得醫療專業人員多加留意其潛在之不良反應。 研究目標 本研究擬以國內藥物不良反應自主通報資料探討:(一)amiodarone相關肝損傷之通報案件的趨勢及其表徵;(二)amiodarone相關肝損傷之危險因子。 研究方法 收集並整理2000年迄2014年藥物不良反應通報中,使用amiodarone引致肝損傷(依MedDRA分類)案例,內容包括病人基本資料、潛伏期、不良反應結果、生化檢驗值む例如alanine aminotransferase (ALT)め、共病症及併用藥物等,敘述性討論案例資料並以統計軟體進行迴歸分析。 研究結果及討論 在十五年期間之肝損傷相關通報案例共3887件,其中由amiodarone引致的有55件(1.4%)。平均年齡為73.8 ± 11.5歲(mean ±SD);男女比為3:2;潛伏期小於7天的案例有35件(63.6%);平均每日劑量為582.3 ± 565.7 mg;大部分案例的受損類型為肝細胞型(81.0%)。單變項分析中,以不良反應結果嚴重度分組並沒有發現任何差異,但以潛伏期分組則發現急性組病人的直接膽紅素值(3.27 vs. 0.47 mg/dL; p = 0.040)、總膽紅素值(3.40 vs. 0.83 mg/dL; p = 0.048)及平均每日劑量(425.6 vs. 115.7 mg/dL; p < 0.001)的中位數都比慢性組高;多變項迴歸分析雖然皆未達到顯著,但可發現一些警訊,可能惡化預後的危險因子包含BSA校正後總劑量(OR = 1.00001; p = 0.413)、ALT最高值(OR = 1.0006; p = 0.168)、具肝病史者(OR = 3.41; 95% CI: 0.35–33.11; p = 0.290)及併用具肝損傷潛性藥品(OR = 1.70; 95% CI: 0.49–5.86; p = 0.403)。 結論 本研究呈現amiodarone相關肝損傷之長期通報狀況,雖因通報數有限及相關資料缺漏而難以提供明確定論,然而所得之初步警訊如劑量、膽紅素值等值得未來再進行更深入探討,亦期望藉此研究討論通報案件量及通報品質提升之意義。 | zh_TW |
dc.description.abstract | Background Vigilance of drug-induced liver injury (DILI) is especially important in hepatitis-prevalent areas such as Taiwan. The special pharmacodynamic and pharmacokinetic characteristics of amiodarone make it among the top ten culprit drugs for mortality due to DILI. Objectives The study aims to: (1) describe reporting tendency and pattern; and (2) delineate possible risk factors related to amiodarone-associated liver injury by using data from the Adverse Drug Reaction Reporting System in Taiwan. Methods Cases of amiodarone-associated liver injury (categorized by MedDRA) reported during 2000~2014 were included. Data on baseline characteristics, latency, adverse drug reaction outcomes, biochemistries [such as alanine aminotransferase (ALT)], underlying diseases, and concomitant drugs were all collected and evaluated by descriptive analysis and multiple logistic regression using statistical software. Results and Discussion Adverse drug reaction (ADR) reports related to liver injury were 3887 in total; 55 cases (1.4%) were associated with amiodarone. The latter cohort had a mean age of 73.8 years old; male to female ratio was 3:2; latency of 35 cases (63.6%) were less than 7 days; average daily dose was 582.3 ± 565.7 mg; hepatocellular type was the most encountered type (81.0%). There was no statistically significant difference between 'severe' (e.g. death, prolonged hospitalization, disability) and 'non-severe' groups by univariate analysis; however, the medians of direct bilirubin (3.27 vs. 0.47 mg/dL; p = 0.040), total bilirubin (3.40 vs. 0.83 mg/dL; p = 0.048), and average daily dose (425.6 vs. 115.7 mg/dL; p < 0.001) were higher in the 'acute group' (latency ≤ 90 days). Further multivariate regression analysis revealed interesting signals for outcome prediction, including cumulative dose/body surface area (OR = 1.00001; p = 0.413), peak ALT level (OR = 1.0006; p = 0.168), preexisting liver disease (OR = 3.41; p = 0.290), and co-medication with drugs of DILI potential (OR = 1.70; p = 0.403), even though statistically significance were not reached. Conclusions Case numbers in the study might be too small to draw conclusive remarks, especially by using the often under-reported and sometimes incomplete nature of the data source. Certain predictors, such as dose and bilirubin, identified in the study deserve to be explored further. Discussion for ways of enhancing quality and quantity of ADR reporting will also be provided. | en |
dc.description.provenance | Made available in DSpace on 2021-06-08T02:27:21Z (GMT). No. of bitstreams: 1 ntu-104-R02451008-1.pdf: 1522119 bytes, checksum: 73520feaf5673f1f551dfd412e1cf0e9 (MD5) Previous issue date: 2015 | en |
dc.description.tableofcontents | 摘要 i Abstract iii 目錄 v 圖目錄 viii 表目錄 ix 第一章 前言 1 第二章 文獻探討 2 第一節 藥物不良反應自主通報系統 2 一、各國藥物不良反應通報系統 2 二、臺灣藥物不良反應通報系統 5 三、藥物引致肝損傷系統 6 第二節 藥物引致肝損傷 7 一、藥物引致肝損傷定義 7 二、相關性評估 10 第三節 心律不整及其治療概述 11 一、正常的心律傳導方式 11 二、心律不整及其處置 12 三、抗心律不整藥物治療簡介 13 第四節 Amiodarone綜述 14 一、Amiodarone藥物特性 14 二、Amiodarone治療地位 15 三、Amiodarone相關不良反應簡介 16 四、Amiodarone與肝損傷 19 第三章 研究目的 20 第四章 研究方法 23 第一節 研究對象 23 一、藥物不良反應通報案例 23 第二節 資料蒐集 25 一、收案內容 25 二、判讀藥物引致肝損傷之種類 25 第三節 統計分析 27 一、描述性分析 27 二、迴歸分析 28 第五章 研究結果 29 第一節 研究對象基本資料 30 一、不良反應通報案例 30 第二節 迴歸分析 50 第六章 討論 51 第一節 研究限制 51 一、研究對象人數 51 二、通報資料評估 51 三、其他限制因素 52 第二節 肝毒性之危險因子 53 一、不良反應結果分組 53 二、潛伏期分組 54 第三節 藥物不良反應自主通報系統 55 一、自主通報系統之應用及價值 55 二、建議事項 55 第八章 結論 57 參考文獻 58 附錄一 Naranjo量表 64 附錄二 Roussel Uclaf Causality Assessment Method (RUCAM)量表 65 | |
dc.language.iso | zh-TW | |
dc.title | Amiodarone相關肝損傷自主通報案例分析:2000-2014年 | zh_TW |
dc.title | An Analysis on Spontaneous Reporting Amiodarone- Associated Liver Injury: 2000-2014 | en |
dc.type | Thesis | |
dc.date.schoolyear | 103-2 | |
dc.description.degree | 碩士 | |
dc.contributor.oralexamcommittee | 陳瓊雪,于明暉,陳文雯 | |
dc.subject.keyword | 藥物不良反應,肝損傷,藥物監測, | zh_TW |
dc.subject.keyword | adverse drug reactions,hepatotoxicity,pharmacovigilance, | en |
dc.relation.page | 66 | |
dc.rights.note | 未授權 | |
dc.date.accepted | 2015-08-17 | |
dc.contributor.author-college | 藥學專業學院 | zh_TW |
dc.contributor.author-dept | 臨床藥學研究所 | zh_TW |
顯示於系所單位: | 臨床藥學研究所 |
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