探討PSS液體口腔敷料干預下CCRT誘導的OM改善對頭頸癌患者健康生活品質的影響：分層隨機對照試驗

Abstract

背景/目的：口腔健康不僅是維持最佳整體健康的基本要素，而且在維持最佳整體健康方面也發揮著重要作用。口腔黏膜炎 (OM) 是同步放化療 (CCRT) 的一種極其痛苦且不可避免的併併發症。這種嚴重的不良症狀不僅會降低患者的生活品質，還會增加醫療費用。本研究的目的是探討使用聚丙烯酸酯銀鹽（PSS）/聚乙烯吡咯烷酮液體口腔敷料是否可以改善頭頸部癌症患者的口腔黏膜和口腔功能受損狀況, 進而在口腔黏膜口腔黏膜炎的改善下是否可以促進病人的健康生活品質。 方法：本實驗設計被設計為分層隨機對照試驗（stratified randomized control trial, stratified RCT）。首先按“口腔癌類型”和“其他頭頸類型”對符合條件的頭頸癌患者進行分層分派，然後在分層內將符合資格的參加者隨機分配實驗組或對照組。符合條件的受試者必須正在接受 CCRT 治療並已有 1 級以上粘膜炎症狀的頭頸癌患者。最終符合條件並完成整個試驗程序的患者人數為 55。所有患者均遵循多國癌症支持治療協會和國際口腔腫瘤學會 (MASCC/ISOO) 處置 OM 的臨床指引，但實驗組的病人會再加上15g PSS液體口腔敷料漱口的步驟。每週評估臨床 OM 和口腔功能連續 4 週直至放療完成後 5-10 天。每兩週對口腔健康相關的生活品質進行評分。評價口腔評估指引（oral assessment guide, OAG）收集口腔粘膜與功能評分數據；口腔健康衝擊量表 (OHIP-14) 用於評估患者的口腔健康相關生活品質 (OHRQoL)。 結果：PSS液體口腔敷料對改善CCRT誘導的頭頸部（H&N）患者的OM和生活品質皆有顯著性改善的效果。試驗組和對照組之間個統計結果比較為： OAG 分數（15.07 對 20.37 p<0.0001）和 OHIP-14 評分（23.85 對 34.2，p<0.0001）。 結論：綜上所述，使用PSS 液體口腔敷料作為改善OM嚴重度，是對需要進行放、化療治療的頭頸癌病人一個可以考慮的選擇。試驗證實在PSS液體口腔敷料的使用介入治療下，患者的口腔健康生活品質也得到顯著改善。

Background/Purpose: Oral health is not only an essential element of and also plays an important role in maintaining optimal overall health. Oral mucositis (OM) is an extremely painful and unavoidable complication of concurrent chemoradiotherapy (CCRT). This severe adverse symptom not only does it reduce the patient’s QoL and it also increases healthcare cost. The purpose of this study is to investigate whether the use of polyacrylate silver salt named as (polyacrylate silver salt, PSS)/Polyvinylpyrrolidone-based liquid oral dressing can improve the condition of OM and oral incapacitation in patients with head and neck cancer (HNC), and then promote their healthy QoL under the improvement of OM. Methods: The design was designed as a stratified RCT. This study first stratified eligible HNC patients by "oral cancer type" and "other HNC type", and then randomly assigned patients to an experimental or control group within each stratum. The subjects must meet the symptoms of head and neck cancer patients who are undergoing CCRT treatment and have more than one grade of OM. The number of eligible patients who ultimately completed the entire trial was 55. All patients followed Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) clinical practice guidelines for the management of OM, but adding gargling with 15g PSS liquid oral dressing right after oral hygiene treaded for the experiment group. Clinical OM and oral function were assessed weekly for 4 consecutive weeks till 5-10 days after the completion of radiotherapy. Oral health related QoL was scored every two weeks. For evaluation, oral assessment guide (OAG) were used for collecting the data of OM status; oral health impact profile-14 (OHIP-14) was used to evaluate patients’ oral health-related QoL (OHRQoL). Results: The results showed that PSS liquid oral dressing a had positive effect on the improvement of CCRT-induced OM and QoL for head and neck cancer patients and all these data all had statistically significant improvement. OAG scores (15.07 vs. 20.37 p<0.0001) and OHIP-14 scores (23.85 vs. 34.2, p<0.0001) between the test group and the control group. Conclusions: In conclusion, oral care using PSS liquid oral dressing for the treatment of head and neck malignancies undergoing CCRT is an effective interventional option for improving the severity of OM. Under the intervention of PSS liquid oral dressing, patients' oral health QoL is also significantly improved.