Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Chitosan-based doxepin nano-formulation might be a promising alternative for routine treatments of oral mucositis.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Chitosan-based doxepin nano-formulation might be a promising alternative for routine treatments of oral mucositis.
摘要：
目的：考虑到口腔粘膜炎的患病率，我们的目的是利用多塞平与壳聚糖的抗菌和生物粘附性质的镇痛作用，制造纳米制剂用于治疗化疗引起的口腔黏膜炎。
方法:纳米凝胶通过离子凝胶化制备并表征。将60例患者随机分为四种不同的治疗方法，为期14天：苯海拉明铝镁漱口水（对照），多塞平漱口水（DOXMW），壳聚糖纳米凝胶（CN），和多塞平/壳聚糖纳米凝胶(CN+DOX)。用四个指标评估病变，国家癌症研究所（NCI），世界卫生组织(世卫组织)世界护理临床与研究会议（WCCNR）和视觉模拟量表（VAS）干预前和干预后3、7和14天。使用Kruskal-Wallis试验进行成对比较。
结果：CN具有半固体稠度，均匀的球形，平均尺寸为47.93±21.69nm，和+1.02±0.16mV的ζ电位。CN+DOX减少了世卫组织，WCCNR,干预后3天,VAS评分明显高于对照组。干预后七天，CN+DOX比对照显著更多地降低NCI和WCCNR;它比CN显著更多地降低WCCNR。干预后14天，CN+DOX显著比对照降低NCI。
结论：壳聚糖基多塞平纳米制剂可能是口腔黏膜炎常规治疗的有希望的替代方案。
方法:纳米凝胶通过离子凝胶化制备并表征。将60例患者随机分为四种不同的治疗方法，为期14天：苯海拉明铝镁漱口水（对照），多塞平漱口水（DOXMW），壳聚糖纳米凝胶（CN），和多塞平/壳聚糖纳米凝胶(CN+DOX)。用四个指标评估病变，国家癌症研究所（NCI），世界卫生组织(世卫组织)世界护理临床与研究会议（WCCNR）和视觉模拟量表（VAS）干预前和干预后3、7和14天。使用Kruskal-Wallis试验进行成对比较。
结果：CN具有半固体稠度，均匀的球形，平均尺寸为47.93±21.69nm，和+1.02±0.16mV的ζ电位。CN+DOX减少了世卫组织，WCCNR,干预后3天,VAS评分明显高于对照组。干预后七天，CN+DOX比对照显著更多地降低NCI和WCCNR;它比CN显著更多地降低WCCNR。干预后14天，CN+DOX显著比对照降低NCI。
结论：壳聚糖基多塞平纳米制剂可能是口腔黏膜炎常规治疗的有希望的替代方案。
