Fluconazole for Preventing Radiation-Induced Oral Mucositis: A Randomized Controlled Trial.

IF 2.3 3区医学 Q1 OTORHINOLARYNGOLOGY Head and Neck-Journal for the Sciences and Specialties of the Head and Neck Pub Date : 2024-12-09 DOI:10.1002/hed.28020

Waranyu Ueangphairot, Pooriwat Muangwong, Phimchat Suwannaphong, Sirida Youngchim, Patcharin Thammasit, Kittikun Kittidachanan, Imjai Chitapanarux

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Abstract

Background: 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).

Methods: 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.

Results: 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).

Conclusions: Fluconazole significantly reduces RIOM severity and Candida colonization in HNC patients undergoing CCRT, suggesting its efficacy as a prophylactic treatment.

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氟康唑预防放射性口腔黏膜炎的随机对照试验

背景：本研究评估了氟康唑预防在头颈癌（HNC）同步放化疗（CCRT）患者中减少放射性口腔黏膜炎（RIOM）和念珠菌携带的疗效。方法：一项前瞻性、双盲、随机对照试验，78例HNC患者在CCRT期间接受氟康唑（100mg / d）或安慰剂治疗。主要终点是2级或以上RIOM的发生率。次要结果包括念珠菌培养和菌落形成单位（cfu）阳性。采用混合效应有序逻辑回归和逻辑回归进行分析。结果：氟康唑显著降低了第7周2级及以上RIOM的发生率（p = 0.039），第4周（p = 0.024）和第7周（p = 0.029）念珠菌携带阳性，以及第7周的中位CFUs （p = 0.050）。结论：氟康唑可显著降低行CCRT的HNC患者RIOM的严重程度和念珠菌定植，提示其具有预防作用。

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来源期刊

Head and Neck-Journal for the Sciences and Specialties of the Head and Neck 医学-耳鼻喉科学

CiteScore

7.00

自引率

6.90%

发文量

278

审稿时长

1.6 months

期刊介绍： Head & Neck is an international multidisciplinary publication of original contributions concerning the diagnosis and management of diseases of the head and neck. This area involves the overlapping interests and expertise of several surgical and medical specialties, including general surgery, neurosurgery, otolaryngology, plastic surgery, oral surgery, dermatology, ophthalmology, pathology, radiotherapy, medical oncology, and the corresponding basic sciences.