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系統識別號 U0026-1908201420421901
論文名稱(中文) 臺灣類風濕性關節炎病患使用DMARDs之順從性與持續性
論文名稱(英文) Adherence to and Persistence with Disease Modifying Anti-rheumatic Drugs in Rheumatoid Arthritis Patients 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 102
學期 2
出版年 103
研究生(中文) 劉宜涵
研究生(英文) Yi-Han Liu
學號 S66014021
學位類別 碩士
語文別 中文
論文頁數 143頁
口試委員 指導教授-高雅慧
口試委員-鄭靜蘭
口試委員-歐凰姿
口試委員-張慧真
口試委員-劉明煇
中文關鍵字 類風濕性關節炎  疾病修飾抗風濕病藥物  生物製劑  腫瘤壞死因子抑制劑  服藥順從性  服藥遵從性  持續性  健保資料庫 
英文關鍵字 Rheumatoid arthritis  Disease-modifying antirheumatic drugs  DMARDs  compliance  adherence  persistence 
學科別分類
中文摘要 研究背景
類風濕性關節炎(Rheumatoid arthritis, RA)為慢性全身性自體免疫疾病,主要特徵是侵犯關節,造成全身多關節的變形及疼痛發炎,使病患生活品質下降甚至失能,和一般族群相比亦有較高死亡率。確診後及早開始使用DMARDs可以顯著改善預後,對於類風濕性關節炎的治療佔有重要地位。然透過文獻回顧,病人對於DMARDs治療的順從性普遍不佳。目前臺灣尚缺乏持續性或順從性相關報告。本研究試圖藉由健保資料庫探討病人在開始DMARDs治療一年內之持續性與順從性,並嘗試分析是否存在預測因子及與預後的關係。另觀察病人整體治療歷程中不同治療組合的使用概況及持續性趨勢。

研究方法
利用2001~2010年全民健康保險資料庫,納入2002~2009年間符合RA診斷且初次申請重大傷病卡者為研究對象,並以重大傷病卡申請日為指標日期,追蹤一年內使用任一DMARDs之處方紀錄,記錄最後持有藥品時間得出使用期間長短為持續性,並計算處方藥品持有率(medication possession ratio, MPR)評估其順從性。第二部分將病人接受的DMARDs治療組合分為11種,分析不同治療組合的頻率、人次、治療期間長短及轉換趨勢。

研究結果
研究對象共18,463人,平均年齡53歲(SD, 13.99),女性佔多數(77.22%)。一年內使用任一DMARDs之持續性為315天,中斷治療比例為34.4%。約65%的病人持續性可達半年以上,小於1個月者低於5%。一年內順從性部分,平均MPR為60.26% (SD, 35.97),MPR達到80%以上(即順從性佳者)佔43.84%。指標日期前一年順從性與第一年相比顯著較低。追蹤三年內的順從性變化,發現隨著使用年數增加,順從性與順從性佳者比例皆呈現逐年下降的趨勢。分析預測因子,女性、偏遠地區、門診利用次數較低等特質與順從性差有關。由順從性佳與否推估後續一年發生嚴重需住院接受注射類固醇之RA復發(flare)風險,結果無顯著相關(adjusted hazard ratio: 1.012, 95%CI [0.866, 1.181])。第二部分最常見的治療組合為hydroxychloroquine和sulfasalazine或兩者合併(HCQ+SSZ);持續性部分,sulfasalazine單獨使用的持續性最低;合併治療中,不含methotrexate的組合持續性較低;而dual therapy又比triple therapy來得低。最後,生物製劑的持續性明顯高於傳統DMARDs。

研究結論
本研究以資料庫基礎方法研究臺灣類風濕性關節炎病患於確診後一年內接受任一種DMARDs治療之持續性及順從性,整體而言病患持續性佳,然順從性並不理想,並且隨著使用時間增加有逐漸下降的趨勢。造成順從性差的因素以及對病患預後的影響,資料庫提供的解釋能力有限;臨床實務上,需要加強病患的順從性,介入方式應針對病患疾病狀況及對治療的觀感作個人化的評估與調整。
英文摘要 Disease-modifying antirheumatic drugs (DMARDs) are the major treatment of rheumatoid arthritis (RA). Although DMARDs are efficacious and highly recommended, literature demonstrated that the adherence to and persistence with treatments are generally poor. This study aimed to evaluate the adherence to and persistence with DMARDs among established RA patients in Taiwan, identify potential predictor for adherence, and assess the association between nonadherence and patients’ outcome. We conducted a retrospective cohort study by analyzing the National Health Insurance Research Database of Taiwan from 2001 to 2010. RA patients issued with Catastrophic Illness certification for the first time between 2002 and 2009 were included. We defined the application date for Catastrophic Illness certification as index date. Adherence was examined by medication possession ratio (MPR). In order to evaluate persistence, we calculated the time to discontinuation after the index date. Logistic regression was used to analyze predictors of adherence. A total of 18,463 patients with RA were included. During the 1st-year-period after the index date, 34.4% of patients discontinued the DMARDs therapy. The median persistence was 315 days. The mean MPR was 60.26% (SD, 35.97). Within 3 years of index date, the adherence became lower as each year elapsed. Some factors such as female, living in rural area and low clinic visits predicted nonadherence. The persistence with DMARDs therapy was generally well, but the adherence was suboptimal. Further studies are needed to confirm the effect of nonadherence on patients’ outcome.
論文目次 第一篇 臺灣類風濕性關節炎病患使用DMARDs之順從性與持續性
第一章 研究背景 1
第二章 文獻回顧 3
第一節 類風濕性關節炎簡介 3
2.1.1 定義及診斷 3
2.1.2 流行病學 5
2.1.3 疾病病程與臨床表徵 6
2.1.4 治療原則與趨勢 7
2.1.5 治療指引 9
第二節 DMARD藥品介紹 11
2.2.1 Traditional DMARDs (Conventional DMARDs) 11
2.2.2 Seldom-used DMARDs 12
2.2.3 Biologics 13
第三節 病人用藥行為:順從性與持續性 17
2.3.1 名詞定義 17
2.3.2 順從性 18
2.3.3 持續性 22
第四節 類風濕性關節炎患者之順從性與持續性 23
2.4.1 類風濕性關節炎患者之順從性 23
2.4.2 影響順從性的因素 29
2.4.3 類風濕性關節炎患者之持續性 33
第五節 國內相關研究 37
第三章 研究目的及重要性 39
第四章 研究方法 40
第一節 研究設計 40
4.1.1 研究類型 40
4.1.2 研究材料與工具 40
4.1.3 研究對象 42
4.1.4 觀察期間 43
4.1.5 研究流程 43
第二節 研究變項與操作定義 45
4.2.1 研究名詞與操作定義 45
4.2.2 研究族群之基本資料 46
4.2.3 共病症(Comorbidity) 47
4.2.4 合併用藥(Concomitant medications) 48
第三節 研究藥品與結果測量 49
4.3.1 研究藥品 49
4.3.2 研究結果測量 51
第四節 資料處理與串檔變項 56
第五節 統計方法 57
4.5.1 統計工具 57
4.5.2 統計模式設定 57
4.5.3 描述性統計 57
4.5.4 推論性統計 57
第五章 研究結果 59
第一節 研究對象納入與排除 59
第二節 研究對象之人口學特性 61
5.2.1 基本資料與醫療利用情形 61
5.2.2 共病症 63
5.2.3 合併用藥 64
第三節 DMARDs治療一年內之持續性與順從性 66
5.3.1 指標日期起一年內接受任一種DMARDs治療之持續性與順從性 66
5.3.2 指標日期起三年內順從性之變化趨勢 69
5.3.3 回溯指標日期前一年之順從性與後續三年比較 70
5.3.4 分析順從性佳的預測因子 71
5.3.5 指標日期起第一年之順從性與第二年發生嚴重需住院接受注射
類固醇之RA復發(flare)相關性 79
第四節 DMARDs治療組合使用概況及持續性 81
5.4.1 各治療組合使用概況及持續性 81
5.4.2 治療組合間轉換情形 85
第六章 研究討論 92
第一節 研究對象納入與排除 92
6.1.1 資料庫代表性 92
6.1.2 納入條件 92
6.1.3 排除條件 92
6.1.4 觀察期間與研究藥品 93
第二節 研究對象之人口學特性 95
第三節 DMARDs治療一年內之持續性與順從性 97
6.3.1 指標日期起一年內接受任一種DMARDs治療之持續性 97
6.3.2 指標日期起一年內接受任一種DMARDs治療之順從性 97
6.3.3 指標日期起三年內順從性之變化趨勢 98
6.3.4 回溯指標日期前一年之順從性與後續三年比較 99
第四節 影響順從性的預測因子 100
第五節 順從性與嚴重RA復發(flare)相關性 102
第六節 DMARDs治療組合使用概況及持續性 103
第七節 研究限制 105
第七章 結論與建議 106
第八章 未來研究方向 107

第二篇 臨床藥事服務:易導致跌倒風險藥品註記整理
第一章 服務背景 108
第二章 文獻回顧 109
第一節 藥物與跌倒風險 109
第二節 評估工具 110
2.2.1 Medication Fall Risk Score (MFRS) 110
2.2.2 Medicines and Falls in Hospital: Guidance Sheet 112
第三章 服務目的及執行方法 113
第一節 服務目的 113
第二節 執行方法 113
3.2.1 工具與參考資料 113
3.2.2 執行流程 113
第四章 服務結果 115
第五章 討論與建議 117
參考文獻 118
附錄
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