中国药物警戒 ›› 2021, Vol. 18 ›› Issue (2): 178-183.
DOI: 10.19803/j.1672-8629.2021.02.17

• 安全与合理用药 • 上一篇    下一篇

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

张丛惠1, 崔小康2, 彭婷婷3, 鹿岩3, 郭琳琳3, 刘健1,3,*   

  1. 1山东中医药大学药学院,山东 济南 250355;
    2山东省药品不良反应监测中心,山东 济南 250014;
    3山东中医药大学第二附属医院药学部,山东 济南 250001
  • 收稿日期:2020-03-12 修回日期:2021-02-26 出版日期:2021-02-15 发布日期:2021-02-26
  • 通讯作者: *刘健,女,硕士,主任药师·硕导,临床药学。E-mail: 13969176108@163.com
  • 作者简介:张丛惠,男,在读硕士,临床药学。
  • 基金资助:
    山东省药品不良反应监测哨点研究课题（2019SDADRKY06）

Efficacy and Safety of Osimertinib in the Treatment of EGFR-mutated Advanced Non-small Cell Lung Cancer：A Meta-analysis

ZHANG Conghui1, XIE Yanjun2, PENG Tingting3, LU Yan3, GUO Linlin3, LIU Jian1,3,*   

  1. 1School of Pharmacy, Shandong University of Traditional Chinese Medicine, Jinan Shandong 250355, China;
    2Shandong Center for ADR Monitoring, Jinan Shandong 250014, China;
    3Department of Pharmacy, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan Shandong 250001, China
  • Received:2020-03-12 Revised:2021-02-26 Online:2021-02-15 Published:2021-02-26

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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Meta分析。结果 纳入8篇RCTs研究,共涉及1 795例患者。Meta分析结果显示,在疗效上奥希替尼组的无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）均优于对照组,差异均有统计学意义（均P<0.05）。在亚组分析中,对于Ex19del/L858R突变的患者,1线治疗使用奥希替尼所达到的PFS、ORR、DCR均优于第一代EGFR-TKIs(吉非替尼/厄洛替尼),除ORR外在差异上均有统计学意义（均P<0.05）;对于出现T790M突变的患者,≥2线治疗使用奥希替尼所达到的PFS、ORR、DCR均优于化疗,且差异均有统计学意义（均P<0.05）;在安全性上奥希替尼组的药品不良反应（ADR）与≥3级ADR发生率均低于对照组,但在ADR发生率的差异上没有统计学意义（P>0.05）;此外奥希替尼组中腹泻、间质性肺炎、QT间期延长、皮疹/痤疮样皮炎的发生率均高于对照组,差异均有统计学意义（均P<0.05）。结论 对于表皮生长因子受体（EGFR）突变的NSCLC患者,无论是1线用药还是出现T790M突变后的≥2线用药,奥希替尼在疗效上均具有优势,且能降低≥3级ADR的发生,但也存在一定的安全性风险,需要对用药患者进行密切关注。

关键词: 奥希替尼, 非小细胞肺癌, 疗效, 安全性, Meta分析

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 1 795 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 first-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.

Key words: osimertinib, non-small cell lung cancer, efficacy, safety, Meta-analysis

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