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研究生:巢杏悠
研究生(外文):Ines Hang-Iao Chow
論文名稱:子宮頸細胞抹片與人類乳突病毒DNA檢測應用於台灣子宮頸癌篩檢之成本效益分析
論文名稱(外文):Cost-Effectiveness Analysis of Cervical Cancer Screening with Pap Smear and Human Papillomavirus DNA Testing in Taiwan
指導教授:蒲若芳蒲若芳引用關係湯澡薰湯澡薰引用關係
學位類別:碩士
校院名稱:臺北醫學大學
系所名稱:醫務管理學研究所
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:2008
畢業學年度:96
語文別:中文
論文頁數:94
中文關鍵詞:子宮頸癌子宮頸細胞抹片人類乳突病毒檢測成本效益篩檢
外文關鍵詞:cervical cancerPap smearHPV DNA testingcost-effectiveness analysisscreening
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台灣是女性子宮頸癌高發生率與高死亡率的國家,如何有效預防子宮頸癌是目前台灣當前重要的公共衛生課題之一,子宮頸癌細胞抹片篩檢於子宮頸癌的防治向來扮演著重要的角色。自從美國食品藥品管理局於2003年正式通過人類乳突病毒檢測與子宮頸細胞抹片可合併使用於30歲以上婦女的子宮頸癌篩檢,諸多國外子宮頸癌篩檢的經濟評估報告亦顯示此合併篩檢之策略較目前篩檢策略具成本效益。因此,本研究目在於評估子宮頸細胞抹片與人類乳突病毒DNA檢測應用於台灣子宮頸癌篩檢之成本效益。
本研究以社會觀點,使用修改成適用台灣子宮頸癌流行病學參數,並彙整篩檢工具之特性及相關成本,透過建構決策分析模式模擬30歲健康婦女實施子宮頸癌篩檢計畫長期之成本效果分析,追蹤其終生之品質調整後存活年數以及相關成本,評估沒有篩檢組分別與其他四個篩檢策略之差異成本效果比。主要四個篩檢策略分別為:一、每年例行性抹片檢查,並以抹片進行陽性個案追蹤。二、每年例行性抹片檢查,並以HPV DNA檢測進行追蹤。三、每三年例行性HPV DNA檢測,並以抹片進行追蹤。四、每五年例行HPV DNA檢測與子宮頸細胞抹片合併篩檢。本研究評估之效果指標是以子宮頸癌累積發生率、累積死亡率、平均餘命,以及品質調整後存活年數來評估,效果與成本使用3%折現比率來計算其現在的價值,並且將模式之參數進行單變項敏感度分析與機率性敏感度分析以了解結果之不確定性。
本研究推估實施子宮頸癌篩檢政策,四個篩檢策略可降低子宮頸癌之累積發生率94.7%至98.7%、以及累積死亡率95.4%至99.0%。研究結果發現篩檢策略以婦女每五年接受一次HPV DNA檢測與子宮頸細胞抹片合併篩檢所獲得之平均餘命為48.97833年最長(48.95905QALY),而每年例行性抹片檢查,並以人類乳突病毒檢測作追蹤,或以抹片作追蹤,平均餘命分別為48.97788年(48.95113QALY),以及48.97785年(48.94886QALY)次之,接著是每三年例行性人類乳突病毒檢測,並以抹片作追蹤,平均餘命為48.97783年再次之(48.95087QALY)。而折現後每人總成本分別為NT$38,027、NT$19,350、NT$17,981,以及NT$21,335,其差異成本效果比值為NT$529,086/QALY至NT$1,002,480/QALY間。單變項敏感度分析計算出不同類別的參數中以折現率之變動範圍最廣,可能導致研究結果方向之改變。若願付代價超過NT$1,200,000/QALY,則四個篩檢策略皆是可以被接受的篩檢策略。
評估台灣子宮頸癌篩檢政策,發現不論以人類乳突病毒檢測作追蹤、或主要篩檢工具、或用以合併篩檢,相較於沒有篩檢介入之策略,其差異成本效果比均低於世界衛生組織所建議之標準閾值。本研究結果顯示加入人類乳突病毒檢測是具有成本效益之篩檢策略。
Background: Cervical cancer is the leading cancer for women in Taiwan. The incidence and mortality rates are both high and therefore cause huge burden to the society. Long-term effectiveness of different cervical cancer screening tests and strategies is of necessity to be explored. Since 2003, U.S. Food and Drug Administration (FDA) has approved the Human Papillomavirus (HPV) DNA testing for women over 30 years of age and had abnormal Pap test results, to determine whether they need to be referred for further examination. HPV DNA testing can identify the high-risk viral types associated with the development of cervical cancer. Women with negative testing result may adapt longer screening interval. The present study was aimed to evaluate the long term cost-effectiveness of different strategies between HPV DNA testing combined with cervical cytology in cervical cancer screening policy in Taiwan among healthly women aged 30 years.
Methods: A decision analytic model was used to simulate the natural history of cervical cancer in Taiwan health care system. We adopted a societal perspective for the cost-effectiveness analysis to estimate the QALYs and lifetime costs per woman for four main screening strategies: 1) annual Pap smear screening, followed by repeat Pap smear, 2) annul Pap smear screening, using HPV DNA testing as a triage, 3) triennial HPV DNA testing, usng Pap smear as a triage, 4) quinquennial combination Pap smear with HPV DNA testing. All strategies were compared with no screening in base case and screening until age 70 years. Outcomes included cumulative incidences and mortality of cervical cancer, life expectancy, quality-adjusted life expectancy, lifetime costs, and incremental cost-effectiveness ratio, expressed as cost per QALY. Future costs and life-years were discounted at an annual rate of 3%. One-way sensitivity anaylsis and probabilistic sensitivity anslysis were performed.
Results: The model predicted that the four main screening strategies reducted the lifetime cervical cancer risk to 94.7% to 98.7%, and the lifetime cervical cancer mortality to 95.4% to 99.0%. Compared with Pap smear triage strategy, repeat Pap smear strategy increased life expectancy from 48.97783(48.95087 QALY) to 48.97785(48.94886 QALY). Compared with HPV triage strategy, combination Pap smear with HPV DNA testing increased life expectancy from 48.97788(48.95113 QALY) to 48.97833(48.95905 QALY). The discounted average total per-woman lifetime costs were NT$ 21,334, NT$17,981, NT$19,350, NT$38,027. Incremental cost-effectiveness ratio for repeat Pap smear strategy, Pap smear triage strategy, HPV triage strategy were NT$529,086/QALY, NT$551,987/QALY and NT$617,699/QALY, respectively. Whereas for combination Pap smear with HPV DNA testing was NT$1,002,480. Results were most sensitive in discount rate, which would change the relative performance. If the willingness-to-pay thresholds consistently cost more than NT$1,200,000/QALY, all four main screening strategies were preferred.
Conclusions: In comparison with no screening, adding HPV DNA testing screening strategies, which were all less than thresholds proposed in the World Health Organization, could be considered cost-effective in Taiwan.
致謝 I
中文摘要 II
英文摘要 IV
目錄 VI
表目次 VIII
圖目次 IX
附錄目次 XI
第一章 緒論 1
第一節 研究背景 1
第二節 研究動機與重要性 4
第三節 研究目的 6
第二章 文獻探討 7
第一節 子宮頸癌疾病臨床分期 7
第二節 子宮頸癌篩檢工具 8
第三節 決策分析 12
第四節 電腦模擬應用於子宮頸癌篩檢工具之經濟評估 13
第三章 材料與方法 18
第一節 經濟評估 18
第二節 資料來源 25
第三節 研究假設 38
第四章 結果 39
第一節 模式預測各策略之子宮頸癌發生個數及死亡個數 39
第二節 成本效果分析之結果 41
第三節 情境分析之結果 50
第四節 敏感度分析之結果 56
第五章 討論 72
第一節 重要結果討論 72
第二節 研究限制 76
第六章 結論與建議 77
第一節 結論 77
第二節 建議 78
參考文獻 79
中文部分 79
英文部分 81
附錄 85

表目次
頁次
表 1 縮寫對照表 ..................................................................................................................... XII
表 2-1 子宮頸細胞抹片之經濟評估研究 ................................................................................ 14
表 2-2 子宮頸細胞抹片與HPV DNA 檢測之篩檢策略比較 ................................................ 16
表 3-1 各個篩檢策略下使用主要與追蹤之篩檢工具,以及篩檢時間間隔 ........................ 23
表 3-2 模式流行病學參數、健康生活品質權數及參數來源 ................................................ 29
表 3-3 模式成本及成本來源 .................................................................................................... 32
表 3-4 2004 年臺閩地區女性30 歲至85 歲簡易生命表 ....................................................... 35
表 3-5 模式使用參數之值及機率性敏感度分析之對應分佈 ................................................ 36
表 4-1 模式預測每十萬名30 歲婦女接受各子宮頸癌篩檢策略之子宮頸癌累積發生個數
及死亡個數 .................................................................................................................. 40
表 4-2 子宮頸癌篩檢策略之分析結果-效果 ........................................................................ 44
表 4-3 子宮頸癌篩檢策略之分析結果-成本 ........................................................................ 46
表 4-4 各個篩檢策略之總成本、總效果及各個篩檢策略分別與沒有篩檢組比較之差異成
本效果比 ...................................................................................................................... 48
表 4-5 在100%篩檢率下,各個篩檢策略之總成本、總效果及分別與沒有篩檢組比較之差
異成本效果比 .............................................................................................................. 52
表 4-6 各個篩檢策略之分析結果-效果 ................................................................................ 53
表 4-7 各個篩檢策略之總成本、總效果及分別與次佳篩檢策略比較之差異成本效果比 54

圖目次
頁次
圖 3-1 子宮頸癌變疾病自然史 ................................................................................................ 22
圖 3-2 各個篩檢策略之示意圖 ................................................................................................ 24
圖 4-1 各個篩檢策略之總成本 ................................................................................................ 45
圖 4-2 子宮頸癌篩檢策略之成本結構圖 ................................................................................ 47
圖 4-3 各個篩檢策略與沒有篩檢組之差異成本效果比 ........................................................ 49
圖 4-4 各個篩檢策略與次次佳篩檢策略比較之差異成本效果比 ........................................ 55
圖 4-5 單變項敏感度分析-策略一比沒有篩檢組之部分疾病轉移機率參數 .................... 59
圖 4-6 單變項敏感度分析-策略一比沒有篩檢組之子宮頸癌存活率參數 ........................ 59
圖 4-7 單變項敏感度分析-策略一比沒有篩檢組之篩檢工具敏感度與特異度參數 ........ 60
圖 4-8 單變項敏感度分析-策略一比沒有篩檢組之健康生活品質效用參數 .................... 60
圖 4-9 單變項敏感度分析-策略一比沒有篩檢組之成本參數 ............................................ 61
圖 4-10 單變項敏感度分析-策略一比沒有篩檢組之折現率參數 ...................................... 61
圖 4-11 單變項敏感度分析-策略二比沒有篩檢組之部分疾病轉移機率參數 .................. 62
圖 4-12 單變項敏感度分析-策略二比沒有篩檢組之子宮頸癌存活率參數 ...................... 62
圖 4-13 單變項敏感度分析-策略二比沒有篩檢組之篩檢工具敏感度與特異度參數 ...... 63
圖 4-14 單變項敏感度分析-策略二比沒有篩檢組之健康生活品質效用參數 .................. 63
圖 4-15 單變項敏感度分析-策略二比沒有篩檢組之成本參數 .......................................... 64
圖 4-16 單變項敏感度分析-策略二比沒有篩檢組之折現率參數 ...................................... 64
圖 4-17 單變項敏感度分析-策略三比沒有篩檢組之部分疾病轉移機率參數 .................. 65
圖 4-18 單變項敏感度分析-策略三比沒有篩檢組之子宮頸癌存活率參數 ...................... 65
圖 4-19 單變項敏感度分析-策略三比沒有篩檢組之篩檢工具敏感度與特異度參數 ...... 66
圖 4-20 單變項敏感度分析-策略三比沒有篩檢組之健康生活品質效用參數 .................. 66
圖 4-21 單變項敏感度分析-策略三比沒有篩檢組之成本參數 .......................................... 67
圖 4-22 單變項敏感度分析-策略三比沒有篩檢組之折現率參數 ...................................... 67
圖 4-23 單變項敏感度分析-策略四比沒有篩檢組之部分疾病轉移機率參數 .................. 68
圖 4-24 單變項敏感度分析-策略四比沒有篩檢組之子宮頸癌存活率參數 ...................... 68
圖 4-25 單變項敏感度分析-策略四比沒有篩檢組之篩檢工具敏感度與特異度參數 ...... 69
圖 4-26 單變項敏感度分析-策略四比沒有篩檢組之健康生活品質效用參數 .................. 69
圖 4-27 單變項敏感度分析-策略四比沒有篩檢組之成本參數 .......................................... 70
圖 4-28 單變項敏感度分析-策略四比沒有篩檢組之折現率參數 ...................................... 70
圖 4-29 四個篩檢策略分別與沒有篩檢組之可接受曲線 ...................................................... 71

附錄目次
頁次
附錄 1 本研究四個篩檢策略及參數 ....................................................................................... 85
附錄 2 策略一、每年例行性抹片檢查,並以抹片作追蹤在健康狀態(Normal)與HPV 感染
狀態之次決策樹 .......................................................................................................... 86
附錄 3 策略一、每年例行性抹片檢查,並以抹片作追蹤在CINI/II/III 狀態之次決策樹 87
附錄 4 策略二、每年例行性抹片檢查,並以HPV DNA 檢測作追蹤在健康狀態(Normal)
與HPV 感染狀態之次決策樹 .................................................................................... 88
附錄 5 策略二、每年例行性抹片檢查,並以HPV DNA 檢測作追蹤在CINI/II/III 狀態之
次決策樹 ...................................................................................................................... 89
附錄 6 策略三、每三年例行性HPV DNA 檢測,並以抹片作追蹤在健康狀態(Normal)與
HPV 感染狀態之次決策樹 ......................................................................................... 90
附錄 7 策略三、每三年例行性HPV DNA 檢測,並以抹片作追蹤在CINI/II/III 狀態之次
決策樹 .......................................................................................................................... 91
附錄 8 策略四、每五年例行HPV DNA 檢測與子宮頸細胞抹片合併篩檢在健康狀態
(Normal)與HPV 感染狀態之次決策樹 ..................................................................... 92
附錄 9 策略四、每五年例行HPV DNA 檢測與子宮頸細胞抹片合併篩檢在CINI/II/III 狀
態之次決策樹 .............................................................................................................. 93
附錄 10 各個篩檢策略在子宮頸癌各期別狀態之次決策樹 ................................................. 94
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