免疫检查点抑制剂和心脏毒性:对观察性研究和随机对照试验的比较元分析
Akash Sharma1,2, Grace Alexander3, Jian H Chu4
1Department of Medicine University at Buffalo-Catholic Health System Buffalo NY.
Journal of the American Heart Association
|May 18, 2024
概括
免疫检查点抑制剂 (ICI) 在临床试验中增加了心脏毒性风险,包括心肌炎和心肌梗塞. 然而,观察性研究显示,风险没有增加,这表明诊断和管理方面的差异.
科学领域:
- 心脏病学 心脏病学
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
背景情况:
- 免疫检查点抑制剂 (ICI) 与心脏毒性有关,这种疾病的死亡率很高.
- 评估ICI心脏毒性风险对于临床决策至关重要,但随机对照试验 (RCT) 和现实观察研究 (OS) 的数据往往不同.
研究的目的:
- 系统地比较随机对照试验 (RCT) 和观察性研究 (OS) 中与免疫检查点抑制剂 (ICI) 相关的心脏毒性风险.
- 评估接受ICI治疗的患者心肌炎,心周病,心肌梗塞和中风的发病率.
主要方法:
- 在PubMed,Embase,Cochrane图书馆和Scopus进行了系统的文献搜索.
- 包括II期和III期RCT和OS报告免疫治疗心脏毒性事件.
- 使用几率比率 (ORs) 汇总结果,将ICI与非ICI疗法进行比较,遵循PRISMA指南.
主要成果:
- 在54个RCT (N=38,264) 中,ICI使用与非ICI治疗相比,与心肌炎 (OR,3.55),心周病 (OR,2.73),心肌梗塞 (OR,1.83) 的风险更高有关.
- 在24个OSS (N=12,561,455) 中,ICI使用与心肌炎,心周病或心肌梗塞无关.
- 组合ICI显示,在OS中,心肌炎的风险高于单次ICI使用 (OR,3.07). 在RCT中,ICI并没有增加中风风险.
结论:
- 免疫检查点抑制剂 (ICI) 在RCT中与心肌炎,心周病和心肌梗塞的风险增加有关,但在OS中没有.
- 随机试验和操作系统之间的差异表明诊断标准和患者管理的潜在差异.
- 需要进一步的研究来协调这些发现,并优化ICI的安全使用.
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