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系統識別號 U0026-1908201416243200
論文名稱(中文) 台灣地區SLE病人類固醇之處方型態分析
論文名稱(英文) Pattern of Glucocorticoids in Taiwan SLE Patients
校院名稱 成功大學
系所名稱(中) 臨床藥學與藥物科技研究所
系所名稱(英) Institute of Clinical Pharmacy and Pharmaceutical sciences
學年度 102
學期 2
出版年 103
研究生(中文) 陳俊名
研究生(英文) Chun-Ming Chen
學號 s66001044
學位類別 碩士
語文別 中文
論文頁數 144頁
口試委員 指導教授-高雅慧
召集委員-劉明煇
口試委員-張慧真
口試委員-戴淑華
中文關鍵字 類固醇  處方型態  全身性紅斑狼瘡  帶狀皰疹 
英文關鍵字 Glucocorticoid  Prescribing patterns  Systemic lupus erythematosus  Herpes zoster 
學科別分類
中文摘要 研究背景
全身性紅斑狼瘡(systemic lupus erythematosus,SLE)是一種侵犯到多重器官的慢性自體免疫疾病,患者必須長期使用藥物以控制病情。其中,類固醇是最常使用到的藥物。但類固醇長期服用,可能導致各種副作用的發生。然而類固醇使用的安全劑量目前尚未被明確定義,但每日劑量< 7.5毫克prednisone/天似乎有較少的副作用發生。因此,本研究希望能分析台灣地區SLE病人之治療用藥及類固醇的處方型態,並探討病患於SLE確診後,經由類固醇治療可能產生的各項共病症發生率為何。且針對類固醇使用與帶狀皰疹發生的相關性進行探討。

研究方法
本研究是一個全國性,以人群為基礎的回溯性世代研究,以台灣全民健康保險研究資料庫數據為資料來源。利用全民健康保險研究資料庫之重大傷病證明明細檔,擷取診斷代碼為「710.0」全身性紅斑狼瘡患者,且其第一筆重大傷病卡申請日期需介於2001年1月1日至2005年12月31日之間,定義為新確診之SLE患者。分析SLE確診後五年期間類固醇以及其他SLE治療用藥處方型態,並進行類固醇相關之共病症發生率分析。此外,本研究亦進行嵌入型病例對照研究。病例組與對照組兩組之間以年齡、性別為配對條件,每一個感染帶狀皰疹且住院之病例組患者最多將配對到8個對照組患者。以多變項條件式邏輯迴歸分析法,並以免疫抑制劑使用與疾病史為校正因子,分析SLE患者類固醇使用與帶狀皰疹發生之相關性。

研究結果
本研究共納入4,894位SLE患者。其中包含4,333位女性患者(88.54 %)。平均年齡為38.55±14.93年。於觀察期間,類固醇平均每日劑量為6.47毫克prednisone相等劑量/天。患者會在第一年使用較高的類固醇劑量(類固醇平均每日劑量為10.79毫克prednisone相等劑量/天),之後逐年減少。病患在確診後第一年罹患與類固醇使用相關之共病症發生率較高,之後亦呈現逐年減少的趨勢。
另一嵌入型病例對照研究法分析SLE患者其類固醇使用與帶狀皰疹發生之相關性。共納入1,927位SLE患者,含發生帶狀皰疹且住院之病例組215位及1:8比例匹配年齡及性別之無帶狀皰疹發生且住院之對照組1,712位。結果顯示,指標日期前365天內,病例組相對於對照組,類固醇的暴露劑量較高。以多變項條件式邏輯回歸分析,暴露高劑量類固醇的(類固醇平均每日劑量≥7.5毫克prednisone相等劑量/天)會增加帶狀皰疹發生之風險( p < 0.001)。

結論
在台灣地區,類固醇是SLE患者最常使用到的藥物。這群病患必須小心監測與類固醇相關副作用的發生。當使用到高劑量類固醇時,亦須特別注意帶狀皰疹的發生。
英文摘要 Glucocorticoids are the mainstay of therapy for SLE, but have been associated with the development of many adverse effects. A daily dose of prednisone < 7.5 mg seems to minimize these adverse effects. This study was aimed to investigate the prescribing patterns of glucocorticoids, the incidence of treatment-related comorbidities and the relationship between the use of glucocorticoids and herpes zoster in Taiwan SLE patient.
This nationwide, population-based, retrospective cohort study used data from the National Health Insurance Research Database of Taiwan. We identified patients who was issued a catastrophic illness certificate for SLE for the first time during 2001-2005 and had used glucocorticoids during the following 5 years. A total of 4,894 incident SLE patients were included. Mean age was 38.55±14.93 years. During the 5-year follow-up, the mean daily dose of glucocorticoid patients received was 6.47 mg prednisone equivalent, respectively. Patients received higher glucocorticoid dose and higher incidence of the comorbidities in the first year and gradually reduced annually.
In another nested case-control study, SLE patients were classified as cases if herpes zoster were occurred in hospital during the following 5 years after SLE diagnosed. SLE patients who never had herpes zoster were eligible as controls and were matched 8:1 to cases for age and sex. The results showed that 365 days before the index date, the case group exposure higher dose of glucocorticoid. In the multivariate logistic regression analysis, exposure of higher dose of glucocorticoids (daily prednisone dose ≥7.5mg) increased the risk of herpes zoster.
論文目次 第一篇、 台灣地區全身性紅斑狼瘡病人類固醇之處方型態分析……………1
第一章、 研究背景………………………………………………………………1
第二章、 文獻回顧………………………………………………………………2
第一節、 流行病學………………………………………………………………2
第二節、 病因學…………………………………………………………………3
第三節、 臨床表徵………………………………………………………………5
第四節、 診斷……………………………………………………………………6
第五節、 治療……………………………………………………………………8
第六節、 SLE治療用藥處方型態分析…………………………………………11
第七節、 類固醇的使用與副作用………………………………………………12
第三章、 研究目的與重要性……………………………………………………17
第四章、 研究方法………………………………………………………………18
第一節、 研究設計(一) 類固醇處方型態分析………………………………18
第二節、 研究設計(二) 類固醇使用與帶狀皰疹發生之相關性……………29
第三節、 資料處理流程…………………………………………………………38
第四節、 統計方法………………………………………………………………39
第五章、 研究結果………………………………………………………………41
第一節、 SLE治療用藥處方型態分析…………………………………………41
第二節、 類固醇處方型態分析…………………………………………………47
第三節、 類固醇使用與帶狀皰疹發生之相關性分析…………………………56
第六章、 研究討論………………………………………………………………72
第一節、 SLE治療用藥處方型態分析…………………………………………72
第二節、 類固醇處方型態分析…………………………………………………76
第三節、 類固醇使用與帶狀皰疹發生之相關性分析…………………………78
第四節、 研究優勢與限制………………………………………………………84
第七章、 結論與建議……………………………………………………………86
第八章、 未來研究方向…………………………………………………………87
第二篇、 建立有效方法改善藥品包裝與標示…………………………………88
第一章、 研究背景………………………………………………………………88
第二章、 研究目的及重要性……………………………………………………93
第三章、 研究方法………………………………………………………………94
第四章、 研究統計方法…………………………………………………………96
第五章、 研究名詞、研究變項與操作定義……………………………………97
第六章、 研究結果與討論………………………………………………………99
第一節、 建立藥品標示及包裝評估準則………………………………………99
第二節、 口服藥品標示及包裝評比……………………………………………99
第三節、 台灣廠及國外廠口服藥品標示及包裝評比…………………………109
第四節、 門診病患口服藥品完整包裝交付率…………………………………127
第七章、 結論與建議……………………………………………………………133
參考文獻…………………………………………………………………………134
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