Ueangphairot Waranyu, Muangwong Pooriwat, Suwannaphong Phimchat, Youngchim Sirida, Thammasit Patcharin, Kittidachanan Kittikun, Chitapanarux Imjai
Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Department of Microbiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Head Neck. 2025 Apr;47(4):1168-1175. doi: 10.1002/hed.28020. Epub 2024 Dec 9.
This study evaluated the efficacy of fluconazole prophylaxis in reducing radiation-induced oral mucositis (RIOM) and Candida carriage in head and neck cancer (HNC) patients undergoing concurrent chemoradiotherapy (CCRT).
A prospective, double-blinded, randomized controlled trial was conducted with 78 HNC patients receiving either fluconazole (100 mg daily) or placebo during CCRT. The primary outcome was the incidence of grade 2 or higher RIOM. Secondary outcomes included positive Candida cultures and colony-forming units (CFUs). Mixed-effects ordinal logistic regression and logistic regression were used for analysis.
Fluconazole significantly reduced the incidence of grade 2 or higher RIOM at week 7 (p = 0.039), positive Candida carriage at week 4 (p = 0.024) and week 7 (p = 0.029), and median CFUs at week 7 (p = 0.050).
Fluconazole significantly reduces RIOM severity and Candida colonization in HNC patients undergoing CCRT, suggesting its efficacy as a prophylactic treatment.
本研究评估了氟康唑预防对头颈部癌（HNC）患者在同步放化疗（CCRT）期间放射性口腔黏膜炎（RIOM）及念珠菌携带情况的疗效。
对78例接受CCRT的HNC患者进行了一项前瞻性、双盲、随机对照试验，这些患者在CCRT期间接受氟康唑（每日100毫克）或安慰剂治疗。主要结局是2级或更高级别RIOM的发生率。次要结局包括念珠菌培养阳性及菌落形成单位（CFU）。采用混合效应有序逻辑回归和逻辑回归进行分析。
氟康唑显著降低了第7周时2级或更高级别RIOM的发生率（p = 0.039）、第4周（p = 0.024）和第7周（p = 0.029）时念珠菌携带阳性率，以及第7周时CFU中位数（p = 0.050）。
氟康唑显著降低了接受CCRT的HNC患者的RIOM严重程度和念珠菌定植，表明其作为预防性治疗的疗效。
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