目的 比较国产和进口替莫唑胺胶囊临床疗效与成本差异，对两者进行药物经济学评价。方法 收集2008年1月—2018年12月在华中科技大学同济医学院附属协和医院肿瘤中心治疗过的240例脑胶质瘤患者进行回顾性研究，其中符合纳入标准的脑胶质瘤患者共103例。其中使用了国产替莫唑胺胶囊进行治疗的患者72例，归为蒂清组；使用了进口替莫唑胺胶囊进行治疗的患者31例，归为泰道组。计算2年疾病控制率和生存率，通过Kaplan-Meier生存曲线分析两组患者2年疾病无进展生存时间（PFS）及总体生存时间（OS），分析两组不良反应发生率，并对两组进行药物经济学评价。结果 蒂清组和泰道组2年疾病控制率分别为52.8%和67.7%；2年生存率分别为68.10%和74.20%；蒂清组和泰道组总费用/2年疾病控制率分别为2 349.43和为2 307.07；总费用/2年生存率分别为1 821.58和2 104.97。结论 国产替莫唑胺胶囊相对于进口替莫唑胺胶囊在脑胶质瘤患者的治疗中具有一定的药物经济学优势。

Objective To compare the clinical efficacy and cost of domestic and imported Temozolomide Capsules, and pharmacoeconomic evaluation of the two groups was carried out. Methods A retrospective study was conducted on 240 patients with glioma treated in the Union Hospital, Tongji Medical College, Huazhong University of Science & Technology from January 2008 to December 2018, among them, 103 patients with glioma met the inclusion criteria. Among them, 72 patients treated with domestic Temozolomide Capsules were classified as diqing group. 31 cases of patients treated with imported Temozolomide Capsules were classified as the Taidao group. The 2-year disease control rate and survival rate were calculated. The 2-year disease-free survival time (PFS) and overall survival time (OS) of two groups were analyzed by Kaplan-Meier survival curve. The incidence of adverse reactions in the two groups was analyzed, and pharmacoeconomic evaluation was conducted for two groups. Results The 2-year disease control rates in the Tiqing and Taitao groups were 52.8% and 67.7%, respectively, the 2-year survival rates were 68.10% and 74.20%, respectively. The total cost/2-year disease control rates for the Tiqing and Taitao groups were 2 349.43 and 2 307.07, respectively, the total cost/2-year survival rates were 1 821.58 and 2 104.97, respectively. Conclusion Compared with imported Temozolomide Capsules, domestic Temozolomide Capsules have some advantages in drug economics in treatment of glioma patients.

R979.1

国家重点研发计划资助项目（2017YFC0909900）