[Translation] A multicenter, randomized, double-blind, placebo-controlled, dose-finding phase II clinical study was conducted to evaluate the efficacy and safety of Meifan Fuxin Liquid in the treatment of radiation-induced oral mucositis in patients with head and neck malignancies.
(1) 评价美蠊复新液治疗头颈部恶性肿瘤患者放射性口腔黏膜炎的有效性及安
全性;
(2) 探索美蠊复新液用于放射性口腔黏膜炎的最佳剂量,为Ⅲ期临床试验剂量选
择提供依据;
(3) 探索获益人群的中医辨证分型。
[Translation] (1) To evaluate the effectiveness and safety of Meifan Fuxin solution in the treatment of radiation-induced oral mucositis in patients with head and neck malignancies;
(2) To explore the optimal dose of Meifan Fuxin solution for radiation-induced oral mucositis and provide a basis for dose selection in phase III clinical trials;
(3) To explore the TCM syndrome differentiation of the beneficiary population.