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系統識別號 U0026-3107201311024800
論文名稱(中文) 臺灣乾眼症之流行病學與處方型態分析
論文名稱(英文) Epidemiology and Prescribing Pattern of Dry Eye Disease in Taiwan
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 101
學期 2
出版年 102
研究生(中文) 陳玫潔
研究生(英文) Mei-Chieh Chen
電子信箱 meijie0114@gmail.com
學號 S66004034
學位類別 碩士
語文別 中文
論文頁數 115頁
口試委員 指導教授-高雅慧
口試委員-張義昇
口試委員-翁孟玉
口試委員-林文亮
中文關鍵字 乾眼症  發生率  長期使用  全民健康保險研究資料庫  處方型態  盛行率  臺灣  眼用製劑  類固醇 
英文關鍵字 dry eye  incidence  long-term use  NHIRD  prescribing pattern  prevalence  Taiwan  topical steroid 
學科別分類
中文摘要 研究背景
乾眼是眼科門診中常見的主訴,各國文獻中的盛行率變異度大,約介於 <0.1~33%,但整體盛行率隨年齡增加而向上攀升,先前的研究顯示亞洲地區有較高盛行率,而目前關於臺灣乾眼症流行病學的研究不多。過去認為乾眼症的治療以給予人工淚液緩解症狀即可,但近年研究發現乾眼症致病機轉與發炎反應有關,因此局部抗發炎藥物在乾眼症的治療中開始佔有一席之地,而臺灣目前缺乏乾眼症處方型態的相關研究。中重度乾眼症患者可能需長期依賴局部抗發炎藥物緩解症狀,目前環孢靈素眼用製劑(cyclosporine)未發現嚴重副作用,但國內價格昂貴且需符合健保給付規定;相對而言,含類固醇眼用製劑則相對便宜且無健保給付限制,因此臨床上醫師有選擇使用後者之可能性,但其潛在副作用風險,通常不建議長期使用。

研究目的
統計臺灣乾眼症的流行病學資料,觀察臺灣乾眼症患者之人口學特性,並分析年齡、性別差異或都市化程度對於發生率之影響,以做為未來乾眼症預防的實證依據。此外,本研究將觀察乾眼症患者的處方型態,並進一步分析患者長期使用含類固醇眼用製劑之相關潛在預測因子。

研究方法
使用臺灣全民健康保險研究資料庫中,2000年與2005年的百萬人承保抽樣歸人檔,共約二百萬人,擷取2000年至2010年的就醫資料。研究對象為2005年至2009年期間於門診紀錄檔中,出現乾眼症診斷碼 (ICD-9 370.33, 375.15, 710.2),且具Schirmer test紀錄者,或經重大傷病檔確認為Sjögren’s syndrome者。新診斷乾眼症為指標日期前五年內未出現乾眼症診斷者。
研究對象自指標日期後追蹤一年,分析臺灣乾眼症患者之處方型態。此外,將指標日期後30天內曾使用含類固醇眼用製劑者,分為長期使用者與非長期使用者,利用單變項與多變項邏輯迴歸,分析臺灣乾眼症患者長期使用含類固醇眼用製劑之潛在預測因子。

研究結果
研究對象共44,501人,平均年齡51.5歲,女性占73.6%,50歲(含)以上占55.7%,僅2.0%為Sjögren’s syndrome。乾眼症平均發生率0.37%,平均盛行率0.86%。研究對象於乾眼症診斷後30天內的乾眼症治療藥物使用率約66.4%,其他眼用製劑約32.5%,未使用眼用製劑約1.1%。研究對象中,於指標日期後365天內再次回診者共23,327人,前30天內的乾眼症治療藥物使用率71.0%,其他眼用製劑占27.6%,未使用眼用製劑占1.4%。就再次回診者的乾眼症治療藥物分組而言,單獨使用人工淚液占19.5%,單獨使用含類固醇眼用製劑占27.6%,其中19.3%患者併用上述二類藥物,單獨使用其他乾眼症治療用藥物僅占4.6%。指標日期後30天到一年,研究對象的乾眼症治療藥物平均使用率為28.5%,僅剩原使用人數的42.9%;再次回診者的平均使用率維持41.8%,為原使用人數的58.9%。
含類固醇眼用製劑的使用者共22,060人,6,338人為長期使用者。長期使用的預測因子,包含年齡、男性、糖尿病、角膜移植術後、青光眼、白內障、結膜炎、眼瞼發炎、眼表受傷或挫傷、人工水晶體置換等,或併服藥物如antihistamines、anticholinergics等,其中角膜移植術後最顯著 (OR 5.95)。

研究結論
臺灣乾眼症的發生率與盛行率有逐年上升的趨勢,其中50歲(含)以上、女性、高度都市化地區的發生率較高。約半數乾眼症患者於指標日期30天後停止使用乾眼症治療藥物,但後續有一定比例的患者會繼續使用藥物緩解乾眼症狀,再次回診者的藥物使用率較高。臨床上的確有長期使用含類固醇眼用製劑的情形,顯示臺灣乾眼症患者長期使用含類固醇眼用製劑符合臨床治療需要,未來可針對此類患者加強類固醇用藥指導,並注意其眼內壓變化,以確保用藥安全。
英文摘要 Background
Dry eye disease (DED) is one of the common chief complaints of the ophthalmologic outpatient. The reported prevalence ranged from <0.1% to 33% based on various definition, and the dry eye disease was more prevalent among the women and the elderly. In addition, the previous studies showed that the prevalence was higher in Asia, and the epidemiology of DED in Taiwan was insufficient. Due to inflammation is a key factor of the pathogenesis for dry eye disease, the anti-inflammatory agents, such as ophthalmologic steroids or cyclosporine, had their place in the treatment of DED other than artificial tears. However, the prescribing pattern of DED in Taiwan was lacking. Topical cyclosporine is the better choice when taking the safety into consideration, but topical steroids are much cheaper and relieve symptoms rapidly with low dose. However, long-term use of steroids is not recommended generally.

Objective
This study aimed to investigate the epidemiology and prescribing pattern of DED in Taiwan. Besides, we analyzed the characteristics of the dry eye patients and identified the predictors associated with the long-term use of topical steroids.

Methods
We conducted a retrospective cohort study based on the Longitudinal Health Insurance Database 2005 and 2010 in National Health Insurance Research Database (NHIRD), and we collected the registration and claims data in the year 2000 to 2010. All patients diagnosed with DED (ICD-9 370.33, 375.15, 710.2) and administered Schirmer test during observation period were included unless patients with Sjögren’s syndrome (SS) as record in the registry for catastrophic illness. Patients without diagnosis of DED prior to five years before the index date would be identified as incident cases. Patients were followed from index date for one year to analyze the prescribing pattern of DED and the status of steroid use in Taiwan. Multiple logistic regression model adjusted by patient demographics, co-morbidities, and co-medications was used to evaluate the predictors of the long-term use of topical steroids.

Results
There were 44,501 patients with mean age of 51.5 years having DED diagnosis during 2005 to 2009. Among them, 32,731 (73.6%) were female, 24,790 (55.7%) were older than 50 years old, only 894 (2.0%) were SS patients, and there were 23,327 patients returning for DED within one year after index date. The average incidence and prevalence of DED in Taiwan was 0.37% and 0.86% respectively, and both of them increased on the yearly basis. Within 30 days after index date, there were 66.4% patients using defined medication for DED, but 71.0% in returned patients. Of the medications for DED in returned patients, 19.5% used artificial tears without ocular steroids, 27.6% used ocular steroids without artificial tears, 19.3% used both, and only 4.6% received other medication for DED.
Among 44,501 patients, 22,060 patients used ocular steroids within 30 days after index date, and 6,338 patients were identified as long-term users. The predictors of long-term use of ocular steroids including age, male, diabetes mellitus, asthma, fracture, cornea transplant, glaucoma, cataract, macular degeneration, keratitis, conjunctivitis, inflammation of eyelids, ocular trauma, pseudophakia, antihistamines, anticholinergics, antidepressants, benzodiazepines, diuretics, vitamins and systemic steroids. The cornea transplant was the most powerful predictor, (OR 5.95) followed by pseukophakia (OR 1.57).

Conclusions
The incidence and prevalence were both increasing during 2005 to 2009, and the incidence of the elderly, women, or high-urbanized area was higher. Half patients discontinued their medications for DED within the first 30 days after index date, but some patients kept using medication to relieve their symptoms in the following days. Long-term use of topical steroids among dry eye patients in Taiwan were reasonable, like the patients with cornea transplant, and the counseling of steroids use should be conducted if ocular steroids is initiated.
論文目次 中文摘要 i
Abstract iii
誌謝 v
目錄 vii
圖目錄 x
表目錄 xi
附錄 xiii
第一篇 臺灣乾眼症之流行病學與處方型態分析
第一章 研究背景 1
第二章 文獻回顧 3
第一節 乾眼症簡介 3
一、 乾眼症的定義 3
二、 乾眼症相關之眼部結構簡介 4
三、 乾眼症的病因 5
四、 乾眼症的致病機轉 10
五、 乾眼症的診斷方法 11
六、 乾眼症的嚴重程度與治療建議 12
第二節 乾眼症的流行病學與危險因子 14
一、 乾眼症的發生率 14
二、 乾眼症的盛行率 14
三、 具統計意義的乾眼症相關危險因子 18
第三節 長期使用含類固醇眼用製劑之安全性探討 19
第四節 文獻回顧總結 20
第三章 研究目的與重要性 21
第一節 研究目的 21
第二節 研究重要性 21
第四章 研究方法 22
第一節 研究設計 22
一、 研究材料與工具 22
二、 研究對象之納入條件與指標日期定義 23
三、 研究對象之排除條件 24
四、 基本資料與分組 24
第二節 研究流程 25
一、 研究變項及操作型定義 27
二、 資料處理流程 33
第三節 統計方法 34
第五章 研究結果 36
第一節 研究對象的納入與排除 36
第二節 研究對象基本資料 38
第三節 臺灣的乾眼症發生率 45
第四節 臺灣的乾眼症盛行率 48
第五節 臺灣乾眼症的處方型態分析 51
第六節 乾眼症患者長期使用含類固醇眼用製劑的潛在預測因子 55
第七節 敏感性分析 59
第六章 研究討論 63
第一節 研究對象的納入與排除分析 63
第二節 研究對象基本資料分析 66
第三節 臺灣乾眼症的發生率分析 67
第四節 臺灣乾眼症的盛行率分析 69
第五節 臺灣乾眼症的處方型態分析 70
第六節 長期使用含類固醇眼用製劑的預測因子分析 73
第七節 研究限制 75
第七章 結論與建議 77
第八章 未來研究方向 78
第二篇 臨床藥事服務:眼科門診用藥指導
第一章 服務背景 79
第二章 服務目的與進行方法 80
第一節 服務目的 80
第二節 服務進行方法 80
一、 服務時間、地點與服務對象 80
二、 標的藥物 80
三、 用藥指導工具與參考資料來源 80
四、 問卷內容之專家效度 82
五、 服務進行流程 83
第三節 服務結果 84
一、 問卷內容的專家效度 84
二、 服務對象的基本特性 86
三、 眼用製劑的了解程度與藥物使用情形 88
四、 服務滿意度與回饋 90
第四節 討論 91
第五節 服務心得與建議 93
參考文獻 110
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