头颈部癌症患者口腔黏膜炎的口内与口外光生物调节疗法：一项多中心、随机、单盲临床试验

Intraoral vs. extraoral photobiomodulation therapy for oral mucositis in head and neck cancer patients: a multicenter, randomized, single-blind clinical trial.

作者信息

Klein Isadora Peres, Pinto Mariana Bitu Ramos, Só Bruna Barcelos, de Farias Gabriel Amanda, Mendonça Nathália Felix, da Cruz Santos Letícia Beatriz, Farias Karina Morais, Mores Ana Leticia, Martins Marco Antonio Trevizani, Silva Ana Carolina Prado Ribeiro E, Brandão Thaís Bianca, Santos-Silva Alan Roger, Alves Fábio Abreu, Martins Manoela Domingues

机构信息

Department of Oral Pathology, School of Dentistry, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.

Stomatology Department, A.C.Camargo Cancer Center, São Paulo, SP, Brazil.

出版信息

Support Care Cancer. 2025 Sep 10;33(10):842. doi: 10.1007/s00520-025-09877-w.

DOI:10.1007/s00520-025-09877-w

PMID:40928526

Abstract

PURPOSE

To compare the efficacy of intraoral (IOPBM) and extraoral photobiomodulation (EOPBM) protocols for the prevention and treatment of oral mucositis (OM) in patients with oral or oropharyngeal squamous cell carcinoma (SCC) to submitted radiotherapy (RT).

METHODS

This randomized, blinded, multicenter clinical trial enrolled 58 patients with oral or oropharyngeal SCC, who were allocated into two groups matched by treatment type, clinical stage, and RT modality. Group I (IOPBM) received intraoral photobiomodulation (PBM) with a continuous InGaAlP diode laser (660 nm, 100 mW, 0.03 cm spot size, 3 s per point, fluence 10 J/cm). Group II (EOPBM) received extraoral PBM using a superpulsed diode laser with dual wavelengths (810/980 nm, 1000 mW, 4.91 cm spot size, 30 s per point, fluence 6.11 J/cm). PBM was performed five times per week during RT or until complete resolution of oral mucositis lesions.

RESULTS

A total of 58 patients were included from February 2021 to August 2023. The mean age of patients was 59.41 years. Forty (69%) were male, and 18 (31%) were female. All patients experienced some degree of OM during RT. No significant differences were observed between the groups for all OM grades (WHO scale, p = 0.69; NCI scale, p = 0.82) or in the meantime to the development of ulcerated OM (WHO scale, p = 0.63; NCI scale, p = 0.61). On day 20 (week 4) and day 30 (week 6), patients in the EOPBM group reported significantly less difficulty swallowing compared to the IOPBM group (Mann-Whitney test, p = 0.02 and p = 0.04, respectively). On day 25 (week 5), the EOPBM group demonstrated a significantly smaller decline in taste perception compared to the IOPBM group, as determined by the Mann-Whitney test (p = 0.01).

CONCLUSION

The EOPBM protocol was found to be as effective as IOPBM in managing OM, with the added benefit of providing greater patient comfort during application.

TRIAL REGISTRATION

Registered with ClinicalTrials.gov (NCT05242991).

摘要

目的

比较口内光生物调节（IOPBM）和口外光生物调节（EOPBM）方案对口腔或口咽鳞状细胞癌（SCC）患者在接受放射治疗（RT）时预防和治疗口腔黏膜炎（OM）的疗效。

方法

这项随机、双盲、多中心临床试验纳入了58例口腔或口咽SCC患者，根据治疗类型、临床分期和放疗方式将其分为两组。第一组（IOPBM）使用连续InGaAlP二极管激光器（660nm，100mW，光斑尺寸0.03cm，每点照射3s，能量密度10J/cm）进行口内光生物调节（PBM）。第二组（EOPBM）使用双波长超脉冲二极管激光器（810/980nm，1000mW，光斑尺寸4.91cm，每点照射30s，能量密度6.11J/cm）进行口外PBM。在放疗期间每周进行5次PBM，或直至口腔黏膜炎病变完全消退。

结果

2021年2月至2023年8月共纳入58例患者。患者的平均年龄为59.41岁。40例（69%）为男性，18例（31%）为女性。所有患者在放疗期间均经历了一定程度的OM。两组在所有OM分级（WHO分级，p = 0.69；NCI分级，p = 0.82）或发生溃疡性OM的时间（WHO分级，p = 0.63；NCI分级，p = 0.61）方面均未观察到显著差异。在第20天（第4周）和第30天（第6周），EOPBM组患者报告的吞咽困难明显少于IOPBM组（Mann-Whitney检验，p分别为0.02和0.04）。在第25天（第5周），通过Mann-Whitney检验确定，EOPBM组患者味觉减退的程度明显小于IOPBM组（p = 0.01）。