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奥希替尼治疗EGFR突变的晚期非小细胞肺癌疗效与安全性的Meta分析
引用本文:张丛惠,崔小康,彭婷婷,鹿岩,郭琳琳,刘健. 奥希替尼治疗EGFR突变的晚期非小细胞肺癌疗效与安全性的Meta分析[J]. 中国药物警戒, 2021, 0(2): 178-183
作者姓名:张丛惠  崔小康  彭婷婷  鹿岩  郭琳琳  刘健
作者单位:山东中医药大学药学院;山东省药品不良反应监测中心;山东中医药大学第二附属医院药学部
基金项目:山东省药品不良反应监测哨点研究课题(2019SDADRKY06)。
摘    要:目的 系统评价奥希替尼治疗非小细胞肺癌(NSCLC)的疗效和安全性.方法 计算机检索The Cochrane Library、EMbase、PubMed、中国知网、维普网、万方数据建库至2019年12月31日,查找奥希替尼治疗NSCLC的随机对照试验(RCTs),并进行质量评价和资料提取,用Stata 12.0进行Me...

关 键 词:奥希替尼  非小细胞肺癌  疗效  安全性  Meta分析

Efficacy and Safety of Osimertinib in the Treatment of EGFR-mutated Advanced Non-small Cell Lung Cancer:A Meta-analysis
ZHANG Conghui,XIE Yanjun,PENG Tingting,LU Yan,GUO Linlin,LIU Jian. Efficacy and Safety of Osimertinib in the Treatment of EGFR-mutated Advanced Non-small Cell Lung Cancer:A Meta-analysis[J]. Chinese JOurnal of Pharmacovigilance, 2021, 0(2): 178-183
Authors:ZHANG Conghui  XIE Yanjun  PENG Tingting  LU Yan  GUO Linlin  LIU Jian
Affiliation:(School of Pharmacy,Shandong University of Traditional Chinese Medicine,Jinan Shandong 250355,China;Shandong Center for ADR Monitoring,Jinan Shandong 250014,China;Department of Pharmacy,the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan Shandong 250001,China)
Abstract:Objective To evaluate the efficacy and safety of osimertinib in the treatment of non-small cell lung cancer(NSCLC).Methods RCTs related to osimertinib used for treating NSCLC were collected by searching PubMed,EMbase,the Cochrane Library,CNKI,VIP and Wanfang database from the beginning to December 31,2019.After quality evaluation and information retrieval,a meta-analysis was conducted using Stata 12.0 software.Results A total of 8 studies and 1795 patients were included.Meta analysis results showed that the progression-free survival(PFS),objective response rate(ORR),and disease control rate(DCR)of the osimertinib group were better than those of the control group,and their differences were statistically significant(all P<0.05).In the subgroup analysis,for patients with Ex19del/L858R mutations,the PFS,ORR and DCR achieved with osimertinib as a first-line therapy were better than those of the first-generation EGFR-TKIs(gefitinib/erlotinib),and their differences were statistically significant.except for ORR(all P<0.05).For patients with T790M mutations,PFS,ORR,and DCR achieved with osimertinib as a second-line treatment were better than those of chemotherapy,and their difference were also statistically significant(all P<0.05).As for safety,the incidence of adverse drug reactions(ADRs)and grade≥3 ADRs in the osimertinib group was lower than that of the control group,but there was no significant difference in the incidence of ADRs(P>0.05).In addition,the incidence of diarrhea,interstitial lung disease,prolonged QT interval,and rash/acne was significantly.whether it is first-line medication or second-line and above medication after T790M mutation.higher in the osimertinib group than in the control group.Conclusion For patients with EGFR-mutant NSCLC,whether it is fi rst-line medicaation or second-line and above medication after T 790M mutation osimertinib is more effective and can reduce the incidence of grade≥3 ADRs,but there is safety risk.
Keywords:osimertinib  non-small cell lung cancer  efficacy  safety  Meta-analysis
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