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博碩士論文 etd-0527115-162844 詳細資訊
Title page for etd-0527115-162844
論文名稱
Title
反應導引療法與固定期間療法對慢性C型肝炎第一基因型病毒感染病人臨床效果和成本效益之比較研究
The Comparisons of Clinical Effect and Cost-effectiveness between Response Guided Therapy and Fixed Duration Therapy for Chronic Hepatitis C Genotype 1 Patients
系所名稱
Department
畢業學年期
Year, semester
語文別
Language
學位類別
Degree
頁數
Number of pages
47
研究生
Author
指導教授
Advisor
召集委員
Convenor
口試委員
Advisory Committee
口試日期
Date of Exam
2015-06-12
繳交日期
Date of Submission
2015-08-10
關鍵字
Keywords
長效型干擾素、C型肝炎基因型第一型、固定期間治療、反應導引治療、成本效益、臨床療效、雷巴非林
hepatitis C virus genotype1, pegylated interferon, ribavirin, cost effectiveness, Response Guided Therapy, Fixed Duration Therapy, clinical effectiveness
統計
Statistics
本論文已被瀏覽 5785 次,被下載 43
The thesis/dissertation has been browsed 5785 times, has been downloaded 43 times.
中文摘要
背景:C型肝炎是一個全球性的肝臟疾病的常見原因,持續性的感染會使部分的病人進展至肝硬化,甚至肝癌,這些疾病以及併發症會嚴重破壞病人的生活品質(可以用數字來代表其quality of life (EuroQol Group)。目前對於C型肝炎的治療方針包含長效型干擾素 (pegylated interferon) 加上雷巴非林(ribavirin),治療的長短依據台灣健康保險局的給付政策有所不同,早期給付24週固定期間治療,目前則是根據治療的反應以決定是否延長到48週,稱為反應導引治療(response-guided therapy)。過去一些研究發現固定期間的治療若治療成功(達到病毒持續反應(sustained virological response); SVR) 可以增加C型肝炎病人的存活率、避免長期併發症以及改善生活品質具成本效益。過去一些臨床試驗顯示反應導引治療的臨床療效似乎比固定期間的治療較佳,但在真實世界實際運用則不清楚。另外,一些研究顯示長效型干擾素加上雷巴非林較短效型干擾素加上雷巴非林更具成本效益;但對於同樣使用長效型干擾素加上雷巴非林其反應導引治療是否比固定期間的治療更具成本效益則不清楚。
目的:我們的研究目標為比較基因型第一型C型肝炎病人接受反應導引治療與固定期間治療(24週)的長效型干擾素加上雷巴非林的臨床療效及成本效益。
方法:1. 療效: 我們做一個回溯性的世代研究,納入603位在高雄長庚紀念醫院規則追蹤,基因型第一型C型肝炎且接受長效型干擾素和Ribavirin治療的病人。依據治療的期間長短,將病人分成二組:第一組276位病人接受治療期間24週、第二組327位病人接受反應導引治療。我們比較兩組的治療效果(SVR rates)
2. 成本效益: 本研究採用Markov model估計45歲基因型第一型慢性C型肝炎病人接受反應導引治療與固定療程治療之終身費用、預期壽命、生命年及品質校正生命年。本研究採用健保署觀點分析,折現率為3%。
結果:1. 反應導引治療與固定期間治療比較其臨床療效較佳,其SVR rate各為71.3%及 59.42% (P=0.002). 2. 固定療程治療的終身費用、預期壽命、生命年及品質校正生命年分別為395,784、 28.9253、18.9997及12.7760。反應導引治療的終身費用、預期壽命、生命年及品質校正生命年分別為411,038、29.6008、19.3595及13.2873。每增加一個QALY的費用為29,835。
結論:反應導引治療相較於過去固定療程治療有較好的療效,也是較為符合成本效益的治療選擇。病人延長治療所增加的藥品費用部分可因減少嚴重的併發症並延長生命及增進生活品質而抵銷。
Abstract
Background: Chronic hepatitis C (CHC) is a common cause of liver disease worldwide. It is a progressive condition which can lead to cirrhosis and hepatocellular carcinoma, impairing one’s quality of life (EuroQol Group) (EuroQol Group). A combination therapy of pegylated interferon-alpha and ribavirin (PegIFN/RBV) is a well-accepted standard of care for patients with chronic hepatitis C. The attainment of sustained virological response (SVR) improves survival, avoids long-term complications, and improves QOL. Over the past decade Taiwan's National Health Plan has reimbursed a fixed 24 week course of PegIFN/RBV before Nov 2009, and after Nov 2009 a response guided therapy in which the treatment duration may extend to 48 weeks has been reimbursed, including early termination depending on the on-treatment response. Several studies suggested that the clinical effectiveness of response guided therapy seems better than fixed duration therapy, however, The clinical effectiveness of response guided therapy in the real world remains unclear. Furthermore, several previous studies have assessed the cost effectiveness of fixed duration PegIFN/RBV therapy versus interferon and ribavirin therapy using hypothetical models to predict cost-utility ratios. However, whether response-guided therapy is more cost effective as compared to fixed duration therapy remains unclear.
Aims: We aim to compare the clinical and cost effectiveness of response-guided therapy and fixed duration (24 weeks) PegIFN/RBV therapy.
Methods: 1. In this retrospective study we enrolled 603 chronic hepatitis C genotype-1 patients from Kaohsiung Chang Gung Memorial Hospital (KCGMH) who had received therapy with PegIFN/RBV. Therapeutic duration was categorized into two groups, Group 1: 276 patients who had received a 24 week fixed duration, and Group 2: 327 patients who had received response-guided therapy. We compared the SVR rates between these two groups. 2. A Markov model was adopted to estimated lifetime cost, life expectancy, life-years (LYs), and quality-adjusted life-years (QALYs) of 45-year-old CHC genotype 1 patients receiving response-guided therapy versus fixed duration therapy. The cost-effectiveness analysis was conducted from the perspective of the National Health Insurance Administration (NHIA) with a discount rate of 3%.
Results: 1. The SVR rate of patients who received response-guided therapy was 71.3%, which was significantly higher than that of patients who received fixed duration therapy (59.42%) (P=0.002). 2. Life-time cost, life expectancy, LYs, and QALYs of the fixed duration therapy group were NTD 395,784, 28.9253, 18.9997, and 12.7760, respectively. Life-time cost, life expectancy, LYs, and QALYs of the response-guided therapy group were NTD 411,038, 29.6008, 19.3595, and 13.2873, respectively. The incremental cost per QALY gained was NTD 29,835.
Conclusion: Response-guided therapy, as compared to the fixed duration therapy, achieved a higher SVR rate and was a cost-effective treatment option. The increasing cost of antiviral treatment due to the extension of treatment duration could be partially offset by cost savings due to reduced cases of severe complications and increases in life quantity and quality.
目次 Table of Contents
論文審定書 i
摘要 ii
Abstract iii
Abbreviations v
Table of Contents vi
List of Tables viii
List of Figures ix
1.Introduction 1
1.1 Epidemiology and Natural history of chronic hepatitis C 1
1.2 Treatment of chronic hepatitis C for prevention of HCC 1
1.3 Treatment regimens and effects 2
1.4 Cost and effectiveness 2
2.Methods 3
2.1 Clinical effectiveness 3
2.1.1 Patients 3
2.1.2 Laboratory assays 4
2.2. Cost effectiveness analysis 5
2.2.1 Model structure 5
2.2.2 Treatment strategies and outcomes 5
2.2.3 Disease progression 6
2.2.4 Costs 7
2.2.5 Quality of life 8
2.2.6 Incremental cost-effectiveness ratio (ICER) 8
2.2.7 Sensitivity analysis 8
3.Results 9
3.1 Clinical effectiveness 9
3.2 Cost effectiveness analysis 9
3.2.1 Cost and effectiveness 9
3.2.2 Sensitivity analyses 9
4. Discussion and Conclusion 10
5. Limitations 12
6. Management implications 13
References 15
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