仙参汤防治鼻咽癌急性放射性口腔黏膜炎的临床研究OA
Clinical Study on Xianshen Decoction in the Prevention and Treatment of Acute Radiation-Induced Oral Mucositis in Patients with Nasopharyngeal Carcinoma
目的 系统评估仙参汤防治鼻咽癌急性放射性口腔黏膜炎(acute radiation-induced oral mucositis,ARIOM)的有效性和安全性.方法 本研究采用多中心、随机、双盲、安慰剂对照的试验设计,共纳入符合入组标准的受试者160例,按照1∶1比例随机分为试验组(仙参汤颗粒)和对照组(中药安慰剂).主要疗效指标为Ⅱ级及Ⅱ级以上急性放射性口腔黏膜炎的发生率;次要疗效指标为首次急性放射性口腔黏膜炎发生时间、两组患者急性放射性口腔黏膜炎分级、以及口腔评估指南(oral assessment guide,OAG)评分;同时记录试验期间不良事件发生情况,并进行安全性指标评价.访视时点为放疗前及放疗第1、2、3、4、5周.结果 共脱落24例,最终纳入试验组68例,对照组68例,试验组急性放射性口腔黏膜炎分级及口腔评估指南评分方面均优于对照组;安全性方面,治疗期间,各组均未出现与研究药物相关的不良反应.结论 在鼻咽癌放疗期间,应用中药复方仙参汤可降低急性放射性口腔炎的发生程度,改善患者生活质量,且安全性良好.
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.
陈爽;蒋梅;钟毓;曹玉婷;黄诗颖;陈薇伊
广州中医药大学第一临床医学院,广东 广州 510405广州中医药大学第一附属医院肿瘤中心,广东 广州 510405广州中医药大学第一附属医院放射治疗科,广东 广州 510405广州中医药大学第一临床医学院,广东 广州 510405广州中医药大学第一临床医学院,广东 广州 510405广州中医药大学第一临床医学院,广东 广州 510405
医药卫生
仙参汤急性放射性口腔黏膜炎随机对照试验清补并用
Xianshen Decoctionacute radiation-induced oral mucositisrandomized controlled trialclearing pathogen and tonifying deficiency simultaneously
《中医肿瘤学杂志》 2026 (1)
45-51,66,8
广州市科技局市校(院)联合资助项目(编号:202201020515).
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