台灣慢性B型肝炎病人之醫療利用、臨床效益及生活品質評估之初探

Evaluation on Medical Utilization, Clinical Effectiveness and Feasibility in Quality of Life Meaures on Patients with Chronic Hepatitis B in Taiwan

林芸亭(Yun-Ting Lin)

指導教授 ： 黃耀斌

共同指導教授 ： 黃志富(Jee-Fu Huang)

高雄醫學大學/藥學院/臨床藥學研究所/碩士(2011年)

https://doi.org/10.6832/KMU.2011.00092

摘要

背景：具高盛行率的慢性B型肝炎的疾病控制及治療預後是我國公共衛生及健康照顧的重大議題。雖然衛生署支持許多新型治療藥品的臨床使用、並逐漸增加健保給付藥品及延長給付療程；有關B型肝炎治療藥的醫療利用、藥物治療果效、及慢性B型肝炎病人的健康相關生活品質測量的本土資料目前仍缺乏。本研究旨在探索B型肝炎治療藥的醫療利用趨勢、評估達既定藥物療程的治療果效、及探討慢性B型肝炎病人與健康相關的生活品質測量方法，以建立本土B型肝炎病人治療相關的果效資料，作為未來成本效益評估及給付政策評估的基礎。方法：首先，採橫斷面研究追蹤2000年至2008年間以健保身分至門診就醫之所有B型肝炎病人，總計其申報醫療件數及醫療花費點數。其次，以一世代研究針對2003年10月至2008年12月間，以健保身分至門診就醫且首次治療達既定藥物治療療程的成年B型肝炎病人，並排除具可能干擾預後判斷因子的病人，追蹤使用不同B型肝炎藥物的病人之肝炎復發事件，並以存活分析方法比較不同治療藥物間復發率的差別。最後，採橫斷面研究探討慢性B型肝炎病人健康相關生活品質測量的相關議題。邀請患有慢性B型肝炎且接受藥物治療的門診病人參與訪談。訪談內容根據錄音檔案逐字翻譯成逐字稿，持續分析逐字稿內容並統整所有受訪者的意見，直至再無法發現新的意見，則以達飽和涵意的研究結果報告。訪談過程中，以歐洲生活品質問卷（EQ-5D）、視覺尺度量表（EQ-VAS）及時間交換法（time-trade off；TTO）測量患者的效用值，並以多變數分析進行探討何種因子會顯著影響受訪者健康相關的生活品質。
結果：橫斷面研究期間，慢性B型肝炎病人每月就醫申報案件數及每月治療花費均呈現顯著增加趨勢，而治療藥中則以entecavir的申報案件（P=0.0017，β=13.90）及花費（P=0.0024，β=57670.80）增加的趨勢最為顯著。世代研究共納入238位首次治療達既定療程的病人，以IFN-α-2a、PegIFN-α2a及adefovir三組各別與lamivudine組互相比較累計無肝炎復發的機率，各組累積無肝炎復發的機率皆高於90%；進一步以log-rank檢定IFN-α-2a與lamivudine、PegIFN-α2a與lamivudine（P=0.8823）及adefovir（P=0.3121）與lamivudine（P=0.9213）的統計檢定結果皆無顯著差異。訪談研究期間，共120位受訪者參與，平均年齡為48.0±11.0歲。部份受訪者表示，治療時感到經濟負擔，或偶爾對病情感到焦慮。三種生活品質調查的結果顯示受訪者在EQ-5D、EQ-VAS及TTO的平均效用值分別為0.89±0.14（119人）、0.83±0.87（118人）及0.65±0.29（110人）。受訪者有工作與EQ-5D及EQ-VAS的效用值分數相關性高；而已婚及年齡特性則與TTO的分數顯著相關。結論：肝炎試辦計畫開辦後，醫療利用顯著增加。顯示此政策確提高病人就醫可近性；首次治療未達既定療程病人，約八成於研究期間沒有再次接受藥物治療，因此病人的後續追蹤及預後結果，是極需繼續探討的健康照顧及公共衛生議題。此外，B型肝炎病人關心治療的經濟負擔及治療的預後，所以隨著肝炎試辦計畫給付條件的放寬，應加強B型肝炎治療的宣導及疾病知識的衛教，提昇病人治療B型肝炎的信賴度。

關鍵字

慢性B型肝炎 ； 醫療利用 ； 肝炎復發 ； 時間交換法 ； 歐洲生活品質問卷

並列摘要

Background: With the high prevalence of chronic hepatitis B (CHB) in Taiwan, the infection control, long-term treatment and complications management have been one of the most important tasks to healthcare authority. However, there is still lacking of outcomes data to justify the cost-effectiveness of treatment and the impact of treatment on quality of life in Taiwan. This study aims to explore the medical utilization of CHB patients, outcomes which associated with completeness of CHB treatments, factors contributing to CHB patients' quality of life (QoL), and the feasibility of QoL measurement tools for CHB patients in Taiwan. Methods: Firstly, a cross-sectional study was conducted from 2000 to 2008 using a nationwide sampled, longitudinal claim-based database (LHID2005) constituting of a million beneficiaries randomly sampled in 2005. CHB patients were included and followed the claim data which was associated with medical utilization and medical cost. All of results were reported by descriptive statistics method and analyzed by linear regression. Secondly, a retrospective cohort study was conducted from October 2003 to December 2008 using LHID2005. Adult CHB patients who received interferon or antivirus (lamivudine, adefovir) treatment were included, and those with underline diseases which may influence the judgment on treatment outcomes (relapse of CHB) were excluded. The relapse features among different therapeutic agents were evaluated and stratified by the completeness of treatment course. All of results were reported by descriptive statistics method and analyzed by log-rank test. Finally, consecutive adult CHB patients who visited liver clinics were invited for interviews. Time-trade off (TTO), EuroQol group 5-dimension (EQ-5D) questionnaire and 100-mm visual analogue scale (EQ-5D VAS) were used to measure participations’ utility. Multivariate analysis was used to evaluate the association between utility values and patients’ demography characteristics and Charlson comorbidity index. Results: During the study period, monthly number of outpatient visits, therapeutic prescriptions and medical costs significantly increased. Furthermore, the monthly number of prescription (P=0.0017, β=13.90) and drug cost (P=0.0024, β=57670.80) of entecavir also significantly increased. Of the 238 included patients (mean age=39.10±12.77 years, 73.5% male) had completed their first CHB treatment courses. There were five patients took another drug treatments after the completeness of the first treatment course. Overall, the recurrent rate of hepatitis B amongst those completed treatment course was less than 10%; and there was no significant difference in the recurrent rates between different agents. A total of 120 participants (mean age=48.02±11.04 years, 85% male) were recruited into QoL measurement study. The mean utility for EQ-5D index, EQ-5D VAS, and TTO were 0.89±0.14, 0.83±0.87 and 0.65±0.29, respectively. The former two utilities were significantly associated with employment status whilst TTO was significantly associated with marriage status. Some of participants felt financial burden of long-term drug therapy and worried about complications of CHB. Conclusion: This study revealed that implementation of the reimbursement scheme for hepatitis B medical treatments significantly increased the medical utilization. There was no significant difference of relapse rates between different therapeutic agents. EQ-5D questionnaire and EQ-5D VAS were feasible QOL measurements for Taiwanese CHB patients.

並列關鍵字

chronic hepatitis B ； hepatitis B relapse ； quality of life ； EuroQol group 5-dimension questionnaire ； Time-trade off

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