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研究生: 陳芳慈
Chen, Fang-Cih
論文名稱: 改編及發展中文化「負壓傷口灌注式治療指引」
Adapting and Developing of the Chinese version of " Negative Pressure Wound Therapy with Instillation and Dwell time (NPWTi-d) guidelines"
指導教授: 柯乃熒
Ko, Nai-Ying
學位類別: 碩士
Master
系所名稱: 醫學院 - 護理學系
Department of Nursing
論文出版年: 2026
畢業學年度: 114
語文別: 中文
論文頁數: 178
中文關鍵詞: 負壓傷口治療負壓傷口灌注式治療臨床指引
外文關鍵詞: Negative pressure wound therapy, NPWTi-d, Negative Pressure Wound Therapy with Instillation and Dwell time, Clinical practice guideline
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  • 背景
    負壓傷口治療可追溯至18世紀,1997年Morykwas 等人透過動物實驗證實其可促進血流與肉芽組織生長,負壓傷口治療現已廣泛應用於糖尿病足、壓力性損傷及燒燙傷等臨床傷口治療。於1998年,Fleischmann 提出結合間歇性沖洗技術之「負壓傷口灌注式治療」(Negative Pressure Wound Therapy with Instillation and Dwell time, NPWTi-d),該方法可加速清創或減少換藥頻率,Kim 團隊隨後於2013年發表了負壓傷口灌注式治療的共識指引,並於2020年進行了更新,儘管國際指引已確立,然而國內尚缺乏本土化且系統性的臨床實證指引。
    研究目的
    本研究旨在轉譯並在地化 Kim 等人(2020)發布之國際指引,並結合本土臨床需求,發展出具備實證基礎與臨床可行性的繁體中文版負壓傷口灌注式治療指引。
    研究方法
    本研究依循 Fervers 等人(2011)所整合之 ADAPTE 臨床指引改編框架,據此發展並建構適合在地化情境之流程,涵蓋三階段、九個模組與 24 個步驟,成繁體中文版臨床指引的轉譯與改編。內部專家首先以 AGREE II 臨床診療工具及修正版德菲法系統性審閱原指引品質,並在整合評估後擬定初稿,此初稿後續採納國內方法學專家與臨床實務專家之意見,針對治療適應症、溶液選擇、禁忌對象、換藥頻率及負壓設定等核心議題,提出具體且標準化之建議,旨在確保指引具備本土化實用性與臨床可行性。
    研究結果與討論
    本研究採用 ADAPTE 方法論,結合修正版德菲法,將 2020 年國際負壓傷口灌注式治療指引改編並發展為符合台灣臨床情境之繁體中文版指引,研究初期由內部專家使用AGREE II 臨床診療評估工具對原始國際指引進行品質評估,結果顯示該指引於「指引發展的嚴謹度」、「應用性」及「編製的公正客觀與獨立性」三個領域得分未達建議之 70% 門檻,然整體品質評分介於 5 至 6 分,顯示具備可接受之基礎品質,經專家共識後,確立作為中文化指引之初稿基礎,並依本土臨床需求進行調整。
    在共識形成階段,第一輪修正版德菲法問卷結果顯示,十一項共識聲明及五十四項細則之評分高度集中於 4 至 5 分,四分位距均小於 2,每項通過比例皆達 80%,僅1-k「階段性/延遲截肢過渡傷口」及2-d「醋酸溶液(0.25% 至1.0%)」兩項細則,經專家討論後因國內實證不足而刪除,第二輪修正版德菲法結果中,各細則平均數介於 4.25 至 5 分之間,四分位距皆低於 2,每項通過比例均達 80%,部分項目更達 100% 共識,最終完成指引定稿。
    外部專家以 AGREE II 臨床診療評估工具進行品質評估,結果顯示,本指引於「適用範圍與目的」(87.7%)、「權益相關人參與情形」(74.4%)、「指引清楚呈現」(74.4%)及「編製的公正客觀與獨立性」(85%)等領域均達建議門檻,顯示指引目的明確、結構清楚,且具備良好透明度與臨床可操作性;惟「指引發展的嚴謹度」(68.3%)及「應用性」(55%)未達建議標準,專家建議未來可強化文獻品質評估、臨床執行障礙與成本效益分析,並增列品質指標與檢核工具。整體品質評分介於 4 至 7 分,達中上水準。
    本研究成功將國際負壓傷口灌注式指引轉化為符合台灣醫療體系與健保制度之臨床實務標準,並透過精確術語定義及檢核表之增補,降低臨床操作變異性,未來可考慮設計標準化流程或流程圖,以利種子教師培訓及本土多中心研究,持續提升指引之證據等級與臨床推廣價值。
    結論
    本研究成功開發出台灣首份具備實證基礎的在地化「負壓傷口灌注式治療」臨床指引,透過 ADAPTE 框架將國際標準與國內專家意見整合,此指引有效填補了國際理論與在地實務之間的差距,並針對適應症、溶液選擇及技術參數設定提供標準化規範,最終旨在提升台灣臨床環境中複雜傷口處理的醫療品質與安全性。

    This study utilized the ADAPTE framework to systematically localize the 2020 international NPWTi-d consensus guidelines for the Taiwanese clinical context, employing the AGREE II instrument and a two-round Modified Delphi Method to ensure methodological rigor and expert consensus. Although the original guidelines showed limitations in certain quality domains, the adaptation process successfully refined 11 statements and 54 specific items, achieving a high consensus rate (80%–100%) and removing clinically incompatible options such as acetic acid solutions. The final Traditional Chinese version demonstrated superior quality in external appraisals, particularly in "Scope and Purpose" (87.7%) and "Editorial Independence" (85.0%), providing a standardized, evidence-based tool for managing indications, dressing changes, and pressure settings in local wound care.

    中文摘要 i 英文延伸摘要 iii 致謝 vi 目錄 viii 表目錄 xi 圖目錄 xii 第一章 前言 1 第一節 背景 1 第二節 重要性 3 第三節 現況分析與問題確立 4 第四節 研究目的 5 第二章 文獻查證 6 第一節 負壓傷口治療在傷口照護領域之文獻回顧與應用 6 第二節 負壓傷口治療與傳統傷口照護之臨床療效比較 6 第三節 負壓傷口灌注式治療在臨床照護之經驗與成果探討 7 第四節 負壓傷口灌注式治療之臨床成效:整體證據概述 8 一、系統性回顧與統合分析之臨床成效比較 8 二、隨機對照試驗之直接成效證據 9 三、共識聲明與現有文獻證據之整合分析 10 第五節 負壓傷口灌注式治療臨床指引的形成與依據 13 第三章 研究方法 15 第一節 研究設計 15 一、成立小組 15 二、選擇主題 15 三、主題是否可行 15 四、確定需要的資源及技術 15 五、制定階段性任務 16 六、編寫指引套用計畫 16 第二節 負壓傷口灌注式治療實證指引之系統性建立與品質評審 16 一、確定主題臨床問題與指引來源 16 二、搜尋策略 17 三、指引評估與品質篩選(AGREE II 臨床診療指引工具) 17 四、修正版德菲法共識程序(Modified Delphi Method) 17 五、共識判讀與統計標準 18 六、指引基礎的確定與選擇 18 七、指引初稿的擬定與共識建立 18 第三節 臨床指引之最終確認與定稿 19 一、指引最終外部審查與專家共識 19 二、指引的定期審查與更新機制 19 三、最終指引的編纂、發佈與推廣 19 第四章 研究結果 20 第一節 臨床指引建置與流程 20 一、內部指引改編小組的成立與職責 20 二、負壓傷口灌注式治療的實證評估與在地化需求 20 三、資源確認、倫理規範與協作機制 21 第二節 原始指引的評估與實證轉譯 21 一、改編指引的確定與核心文獻的篩選 21 二、第一階段:AGREE II 指引品質評估 21 三、第二階段:修正版德菲法共識形成 24 第三節 專家共識建立與建議強度確立 29 一、外部專家審核指引 29 二、指引定期審查與更新機制 31 三、中文版指引終稿之定稿 31 四、研究經費來源聲明 31 五、利益衝突聲明 32 第五章 討論 33 第一節 中文化臨床指引與原始指引之內容比較 33 第二節 臨床指引之本土化適用性評估 34 第三節 改編臨床指引之臨床實施與效益 35 第六章 結論與建議 36 第一節 結論 36 第二節 研究限制 36 第三節 指引的推廣與未來研究 37 第七章 參考文獻 39 附件目錄 155 附件一 人體研究倫理審查委員會免審證明 155 附件二 利益衝突聲明書 156 附件三 《負壓傷口灌注式治療國際共識指引更新版》之版權授權書 161

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