口腔冷凍療法能否預防施打5-Fluorouracil化學治療後口腔黏膜炎之發生率Oral cryotherapy for preventing oral mucositis induced by 5-fluorouracil-based chemotherapy

754 2 209         DOI:doi.org/10.30131/TWNA_EBHC_Library.DB_2022020011B/Text

2023-03-31 已刊登
綜 整 預防/治療/介入類型

作  者

謝雅玲 謝佩琪* 陳淑真

文章類別

B 類:實證健康照護應用

問題類型

治療/預防性問題

健康狀況

腫瘤醫學 (Oncology)  

治療/介入措施

臨床護理技術相關措施(Clinical Nursing Skills and Techniques) - 口腔冷凍療法

專長類別

腫瘤及安寧/緩和

中文關鍵詞

#5-氟尿嘧啶 #化學治療 #口腔冷凍療法 #口腔黏膜炎

英文關鍵詞

#5-fluorouracil-based # Chemotherapy # Oral cryotherapy # Oral mucositis

機構名稱

長庚醫療財團法人嘉義長庚紀念醫院

申請單位

護理部腫瘤科組11F病房

中文摘要

形成臨床提問:
施打5-Fluorouracil化學治療的病人約90%會產生不同程度的口腔黏膜受損形成口腔黏膜炎,嚴重的口腔黏膜炎會降低營養攝入、言語溝通困難及影響生活品質。為了降低口腔黏膜炎的發生,臨床上常會建議病人在接受5-Fluorouracil治療時使用口腔冷凍療法,然而,是否口腔冷凍療法真能預防口腔黏膜炎的發生尚缺乏實證證據支持,因此,臨床問題為:口腔冷凍療法是否能預防因接受5-Fluorouracil治療後而引起的口腔黏膜炎。
文獻搜尋的方法與分析:
本文以PICO形成問題,探討口服冷凍療法,對初次施打5-Fluorouracil化學治療口腔黏膜炎之發生率,利用自然語言或醫學主題(MeSH)及布林邏輯(and/or)的方式,檢索CEPS、Cochrane Library、Embase、Pubmed和Scopus等五種電子資料庫,將P、I、O各組合關鍵字及同義字使用OR聯集,再使用AND交集。經第一和第二作者依關鍵字檢索已確認的文獻,再由第三位專家審核文獻搜尋結果,共同討論後達成共識。根據定義的納入和排除標準選擇,採分層式搜索截至2021年12月發表的中英文文獻,搜尋結果共174篇,經篩選後,最終共納入4篇隨機試驗文獻(Randomized Controlled Trial; RCT)。
文獻的品質評讀與結果:
文獻評讀工具依據2018年CASP Randomised Controlled Trials Checklist,針對4篇RCT文獻進行評析,結果每篇RCT文獻CASP皆為8/11分,本篇研究證據等級根據英國牛津大學CEBM發表的Oxford Centre for Evidence-based Medicine 2011 Levels of Evidence,結果Oxford證據等級皆Level 2,文獻均支持口腔冷凍療法可使口腔局部血管收縮,降低口腔黏膜炎發生率進而緩解口腔疼痛,研究對象為年滿18歲以上施打5-Fluorouracil化學治療乳癌、大腸癌或胃癌之病人。介入措施為口腔冷凍療法,操作方法:每次化學治療前5分鐘開始口服冰塊至少30分鐘。評估工具透過WHO口腔黏膜炎分級量表,檢視病人口腔內膜的嚴重程度,進一步透過視覺類比量表評估病人主觀口腔疼痛程度。
證據之臨床應用:
以南部某區域教學醫院腫瘤科病房進行初步測試,試驗期間自2021年12月13日至2022年2月16日,共招募20名預接受5-Fluorouracil治療癌症的病人,將其隨機分配為實驗組和對照組。實驗組在執行5-Fluorouracil治療前、中、後接受口腔冷凍療法至少30分鐘,對照組病人則接受常規口腔護理。在治療後7,14和21天收集有關口腔黏膜炎的數據,以卡方檢定分析數據。
成效評值:
以統計分析的方式,比較化療期間口服冷凍療法施打5-Fluorouracil化學治療口腔黏膜炎之成效,試驗結果顯示,在治療後7,14和21天口服冷凍療法能有效緩解施打5-Fluorouracil化學治療口腔黏膜炎之發生率,實驗組口腔黏膜炎平均分數為0.17(SD=0.28),而對照組為1.13(SD=0.78);實驗組口腔黏膜疼痛平均分數為0.23(SD=0.39),對照組為1.60(SD=1.14),介入後實驗組口腔黏膜炎及口腔黏膜疼痛顯著低於對照組,皆達統計學意義(p<0.05)。
結論與建議:
本文探討口腔冷凍療法能否預防施打5-Fluorouracil化學治療後口腔黏膜炎之發生率?透過文獻評讀,篩選最終策略進行臨床應用。結果發現口腔黏膜炎發生率於統計檢定上有顯著差異。經實證應用後發現確實透過口服冰塊可以緩解口腔黏膜炎,口腔冷凍療法不只低成本且介入措施是可信的,是預防施打5-Fluorouracil化學治療後病人黏膜炎發生率和緩解嚴重程度的有效方案,此篇計畫目前為前導性研究,建議進行正式的隨機對照試驗,以進一步研究。

英文摘要

Ask an answerable question (PICO):
Among patients receiving 5-fluorouracil-based chemotherapy, approximately 90% patients experience varying degrees of oral mucositis, which reduce nutrient intake, cause difficulty in communication, and decrease the quality of life. To prevent oral mucositis from receiving 5-fluorouracil treatment, oral cryotherapy is commonly recommended to patients. However, whether oral cryotherapy can prevent oral mucositis lacks empirical evidence. A clinical problem emerges as whether oral cryotherapy prevents oral mucositis induced by 5-fluorouracil-based chemotherapy.
The Method and Analysis of Literature Review:
Five scientific databases (CEPS, Cochrane Library, Embase, Pubmed, and Scopus) were searched from inception until December 2021 with Chinese and English language restrictions, using keywords and related MeSH terms. A total of 174 studies was retrieved. After examination of the inclusion and exclusion criteria, four randomized controlled trials (RCTs) studies have been included in the systematic review.
Critical Appraisal:
The CASP Checklist was used to examine the 4 RCTs studies, each of which attained 8 of 11 points, revealing that 4 studies were valid. The Oxford Centre for Evidence-based Medicine (CEBM) 2011 was used to evaluate the levels of evidence, and the results indicated that all the 4 RCTs studies reached Level 2. In the four RCTs studies, the participants (> aged 18) underwent 5-fluorouracil-based chemotherapy for breast, colorectal or gastric cancers. The participants suck on ice or hold ice in their mouths 5 minutes prior to 5-fluorouracil-based chemotherapy and continued for at least 30 minutes. The evaluation tool included WHO Oral Mucositis Grading Scale and the Visual Analogue Scale. The 4 RCTs studies concluded that oral cryotherapy induced oral vasoconstriction which reduced the incidence of oral mucositis. Meanwhile, pain was also alleviated.
Clinical Application of Evidence:
A preliminary study was conducted in the oncology wards of a regional teaching hospital in southern Taiwan. The study period was from December 13, 2021 to February 16, 2022. A total of 20 participants received 5-fluorouracil-based chemotherapy, and was randomly allocated into experimental and control groups. The participants in the experimental group received oral cryotherapy for at least 30 minutes while receiving 5-fluorouracil-based chemotherapy, whereas those in the control group received conventional oral care. Data were collected on Day 7, 14, and 21 after the chemotherapy. Chi-squared test was used for data analysis.
Evaluation of Effectiveness:
The results revealed that the experimental group has significantly lower rate of oral mucositis than the control group on Day 7, 14, and 21 after the chemotherapy. The mean of mucositis was 0.17 (SD=0.28) in the experimental group and 1.13 (SD=0.78) in the control group. It is the same as mucositis that the mean of mucosal pain scale was 0.23 (SD=0.39) in the experimental group and 1.60 (SD = 1.14) in the control group. The oral mucositis and mucosal pain in the experimental group were significantly lower than those in the control group (p<0.05).
Conclusions and Recommendations:
This article explores the effectiveness of oral cryotherapy on preventing oral mucositis after receiving 5-fluorouracil-based chemotherapy. The four RCTs studies concluded the effectiveness of oral cryotherapy on preventing oral mucositis, and then a preliminary test was conducted in our clinical settings. The results showed that the rate of oral mucositis was significantly lower in the experimental group than in the control group, indicating that oral cryotherapy is a reliable intervention for preventing oral mucositis. Because of methodological limitation, we recommend a RCT study with appropriate sample size for further examination.