銀離子敷料應用於癌症惡性蕈狀傷口病人傷口床狀況及健康相關生活品質之成效

Abstract

研究目的：本研究目的在探討頭頸部癌症惡性蕈狀傷口病人應用銀離子敷料，其健康相關生活品質與傷口床狀況之成效。 研究背景：惡性蕈狀傷口是一非癒合性、慢性、複雜性傷口，容易導致出血、滲出液、惡臭和疼痛，引發病人生理、心理、社會、靈性等層面巨大衝擊。銀離子敷料於慢性傷口之系統性回顧及統合分析，文獻指出其可以促進傷口癒合、降低臭味、減少傷口滲液以及增進病人生活品質。然而，當前銀離子敷料應用於惡性蕈狀傷口病人研究付之闕如。 研究設計：本研究為一前瞻性、單一試驗場所、單盲、隨機分派的臨床試驗。 研究方法：研究對象主要收集北部某1000床教學醫學中心，六個病房之頭頸部癌症惡性蕈狀傷口病人，共32位研究對象隨機分派至銀離子敷料(SD)實驗組(n=14)或是非銀離子敷料(NSD)對照組(n=18)，介入處置時間為二星期；主要結果測量指標為傷口床狀況，採用惡性蕈狀傷口評估工具進行測量，次要結果指標則是健康相關生活品質，以McGill台灣版生活品質問卷進行評核。研究資料採用Wilcoxon配對組符號等級檢定、曼惠特尼U檢定及廣義估計方程式模式進行統計分析。 研究結果：本研究對象二組在基本屬性沒有顯著不同。採用無母數統計之魏可遜二獨立樣本檢定-曼惠特尼U檢定(Mann-Whitney U test)，在MFWAT-N之總量表(P=0.005)、壞死組織量( P=0.006)、傷口滲液量( P=0.028)、傷口滲液性質( P=0.001)、傷口出血量(P=0.025)及傷口滲液重量(P=0.042)等實驗組改善狀況明顯優於對照組；MFWAT-P總量表未呈顯著差異。此外，McGill-QOL皆未呈顯著差異( P=0.133)，僅身體症狀範疇(P=0.049)有統計顯著差異。本研究亦採用廣義估計方程式分析傷口床狀況及健康相關生活品質在介入期間二週的變化，MFWAT-N(P=0.014)、傷口滲液重量(P=0.018)、出血量(P=0.000)呈現顯著差異。 結論：惡性蕈狀傷口對病人生活品質影響甚劇。對於緩和照護期間，親水性纖維銀離子敷料可控制惡性蕈狀傷口之傷口滲液、出血、滲液重量。未來研究可以將本研究結果作為建構惡性蕈狀傷口照護指引時的依據，此外，需要評估銀離子敷料成本效益及進行長期追蹤性研究建構更完善的實證資料。 經費補助：本研究經費由慈濟技術學院提供

Aim. This study examined the effectiveness of a silver ionic dressing on health related quality of life and wound bed status of head and neck cancer patients with malignant fungating wounds (MFW). Background. Malignant Fungating Wounds (MFWs) are chronic, slow-healing complex wounds that can bleed, generate exudates, become malodorous and painful, and cause both physical and psychological distress to patients. A systematic review and meta-analysis of the effectiveness of silver-containing dressings for management of various chronic wounds has demonstrated their effectiveness in wound healing, reducing odor, decreasing wound exudates and improving patients’ quality of life. However, few studies have empirically tested this treatment approach in managing MFWs. Design. A randomized control trial, single blind, and parallel experimental study design was developed and implemented to assess the impact on patient quality of life when using silver-containing dressings in the treatment of MFWs. Methods: Subjects were recruited from a 1,000-bed academically based medical center with six special units ward (palliative care, oncology ward) for head and neck cancer patients with MFW in north Taiwan. A total of 32 MFW participants were randomly assigned to silver dressing (SD) group (n=14) or non silver dressing group (NSD) (n=18) with a follow-up at two weeks after treatment. The primary outcome variable was wound bed status as measured by a malignant fungating wound assessment tool. The secondary outcome variable was health related quality of life as measured by the McGill quality of life questionnaire. Data were analyzed by Wilcoxon test , Mann-Whitney U-test and generalized estimating equations (GEE) using SPSS 17.0 software. Results: The intervention and control groups were comparable at baseline .There was no significant difference in demographic variables between SD and NSD groups (p>.05). This study shows that the MFWAT-N(P=0.005) , amount of necrotic tissues(P=0.006), amount of exudates(P=0.028), quality of exudates (P=0.001), bleeding(P=0.025), weight of exudates(P=0.042) in the experimental group saw a greater improvement than in the control group, as determined by the Mann-Whitney U-test. The SD group also reported significantly higher scores on the MQOL physical symptoms subscale than the NSD group (P=0.049). Also , GEE analysis showed that participants in the SD group had significant improvements in the MFWAT-N (P=0.014), amount of exudates (P=0.018) and bleeding( P=0.000) over those in the NSD group. Conclusions. MFWs have a negative impact on patients’ HRQOL. Hydrofiber dressings that contain silver can control malodor, exudates, and amount of bleeding in patients undergoing MFW palliative care, thereby improving HRQOL in these patients. Further research is needed in order to developed well-structured MFW management guidelines. A more comprehensive health economic evaluation needs to be undertaken. Further studies exploring a longer term follow up are also required. Declaration of in interest: The study was financially supported by TZU-CHI College of Technology project No.TCCT-961A10, Hualien, Taiwan.