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

Effect of sodium glycididazole on severe radiation-induced mucositis in patients with head and neck squamous cell carcinoma： a randomized phase Ⅱ clinical trial

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 800 mg/m^2为放疗前30 min静脉滴注,隔天使用。CRT方案为PGTV和阳性淋巴结处方剂量69.96~73.92 Gy分33次,PTV处方剂量为60.06 Gy分33次,顺铂100 mg/m^2。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。

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/m^2 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/m^2;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.