替莫唑胺治疗多形性胶质母细胞瘤及间变性星形细胞瘤的快速卫生技术评估  

Rapid Health Technology Assessment of Temozolomide in the Treatment of Glioblastoma Multiforme and Anaplastic Astrocytoma

作　　者：朱云珊 赵紫楠[1] 朱翊[1] 张闪闪 张亚同[1] 金鹏飞[1] ZHU Yunshan;ZHAO Zinan;ZHU Yi;ZHANG Shanshan;ZHANG Yatong;JIN Pengfei(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730

出　　处：《中国医院用药评价与分析》2023年第9期1098-1104,共7页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家重点研发计划课题(No.2020YFC2009001)。

摘　　要：目的:基于快速卫生技术评估(HTA)方法,评价替莫唑胺(TMZ)的有效性、安全性和经济性,为临床决策提供循证依据。方法:系统检索PubMed、Embase、the Cochrane Library、中国知网、万方数据库和HTA相关网站及数据库,纳入TMZ治疗多形性胶质母细胞瘤(GBM)及间变性星形细胞瘤(AA)的HTA报告、Meta分析/系统评价及药物经济学研究。检索时间均为建库至2021年7月20日。由2名评价者独立筛选文献、提取数据、评价文献质量、交叉汇总核对,最终对结果进行定性分析与描述。结果:共纳入0篇HTA报告、17篇Meta分析/系统评价和6篇经济学评价。(1)有效性方面,在治疗新诊断GBM和AA中,13项研究结果显示,与单纯放疗比较,TMZ联合/不联合放疗方案更具优势,能够显延长总生存期(OS)、无进展生存期(PFS)等;4项研究比较了TMZ单药与单纯放疗方案的有效性,其中1项研究结果显示TMZ在延长OS方面比放疗有优势,其余3项研究结果显示两者效果相当,研究结论并不完全统一,需要进一步论证。1项研究结果显示,新诊断GBM使用西仑吉肽方案、贝伐珠单抗联合伊立替康方案结合/不结合TMZ联合放疗方案,在提高生存率方面均优于TMZ联合放疗方案。另1项研究结果显示,新诊断GBM使用贝伐珠单抗联合TMZ或伊立替康治疗相较于TMZ单药治疗可显著提高6个月无进展生存率和延长中位PFS,复发性GBM使用贝伐珠单抗与伊立替康联合治疗相较于TMZ单药和贝伐珠单抗联合TMZ治疗可显著提高6个月无进展生存率。(2)安全性方面,TMZ可能增加患者血液毒性反应,但3—4级严重的血液毒性反应极少发生,大部分患者(包括老年患者)仍然耐受TMZ治疗。(3)经济性方面,2项来自我国的经济性研究结果显示,TMZ联合放疗相较于单独放疗不具有经济性。2项来自其他国家的经济性研究结果显示,TMZ联合放疗相较于单独放疗更有经济性。另2项经济性研OBJECTIVE:To evaluate the efficacy,safety and economy of temozolomide(TMZ)based on rapid health technology assessment(HTA),so as to provide evidence-based basis for clinical decision.METHODS:PubMed,Embase,the Cochrane Library,CNKI,Wanfang Data and websites and databases related to HTA were systematically searched.HTA reports,Meta-analysis/systematic review and pharmacoeconomic studies related to TMZ for glioblastoma(GBM)and anaplastic astrocytoma(AA)were included.The retrieval time was from the establishment of the database to Jul.20th,2021.Two reviewers independently screened the literature,extracted and summarized data,evaluated the literature quality,analyzed and described the results with qualitative description method.RESULTS:A total of 0 HTA,17 Meta-analysis/systematic reviews and 6 economic evaluations were included.(1)In terms of effectiveness,in the treatment of newly diagnosed GBM and AA,results of 13 studies showed that TMZ with/without radiotherapy regimen was more advantageous compared with radiotherapy alone,and was able to significantly prolong overall survival(OS),progression-free survival(PFS).Four studies compared the effectiveness of TMZ monotherapy and radiotherapy alone in the treatment of newly diagnosed GBM and AA.Results of one study showed that TMZ had an advantage over radiotherapy in prolonging OS,while the results of the other three studies showed that the effects of the two were comparable,and the conclusions were not completely uniform,which needed to be further verified.Results of one study showed that cilengitide regimen,bevacizumab combined with irinotecan regimen combined with/without TMZ combined with radiotherapy regimen were superior to TMZ combined with radiotherapy regimen in improving the survival rate of newly diagnosed GBM.Another study showed that treatment with bevacizumab combined with TMZ or irinotecan significantly increased the six-month PFS rate and prolonged median PFS compared with TMZ monotherapy for newly diagnosed GBM.Treatment of recurrent GBM with bevacizuma

关 键 词：替莫唑胺 多形性胶质母细胞瘤 间变性星形细胞瘤 有效性 安全性 经济性 快速卫生技术评估 

分 类 号：R979.1[医药卫生—药品]