叶酸对肺癌同期放化疗导致放射性食管炎影响的RCT研究  

A prospective randomized clinical study of folic acid in the intervention of radiation esophagitis induced by concurrent chemoradiotherapy in lung cancer

作　　者：张浩 祝义滢 欧阳伟炜 苏胜发 马筑 李青松 耿一超 杨文刚 陈霞霞 卢冰 Zhang Hao;Zhu Yiying;Ouyang Weiwei;Su Shengfa;Ma Zhu;Li Qingsong;Geng Yichao;Yang Wengang;Chen Xiaxia;Lu Bing(Department of Oncology,Affiliated Hospital of Guizhou Medical University,Guiyang550004,China;Department of Thoracic Oncology,Affiliated Cancer Hospital of Guizhou Medical University,Guiyang550004,China;Teaching and Research Section of Oncology,School of Clinical Medicine for Guizhou Medical University,Guiyang550004,China)

机构地区：[1]贵州医科大学附属医院肿瘤科,贵阳550004 [2]贵州医科大学附属肿瘤医院胸部肿瘤科,贵阳550004 [3]贵州医科大学临床医学院肿瘤学教研室,贵阳550004

出　　处：《中华放射肿瘤学杂志》2025年第1期65-72,共8页Chinese Journal of Radiation Oncology

摘　　要：目的探讨肺癌同期放化疗患者全程口服叶酸降低放射性食管炎(RE)发生率及严重程度的效果。方法前瞻性收集2022年6月至2023年10月于贵州医科大学附属肿瘤医院收治的82例N 2~N 3期肺癌患者(包括小细胞肺癌和非小细胞肺癌),采用简单随机法按1∶1分为试验组(叶酸组)及对照组,两组患者均接受肺部病灶及纵隔转移淋巴结的放射治疗(放疗同期完成≥2个周期一线化疗或分子靶向治疗,接受放疗剂量≥40 Gy,分20次)。从两组出现RE开始,每周按美国国家癌症研究所常见不良事件改良分级标准评估RE严重程度,至放疗结束后1周。RE常规处理按照美国肿瘤放射治疗协作组分级标准中的建议进行。叶酸组从放疗开始时口服叶酸至放疗结束,30 mg/d;对照组无药物干预。记录并分析RE的开始时间、程度及持续时间、常规治疗后食管不良反应程度的变化,并测定放疗开始前及放疗结束时患者血清叶酸值、血清维生素B 12值及同型半胱氨酸值。对于连续性定量变量,组间比较采用独立样本t检验或独立样本秩和检验。对于计数分类资料,组间比较采用卡方检验或Fisher精确概率法。结果在观察期间,叶酸组和对照组均未发生4级及以上的RE,0、1、2、3级RE发生率分别为10%(4/40例)和5%(2/41例)、70%(28/40例)和41%(17/41例)、15%(6/40例)和51%(21/41例)、5%(2/40例)/和2%(1/41例),差异无统计学意义(P=0.456),但叶酸组0~1级RE的发生率显著高于对照组(Z=2.72,P=0.006)。叶酸组和对照组出现RE的中位时间分别为放疗开始后12 d(范围为7~52 d)和15 d(范围为11~56 d),差异无统计学意义(χ^(2)=-0.75,P=0.456);但个体最严重RE中位持续时间分别为12 d(范围为4~36 d)和21 d(范围为7~38 d),差异有统计学意义(χ^(2)=2.10,P=0.039)。叶酸组在经叶酸干预后的吞咽疼痛及吞咽困难分级均有明显的下降趋势,特别是在RE发生后2周的降低较明显(P=0.001、0.002),�Objective To investigate the efficacy of oral folic acid intervention in lung cancer patients with radiation esophagitis(RE)caused by concurrent chemoradiotherapy.MethodsIn this randomized,controlled,single-center clinical trial,a total of 82 patients with stage N 2-N 3 lung cancer including small cell lung cancer(SCLC)and non-small cell lung cancer(NSCLC)admitted to the Affiliated Cancer Hospital of Guizhou Medical University from June 2022 to October 2023 were prospectively included.All enrolled patients were randomly divided into the experimental group(folic acid group)and control group according to 1 vs.1 of simple random method,and patients in both groups were required to receive radiation therapy for lung lesions and mediastinal metastatic lymph nodes[≥2 cycles of chemotherapy were completed during the same period of radiotherapy(≥40 Gy/20 F)or targeted drugs were given simultaneously].The severity of RE was evaluated using the modified common terminology criteria for adverse events criteria of the National Cancer Institute in both groups weekly at the onset of radiation esophagitis symptoms and thereafter until 1 week after the end of radiotherapy.Conventional treatment of RE was delivered according to the grading criteria of the Radiation Therapy Oncology Group.Patients in the folic acid group were given with folic acid tablets 30 mg/d orally at the beginning of radiotherapy until the end of radiotherapy,while those in the control group did not receive any drug intervention.The onset time,severity and duration of RE,and changes in the severity of esophageal toxicity after conventional treatment were recorded and analyzed.Serum folate value,serum vitamin B 12 value and homocysteine value were measured before and after radiotherapy.For continuous quantitative variables,independent sample t-test or independent sample rank-sum test was used for comparison among different groups.For categorical data,Chi-square test or Fisher's exact probability method was used for comparison among different groups.ResultsD

关 键 词：肺肿瘤 叶酸 放射疗法 放射性食管炎 

分 类 号：R734.2[医药卫生—肿瘤]