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研究生:陳怡瑾
研究生(外文):Yi-Chin Chen
論文名稱:氫離子幫浦阻斷注射劑用於治療非惡性腫瘤上消化道出血病人之成本效益分析
論文名稱(外文):Cost-effectiveness of the iv proton pump inhibitors in the treatment of non-variceal upper gastrointestinal bleeding
指導教授:蔡東榮蔡東榮引用關係
指導教授(外文):Tong-Rong Tsai
學位類別:碩士
校院名稱:高雄醫學大學
系所名稱:藥學研究所碩士在職專班
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2005
畢業學年度:93
語文別:中文
論文頁數:152
中文關鍵詞:上消化道出血成本效益分析質子幫浦阻斷劑
外文關鍵詞:proton pump inhibitors (PPIs)upper gastrointestinal bleeding (UGIB).cost- effectiveness
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研究背景:非惡性腫瘤造成的上消化道出血是一種復發性疾病,也是全世界包括台灣地區常見急診住院的原因,住院中的病人也經常發生,出血的病人很容易發生再次出血的情形,而造成龐大的醫療支出,如何有效避免再出血的發生,成為治療的首要目標。目前藥物治療方面的研究指出,出血病人接受質子幫浦阻斷注射劑(PPI)的注射,將有助於減少再出血的可能,然而美國FDA至今仍未核准IV PPI用於此適應症,台灣方面也缺乏此藥物治療相關的成本效益分析。
研究目的:藉由健保資料分析,比較IV PPI 和IV Histamin2- receptor antagonist(H2RA)用於內視鏡止血治療前後,非惡性腫瘤之上消化道出血病人,其成本效益分析。
研究方法:本研究為一項從2002年1月至2004年1月為止,為期共兩年的回顧性世代分析,資料分析來源取自於健保資料庫,採用決策模型分析方式及健康保險機構立場,比較內視鏡止血前後以IV PPI和IV H2-RA治療上消化道出血病人的成本效益分析。病人蒐集須於半年內就醫時不曾被診斷出ICD-9-CM含531、532、533、534,且第一次就診即含有內視鏡止血紀錄之上消化道出血病患,排除所有惡性腫瘤患者,並連續追蹤這些病人達60天,以健保給付價格資料庫來計算實際付出金額,所有的花費計算,以2004年的金額表示,變數的預估經由敏感度分析,治療失敗的指標為再出血的發生,比較所有符合分析條件的兩組,其所有就醫記錄,進行藥物使用、檢查診斷、內視鏡止血、再出血、及耗用金額等比較分析。
研究結果:上消化道出血病人在內視鏡止血治療之後,還是高達7%左右的病人,會再度出現嚴重的出血現象,再出血發生機率會隨著病患年齡、合併症、及藥物使用而增加,在藥物使用方面,NSAID和上消化道出血具高度相關性,而再出血病患治療費用遠大於未再出血的費用。
結論:我們的研究顯示,對於高再出血風險的上消化道出血病患,內視鏡止血治療合併H2RA注射,具有較好的成本效益。
Background: Non-variceal upper gastrointestinal bleeding (UGIB) is a common cause of hospitalization all over the world including in Taiwan. Recent data indicate that IV proton pump inhibitors (PPIs) have the potential to treat UGIB. Despite clinical evidence in favour of IV PPIs, FDA has not yet been proved PPIs in this indication. Data on the cost-effectiveness of this approach in Taiwan is still lacking.
Objectives: The objective is to compare the cost- effectiveness of IV PPIs and Histamin2-recptor antagonist(H2-RA)in the treatment of UGIB. We assessed the effect of initial medication choice (ie, PPIs, H2-RA, or others) following endoscopic haemostasis on cost using healthcare claims data in Taiwan .
Methods: This study was a 2-year, retrospective longitudinal analysis of data from the healthcare claims in southern Taiwan, with about 3 million members, between January 1, 2002, and January 31, 2004. On the basis of International Classification of Disease, Ninth Revision, Clinical modification (ICD-9-CM), we constructed a decision tree model comparing three main strategies: IV PPIs started、IV H2-RA started and others started in non-variceal UGIB patients following endoscopic therapy. The decision analysis used base case estimates of the most likely clinical scenarios and then used sensitivity analysis to evaluate the strategies. Outcome measure was the 60-day rebleeding rate.
Failure is rebleed within 60 days. Effectiveness was reported as the percentage of patients in whom rebleeding was prevented. The model evaluated the rebleeding to initial therapy and the rebleeding prevented by competing different strategies.
Results:After endoscopic therapy, rebleeding rate is still high in Taiwan. Rebleeding appears to correlate with clinical characteristics of the patients: it increase with age, comorbidity, and drugs used. Among drugs, NSAIDS are associated with higher risk of UGIB.
Conclusion: The analysis demonstrates that the use of IV H2-RA in conjunction with endoscopy haemostasis was both superior effectiveness and lower cost based on the probability determination used in the sensitivity analysis.
目 錄
中文摘要 I
英文摘要 III
表目錄 VII
圖目錄 X
本 文
第一章、前言………………………………………………… 1
一、研究背景與動機……………………………………… 1
二、研究目的……………………………………………… 6
三、研究發現之重要性…………………………………… 8
第二章、文獻探討…………………………………………… 9
一、上消化道出血的定義………………………………… 10
二、上消化道出血之生理學及致病機轉………………… 18
三、上消化道出血的治療………………………………… 25
四、藥物經濟學評估方法及運用範疇…………………… 41
五、上消化道出血治療費用及相關成本效益分析……… 46
六、治療上消化道出血相關藥物比較…………………… 62
七、國內外相關研究比較………………………………… 67
第三章、研究設計與方法…………………………………… 77
一、研究設計與架構……………………………………… 77
二、資料收集與研究對象………………………………… 80
三、研究變項及定義……………………………………… 84
四、資料的合併與處理方法……………………………… 87
五、統計及分析方法……………………………………… 90
第四章、研究結果描述與分析……………………………… 91
一、研究對象基本資料描述與分析……………………… 92
二、相關藥物使用統計分析……………………………… 107
三、相關費用分析………………………………………… 118
四、成本效益相關分析…………………………………… 127
第五章、討論
一、結果與討論…………………………………………… 131
二、研究限制及未來發展………………………………… 139
第六章、結論與建議………………………………………… 146
第七章、參考文獻…………………………………………… 145
第八章、附錄………………………………………………… 151
表目錄
表一 臨床試驗和經濟學試驗的比較………………………… 5
表二 各地區上消化道出血的機率比較………………………. 13
表三 胃潰瘍及十二指腸出血之死亡率年齡層
及性別分佈,每十萬人中的發生率…………………… 14
表四 上消化道出血年齡層的趨勢…………………………… 14
表五 各年齡層住院天數及花費……………………………… 15
表六 上消化道出血於1993/1994和2000年所作的
時間趨勢分析…………………………………………… 16
表七 上消化道出血持續出血及再出血的發生率…………… 17
表八 與上消化道出血相關的病因…………………………… 20
表九 造成上消化道出血疾病的發生率及死亡率…………… 21
表十 非類固醇類止痛劑引發潰瘍及出血等併發症
相對風險研究…………………………………………… 22
表十一 急性上消化道出血的診斷病因比例…………………… 23
表十二 阿斯匹靈引發吐血及便血等上消化道出血
問題回溯性控制研究…………………………………… 24
表十三 病人再出血的風險判定:以內視鏡觀察為分類……… 28
表十四 內視鏡觀察預測及處理方法…………………………… 29
表十五 Rockall 對於再出血或死亡的預測評分……………… 30
表十六 間歇性輸注PPI 用於上消化道出血的試驗比較……… 39
表十七 市面上所有的質子幫浦阻斷劑之藥動學比較-吸收…… 64
表十八 市面上所有的質子幫浦阻斷劑之藥動學比較-分佈…… 65
表十九 市面上所有的質子幫浦阻斷劑之藥動學比較-代謝…… 66
表二十 IV H2-RA和PPI用於NVUGIB的研究比較……………… 69
表二十一 回顧RCTs中PPI用來治療上消化道出血的角色……… 73
表二十二 治療上消化道出血的藥物meta-analyses 分析比較… 74
表二十三 PPI目前核准治療的適應症及劑量比較……………… 75
表二十四 PPI目前核准治療的適應症及劑量比較……………… 76
表二十五 研究樣本基本特質描述………………………………… 95
表二十六 研究樣本基本特質檢定………………………………… 96
表二十七 上消化道出血病人就診之合併症分析………………… 97
表二十八 上消化道出血病人診斷分析…………………………… 100
表二十九 研究樣本醫療利用情形(1)………………………… 101
表三十 研究樣本醫療利用情形(2)………………………… 102
表三十一 上消化道出血病患狀況與發生再出血之分析……… 103
表三十二 上消化道出血病患就醫層級與發生再出血之分析... 104
表三十三 上消化道出血病患治療情形與發生再出血之分析... 105
表三十四 上消化道出血病患合併用藥情形與發生再出血之分析.106
表三十五 研究樣本藥物使用分析檢定………………………… 109
表三十六 病患第一次就診用藥分析-依藥理代碼分類……… 110
表三十七 病患第一次就診用藥分析-依成份名稱分類……… 112
表三十八 病患第一次就診用藥分析-依藥品成份名稱分類… 114
表三十九 病患第一次就診用藥分析-依ATC-CODE分類……… 116
表四十 再出血與未再出血醫療利用情形…………………… 120
表四十一 研究樣本醫療利用情形……………………………… 121
表四十二 藥品使用及內視鏡處置金額分析…………………… 122
表四十三 醫療資源之種類及費用……………………………… 125
表四十四 各性別與年齡層上消化道出血後再出血之醫療情形 126
表四十五 Base Case cost-effectiveness 分析結果……… 127
表四十六 不確定的原因產生種類分析及其對應處理方式……… 129
圖目錄
圖一 上消化道出血治療流程………………………………… 32
圖二 成本效益平面圖………………………………………… 43
圖三 Recent Advances in Care: Treatment of
Acid-Related Disorders…………………………… 62
圖四 研究過程決策分析……………………………………… 79
圖五 病患收集流程…………………………………………… 82
圖六 病患合併與處理流程…………………………………… 89
圖七 Markov Model…………………………………………… 132
圖八 蒙地卡羅成本效益模擬圖……………………………… 134
圖九 成本效益平面圖九種可能不確定性的狀況情形……… 135
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