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| 研究生： |
蔡文珊 Tsai, Wen-Shan |
|---|---|
| 論文名稱： |
末期腎臟病患者嚴重型皮膚不良反應之藥物流行病學研究 Pharmacoepidemiologic Research on Severe Cutaneous Adverse Reactions among Patients with End-stage Renal Disease |
| 指導教授： |
鄭靜蘭
Cheng, Ching-Lan 許釗凱 Hsu, Chao-Kai |
| 學位類別： |
碩士 Master |
| 系所名稱： |
醫學院 - 臨床藥學與藥物科技研究所 Institute of Clinical Pharmacy and Pharmaceutical sciences |
| 論文出版年： | 2018 |
| 畢業學年度： | 106 |
| 語文別： | 中文 |
| 論文頁數： | 143 |
| 中文關鍵詞： | 嚴重型皮膚不良反應 、末期腎臟病 、發生率 、危險因子 |
| 外文關鍵詞： | Severe Cutaneous Adverse Reactions, end-stage renal disease, incidence, risk factors |
| 相關次數： | 點閱：47 下載：0 |
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研究背景
嚴重型皮膚不良反應（Severe Cutaneous Adverse Reactions, SCARs）為延遲性的不良反應，通常於藥物使用幾週後發生，雖然發生率極低，但死亡率卻比一般的藥物不良反應更高，隨之而來的後遺症也對病患的生活品質造成影響。SCARs主要由藥物引起，不過病患本身的特性與共病症也會影響發生的風險，慢性腎臟病即為其中一個風險因子。末期腎臟病患者為慢性腎臟病中較為特殊的族群，但目前鮮少有探討末期腎臟病患者發生SCARs的相關研究，僅有幾篇零星的案例報告。至2016年為止，台灣約有七萬多名末期腎臟病患者，本研究希望藉由探討末期腎臟病患者發生SCARs的發生率與危險因子，提供臨床醫療的參考依據，促進末期腎臟病患者的用藥安全。
研究方法
運用2000年至2011年全民健康保險研究資料庫，納入罹患長期末期腎臟病且在確診前未曾發生過SCARs之患者，進行以下兩個研究：
研究一為回溯性世代研究，研究對象為首次使用研究藥物，且有一年以上就醫紀錄的末期腎臟病患者，追蹤180天觀察是否發生SCARs，並計算此族群發生SCARs的發生率。
研究二為巢式病例─對照研究，篩選確診末期腎臟病後首次發生SCARs的病患作為病例組，對照組為從未發生SCARs的末期腎臟病患者，兩組間依性別、年齡、末期腎臟病確診日期進行配對，配對比例為1:1至1:10，且每個對照組僅會與一個病例組配對。配對後將病例組發生SCARs的日期指派給相對應的對照組，並且僅納入有一年以上就醫紀錄的病患，最後分析發生SCARs的風險因子，包含病患七天內的藥物暴露與一年內的共病症。
研究結果
研究一經過納入與排除條件篩選後，有102,132位末期腎臟病患者，共381,987人次初次使用指標藥物，追蹤180天後共發生91件SCARs，包含36件SJS/TEN（39.6%）與55件DRESS（60.4%）。SJS/TEN的發生率為每百萬人年88.5例至899.8例，DRESS的發生率為每百萬人年161例至5949例，發生率的高低依序為allopurinol與抗癲癇藥物、抗生素、NSAIDs、PPIs與H2-blockers，allopurinol的潛伏期中位數為49天。
研究二經過納入、排除、配對條件篩選後，共有571位病例組與5,657位對照組進行發生SCARs與風險因子關聯性之分析。經過模型分析篩選後發現，當病患合併有高血壓、肝臟疾病、癌症時會增加發生SJS/TEN或DRESS的風險；在NSAIDs藥物中，使用fenamates的病患發生SJS/TEN的勝算比為0.53（95% CI 0.34-0.82），使用propionic acids發生DRESS的勝算比為0.71（95% CI 0.52-0.90）。
結論
本研究分析末期腎臟病患者發生SCARs之發生率與危險因子，結果顯示末期腎臟病患者發生SCARs的發生率較一般族群高，且allopurinol的潛伏期有延長之趨勢。當病患合併有高血壓、肝臟疾病、癌症時會增加發生SCARs的風險；另一方面，當末期腎臟病患者需要使用NSAIDs時，fenamates與propionic acids似乎是風險較低的選擇。
Severe Cutaneous Adverse Reactions (SCARs) are rare but life-threatening diseases that predominantly occur as adverse reactions to newly administered drugs. Comorbidities may increase risk of SCARs such as chronic kidney disease, but research of SCARs and ESRD is limited and only has few case reports. Therefore, we conducted a retrospective cohort study and a case-control study by using National Health Insurance Research Database from 1st Jan 2000 through 31st Dec 2011. We calculated incidence rates of SJS/TEN and DRESS after 180-day follow up period, and we also analyzed the risk factors of SJS/TEN and DRESS. The incidence rates of SJS/TEN ranged from 88.5 to 899.8 cases per million person-years, and the incidence rates of DRESS ranged from 161 to 5949 cases per million person-years. The risk factors of SJS/TEN were phenytoin, oxcarbazepine, hypertension, liver disease, heart failure, rheumatoid arthritis, and cancer. In the other hand, the risk factors of DRESS were levetiracetam, glycopeptides, hypertension, liver disease, ischemic heart disease, arrhythmia, peripheral artery disease, atopic dermatitis, and cancer. It seems that ESRD patients have higher incidence rates of SJS/TEN and DRESS. And when ESRD patients have comorbidities such as hypertension, liver disease, or cancer, they have higher risk of SJS/TEN and DRESS events. And we alse found that fenamates and propionic acids is safer than other NSAIDs for ESRD patients. This study provided evidence-based information to clinical practice for patients with ESRD, but further observational studies may be conducted.
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校內：2023-08-01公開校外：不公開