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甘氨双唑钠降低头颈部鳞癌患者严重放射性黏膜炎的Ⅱ期随机临床研究
王健仰,黄晓东,王凯,王惠丽,王文卿,王静波,徐国镇,高黎
100021 北京,国家癌症中心/中国医学科学院北京协和医学院肿瘤医院放疗科
Effect of sodium glycididazole on severe radiation-induced mucositis in patients with head and neck squamous cell carcinoma:a randomized phase Ⅱ clinical trial
Wang Jianyang, Huang Xiaodong,Wang Kai,Wang Huili,Wang Wenqing,Wang Jingbo,Xu Guozhen,Gao Li
Department of Radiation Oncology,National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100021,China
Abstract：Objective To evaluate the effect of a radiosensitizer, sodium glycididazole (CMNa), on radiation-induced mucositis during concurrent intensity-modulated radiotherapy (IMRT) and chemotherapy (CRT) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Methods From 2014 to 2015, 63 patients were randomly assigned to CRT+CMNa group and CRT group at a 1:2 ratio. In those patients, 57 completed the treatment. CMNa of 800 mg/m2 was administered intravenously 30 min before radiotherapy, three times a week. For CRT, the prescribed radiation doses were 69.96-73.92 Gy in 33 fractions for the planning gross tumor volume (PGTV) and positive lymph nodes, and 60.06 Gy in 33 fractions for the planning target volume (PTV);the dose of cisplatin was 100 mg/m2;IMRT or helical tomography was used in radiotherapy. Results Nineteen patients were enrolled in the CRT+CMNa group and thirty-eight in the CRT group. There were no significant differences in baseline clinical data (P=0.34-1.00), prescribed doses to PGTV ((73.00 ± 2.66) Gy vs.(71.66 ± 3.99) Gy,P=0.19)) and PTV ((60.58 ± 2.27) Gy vs.(59.67 ± 2.08) Gy,P=0.14), and number of chemotherapy cycles (P=0.28) between the two groups. During CRT, the incidence of grade ≥3 radiation-induced mucositis and visual analogue scale (VAS) pain score were both significantly reduced in the CRT+CMNa group than in the CRT group (32% vs. 61%, P=0.04;4.6±1.6 vs. 6.2±1.6, P=0.00). Moreover, there were no significant differences in antibiotic usage and hematologic toxicity between the two groups (P=0.08-0.80). Conclusions In patients with LA-HNSCC, CMNa can reduce the incidence of radiation-induced mucositis and pain score during CRT.
Wang Jianyang,Huang Xiaodong,Wang Kai et al. Effect of sodium glycididazole on severe radiation-induced mucositis in patients with head and neck squamous cell carcinoma:a randomized phase Ⅱ clinical trial[J]. Chinese Journal of Radiation Oncology, 2016, 25(7): 671-675.
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2016, Vol. 25 
