應用病患支持策略於治療C型肝炎之效益研究

背景 C型肝炎是台灣地區肝硬化(liver cirrhosis)及肝細胞癌(hepatocellular carcinoma)盛行率僅次於B型肝炎排名第二之致病原因，台灣地區約有2-4%的人口(約三十萬人)感染C型肝炎，而慢性C型肝炎約有30%會演變成肝硬化，25%會演變成肝細胞癌。肝炎係病毒感染造成，以往並無特殊藥物治療，B型肝炎已有預防性疫苗，而C型肝炎則無。近年來醫藥科技之進步，慢性C型肝炎之治療以干擾素合併Ribavirin之「合併療法」(combined therapy)最有效。然而干擾素的副作用會嚴重影響病患日常生活功能，使病患容易中途放棄治療，大大降低藥物的成效，所以病患藥物治療的「順從性」(compliance)成為影響預後的關鍵。如何增加C型肝炎病患治療的順從性以達到有效治療的目的，目前國內外已有門診衛教護士方式輔導，其效果如何？以及有無其他更有效方法，尚無深入及系統性之研究分析以及比較。近年來由於通訊科技之進步，家用電話及個人行動電話極為普遍，且成本逐年降低，各種快速及便利之通訊諮詢中心逐漸盛行，特別是在醫藥健康方面。本研究的目的是比較一般門診衛教護士(對照組)以及經由健康諮詢中心(實驗組)執行兩種病患支持計劃，研究其改善病患治療「順從性」的差異與效益。方法將符合收納標準的慢性C型肝炎病患，依照其個人喜好自由選擇一種病患支持計劃。病患支持計劃(一) (對照組)由門診衛教護士於病患門診時間執行及提供諮詢。病患支持計劃(二)(實驗組)是利用通訊科技，由一個24小時健康諮詢中心執行。兩組均接受相同標準劑量的合併療法及療程共72週。治療結束後均追蹤24週。本研究比較兩組病患的(1)基本資料、(2)實驗室檢查結果、(3)藥物副作用種類及頻率、(4)治療順從率以及(5)病患支持計劃之成本。結果本研究共收集對照組及實驗組分別為150及148名病患。兩組病患在(1)基本資料以及治療前實驗室檢查結果顯示無統計學之差異。(2)兩組病患治療後實驗室檢查結果亦顯示血清生化值的改善及持續病毒反應率(sustained virologic response rate)各為66% 及68.9% (p>0.05)，亦無統計學之差異。(3) 兩組在藥物副作用頻率及種類亦相似。(4)對照組共有132位病患完成治療及追蹤，治療順從率為88% (132/150)。實驗組共有140位病患完成治療及追蹤，治療順從率為94.6% (140/148)，兩組之治療順從率在統計上有顯著之差異(p<0.05)。(5)兩組病患支持計劃之所需成本分別為11,970,000及3,656,250元，亦有顯著之差異。結論本研究顯示由門診衛教方式及健康諮詢中心執行之兩種病患支持計劃，均能增加慢性C型肝炎病患治療之順從性，可以提升治療C型肝炎之成功率，但健康諮詢中心執行之病患支持計劃，較門診衛教方式更能增加慢性C型肝炎病患之順從性，降低治療中斷率，且更具經濟成本效益。

關鍵字

病患支持計劃； C型肝炎；順從性

並列摘要

Background Chronic hepatitis C virus (HCV) infection is a serious health problem in Taiwan. The high dropout rate due to side effects limits the efficacy of treatment. The objective of this study is to evaluate the effectiveness of the telecommunication-based patient support program in improving patient outcome and patient safety in comparison to the commonly used clinic-based patient support program. Methods All eligible patients were randomly assigned to one of the following two groups: (1) Group 1: Consultation with a public health nurse was provided in the outpatient clinic during outpatient visit. (2) Group 2: Patients were offered structured, scheduled phone follow-up and additional phone consultation with physicians and nurses at the health communication center whenever advice was needed throughout their treatment period. All patients were treated with standard therapy and followed up for 72 weeks. Patients’ demographics, laboratory data, adverse events, dropout rate and costs were collected and analyzed. Results Normalization of serum biochemistry was found both in Group 1(150 patients) and Group 2(148 patients). The most common types of side effect in both groups were influenza-like symptoms. A total of 132 and 140 patients completed the course of treatment and follow-up in the Group 1 and Group 2. Patient compliance was 88 % (Group 1) and 94.6 % (Group 2). Total dropout cases were 18(12%) in Group 1 and 8(5.4%) in Group 2. The program costs were 368,334 USD (Group 1) and 112,500 USD (Group 2). Conclusions Even though compliance rates were higher in both groups than previous studies that without patient support program, the telecommunication-based patient support program model is significant in reducing dropout rate and is more effective combining interpersonal communication with easy access.

並列關鍵字

patient support program ； hepatitis C ； compliance

參考文獻

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應用病患支持策略於治療C型肝炎之效益研究

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