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

摘要

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 (LAHNSCC).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.%目的 观察放射增敏剂甘氨双唑钠(CMNa)对局部晚期头颈部鳞癌患者IMRT同步化疗期间咽部黏膜炎的影响.方法 2014-2015年间63例患者按照1∶2比例随机入组同步放化疗+CMNa (CRT+CMNa)和同步放化疗(CRT),57例完成治疗方案.CMNa 800mg/m2为放疗前30min静脉滴注,隔天使用.CRT方案为PGTV和阳性淋巴结处方剂量69.96～73.92Gy分33次,PTV处方剂量为60.06Gy分33次,顺铂100mg/m2.放疗技术采用IMRT或HT.结果 CRT+CMNa组19例,CRT组38例.两组间基线临床资料相近(P=0.34～1.00),PGTV(73.00±2.66) Gy比(71.66±3.99) Gy,P=0.19) 、PTV (60.58±2.27) Gy比(59.67±2.08) Gy,P=0.14)处方剂量相近,化疗周期数也相近(P=0.28).CRT+CMNa较CRT组放疗期间≥3级放射性黏膜炎发生率下降,分别为32％、61％(P=0.04),疼痛VAS评分降低,分别为4.6±1.6、6.2±1.6(P=0.00),放疗期间抗生素使用和血液毒性两组也相近(P=0.08～0.80).结论 CMNa可以减轻头颈部鳞癌IMRT同步化疗期间黏膜炎发生率和程度及疼痛评分.