Stadler B, Kärcher K H, Kogelnik H D, Szepesi T
Int J Radiat Oncol Biol Phys. 1984 Sep;10(9):1713-7. doi: 10.1016/0360-3016(84)90534-0.
A randomized study investigating the value of misonidazole in patients irradiated for grade III and IV supratentorial astrocytomas was started in June 1977. With a minimum follow-up time of 6 months, 45 patients who completed therapy are available for analysis. All patients received the same radiation treatment (66.5 Gy in 31 fractions over 7.5 weeks, field size reduction after 45 Gy). In the first, second and eighth week, a 4 Gy tumor dose was given on Monday and Thursday. Misonidazole was given 4 hours before irradiation to 18 randomized patients on those 6 treatment days (2.1-2.7 g/m2 per treatment day). Daily tumor doses of 1.7 Gy were administered Monday through Friday from the third until the seventh week. Median survival for patients treated with misonidazole is 13.8 months; for those treated by irradiation alone it was 9.8 months. The corresponding 1 year survival rates are 64 and 25%, respectively. Survival plots indicate some advantage for the patients treated with misonidazole, however statistically there is no significant difference observed (p greater than 0.08). There are no significant differences in Karnofsky performance status, sex and in histological grade or in age distribution between the groups. However, the type of surgery (complete or subtotal) influenced survival markedly: patients with complete surgery lived significantly longer (p less than 0.0009). Neurotoxic side effects of misonidazole were minimal.
一项关于米索硝唑对Ⅲ级和Ⅳ级幕上星形细胞瘤放疗患者价值的随机研究于1977年6月启动。在最短随访时间为6个月的情况下，有45名完成治疗的患者可供分析。所有患者均接受相同的放射治疗（7.5周内分31次给予66.5 Gy，45 Gy后缩小照射野）。在第一、第二和第八周，于周一和周四给予4 Gy的肿瘤剂量。在这6个治疗日，对18名随机分组的患者在放疗前4小时给予米索硝唑（每次治疗日剂量为2.1 - 2.7 g/m²）。从第三周直到第七周，周一至周五每日给予1.7 Gy的肿瘤剂量。接受米索硝唑治疗的患者中位生存期为13.8个月；单纯接受放疗的患者为9.8个月。相应的1年生存率分别为64%和25%。生存曲线表明米索硝唑治疗的患者有一定优势，但在统计学上未观察到显著差异（p大于0.08）。两组在卡诺夫斯基功能状态、性别、组织学分级或年龄分布方面均无显著差异。然而，手术类型（全切或次全切）对生存期有显著影响：接受全切手术的患者生存期显著更长（p小于0.0009）。米索硝唑的神经毒性副作用极小。
