甘氨双唑钠对鼻咽癌放疗增敏的有效性及安全性

The role of Sodium Glycididazole and its safety in combination with radiotherapy for nasopharyngeal carcinoma

目的研究甘氨双唑钠（CMNa）对鼻咽癌的放射增敏作用以及副作用。方法将62例确诊为鼻咽癌的患者随机分为增敏组和对照组，每组31例。增敏组：将甘氨双唑钠800mg／m^2的剂量，30min内静脉滴注后于1～3h内行常规放疗，每周3次，连续用药至放疗结束，共21次。对照组：6MV X线常规外照射，鼻咽癌原发灶DT68～70Gy／7周，颈转移灶DT64-66Gy／6．5-7周。计算肿瘤部分缓解（PR）剂量和完全缓解（CR）剂量，并观察副作用。结果鼻咽癌原发灶和颈转移灶达CR时放射增敏比（sER）分别为1．32和1．31。增敏组和对照组鼻咽癌原发灶CR分别为90．32％（28／31）、67．74％（21／31），P〈0．05；颈淋巴结转移灶CR分别为80．65％（25／31）、58．07％（18／31），P〈0．05。增敏组达到PR和CR的剂量低于对照组（P〈0．01），两组患者的主要副作用为粘膜、皮肤反应，但差异无显著性。结论甘氨双唑钠可以增加鼻咽癌原发灶及颈淋巴结转移灶的放疗敏感性，提高鼻咽癌近期疗效，无严重不良反应，能否降低放疗总剂量仍需进一步临床观察。

Objective To outline the radiation sensitivity efficacy of Sodium Glycididazole （CMNa） and its toxicity combined with radiotherapy for nasopharyngeal cancer （NPC）. Methods Sixty- two patients with NPC were randomly divided into radiotherapy plus CMNa （group A, n = 31） and radiotherapy alone group （group B, n =31）. Group A： patients receiving i.v. CMNa 800mg/m^2 within 30 minutes, and 1-3 h after that the patients were given conventional radiotherapy, 3 times every week, CMNa was used till the end of radiotherapy, 21 times for one cycle. Group B： radiotherapy was given by conventional schedule, 6MV X - ray conventional irradiation, total dose of the primary site was 68-70 Gy every 7 weeks, and the metastatic neck lymph nodes was 64-66 Gy every 6.5-7 weeks. Calculating the was observed. Results partial remission （PR） dosage and complete remission （CR） dosage, and the side reaction In patients with CR, the sensitization rate （SER） of primary site and neck metastatic site was 1.32 and 1.31, respectively. The CR of NPC primary site in groups A and B was 90.32 % （28/31） and 67.74 % （21/31）, respectively, P 〈0.05; the CR of neck lymph node metastatic site was 80.65% （25/31） and 58.07% （18/31）, respectively, P 〈0.05. The PR and CR dosages of radiation in group A were statistically lower comparing to group B （ P 〈0.01）. The main toxicities were the reaction of skin and mucous membrane, there was no statistical difference between these two groups.Conclusion CMNa can increase the radiation sensitivity of primary and neck lymph node metastatic site, and improve the shortterm efficacy of nasopharyngeal cancer, no side reaction occurred, whether it can reduce the radiotherapy dosage needs further study.