中医肿瘤学杂志2026，Vol.8Issue(1)：45-51,66,8.DOI:10.19811/j.cnki.ISSN2096-6628.2026.01.006
仙参汤防治鼻咽癌急性放射性口腔黏膜炎的临床研究
Clinical Study on Xianshen Decoction in the Prevention and Treatment of Acute Radiation-Induced Oral Mucositis in Patients with Nasopharyngeal Carcinoma
摘要
Abstract
Objective To evaluate the efficacy and safety of Xianshen Decoction(XSD)in the prevention and treatment of acute radiation-induced oral mucositis(ARIOM)in patients undergoing radiotherapy for nasopharyngeal carcinoma(NPC).Methods This multicenter,randomized,double-blind,placebo-controlled trial enrolled 160 eligible NPC patients.They were randomly assigned in a 1∶1 ratio to either the experimental group(receiving XSD granules)or the control group(receiving matched placebo granules).The primary efficacy endpoint was the incidence of grade Ⅱ or higher ARIOM.The secondary endpoints included the time to onset of first ARIOM,the severity grading of ARIOM and the oral assessment guide(OAG)score.Safety was evaluated by monitoring adverse events throughout the study.Assessments were conducted at baseline(pre-radiotherapy)and at weeks 1 to 5 of radiotherapy.Results With a total dropout of 24 cases,136 patients(68 patients in each group)were included in the final analysis.The experimental group demonstrated superior outcomes in terms of ARIOM grade and OAG scores compared with the control group.Regarding safety,no adverse events related to the study medication were observed in either group during the treatment period.Conclusion The application of Xianshen Decoction during radiotherapy for NPC can effectively reduce the severity of acute radiation-induced oral mucositis and improve patients'quality of life,with a favorable safety profile.关键词
仙参汤/急性放射性口腔黏膜炎/随机对照试验/清补并用Key words
Xianshen Decoction/acute radiation-induced oral mucositis/randomized controlled trial/clearing pathogen and tonifying deficiency simultaneously分类
医药卫生引用本文复制引用
陈爽,蒋梅,钟毓,曹玉婷,黄诗颖,陈薇伊..仙参汤防治鼻咽癌急性放射性口腔黏膜炎的临床研究[J].中医肿瘤学杂志,2026,8(1):45-51,66,8.基金项目
广州市科技局市校(院)联合资助项目(编号:202201020515). （院）
