Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, 501-1194, Japan.
Department of Medical Data Science, Graduate School of Medicine, Wakayama Medical University, Wakayama, 641-8509, Japan.
Clin Nutr ESPEN. 2022 Jun;49:172-180. doi: 10.1016/j.clnesp.2022.03.005. Epub 2022 Mar 14.
BACKGROUND & AIMS: During chemo- or radiotherapy, oral mucositis is associated with severely affected nutrition, prolonged hospital stays, increased risk of infections, death, hindered cancer treatment, and compromised patient prognosis. Although oral mucositis management is critical, no preventive methods have been firmly established. Nutritional therapy with the oral amino acid-rich elemental diet (ED) Elental® may prevent body composition changes and oral mucositis as dose-limiting toxicities of cancer therapy. This meta-analysis evaluated the effectiveness of ED for the prevention of grade ≥2 oral mucositis in patients with cancer undergoing chemotherapy or radiotherapy.
A PubMed literature search for randomized clinical trials and/or observational studies in English was conducted. Odds ratios and their confidence intervals were calculated, and fixed- or random-effects models applied.
Of 24 relevant studies, nine conducted in Japan (including 445 patients) were subjected to a meta-analysis. Heterogeneity was 56%. Using a random-effects model, the resulting odds ratio (95% confidence interval) was 0.25 (0.10, 0.61). Funnel plot analysis showed no publication bias. There was no heterogeneity by study design, but esophageal cancer exhibited heterogeneity. The respective odds ratios (fixed-effects model) were 0.10 (0.03, 0.30) for observational studies and 0.48 (0.28, 0.82) for randomized control trials. The odds ratio (confidence interval) using a random-effects model was 0.35 (0.12, 0.99) for esophageal cancer; using a fixed-effects model, odds ratios were 0.07 (0.02, 0.29) for gastroenterological cancer and 0.26 (0.04, 1.60) for oral cancers.
The ED reduced the risk of developing oral mucositis, regardless of study design. The effectiveness was more marked in patients with gastroenterological cancer followed by esophageal cancer; ED was not effective in patients with oral cancer.
在化疗或放疗期间，口腔黏膜炎会严重影响营养状况，延长住院时间，增加感染风险、死亡风险，阻碍癌症治疗，并影响患者预后。尽管口腔黏膜炎的管理至关重要，但目前尚无明确的预防方法。口服富含氨基酸的要素饮食（ED）能全素可预防癌症治疗的剂量限制性毒性导致的机体成分改变和口腔黏膜炎。本荟萃分析评估了 ED 用于预防接受化疗或放疗的癌症患者发生≥2 级口腔黏膜炎的有效性。
对英文发表的随机临床试验和/或观察性研究进行了 PubMed 文献检索。计算了比值比及其置信区间，并应用固定效应或随机效应模型。
在 24 项相关研究中，有 9 项来自日本（包括 445 例患者）的研究进行了荟萃分析。存在 56%的异质性。采用随机效应模型，得出的比值比（95%置信区间）为 0.25（0.10，0.61）。漏斗图分析未显示发表偏倚。研究设计无异质性，但食管癌存在异质性。相应的比值比（固定效应模型）为观察性研究为 0.10（0.03，0.30），随机对照试验为 0.48（0.28，0.82）。采用随机效应模型的比值比（95%置信区间）为食管癌 0.35（0.12，0.99）；采用固定效应模型，比值比为胃肠癌 0.07（0.02，0.29）和口腔癌 0.26（0.04，1.60）。
无论研究设计如何，ED 均可降低口腔黏膜炎的发生风险。在胃肠癌患者中效果更为显著，其次是食管癌患者；ED 对口腔癌患者无效。
