Photobiomodulation in the prevention of oral mucositis in blood cancer patients undergoing high-dose methotrexate: preliminary findings of a prospective, randomized, double-blind clinical study

IF 1.9 3区医学 Q2 DENTISTRY, ORAL SURGERY & MEDICINE Oral Surgery Oral Medicine Oral Pathology Oral Radiology Pub Date : 2025-02-01 Epub Date: 2025-01-07 DOI:10.1016/j.oooo.2024.10.100

Ana Carolina Prado-Ribeiro , Leticia Rodrigues-Oliveira , Ana Leticia Mores , Maria Claudia Cuzzullin , Carolina Alves Guimarães , Natalia Palmier , Maria Cecilia Querido de Oliveira , Pablo Vargas , Alan Roger Santos-Silva , Thaís Bianca Brandão

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Abstract

Objective

This study aimed to assess the efficacy of photobiomodulation (PBM) in preventing oral mucositis (OM) in adults with blood cancer undergoing high-dose methotrexate (HD-MTX ≥1 g/m²) treatment. Additionally, the correlation between serum creatinine and MTX, urinary pH, and the development and severity of OM were investigated.

Methods

A prospective, randomized, and double-blind study recruited patients before their first cycle of HD-MTX. Participants were assigned to 2 groups: group 1 (prophylactic PBM) and group 2 (placebo), and assessments were conducted at infusion (D0)/D1 (24 h)/D2 (48 h) /D3 (72 h) /D4 (96 h)/D10. Group 1 received PBM (660 nm, 100 mW, spot size 0.028 cm², fluence 10 J/cm² per point/10 s) in the oral mucosa from the first day until D5 post HD-MTX infusion or until MTX plasma concentrations were <5 µmol/L at D1, <1 µmol/L at D2, and <0.1 µmol/L at D3. Serum MTX and creatinine, and urine pH were assessed at D1/D2/D3. OM was classified according to World Health Organization criteria. Logistic regression, Mann-Whitney U, and χ² tests were used to identify predictive factors for OM.

Results

A total of 36 patients were allocated to the PBM or placebo group (50% each). Most patients (66.6%) were female, with mean ages of 39.8 and 39.6 in groups 1 and 2, respectively. Regarding OM, group 2 developed grade 2 earlier at D2 (5.6%), D3 (11.1%), and D4 (50%) compared with group 1, which only developed grade 2 at D4 (5.6%). The Mann-Whitney test for overall OM grade comparison (group 1 vs group 2) at D4 showed a P < .001, and the χ² test demonstrated a P = .003 (grades 0 and 1 vs grades 2/ 3). Elevated creatinine serum levels at D2 postinfusion predicted the incidence of OM. No correlation was found between serum MTX levels, urine pH, and OM.

Conclusion

PBM proves effective in preventing OM and reducing its incidence and severity in patients undergoing HD-MTX protocols. Elevated creatinine serum levels at D2 appear to be a predictor of OM.

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光生物调节在接受高剂量甲氨蝶呤治疗的血癌患者预防口腔黏膜炎中的作用：一项前瞻性、随机、双盲临床研究的初步结果

目的评价光生物调节（PBM）对接受高剂量甲氨蝶呤（HD-MTX≥1 g/m2）治疗的成人血癌患者预防口腔黏膜炎（OM）的疗效。此外，还研究了血清肌酐、MTX、尿pH值与OM的发展和严重程度之间的相关性。方法一项前瞻性、随机、双盲研究招募了首次接受HD-MTX治疗前的患者。参与者被分为2组：1组（预防性PBM）和2组（安慰剂），并在输注(D0)/D1（24小时）/D2（48小时）/ D3（72小时）/ D4（96小时）/D10时进行评估。组1在HD-MTX输注后第1天至第5天在口腔黏膜中给予PBM (660 nm, 100 mW，斑点大小0.028 cm2，每点影响10 J/cm2 /10 s)，或直到MTX血浆浓度D1为5µmol/L， D2为1µmol/L， D3为0.1µmol/L。测定血清MTX、肌酐和尿液pH值D1/D2/D3。根据世界卫生组织的标准对OM进行分类。采用Logistic回归、Mann-Whitney U检验和χ2检验确定OM的预测因素。结果36例患者被分为PBM组和安慰剂组（各占50%）。1、2组患者以女性为主（66.6%），平均年龄分别为39.8岁和39.6岁。关于OM， 2组在D2（5.6%）、D3（11.1%）和D4（50%）较早发展为2级，而1组仅在D4（5.6%）发展为2级。在D4时，总体OM等级比较（1组与2组）的Mann-Whitney检验显示P <；.001， χ2检验P = .003（0级和1级vs 2/ 3级）。D2输注后血清肌酐水平升高预测OM的发生。血清MTX水平、尿pH值与OM无相关性。结论pbm在HD-MTX治疗中可有效预防OM，降低OM的发生率和严重程度。D2期血清肌酐水平升高似乎是OM的一个预测指标。

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来源期刊

Oral Surgery Oral Medicine Oral Pathology Oral Radiology DENTISTRY, ORAL SURGERY & MEDICINE-

CiteScore

3.80

自引率

6.90%

发文量

1217

审稿时长

2-4 weeks

期刊介绍： Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology is required reading for anyone in the fields of oral surgery, oral medicine, oral pathology, oral radiology or advanced general practice dentistry. It is the only major dental journal that provides a practical and complete overview of the medical and surgical techniques of dental practice in four areas. Topics covered include such current issues as dental implants, treatment of HIV-infected patients, and evaluation and treatment of TMJ disorders. The official publication for nine societies, the Journal is recommended for initial purchase in the Brandon Hill study, Selected List of Books and Journals for the Small Medical Library.