考虑到口腔粘膜炎的流行率，我们旨在利用多塞平的镇痛效果与壳聚糖的抗微生物和生物粘附性质，制备一种用于治疗化疗引起的口腔粘膜炎的纳米制剂。通过离子交联法制备纳米凝胶，并进行表征。将60名患者随机分为4组，连续接受4种不同的治疗，为期14天：二苯基苯酮加铝镁漱口液（对照组）、多塞平漱口液（DOX MW）、壳聚糖纳米凝胶（CN）、多塞平/壳聚糖纳米凝胶（CN+DOX）。在干预前和干预后的第3天、第7天和第14天，用四个指标评估病变，包括国家癌症研究所（NCI）、世界卫生组织（WHO）、世界临床与护理研究会议（WCCNR）和视觉模拟量表（VAS）。使用Kruskal-Wallis检验进行两两比较。CN具有半固体一致性，均匀的球形形状，平均尺寸为47.93±21.69纳米，电位为+1.02±0.16毫伏。CN+DOX干预后三天，WHO、WCCNR和VAS评分较对照组显著降低。干预后七天，CN+DOX降低NCI和WCCNR的幅度明显高于对照组；同时，它降低WCCNR的幅度也高于CN。干预后十四天，CN+DOX明显降低NCI的程度远高于对照组。基于壳聚糖的多塞平纳米制剂可能是口腔粘膜炎例行治疗的一种有希望的替代方案。© 2023. 作者（们），在Springer Nature Switzerland AG的独家许可下。

Considering the prevalence of oral mucositis, we aimed to use the analgesic effects of doxepin with chitosan's antimicrobial and bio-adhesive nature to fabricate a nano-formulation for treating chemotherapy-induced oral mucositis.Nanogel was fabricated via ionic gelation and characterized. Sixty patients were randomly divided and received four different treatments for 14 days: diphenhydramine + aluminum-magnesium mouthwash (control), doxepin mouthwash (DOX MW), chitosan nanogel (CN), and doxepin/chitosan nanogel (CN + DOX). Lesions were assessed with four indices, National Cancer Institute (NCI), World Health Organization (WHO), World Conference on Clinical and Research in Nursing (WCCNR) and visual analog scale (VAS) before and 3, 7, and 14 days after interventions. Kruskal-Wallis test was used for pairwise comparison.CN had semisolid consistency, uniform spherical shape, an average size of 47.93 ± 21.69 nm, and a zeta potential of + 1.02 ± 0.16 mV. CN + DOX reduced WHO, WCCNR, and VAS scores significantly more than the control three days after the intervention. Seven days after the intervention, CN + DOX reduced NCI and WCCNR considerably more than the control; it reduced WCCNR significantly more than CN. Fourteen days after the intervention, CN + DOX decreased NCI markedly more than the control.Chitosan-based doxepin nano-formulation might be a promising alternative for routine treatments of oral mucositis.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.