目的 比較國產(chǎn)和進口替莫唑胺膠囊臨床療效與成本差異，對兩者進行藥物經(jīng)濟學評價。方法 收集2008年1月—2018年12月在華中科技大學同濟醫(yī)學院附屬協(xié)和醫(yī)院腫瘤中心治療過的240例腦膠質(zhì)瘤患者進行回顧性研究，其中符合納入標準的腦膠質(zhì)瘤患者共103例。其中使用了國產(chǎn)替莫唑胺膠囊進行治療的患者72例，歸為蒂清組；使用了進口替莫唑胺膠囊進行治療的患者31例，歸為泰道組。計算2年疾病控制率和生存率，通過Kaplan-Meier生存曲線分析兩組患者2年疾病無進展生存時間（PFS）及總體生存時間（OS），分析兩組不良反應(yīng)發(fā)生率，并對兩組進行藥物經(jīng)濟學評價。結(jié)果 蒂清組和泰道組2年疾病控制率分別為52.8%和67.7%；2年生存率分別為68.10%和74.20%；蒂清組和泰道組總費用/2年疾病控制率分別為2 349.43和為2 307.07；總費用/2年生存率分別為1 821.58和2 104.97。結(jié)論 國產(chǎn)替莫唑胺膠囊相對于進口替莫唑胺膠囊在腦膠質(zhì)瘤患者的治療中具有一定的藥物經(jīng)濟學優(yōu)勢。

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

國家重點研發(fā)計劃資助項目（2017YFC0909900）