Efficacy of rhGM-CSF in treatment of radiation-induced oral mucositis: A prospective randomized controlled trial / 肿瘤

ABSTRACT

Objective: The aim of this study was to evaluate the efficacy and safety of recombinant human granulocyte macrophage colony-stimulating factor (rhGM-CSF) in treatment of nasopharyngeal cancer with radiation-induced oral mucositis. Methods: Sixty patients with nasopharyngeal cancer who received radiation (70 Gy) and chemotherapy were randomly divided into two groups the patients (n = 30) in the experiment group rinsed their mouths with 25 mL of rhGM-CSF solution (1 μg/mL) for 3 minutes a time and four times daily from the occurrence of oral mucositis until the healing in the oral mucosa or completing 14 days of mouth rinse; the patients (n = 30) in the control group received chlorhexidine with the same dosage and administration. The serverities of mucosal damage and oral pain, the swallowing functions, time to treatment discontinuation and adverse reactions were recorded. Results: As compared with the control group, the degree of mucosal damage in the experiment group was significantly reduced with a lower score (2.04±0.96 vs 1.36±1.29, P = 0.034) after 7 days of rhGM-CSF administration. The numbers of patients with complete oral mucosal healing in the experiment group and the control group were 11 (44.0%) and 4 (14.3%), respectively (P = 0.017); the rates of oral mucosal healing were 72.0% (18/25) and 28.6% (8/28), respectively (P = 0.002) after 14 days of administration. The degrees of mucosal damage and oral pain were obviously reduced and the swallowing functions in the experiment group were significantly improved as compared with those in the control group (P < 0.001). Conclusion: rhGM-CSF can significantly improve the rate of oral mucosal healing, reduce the severities of mucosal damage and oral pain, and improve the swallowing functions, which can ensure the completion of chemotherapy and radiation therapy for nasopharyngeal cancer. Copyright© 2014 by TUMOR.