糖尿病照護世代之C型肝炎照護鏈與根除成效研究:以基層醫療單位為例

Hepatitis C Elimination of Care Cascade in the Diabetes Population from a Share Care Cohort-A Primary Care Model in Taiwan

曹佑羽(Yo-Yu Tsao)

指導教授 ： 陳秀熙

共同指導教授 ： 許辰陽 ； 葉彥伯(Yen-Po Yeh)

國立臺灣大學/公共衛生學院/公共衛生碩士學位學程/碩士(2021年)

https://doi.org/10.6342/NTU202101540

摘要

研究背景
臺灣C型肝炎盛行率約4% (2020)，高於全球平均2.8%。C肝患者約25%會自行清除病毒，其餘75%成為慢性感染，對於C型肝炎慢性感染者若未妥善治療則可能進展成為肝硬化與肝癌。截至2017年止，台灣未接受治療之C型肝炎慢性感染病患至少仍有35萬人。健保自2017年起提供口服新藥(Direct acting antivirals，簡稱DAA)，相較干擾素合併Ribavirin的組合療法(約可達7成持續性病毒清除(Sustained Virologic Response，SVR))，DAA的治療效果大幅提升(SVR可達9成以上)。我國於2016年12月成立國家消除C肝辦公室，隨後完成「國家消除C肝政策綱領」白皮書，並訂定以C肝口服新藥治療25萬名C肝病人，並減少80%以上C肝病患為目標。為了使C肝根除目標在執行與評估面項建立實證基礎，國際間亦提出C肝根除評估報導共識。然而目前對於如何將C肝照護鏈模式推行於族群層次，並且以實證指標評估其推展之過程與結果，尚未有系統性之研究與科學證據。
研究目的
本研究旨在以C肝根除計畫結合現有的糖尿病共同照護網，執行C肝篩檢與治療，以國際建立之共識標準評估糖尿病患者之C肝根除成效及照護鏈各項指標達成率，並分析此一根除模式之推展在各鄉鎮間是否具有同質性。
研究方法
本研究選定彰化縣27家衛生所糖尿病患者總計10,848人。糖尿病收案條件為符合疾病診斷碼前3碼E08-E13及糖尿病藥品藥理治療分類代碼A10，且就醫期間介於2018年1月1日至2020年12月31日之間。本研究執行方式結合彰化縣C肝根除計畫與彰化縣糖尿病共同照護網，以糖尿病疾病管理模式進行C肝根除。主要分為五大步驟，建立糖尿病患者C肝追蹤名冊，比對C肝資料庫並註記，於糖尿病患者回診照護時一併進行C肝檢測與轉介治療，定期收集資料並檢核與除錯，資料分析後提供各衛生所追蹤與照護。統計分析方法主要採用羅吉斯回歸（Logistic regression model），對C肝照護鏈各項實證指標(抗體篩檢率、RNA檢測率及C肝治療率)進行評估並剖析影響因子。對於本根除計畫於彰化縣各鄉鎮推展可能存在之異質性，本模式則運用隨機效應模型(Random effect model)進行評估。若該效應未達統計顯著，即採固定效應模型(Fixed effect model)進行成效分析。模型配適評估採用Wald-type test 及Akaike Information Criterion (AIC)以卡方分佈檢定為之。並運用所建構之模型對於各鄉鎮進行結果預測。
研究結果
本研究的糖尿病世代共納入10,848人，結果顯示，C肝陽性的風險，女性高於男性，年齡呈現正相關，教育程度越低染患C肝之風險亦上升。截至2020年12月1日止，本根除計畫之篩檢目標總計達10,702人，接受C肝抗體篩檢率達93.2% (9,978人)，抗體陽性率6.1%(608人)，可進行RNA檢測率97.0% (590人)，接受RNA病毒檢測率88.6% (523人)，RNA檢測病毒陽性率69.6% (364人)，染患C肝個案中適合治療率為98.1% (357人)，其中接受治療率為91.6% (327人)。在考慮各鄉鎮異質性並加入隨機效應模型後，在RNA陽性率與治療率部分未達顯著，顯示本計畫之RNA陽性與治療率在各鄉鎮間無明顯不同。
結論
本研究以糖尿病患者定期回診照護，結合環環相扣的照護鏈模式，從篩檢抗體、偵測病毒到最後的轉介治療，積極發現與治療C肝個案。整合基層醫療資源，透過完善的糖尿病個案管理照護，並且建立轉介治療快速通道，使每個鄉鎮均能提供C肝篩檢與轉介治療服務，大幅提升C肝篩檢率與治療率，以達到各鄉鎮一致且平等的C肝根除目標。

關鍵字

C肝 ； 根除 ； 照護鏈 ； 糖尿病 ； 基層醫療

並列摘要

Background
The prevalence rate of Hepatitis C Virus (HCV) in Taiwan is about 4% (2020), which is higher than the global average of 2.8%. About 25% of HCV patients will reach viral clearance, and the remaining 75% will become chronic infection status. Without proper treatment, those with HCV chronic infection may progress to liver cirrhosis and further to liver cancer. As of 2017, there are at least 350,000 subjects who have not received treatment for HCV. Since 2017, the National Health Insurance (NHI) in Taiwan has provided oral new drugs (Direct acting antivirals, DAA) for treating chronic HCV infection to reach the goal of the elilmination of HCV in Taiwan. Compared with the therapy combining interferon and Ribavirin (about 70% Sustained Virologic Response (SVR)), the effect of DAA is greatly improved (more than 90% SVR). The National Hepatitis C Elimination Office was established in December 2016 in Taiwan. Guided by the policy of "National Hepatitis C Elimination Policy Program", the goal of treating 250,000 HCV patients with DAA and reducing HCV patients by more than 80% was set. In order to establish an empirical basis for the implementation and evaluation of this goal, the international consensus on HCV reporting has also been adopted. However, there is a lack of systematic approach with empirical evidence on the implementation of the cascade for caring HCV at population level.
Aims
The aim of the study is first to establish the model for HCV screening and treatment for the population of diabetes by using the network of diabetes management. Following the establishment of the cascade for caring HCV patient, the effectiveness on HCV eradication for the diabetic cohort was then evaluated by using a series of indicators guided by international concensus. The homogeneity on the implemention of the model for caring HCV across the townships of Changhua was also evaluated.
Methods
In this study, a total of 10,848 diabetic patients were selected from 27 health centers in Changhua County. The eligible criteria for the enrollment of diabetes cohort including (1) Subjects with the disease diagnosis code of E08-E13; (2) receiving and the diabetes treatment using the pharmacological classification code A10; (3) enrolled during the period between January 1, 2018 to December 31, 2020. The implementation of the HCV caring project was archieved by the interlink of the HCV eradication project and the network of diabetes care in Changhua. The process for implementation as as follows. (1) Develop of the list for tracking HCV patient for the diabetic cohort. (2) Compare and make notes for the status of HCV in the database of enrolled diabetes cohort. (3) Performs HCV testing and referral for treatment for the diabetic patients with positive results. (4) Monitor the progress of each steps by using the empirical data regularly. (5) Feedback to health care units following the principle of the HCV caring cascade. A series of logistic regression models were applied to evaluate the effectiveness of the project focusing on the indicators of the HCV caring cascade including antibody screening rate, RNA detection rate, and treatment rate. The heterogeneity across the townships of Changhua in terms of the implementation of the project was assessed by using a random effect model. The model fitting statistics including Wald-type test and Akaike Information Criterion (AIC) were used for model selection by comparing with a central chi-square distribution. The parsimonious model was used to predict the results of each township.
Result
A total of 10,848 subjects were enrolled in the diabetic cohort in this study. The results showe that the risk of HCV was higher in women compared with men. There is a positive correlation between age and the risk of HCV. The lower the education level, the higher the HCV risk. As of December 1, 2020, a total of 10,702 people were screened for the HCV status by using antibody test. The screening rate for HCV antibodies reached 93.2% (9,978 people), and the antibody positive rate was 6.1% (608 people). The RNA testing rate was 97.0% (590 people). The RNA virus testing rate was 88.6% (523 people). The RNA virus positive rate was 69.6% (364 people). The rate of hepatitis C infection and suitable for treatment was 98.1% (357 people). The treatment rate was 91.6% (327 persons). There was no significant heterogeneity across the townships of Changhua in terms of RNA positive rate and treatment rate.
Conclusion
In this study, we demonstrated the establishment of the model of caring HCV for the diabetic cohort in Changhua. The implementation of the model followed the cascade HCV care including the screen for HCV antibody, virus detection, the referral for treatment. The HCV cases were actively detected for the cohort. The integration of primary care with the network of diabetes management and the establishmet of fast-track for referral treatments in the townships in Changhua has greatly increased the screening rate and treatment rate for HCV, which further contribute significantly to the goal of HCV eradication.

並列關鍵字

HCV ； Elimination ； Care Cascade ； Diabetes ； Primary Care

參考文獻

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