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研究生:林瑜莉
研究生(外文):Yu-Li Lin
論文名稱:腹腔鏡子宮肌瘤切除手術之成本效益分析
論文名稱(外文):Cost-Effectiveness Analysis of Laparoscopic Surgery for Presumed Leiomyomas
指導教授:郎慧珠郎慧珠引用關係
指導教授(外文):Hui-Chu Lang
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:醫務管理研究所
學門:商業及管理學門
學類:醫管學類
論文種類:學術論文
論文出版年:2016
畢業學年度:104
語文別:中文
論文頁數:99
中文關鍵詞:子宮肌瘤組織切除器成本效益
外文關鍵詞:Uterine leiomyomaMorcellatorCost-Effectiveness
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研究背景
子宮肌瘤為生育年齡女性常見良性腫瘤,臨床醫療人員或國內外研究表示切除手術為最根本的治療且多採用腹腔鏡進行,惟腹腔鏡手術使用的組織切除器近年被質疑其安全性,因此腹腔鏡手術之成本效益亦受到重視。目前台灣尚未有關子宮肌瘤採用腹腔鏡手術或開腹式手術之成本效益分析。

研究方法
本研究針對台灣18至65歲被診斷患有良性子宮肌瘤之女性病患,以健保署觀點透過決策樹分析模式進行腹腔鏡手術與開腹式手術之成本效益分析。採用健保資料庫計算研究對象術後5年觀察期間內各治療階段之機率與成本、相關參考文獻之機率與效用值作為參數,研究結果以QALYs及ICER值來評估。同時考量參數具有不確定性,分別就機率、效用值及成本進行敏感性分析,效益及成本以3.5%折現率計算。

研究結果
以健保資料庫為計算基礎得出之參數值進行成本效益分析之結果為腹腔鏡手術與開腹式手術平均每人5年總成本分別為NT$ 56,544、NT$ 33,782;QALYs為4.1911、4.188;ICER值為NT$ 7,265,723。以文獻數值為計算基礎得出之參數值帶入後其平均每人5年總成本為NT$ 56,470、NT$ 35,424;QALYs為4.19、4.1877;ICER值為NT$ 9,311,161。
以健保資料庫為計算基礎得出之參數值進行機率敏感性分析之結果為腹腔鏡與開腹式手術平均每人5年總成本為NT$ 56,163、NT$ 33,916;QALYs為4.188、4.1843;ICER值為NT$ 6,032,384。以文獻數值為計算基礎得出之參數值帶入後其平均每人5年總成本為NT$ 57,236、NT$ 36,245;QALYs為4.1842、4.1836;ICER值為NT$ 33,824,057。

結 論
  無論以健保資料庫或文獻數值為計算基礎得出之參數值進行成本效益分析與敏感性分析,其ICER值均大於WHO建議閾值NT$ 1,957,287 (3倍台灣GDP),顯示腹腔鏡手術較開腹式手術不具成本效益。


關鍵字:子宮肌瘤、組織切除器、成本效益
Background
Uterine leiomyomas, the common benign tumors in premenopausal women, are primarily treated with the laparoscopic surgery. However, the safety concern of using a morcellator in a laparoscopic surgery results in the emergence of the Cost-Effectiveness Analysis on this modern surgical technique. As little Taiwanese research has explored this area of knowledge, this study aimed to fill the gap with utilizing the Cost-Effectiveness Analysis to evaluate a laparoscopic surgery with morcellation and an abdominal surgery for presumed leiomyomas in Taiwan.

Methods
This study constructed a decision analysis model from the perspective of the National Health Insurance Administration. Taiwanese women aged from 18 to 65 diagnosed with presumed benign leiomyomas were included in this study to compare the cost-effectiveness of a laparoscopic surgery and an abdominal surgery. Parameters were derived from the probabilities and cost estimates of therapeutic states during the 5-year observation period calculated from the National Health Insurance Research Database (NHIRD) and the probabilities and utilities of published literature. This study was summarized with the Quality-Adjusted Life Years (QALYs) and the Incremental Cost-Effectiveness Ratio (ICER). The sensitivity Analysis was performed to assess the effect of various parameters. As a result, effectiveness and costs were discounted at 3.5%.


Results
Using the parameters calculated from the NHIRD to perform the Cost-Effectiveness Analysis, the average total costs comparing a laparoscopic surgery to an abdominal surgery for 5 years per woman were NT$ 56,544 and NT$ 33,782. The QALYs were 4.1911 and 4.188, and the ICER was NT$ 7,265,723. Using the parameters calculated from published literature, the results were NT$ 56,470 and NT$ 35,424 (costs), 4.19 and 4.1877 (QALYs), NT$ 9,311,161 (ICER), respectively.
Using the parameters calculated from the NHIRD to perform the Probabilistic Sensitivity Analysis, the average total costs comparing a laparoscopic surgery to an abdominal surgery for 5 years per woman were NT$ 56,163 and NT$ 33,916. The QALYs were 4.188 and 4.1843, and the ICER was NT$ 6,032,384. Using the parameters calculated from published literature, the results were NT$ 57,236 and NT$ 36,245 (costs), 4.1842 and 4.1836 (QALYs), NT$ 33,824,057 (ICER), respectively.

Conclusion
All the ICERs of the laparoscopic surgery for presumed leiomyomas were higher than the thresholds proposed by the World Health Organization, with both the parameters calculated from the NHIRD and those from published literature to perform the Cost-Effectiveness Analysis and the Sensitivity Analysis. Therefore, this study concluded that the laparoscopic surgery is not cost-effective.


Key words:Uterine leiomyoma, Morcellator, Cost-Effectiveness
目 錄
誌 謝 i
中文摘要 ii
英文摘要 Abstract iv
目 錄 vi
表 目 錄 viii
圖 目 錄 ix
第一章 緒論 1
一、研究背景與動機 1
二、研究問題 3
三、研究重要性 3
四、研究目的 4
第二章 文獻探討 5
一、子宮肌瘤臨床表現 5
二、子宮肌瘤診斷治療 8
三、子宮肌瘤切除手術 11
四、腹腔鏡子宮肌瘤切除手術 14
五、子宮平滑肌肉瘤 16
六、相關議題經濟評估 18
第三章 研究方法 21
一、研究架構 21
二、研究假設 25
三、研究對象或資料來源 25
四、研究工具 37
五、測量方法或研究變項操作型定義 37
六、分析方法 50
第四章 研究結果 51
一、成本效益分析 51
二、敏感性分析 55
第五章 討論 67
一、成本效益分析 67
二、敏感性分析 69
第六章 結論與建議 70
一、結論 70
二、建議 70
三、研究限制 71
參考文獻 72
附 錄 79


表 目 錄
表2-1:子宮肌瘤切除手術各項併發症分類表 13
表2 2:子宮肌瘤切除手術經濟評估相關文獻整理 19
表3-1:開腹式手術各治療階段機率值(以健保資料庫為計算基礎) 39
表3-2:腹腔鏡手術各治療階段機率值(以健保資料庫為計算基礎) 40
表3-3:開腹式手術各治療階段機率值(以文獻數值為計算基礎) 41
表3-4:腹腔鏡手術各治療階段機率值(以文獻數值為計算基礎) 42
表3-5:開腹式手術各治療階段效用值(以健保資料庫為計算基礎) 43
表3-6:腹腔鏡手術各治療階段效用值(以健保資料庫為計算基礎) 44
表3-7:開腹式手術各治療階段效用值(以文獻數值為計算基礎) 45
表3-8:腹腔鏡手術各治療階段效用值(以文獻數值為計算基礎) 46
表3-9:開腹式手術各治療階段成本 47
表3-10:腹腔鏡手術各治療階段成本 48
表3-11:子宮肌瘤切除手術住院天數 49
表4-1:不同參數值來源、不同折現率之成本效益分析數值 52
表4-2:以不同參數值來源為計算基礎之機率敏感性分析數值 61


圖 目 錄
圖3-1:子宮肌瘤切除手術決策樹架構 22
圖3-2:開腹式子宮肌瘤切除手術決策樹架構 23
圖3-3:腹腔鏡子宮肌瘤切除手術決策樹架構 24
圖3-4:健保資料庫各類明細檔串聯示意圖 29
圖3-5:健保資料庫資料擷取流程圖 30
圖3-6:經剪枝之開腹式子宮肌瘤切除手術決策樹架構 34
圖3-7:經剪枝之腹腔鏡子宮肌瘤切除手術決策樹架構 35
圖3-8:經剪枝之子宮肌瘤切除手術決策樹架構 36
圖4-1:以健保資料庫為計算基礎之成本效益分析 53
圖4-2:以文獻數值為計算基礎之成本效益分析 53
圖4-3:以健保資料庫為計算基礎之成本效益分析(折現率3.5%) 54
圖4-4:以文獻數值為計算基礎之成本效益分析(折現率3.5%) 54
圖4-5:以健保資料庫為計算基礎之ICER值變動範圍(機率) 56
圖4-6:以文獻數值為計算基礎之ICER值變動範圍(機率) 56
圖4-7:以健保資料庫為計算基礎之ICER值變動範圍(效用值) 58
圖4-8:以文獻數值為計算基礎之ICER值變動範圍(效用值) 58
圖4-9:以健保資料庫為計算基礎之ICER值變動範圍(成本) 60
圖4-10:以文獻數值為計算基礎之ICER值變動範圍(成本) 60
圖4-11:以健保資料庫為計算基礎之機率敏感性分析 62
圖4-12:以文獻數值為計算基礎之機率敏感性分析 62
圖4-13:以健保資料庫為計算基礎之成本效益可接受曲線 64
圖4-14:以文獻數值為計算基礎之成本效益可接受曲線 64
圖4-15:以健保資料庫為計算基礎之機率敏感性分析成本效益散佈圖 65
圖4-16:以文獻數值為計算基礎之機率敏感性分析成本效益散佈圖 65
圖4-17:以健保資料庫為計算基礎之機率敏感性分析遞增成本效益散佈圖 66
圖4-18:以文獻數值為計算基礎之機率敏感性分析遞增成本效益散佈圖 66
附 錄
表2-1:台灣歷年子宮平滑肌肉瘤初次診斷個案數 79
表3-1:US CDC, Five-Year Relative Survival, Uterine Cancer 80
表3-2:子宮肌瘤及相關惡性腫瘤ICD-9-CM診斷碼 81
表3-3:子宮肌瘤切除手術相關健保代碼及ICD-9-CM手術碼 82
表3-4:其他女性生殖器官惡性腫瘤ICD-9-CM診斷碼 83
表3-5:子宮肌瘤切除手術各項併發症相關代碼 85
表3-6:健保資料庫明細檔納入計算為直接醫療成本之項目 86
表3-7:各縣市醫院自費醫材"蓋那客"艾克斯組織切除器收費標準 87
表3-8:行政院主計總處各年度GDP 88
表3-9:住院期間併發症機率值 89
表3-10:住院期間有併發症其出院後6星期內有併發症機率值 90
表3-11:住院期間無併發症其出院後6星期內有併發症機率值 91
表3-12:U.S. DCCPS, SEER Database 92
表3-13:住院期間併發症效用值(以健保資料庫為計算基礎) 93
表3-14:出院後6星期內併發症效用值(以健保資料庫為計算基礎) 94
表3-15:住院期間併發症效用值(以文獻數值為計算基礎) 95
表3-16:出院後6星期內併發症效用值(以文獻數值為計算基礎) 96
圖3-1:子宮肌瘤切除手術決策樹架構及參數 97
圖3-2:開腹式子宮肌瘤切除手術決策樹架構及參數 98
圖3-3:腹腔鏡子宮肌瘤切除手術決策樹架構及參數 99
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