Koopaie Maryam, Vaziri Sahar, Manifar Soheila, Younespour Shima, Kolahdooz Sajad
Department of Oral Medicine, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.
School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.
Support Care Cancer. 2025 May 19;33(6):481. doi: 10.1007/s00520-025-09522-6.
Head and neck squamous cell carcinoma (HNSCC) is a common type of malignancy that is often treated with radiotherapy. This treatment can lead to the development of oral mucositis. This study investigates the effectiveness of a synbiotic mouthwash in reducing the severity of oral mucositis and in modulating salivary toll-like receptor 2 (TLR2) levels in HNSCC patients undergoing radiotherapy.
A triple-blind, placebo-controlled randomized clinical trial was conducted on 44 HNSCC patients, randomly assigned to either a synbiotic mouthwash (synbiotic group) or a normal saline mouthwash (placebo group). Salivary TLR2 levels were measured at baseline and after the completion of radiotherapy and oral mucositis treatment using an enzyme-linked immunosorbent assay (ELISA). The severity of oral mucositis was evaluated at each follow-up session using the MASCC/ISOO grading system. Statistical analyses included generalized estimating equations and Kaplan-Meier survival curves.
Compared to the placebo group, the synbiotic group showed a significant delay in the onset of oral mucositis in grades II and III. Patients in the synbiotic group experienced a slower progression to severe mucositis, with a longer duration of grade II mucositis and fewer cases of grade III mucositis. Moreover, the mean salivary level of TLR2 in patients significantly decreased by the end of the study. However, the two groups found no statistically significant difference in salivary TLR2 levels.
The synbiotic mouthwash significantly reduced the severity of oral mucositis and delayed its progression in HNSCC patients undergoing radiotherapy. TLR2 levels decreased significantly in both groups. IRCT20230624058564N1, registration date: 2023-08-06. https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02591897/full https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20230624058564N1 http://en.irct.ir/trial/70874.
头颈部鳞状细胞癌（HNSCC）是一种常见的恶性肿瘤，常采用放射治疗。这种治疗可能导致口腔黏膜炎的发生。本研究调查了一种合生元漱口水在降低接受放射治疗的HNSCC患者口腔黏膜炎严重程度以及调节唾液中Toll样受体2（TLR2）水平方面的有效性。
对44例HNSCC患者进行了一项三盲、安慰剂对照的随机临床试验，随机分为合生元漱口水组（合生元组）或生理盐水漱口水组（安慰剂组）。在基线以及放射治疗和口腔黏膜炎治疗完成后，使用酶联免疫吸附测定（ELISA）测量唾液中TLR2水平。在每次随访时，使用MASCC/ISOO分级系统评估口腔黏膜炎的严重程度。统计分析包括广义估计方程和Kaplan-Meier生存曲线。
与安慰剂组相比，合生元组II级和III级口腔黏膜炎的发病明显延迟。合生元组患者发展为严重黏膜炎的进程较慢，II级黏膜炎持续时间更长，III级黏膜炎病例更少。此外，研究结束时患者唾液中TLR2的平均水平显著下降。然而，两组在唾液TLR2水平上没有发现统计学上的显著差异。
合生元漱口水显著降低了接受放射治疗的HNSCC患者口腔黏膜炎的严重程度，并延迟了其进展。两组中TLR2水平均显著下降。IRCT20230624058564N1，注册日期：2023年8月6日。https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02591897/full https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20230624058564N1 http://en.irct.ir/trial/70874
