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研究生: 黃郁涵
Huang, Yu-Han
論文名稱: 退化性關節炎患者使用不同材質的全人工髖關節之健康科技評估
Health technology assessment of different implant combinations of total hip arthroplasty for degenerative joint disease patients
指導教授: 古鯉榕
Ku, Li-Jung
學位類別: 碩士
Master
系所名稱: 醫學院 - 公共衛生研究所碩士在職專班
Graduate Institute of Public Health(on the job class)
論文出版年: 2024
畢業學年度: 112
語文別: 中文
論文頁數: 86
中文關鍵詞: 退化性髖關節炎全人工髖關節置換再置換成本效果
外文關鍵詞: osteoarthritis, total hip arthroplasty, revision, cost-effectiveness
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  • 背景:全髖關節置換術是嚴重退化性關節炎( osteoarthritis,以下簡稱OA)結構問題的常見手術。三種常見全人工髖關節醫材,分別是健保給付之金屬對聚乙烯( metal-on-polyethylene,以下簡稱MoP),以及自付差額之陶瓷對陶瓷( ceramic-on-ceramic,以下簡稱CoC)或陶瓷對聚乙烯( ceramic-on-polyethylene,以下簡稱CoP)人工髖關節。民眾選擇使用健保或自付差額醫材,將同時考量術後結果與醫材自付差額。

    目的:本研究追蹤OA病人的存活率、術後不良臨床結果發生風險,計算自付差額醫材相對於健保給付醫材之成本效果,回答患者問題:「自付差額醫材是否能降低手術的併發症風險,減少反覆就醫的狀況」?

    方法:使用健保資料庫分析,納入50歲以上退化性髖關節炎,並於2010-2018年進行首側初次全人工髖關節置換手術的患者。以性別、年齡組(5歲)、手術年、嚴重共病症,以及包含患者、醫院及醫師特質的傾向分數配對,以建立研究樣本,將選擇自付差額之CoC及CoP患者,分別與選擇健保給付之MoP患者進行1:1配對,建立可比較族群。計算健保給付與自付差額共三組的再置換、術後併發症、90天醫療併發症累積發生率,並以Cox回歸模型校正患者、醫院、醫師特質、骨水泥及組合式股骨柄等因素後計算醫材的校正危險比。本研究把健保費用聯結醫材比價網登錄之自付差額費用,成本估計使用廣義線性模型(GLM),計算醫材對於費用的影響程度,並使用分位數回歸(quantile regression)進行非參數方法的估計。

    結果:CoC與CoP與MoP分別配對為兩組後,CoC組(N=4,103)的觀察時間中位數4.2年,CoC的存活率優於MoP(P<0.01),校正死亡與其他風險因子後,CoC有比較低的術後併發症(aHR:0.70, 95%CI: 0.57-0.95, P=0.02)及醫療併發症(aHR: 0.51, 95%CI: 0.31-0.84, P=0.01)風險,再置換風險則無顯著差異。CoP組(N=1,196)的觀察時中位數2.7年,CoP的存活率(P=0.83),校正後再置換、術後併發症及醫療併發症風險皆無顯著差異。選擇CoC需要自付差額平均10.1±0.3萬元,醫材費用為當次手術費用之47%,CoC相對於MoP對當次手術費用的邊際效果值為98,057(95%CI: 96,263-99,851)元。選擇CoP需要自付差額平均6.7±0.5萬元,醫材費用為當次手術費用之37%,CoP相對於MoP對當次手術費用邊際效果值為63,871(95%CI: 62,346-65,396)元。相較於MoP,CoC減少1%術後併發症發生率的增量成本效果比(incremental cost-effectiveness ratio,以下簡稱ICER)為7.6萬元,減少1%之90天醫療併發症發生率的ICER為16.8萬元;CoP較貴且在術後效果無顯著差異。

    結論:對於50歲以上因退化性關節炎進行初次髖關節置換的病人,相較於健保給付MoP,自付約10萬元差額選擇CoC,可減少術後併發症1.31%與90天醫療併發症0.59%,是有效但昂貴的選擇;自付差額約6萬元選擇CoP,其術後不良臨床結果發生率與MoP無顯著差異,顯示並不符合成本效果。

    Introduction: This study assesses the cost-effectiveness of copay implants of CoC and CoP, compared to fully covered MoP implants in patients aged 50 years and older undergoing THA for OA.

    Methods: The study included 10,640 patients identified from the NHI claims data (2009-2019). 1-to-1 matching was used to create two comparable implant groups. We compared cumulative incidence rates of revision, postoperative, and medical complications and used Cox models to adjust for death and other factors. We integrated the copay for implants with NHI-covered expenses to calculate total medical costs. A GLM assessed the implants' cost contribution, while quantile regression provided non-parametric estimates of cost differences.

    Results: The CoC demonstrated lower cumulative incidence rates in revision, postoperative, and 90-day medical complications than the MoP after matching. Compared to the MoP, the CoC also showed lower adjusted hazard ratios in postoperative and 90-day medical complications. The CoC were more effective at an incremental cost of $NT 101 thousand dollars. The resulting ICER was $NT 76 thousand dollars per 1% reduction in postoperative complication rate, and $NT 168 thousand dollars per 1% reduction in medical complication rate. For the CoP, there was no significant difference in any complication rate compared with the MoP, but required a copay of 67 thousand dollars, making the CoP dominated.

    Conclusion: Comparing with the MoP, the CoC demonstrated a protective effect but were more expensive; the CoP showed less effective and more costly.

    摘要 I 誌謝 VI 第壹章、 前言 1 第一節、 研究背景 1 第二節、 研究目的 3 第三節、 研究假說 3 第四節、 名詞解釋 3 第貳章、 文獻探討 5 第一節、 全人工髖關節置換術的流行病學 5 第二節、 使用不同材質人工髖關節之術後結果 6 第三節、 選擇不同材質之人工髖關節的影響因素 8 第四節、 影響全人工髖關節術後結果差異的效果修飾因子 9 第五節、 全人工髖關節手術的成本效果 12 第參章、 研究方法 16 第一節、 資料來源 16 第二節、 研究對象 17 第三節、 健保資料庫變項定義 19 第四節、 統計分析 21 第肆章、 結果 26 第一節、 術後存活 30 第二節、 臨床不良結果 33 第三節、 醫療費用 44 第伍章、 討論與結論 55 第一節、 研究假說與研究結果討論 55 第二節、 結論與建議 61 第陸章、 參考文獻 65 第柒章、 附錄 72

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