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目的 研究顺铂联合替莫唑胺放化疗治疗MGMT启动子未甲基化胶质母细胞瘤临床随机对照试验的设计方案, 及其治疗效果.方法 对2016年6月-2017年8月新诊断的50例MGMT启动子未甲基化胶质母细胞瘤患者, 进行临床随机对照试验.患者随机分为替莫唑胺标准放化疗组 (对照组, 24例) 及顺铂联合替莫唑胺放化疗组 (联合治疗组, 26例) .观察并比较两组患者在同期放化疗和放疗后辅助化疗期间的不良反应;分析两组患者的生存情况.结果 患者主要的不良反应为骨髓抑制、恶心呕吐、食欲减退、便秘和疲乏.对照组中2例患者发生骨髓抑制, 联合治疗组中共有12例患者发生骨髓抑制;两组骨髓抑制发生率比较, 差异有统计学意义 (P=0. 002) .经对症处理后, 患者的骨髓抑制均得到改善.联合治疗组中有42％～50％的患者出现恶心呕吐、食欲减退、便秘, 对照组中有25％～33％的患者出现以上症状;对照组中出现疲乏者5例, 联合治疗组为8例;两组比较, 差异均无统计学意义 (均P＞ 0. 05) .两组患者中均未有肝肾功能损害及耳毒性发生者.联合治疗组有23％的患者、对照组有8％的患者出现生活质量评分下降, 两组的差异无统计学意义 (P＞ 0. 05) .两组患者中均无因严重不良反应退出研究者.截至2018年3月, 共有29例患者出现复发, 其中联合治疗组14例、对照组15例;13例患者死亡, 其中联合治疗组6例、对照组7例.Kaplan-Meier生存函数分析显示, 两组OS和PFS的差异无统计学意义 (均P＞ 0. 05) .结论 顺铂联合替莫唑胺组治疗后的骨髓抑制较为严重, 但经对症处理后均能恢复;没有患者因不良反应退出治疗.患者的1年生存率与单用替莫唑胺放化疗的患者相仿.“,”Objective To investigate the efficacy and safety of cisplatin combined with radiotherapy and concurrent chemotherapy of temozolomide in glioblastomas (GBM) of MGMT unmethylated and trial design. Methods The random clinical study with comparative method was used. The patients were divided into control group and test group. From Jun 2016 to Aug 2017, 50 patients were enrolled, 24 in control group and 26 in test group. The control group was treated with temozolomide and radiotherapy. The test group was treated with cisplatin combined with temozolomide and radiotherapy. Adverse reactions and survival time were documented in both groups. Results The most commonly adverse events include bone marrow inhibition, nausea and vomiting, loss of appetite, constipation, fatigue. Control group had 2 cases of bone marrow inhibition, and test group had 12 cases. The difference in the bone marrow inhibition of the two groups was prominent (P = 0. 002). 42％-50％ of test group patients sufferd nausea and vomiting, loss of appetite, constipation and 25％-33％ in control group, but both groups had no statistically significant difference. Control group had 5 cases of fatigue, and test group had 8 cases, the difference is not significiant. No patients had liver or kieney dysfunction, and no patients had hearing impairment. The difference in quality of life scores was not significant. Both groups were tolerated. No patients withdrew from the study. By the time to 29 th Feb 2018, patients had recurrence (15 cases in the control group and 14 cases in the test group). 13 patients died (7 cases in the control group and 6 cases in the test group). The differences in OS and PFS were not statistically significant (all P＞ 0. 05). Conclusion All patients have good tolerance. Cisplatin combined with temozolomide and radiotherapy may increase bone marrow inhibition, but it can be relieved after treatment and no patients withdrew from the study. The two groups are similar in efficacy. Further study should be conducted upon larger samples.