贝伐珠单抗联合替莫唑胺用于复发性高级别脑胶质瘤的有效性及安全性分析  

Efficacy and Safety of Bevacizumab Combined with Temozolomide for Recurrent High-Grade Glioma

作　　者：杨东艳 林华[3] 张宇箫[1] 赵昆颖 向丽蓉 杨淑达 胡炜彦 YANG Dongyan;LIN Hua;ZHANG Yuxiao;ZHAO Kunying;XIANG Lirong;YANG Shuda;HU Weiyan(School of Pharmaceutical Science&Yunnan Key Laboratory of Pharmacology for Natural Products,Kunming Yunnan 650500;Dept.of Pharmacy,The 3rd Affiliated Hospital of Kunming Medical University,Kunming Yunnan 650100;Biomedical Engineering Research Institute of Kunming Medical University,Kunming Yunnan 650500,China)

机构地区：[1]昆明医科大学药学院暨云南省天然药物药理学重点实验室,云南昆明650500 [2]昆明医科大学第三附属医院药学部,云南昆明650100 [3]昆明医科大学生物医学工程研究院,云南昆明650500

出　　处：《昆明医科大学学报》2024年第4期67-73,共7页Journal of Kunming Medical University

基　　金：云南省科技厅人才与平台计划基金资助项目(202105AC160078);云南省教育厅科学研究基金资助项目(2021J0227)。

摘　　要：目的探讨贝伐珠单抗(bevacizumab,BEV)单用及贝伐珠单抗联合替莫唑胺(temozolomide,TMZ)治疗复发性高级别脑胶质瘤(high-grade glioma,HGG)的近期疗效、安全性及影响复发性高级别脑胶质瘤患者总生存期(overall survival,OS)的预后因素。方法按照脑胶质瘤治疗效果评估(response assessment in neuro oncology,RANO)标准,以客观有效率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)为指标,回顾性分析云南省肿瘤医院2020年8月至2023年7月31例复发性HGG患者的临床病历资料,分为对照组(BEV)和治疗组(BEV+TMZ),评价2组近期疗效。采用Cox单因素和多因素分析方法分析组别(对照组与治疗组)、性别、年龄、疾病分级、入院评分、组织病理型分类等对31例复发性HGG患者OS的影响;通过χ^(2)检验比较2组不良反应(adverse reactions,ADR),评价安全性。结果治疗组ORR=63.16%,对照组ORR=16.67%,差异有统计学意义(χ^(2)=6.419,P=0.011);治疗组DCR=89.47%,对照组DCR=75.00%,DCR比较差异无统计学意义(χ^(2)=0.320,P=0.571)。对照组中位生存期(mOS)为7个月(95%CI:3.605~10.395),治疗组中位生存期(mOS)为14个月(95%CI:3.853~24.147),2组mOS差异无统计学意义(χ^(2)=0.829,P=0.363)。31例复发性HGG患者Cox单因素分析入院评分和组织病理型分类差异有统计学意义(P<0.05),多因素分析组织病理型分类差异有统计学意义(P<0.05)。2组治疗后ADR比较,恶心呕吐、乏力及腹泻,差异无统计学意义(P>0.05);血小板及白细胞降低率比较,差异有统计学意义(P<0.05),2组出现的ADR对症处理后均得到了缓解。结论治疗组治疗复发性HGG近期疗效优于对照组,2组治疗复发性HGG后的ADR可耐受,安全性良好。组织病理型分类可能是影响31例复发性HGG患者OS的预后因素。Objective To explore the short-term efficacy,safety,and prognostic factors affecting the overall survival(OS)of patients with recurrent high-grade glioma(HGG)treated with bevacizumab(BEV)alone and bevacizumab in combination with temozolomide(TMZ).Methods According to the response assessment in neurooncology(RANO)criteria for the treatment of gliomas,objective response rate(ORR)and disease control rate(DCR)were used as indicators to retrospectively analyze the clinical medical records of 31 patients with recurrent HGG at Yunnan Cancer Hospital from August 2020 to July 2023.The patients were divided into a control group(BEV)and a treatment group(BEV+TMZ),and the recent efficacy of the two groups was evaluated.Cox univariate and multivariate analysis methods were used to analyze the impact of group(control group vs.treatment group),gender,age,disease grading,admission score,histopathological classification,etc.,on the overall survival(OS)of 31 patients with recurrent HGG.Adverse reactions(ADR)between the two groups were compared using a chi-square test to evaluate the safety.Results The ORR of the treatment group was 63.16%,and the ORR of the control group was 16.67%.The difference was statistically significant(χ^(2)=6.419,P=0.011).The DCR of the treatment group was 89.47%,and the DCR of the control group was 75.00%.There was no significant difference in DCR(χ^(2)=0.320,P=0.571).The median survival time(mOS)in the control group was 7 months(95%CI:3.605~10.395),and the median survival time(mOS)in the treatment group was 14 months(95%CI:3.853~24.147).There was no significant difference in mOS between the two groups(χ^(2)=0.829,P=0.363).There were significant differences in Cox univariate analysis admission score and histopathological classification among 31 patients with recurrent HGG(P<0.05),and statistically significant differences in histopathological classification by multivariate analysis(P<0.05).There was no significant difference in nausea,vomiting,fatigue and diarrhea between the two groups after treatment(

关 键 词：高级别脑胶质瘤 贝伐珠单抗 替莫唑胺 

分 类 号：R979.1[医药卫生—药品]