- 學位論文
胃幽門桿菌糞便抗原及大腸癌糞便潛血二合一篩檢之成本效益分析
Cost-Effectiveness analysis of Fecal Immunochemical Test and Helicobacter Pylori Stool Antigen Co-Testing
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摘要
研究背景: 大腸癌及胃癌常年位於全球十大癌症死因之中，如何設計有效的篩檢策略非常重要。糞便潛血檢驗已被驗證可以有效降低死亡的風險；在胃癌發生率高的地區，幽門螺旋桿菌(Helicobacter pylori)篩檢被認為是預防胃癌的一種有效策略。由於大腸癌及胃癌同為消化道癌症，有許多共同的危險因子，使用糞便檢體同時針對兩種癌症進行篩檢為一個創新的模式，因此本研究的目的在評估此二合一篩檢的成本效益。 研究目的 評估和比較使用幽門螺桿菌糞便抗原檢測(HPSA)結合糞便免疫化學檢測(FIT)的篩檢策略，相較於單獨檢測FIT，以不進行篩檢為基準，進行成本效益分析。 研究方法: 本研究建構結合胃癌篩檢和大腸癌篩檢的馬可夫決策模型。數據來自一項彰化地區的務實性隨機臨床試驗，該試驗邀請符合條件的受試者接受糞便免疫潛血篩檢，參與者被分配接受額外的幽門螺旋桿菌糞便抗原檢查或僅接受糞便免疫潛血篩檢。目標人群為年齡50至69歲並符合糞便免疫潛血篩檢條件的成人。決策樹模型選項包括二合一篩檢、僅接受糞便免疫潛血篩檢或完全不篩檢。幽門螺旋桿菌糞便抗原檢測陽性者接受抗生素治療，糞便免疫潛血篩檢陽性者進行大腸鏡檢查，若發現腺瘤則進行切片及移除。主要結果為直接和間接成本、生活年數（life years）、生活品質調整後年數（Quality-Adjusted Life Years [QALYs]），以及增量成本效益比（Incremental Cost-Effectiveness Ratio [ICER]）。 研究結果: 基準值分析結果顯示，相較於單獨進行糞便潛血篩檢和不進行任何篩檢，二合一篩檢都具有成本效益上的絕對優勢，是既節省成本同時獲得更多生命年的策略。二合一篩檢相較於單獨進行糞便潛血篩檢更符合成本效益，增量成本效果比是每獲得一品質調整生命年同時還可節省3415.54美元。在敏感度分析中，幽門桿菌的盛行率、成功除菌率和再感染率是影響因素：當幽門桿菌的盛行率低於8.6%時，二合一篩檢相比單獨糞便潛血篩檢多獲得一單位品質調整生命年所需成本會超過支付意願閾值33365美元；當殺菌成功率小於63.5%、再感染率超過每人年3.5%時，與單獨糞便潛血篩檢比較二合一篩檢就不再是優勢策略。 另外，由於幽門桿菌篩檢是初段預防、糞便潛血檢查屬於次段預防，理想的起始與結束之篩檢年齡受到兩者預防篩檢型態不同，而有所影響，二合一基準篩檢開始及結束的年紀為50-69歲，與單一糞便潛血檢查相較具有節省成本的效果，二合一篩檢的起始年紀若逐步設定年紀較輕，在約42歲開始施行時，其結合初段與次段預防的額外效益最高，但若二合一開始篩檢年紀更為年輕，其成本效益將逐漸減少，當開始篩檢年紀輕於32歲，二合一相較於單一糞便潛血篩檢，將不會有節省成本的效果。二合一篩檢結束的基準為69歲，若逐步設定年紀較老至74歲為止，其額外效益將逐步提高。綜合來說，二合一篩檢的目標族群效益最高為42至74歲。 研究結論: 將幽門螺旋桿菌糞便抗原檢測整合大腸癌篩檢，相較於單一糞便潛血篩檢策略更具有成本效益，惟其相對成本效益受到幽門桿菌盛行率、成功除菌率和再感染率的影響，二合一篩檢之起始年齡與結束年齡有進一步擴展的空間。
並列摘要
Background: Screening for Helicobacter pylori is considered an effective strategy for preventing gastric cancer and can be integrated into an organized colorectal cancer screening program to improve overall healthcare efficiency. Aims: To evaluate and compare the cost-effectiveness of screening with the Helicobacter pylori stool antigen (HPSA) test combined with the fecal immunochemical test (FIT) versus FIT alone. Materials and Methods: This study used a combined Markov cohort model for both gastric and colon cancers. Data collected from a pragmatic randomized clinical trial that invited eligible subjects for colorectal cancer screening using FIT, with participants assigned to receive either an additional HPSA test or FIT alone. target population was adults aged 50–69 years and eligible for FIT screening. Invitation to screening options including HPSA+FIT co-testing and FIT alone. Individuals testing positive for HPSA receive antibiotic treatment, while those testing positive for FIT undergo colonoscopy. Life expectancy life years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) were the study outcomes. Results: The base-case analysis results indicate that, compared to FIT alone or no screening, the co-testing screening strategy demonstrates better cost-effectiveness, offering a strategy that saves costs while achieving more quality adjusted life years gained. The ICER of co-testing compared to FIT alone shows the cost-saving of $3,415.54 per quality-adjusted life year (QALY) gained. In the sensitivity analyses, the prevalence, eradication rate, and reinfection rate of H. pylori were identified as the influential factors. When the prevalence of H. pylori is below 8.6%, the cost to gain one additional QALY with co-testing compared to FIT alone exceeds the maximal willingness-to-pay threshold of $33,365. Additionally, when the eradication success rate is less than 63.5% or the reinfection rate exceeds 3.5% per person-year, co-testing screening is no longer the dominant strategy compared to FIT alone. Since H. pylori screening is a form of primary prevention and FIT belongs to secondary prevention, the ideal starting and ending ages for screening are determined by the trade-offs between two prevention types. For the co-testing, the range of starting and ending age is set at 50-69 years old at baseline, which is more cost-effective compared to FIT alone. If the starting age for co-testing is gradually lowered to around 42 years, the combined effectiveness generated from primary and secondary prevention can be maximized. However, if the starting age is further reduced, the additional cost-effectiveness will gradually decrease. When the starting age is younger than 32 years old, the co-testing will no longer be cost-saving as compared with FIT alone. If the stopping age of the co-testing is gradually extending to the upper age limit of 74 years, the additional benefits will increase. Collectively, the most optimal benefit of co-testing can be achieved when targeting individuals aged 42–74 years. Conclusion: Integrating HPSA testing into colorectal cancer screening can be more cost-effective than FIT alone, which is dependent on the H. pylori prevalence rate, eradication rate, and the re-infection rate. The starting and ending ages for co-testing have the potential for further extension.
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