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研究生:張育偉
研究生(外文):Yu-wei Chang
論文名稱:台灣地區引進人類乳突病毒疫苗之成本效果分析
論文名稱(外文):Cost-effectiveness analysis of introducing a human papillomavirus vaccine in Taiwan
指導教授:陳國東陳國東引用關係
指導教授(外文):Kow-tong Chen
學位類別:碩士
校院名稱:國立成功大學
系所名稱:公共衛生研究所
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2009
畢業學年度:97
語文別:中文
論文頁數:99
中文關鍵詞:人類乳突病毒疫苗成本效果分析台灣
外文關鍵詞:TaiwanHuma papillomavirus vaccinecost-effectiveness analysis
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研究背景: 台灣為子宮頸癌高發生率的國家,每年約有1,900人罹患子宮頸侵襲癌,而其中又約有800人因此而死亡,人類乳突病毒感染是造成子宮頸癌的主要原因。接種人類乳突病毒疫苗會減少子宮頸癌與其他因感染人類乳突病毒所致相關病症之疾病負擔;不過,台灣地區甚少評估引進人類乳突病毒疫苗接種計畫之成本效果研究。

研究目的: 探討台灣地區引進人類乳突病毒疫苗之潛在成本效果,以作為擬訂疫苗接種政策之參考依據。

研究方法:本研究以健康照護系統觀點進行分析,透過馬可夫模式模擬子宮頸癌之疾病自然史,以比較接種人類乳突病毒疫苗與未接種人類乳突病毒疫苗兩策略之成本效果,研究模式的結果包括:癌症發生率的減少、預期壽命、成本等。本研究假設疫苗接種年齡為12歲,人類乳突病毒疫苗預防因感染人類乳突病毒第16型與第18型相關病症之效力為95%、疫苗保護期為十年、疫苗涵蓋率為85%。本模式評估因感染人類乳突病毒所造成子宮頸癌之生命期風險與整體之直接醫療花費,主要的測量指標為每增加一個品質調整存活人年(QALY)所需花費之成本。

研究結果:針對12歲女性接種人類乳突病毒疫苗方案相較於不接種疫苗,需要耗費較多的成本,不過卻可獲得更多的品質調整存活人年亦即針對12歲女性接種人類乳突病毒疫苗能夠增加平均餘命0.0022年(約0.8天),並多獲得0.0088 QALY(約3.2天),不過相較於不接種疫苗(NT$2,972元),接種人類乳突病毒疫苗需要多花費NT$10,144元。進一步針對台灣地區12歲女性(截至中華民國97年十二月底止,約154,204人)接種人類乳突病毒疫苗(假設疫苗保護期為十年),預期將可避免5,616個輕度子宮頸上皮內贅瘤的個案發生、可避免3,425個中/重度子宮頸上皮內贅瘤的個案發生、可避免134個子宮頸癌新個案發生以及可避免22個子宮頸癌死亡個案;並得出預防一個子宮頸癌個案之發生需要接種約1,151位女性。

結論:在假設疫苗僅具備十年保護期的情況下,台灣地區引進12歲健康女性人類乳突病毒疫苗接種計畫,相較於不接種疫苗,仍符合成本效果(ICER值為NT$1,152,727/QALY低於世界衛生所建議ICER之標準閾值=3倍的GDP NT$1,510,875/QALY);且若疫苗具備終身保護期(終身免疫),則人類乳突病毒疫苗接種方案將非常符合成本效果(ICER值為NT$201,346/QALY低於NT$503,625/QALY)。
Background: The incidence rate of cervical cancer is high in Taiwan, with about 1,900 incident cases and 800 deaths due to cervical cancer every year. Introduction of a human papillomavirus vaccine is expected to significantly reduce the burden of cervical cancer and HPV-related diseases. But, there is seldom cost-effectiveness analysis research related to the human papillomavirus vaccine in Taiwan.

Objective: To determine the cost effectiveness of providing a HPV vaccination program in adolescent females aged 12-year-old in addition to the existing cervical cancer screening program in Taiwan.

Methods: The analysis was conducted from the perspective of the healt hcare system. A Markov state-transition model was developed for Taiwan in order to evaluate the long-term impact of vaccinating a cohort of girls aged 12 years alongside the existing screening programme. We assumed the efficacy of HPV vaccine was 95%, with 10 years duration of immunity, the coverage rate was 85%. The model estimated lifetime risks and total lifetime healthcare costs for cervical cancer. Model outcomes mainly included incremental costs per QALY gained.

Results: A prophylactic vaccine against high-risk HPV types is more expensive than current screening practice but results in greater quality-adjusted life expectancy. HPV vaccination of 12-year-old girls in Taiwan improves their life expectancy by 0.0022 (about 0.8 days) or 0.0088 QALY (about 3.2 days) at a cost of NT$10,144 relative current screening practice. Furthermore, vaccinating the present Taiwan cohort of 12-year-old girls with such a ten years duration of immunity vaccine would avert 5,616 cases of CIN1, 3,425 cases of CIN2/3, 134 cases of cervical cancer, and 22 cervical-cancer deaths over the cohort’s lifetime.Prevention of one case of cervical cancer would require vaccination of 1,151 girls.

Conclusions: Given the duration of immunity is 10 years, introducing a HPV vaccination program in 12-year-old girls in Taiwan compared to current screening practice remained fairly cost-effectiveness (ICER of NT$1,152,727/QALY).And if vaccine could provide lifetime immunity, vaccination program would be very cost-effectiveness (ICER of NT$201,346/QALY).
目錄
中文摘要 i
Abstract ii
致謝 iii
目錄 iv
表目錄 vi
圖目錄 vii
第一章 前言 1
第一節 研究背景 1
第二節 研究動機 3
第三節 研究目的 4
第二章 文獻探討 5
第一節 人類乳突病毒介紹 5
1.1 病毒特徵 5
1.2 傳染途徑 6
1.3 流行病學 6
1.4 致病機轉 8
1.5 感染清除/感染持續(clearance/persistence) 10
1.6 同時感染多種病毒型別 10
第二節 子宮頸癌疾病自然史 12
2.1 癌前病變 12
2.2 子宮頸癌 13
2.3 子宮頸癌造成的疾病負擔 14
第三節 其他輔助因子(Co-factor)在子宮頸癌所扮演的角色 15
3.1 賀爾蒙口服避孕藥 15
3.2 吸菸 15
3.3 多產(high-parity) 16
3.4 同時感染其他性傳染病病原 16
第四節 子宮頸癌篩檢工具 17
4.1 子宮頸細胞抹片(Papanicolaou Smear) 17
4.2 人類乳突病毒DNA檢測(HPV DNA Testing) 17
第五節 人類乳突病毒疫苗 19
5.1 Gardasil疫苗介紹(四價人類乳突病毒疫苗) 19
5.2 Cervarix疫苗介紹(二價人類乳突病毒疫苗) 21
第六節 成本效果分析 23
6.1 經濟評估方法 23
6.2 成本效果分析 23
6.3 研究執行 24
第七節 評估疫苗接種計畫所使用的模式 26
第八節 國外人類乳突病毒疫苗之效果分析 28
第九節 國外人類乳突病毒疫苗之成本效果分析 34
第三章 研究材料與方法 39
第一節 研究方案 39
第二節 研究對象 40
第三節 研究模式架構 40
第四節 研究假設與分析方法 42
4.1 研究假設 42
4.2 分析方法 42
第五節 資料來源 44
5.1 疾病自然史(疾病狀態轉移)參數 44
5.2 篩檢參數 44
5.3 疫苗參數 45
5.4 健康生活品質效用參數(Utilities) 45
5.5 成本參數 46
第四章 研究結果 47
第一節 模式驗證(Model validation) 47
第二節 基準值分析 48
第三節 敏感度分析 49
3.1 單維敏感度分析 49
3.2 影響分析(Tornado analysis) 50
3.3 雙維敏感度分析 50
3.4 多維敏感度分析 51
第五章 討論 52
第一節 重要結果討論 52
1.1 預測子宮頸癌累積發生率與死亡率之討論 52
1.2 成本效果分析結果之討論 52
1.3 模式參數之討論 53
第二節 研究限制 55
第六章 研究結論與建議 56
第一節 研究結論 56
第二節 建議 57
參考文獻 58
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