A randomized controlled study on the prevention and treatment of radiation-induced oral mucositis by Chinese herbal compound prescription / 中华放射医学与防护杂志

ABSTRACT

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 ( χ2=9.007, P=0.003). Compared to the integrated group, the conventional western medicine group showed a significantly increase dseverity degree of RTOM ( OR=3.269, 95% CI 1.627-6.567, P<0.001) and higher risk of malnutrition ( OR=3.021, 95% CI 1.786-5.109, 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; χ2=5.493, P=0.019) and decreased incidence of neutrophilcount reduction(12.24% and 30.00%, respectively, χ2=4.668, 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. 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.