本临床试验旨在评估健渡颗粒（一种中药中成药方剂）对接受顺行化疗放疗的鼻咽癌患者口腔黏膜炎的疗效和安全性。采用单中心、开放标签、随机对照试验的研究设计，纳入138例局部晚期鼻咽癌患者。患者被随机分配到实验组（n=69）或对照组（n=69）。两组均接受顺行化疗放疗和口腔黏膜炎的标准治疗，实验组还接受健渡颗粒干预。主要观察指标是重度口腔黏膜炎的发生率（III至IV级）。在全分析样本集中，实验组有14例患者（20.3%）出现重度口腔黏膜炎，对照组有31例患者（44.9%）出现（绝对风险差异：24.6%；相对风险差异：54.8%；p=0.002；需要治疗数为4）。健渡颗粒与轻/中度胃肠反应相关，总体发生率为5.9%。健渡颗粒降低了鼻咽癌患者在顺行化疗放疗期间发生重度口腔黏膜炎的风险，并且安全性可接受。 © 2023 Wiley Periodicals LLC.

This clinical trial aimed to evaluate the efficacy and safety of Jiandu granule, a Chinese herbal medicine formula, for preventing oral mucositis in patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy.A single-centre, open-label, randomised controlled trial was conducted, enrolling 138 patients with locally advanced nasopharyngeal carcinoma. Patients were randomly allocated to either the experimental group (n = 69) or the control group (n = 69). Both groups received concurrent chemoradiotherapy and standard care for oral mucositis, with the experimental group additionally receiving Jiandu granule intervention. The primary outcome was the incidence of severe oral mucositis (grade III to IV).In the full-analysis set, severe oral mucositis occurred in 14 of 69 (20.3%) patients in the experimental group and 31 of 69 (44.9%) patients in the control group (absolute risk reduction: 24.6%; relative risk reduction: 54.8%; p = 0.002; number needed to treat: 4). Jiandu granule was associated with mild/moderate gastrointestinal reactions, with an overall incidence of 5.9%.Jiandu granule reduced the incidence of severe oral mucositis in nasopharyngeal carcinoma patients during concurrent chemoradiotherapy and had an acceptable safety profile.© 2023 Wiley Periodicals LLC.