| 纳武利尤单抗治疗非小细胞肺癌有效性及安全性的Meta分析 |
| 投稿时间：2023-10-23 修订日期：2024-03-12 点此下载全文 |
| 引用本文：刘丽艳,余小翠,孙传铎.纳武利尤单抗治疗非小细胞肺癌有效性及安全性的Meta分析[J].药学实践杂志,2024,42(10):451~456 |
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| 中文摘要:目的 系统评价纳武利尤单抗治疗非小细胞肺癌（NSCLC）的有效性和安全性。方法 系统检索PubMed、Embase、Cochrane Library、中国知网（CNKI）、维普中文科技期刊数据库、万方医学数据库，时间均为自建库至2023年3月；纳入公开发表的纳武利尤单抗治疗非小细胞肺癌患者的Ⅲ期随机对照临床试验，以总生存期、无进展生存期和不良反应发生率作为结局指标，采用STATA13.1版统计软件进行Meta分析。结果 8项Ⅲ期随机对照试验共计4 945例患者的Meta分析结果显示，纳武利尤单抗治疗组在整体生存期方面相较于传统化疗组能显著降低患者死亡风险（HR=0.73，95%CI=0.65～0.82，P<0.05），纳武利尤单抗治疗组在无进展生存期方面相较于传统化疗组且能显著降低患者复发风险（HR=0.74，95%CI=0.63～0.88，P<0.05）。在安全性方面，对于腹泻，纳武利尤单抗组和传统化疗组没有显著差异。然而，对于恶心、中性粒细胞减少、贫血、食欲下降、疲劳等不良事件，纳武利尤单抗组的发生率均低于传统化疗组。值得注意的是，纳武利尤单抗组免疫相关性不良事件（如皮疹）的发生率显著高于传统化疗组，且具有统计学意义（OR=3.85，95%CI=2.05～6.25，P<0.05）。结论 相较于传统化疗，纳武利尤单抗治疗非小细胞肺癌的疗效和安全性更优，但增加了免疫相关不良事件的风险。 |
| 中文关键词:纳武利尤单抗 非小细胞肺癌 Meta分析 有效性 安全性 |
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| Efficacy and safety of nivolumab in the treatment of non-small cell lung cancer：a meta-analysis |
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| Abstract:Objective To systematically evaluate the efficacy and safety of nivolumab in the treatment of non-small cell lung cancer. Methods PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure（CNKI）, Weipu Chinese Science and Technology Journal Database, Wanfang Medical Database were searched for articles published from the establishment of the database to March 2023. Published randomized controlled clirical trials of nivolumab in the treatment of patients with non-small cell lung cancer were selected, overall survival, progression-free survival, and adverse reaction rate as outcome indicators were used. A meta-analysis using STATA version 13.1 statistical software was conducted. Results A total of 8 phase Ⅲ randomized controlled trials involving 4945 subjects were included. Compared with the traditional chemotherapy group, patients in the nivolumab group had significantly reduced risk of death in terms of overall survival （HR=0.73, 95%CI=0.65-0.82, P<0.05）, and in terms of progression-free survival, nivolumab significantly reduced the risk of recurrence compared with the traditional chemotherapy group （HR=0.74, 95% CI=0.63-0.88, P<0.05）. In terms of safety, there was no significant difference between the nivolumab group and the traditional chemotherapy group for diarrhea, but the incidence of nausea, neutropenia, anemia, decreased appetite, and fatigue in the nivolumab group was lower than that in the traditional chemotherapy group. However, it should be worth noting that the incidence of immune-related adverse events such as rash was higher in the nivolumab group than in the traditional chemotherapy group, and the difference was statistically significant （OR=3.85，95%CI=2.05-6.25，P<0.05）. Conclusion Compared to traditional chemotherapy, the efficacy and safety of nivolumab in the treatment of non-small cell lung cancer were better, but the risk of immune-related adverse events increased. |
| keywords:nivolumab non-small cell lung cancer Meta-analysis efficacy safety |
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