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目的观察甘氨双唑钠(CMNa)放射增敏作用。方法对55例经病理学和(或)细胞学证实的肺癌、食管癌采用随机双盲对照法分为A组(放疗+CMNa组)和B组(放疗+安慰剂组)。A组CMNa按800mg/m2于放疗前1h内静脉滴注,3次/周滴注至放疗结束。B组用同样剂量的安慰剂。静脉滴注后30~60min内进行放疗,直至疗程结束。放疗总剂量60~70Gy,2Gy/次,5次/周,共6~7周。结果治疗组2例肺癌患者因过敏反应(皮疹)退组未参与疗效评价。肺癌A组和B组的有效率分别为42%和53%(P=0·516),食管癌中A组和B组有效率分别为100%和43%(P=0·015),A组和B组总有效率分别为62%和50%(P=0·378)。中位生存期A组为11个月,B组为10个月。1、3、5年总生存率A组分别为31%、13%、10%,B组分别为25%、15%、6%(P=0·475)。1、3、5年局部控制率A组分别为32%、18%、16%,B组分别为28%、19%、13%(P=0·518)。除偶见皮疹,两组毒副反应相似。结论CMNa对食管癌有放射增敏作用,而对肺癌疗效不明显,其毒副作用轻微。CMNa配合放疗远期疗效不明显,仍需追踪观察和扩大病例试验。
Objective To observe the radiosensitization effect of glycididazole sodium (CMNa). Methods 55 cases of lung cancer and esophageal cancer confirmed by pathology and / or cytology were divided into group A (radiotherapy + CMNa group) and group B (radiotherapy + placebo group) by randomized double-blind control. Group A CMNa by 800mg / m2 intravenous infusion within 1h before radiotherapy, 3 times / week instillation to the end of radiotherapy. B group with the same dose of placebo. Intravenous infusion of 30 ~ 60min radiotherapy until the end of treatment. The total dose of radiotherapy 60 ~ 70Gy, 2Gy / times, 5 times / week, a total of 6 to 7 weeks. Results Two patients with lung cancer in the treatment group were not involved in the evaluation of the curative effect due to anaphylactic reaction (rash). The effective rates of lung cancer in groups A and B were 42% and 53%, respectively (P = 0.056). The effective rates of esophageal cancer in groups A and B were 100% and 43%, respectively The total effective rate was 62% in group B and 50% in group B (P = 0.378). The median survival was 11 months in group A and 10 months in group B. The overall survival rates at 1, 3 and 5 years were 31%, 13% and 10% in group A, 25%, 15% and 6% in group B respectively (P = 0.475). The local control rates of 1, 3 and 5 years were 32%, 18% and 16% in group A, and 28%, 19% and 13% in group B respectively (P = 0.1818). In addition to occasional rash, two groups of similar side effects. Conclusion CMNa has a radiosensitizing effect on esophageal cancer, while its effect on lung cancer is insignificant, with minor side effects. CMNa with long-term efficacy of radiotherapy is not obvious, still need to follow-up observation and expansion of case trials.