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目的:评估在西医常规基础上联合口服中药复方的中西医结合方案防治同期放化疗鼻咽癌患者放射性口腔黏膜炎(RTOM)有效性及安全性。方法:本研究是一项单中心、开放标签、随机对照试验。使用随机数表法，将2021年3月至10月四川省肿瘤医院100例鼻咽癌患者按1∶1的比例随机分配至中西医结合组和西医常规组，每组50例。研究的主要终点是Ⅲ级RTOM发生率，次要终点是RTOM严重程度、营养不良风险以及安全性。结果:中西医结合组和西医常规组Ⅲ级RTOM发生率分别为18%和46%，差异具有统计学意义(n χ2＝9.007，n P＝0.003)。与中西医结合组相比，西医常规组的RTOM严重程度等级显著更高(n OR＝3.269，95%n CI：1.627~6.567，n P<0.001)，且营养不良风险更高(n OR＝3.021，95%n CI：1.786~5.109，n P<0.001)。中西医结合组较西医常规组降低了放疗/化疗所致的口干发生率(48.97%和72.00%，n χ2＝5.493，n P＝0.019)、3~4级中性粒细胞减少发生率(12.24%和30.00%，n χ2＝4.668，n P＝0.031)。与中药复方相关轻/中不良事件发生率为4.08%(2/49)，未观察到与其相关严重不良事件。n 结论:与西医常规方案相比，中西医结合方案能更有效防治RTOM，且临床应用安全可靠。“,”Objective:To evaluate the efficacy and safety of the combination of conventional western medicine therapy and oral traditional Chinese medicine (TCM) compound in the prevention and treatment of radiotherapy-inducedoral mucositis (RTOM) of nasopharyngeal carcinoma patients treated with concurrent radiotherapy and chemotherapy.Methods:A randomized, single-center, and open-label controlled experiment was conducted. Software Stata was used to generate random numbers, and 100 subjects were randomly assigned to two groups ata 1∶1 ratio, namely the integrated Chinese and western medicine group(the integrated group) and the conventional western medicine group. This study focused on the incidence of level-ⅢRTOM, followed by these verity degree of RTOM, therisk of malnutrition, and safety.Results:The incidences of level-III RTOM in the integrated group and the conventional western medicine group were 18% and 46%, respectively, with a statistically significant difference (n χ2=9.007, n P=0.003). Compared to the integrated group, the conventional western medicine group showed a significantly increase dseverity degree of RTOM (n OR=3.269, 95%n CI: 1.627-6.567, n P<0.001) and higher risk of malnutrition (n OR=3.021, 95%n CI: 1.786-5.109, n P<0.001). Moreover, compared to the integrated group, the conventional western medicine group showed decrease dincidence of thirst (48.97% and 72.00% respectively;n χ2=5.493, n P=0.019) and decreased incidence of neutrophilcount reduction(12.24% and 30.00%, respectively, n χ2=4.668, n P=0.031). The incidence of mild/moderate adverse events related to TCM compound was 4.08%(2/49), and no serious adverse events related to TCM compound were observed.n Conclusions:Compared to the conventional western medicine regimen, the integrated Chinese and western medicine regimen IS more effective in the prevention and treatment of RTOM. Meanwhile, its clinical application is safe and reliable.