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免疫检查点抑制剂的安全性:对不成比例性分析研究的系统审查

Mahesh Rathod¹, Maheshwari Kadari¹, Anjana Das Kadavath¹

¹Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER) Guwahati, Kamrup, 781 101, Assam, India.

European journal of clinical pharmacology

|January 17, 2026

概括

免疫检查点抑制剂 (ICI) 的不成比例性分析揭示了免疫相关不良事件 (irAEs) 的显著安全信号,但缺乏标准化的方法. 改善报告和方法对于免疫治疗中的患者安全至关重要.

科学领域:

药物监督药物监督药物监督
免疫治疗是一种免疫疗法.
在瘤学瘤学.

背景情况:

免疫检查点抑制剂 (ICI) 已经彻底改变了癌症治疗,但与免疫相关的不良事件 (irAEs) 有关.
需要对不成比例性分析进行系统审查,以了解ICI安全信号和方法限制.

研究的目的:

系统地审查ICI公布的不成比例性分析.
总结这些分析的方法,优势和安全信号.
突出报告和不成比例研究质量的差距.

主要方法:

在PubMed,Scopus和谷歌学者中进行了全面的文献搜索,寻找ICI的不成比例分析.
包括在药监数据库中使用不成比例性分析的研究,专注于ICI及其不良药物反应 (ADR).
使用READUS-PV检查清单评估研究质量,并评估人口参数报告.

主要成果:

确定了89个符合条件的不成比例分析 (2019-2024年),其中超过50%使用报告几率比率 (ROR) 和比例报告比率 (PRR).
揭示了ICI相关ADRs发病时间的显著变化,其中一些迅速表现 (例如,心肌炎),而另一些则延迟 (例如,缺血炎).
发现了重大报告缺陷,其中38.2%没有报告基本要素,只有16.8%符合全面报告标准.

结论:

对ICI药监中的不成比例性分析缺乏标准化的方法,这阻碍了可靠的信号检测.
清晰的指导方针,严格的方法和开放科学实践对于提高透明度,可复制性和患者安全至关重要.
主要受影响的器官包括皮肤,消化系统,肝脏,肺部,风湿和内分泌系统.

关键词:

药物不良反应药物不良反应不成比例的分析分析.免疫检查点抑制剂免疫检查点抑制剂药物监督药物监督药物监督安全信号安全信号系统性审查系统性审查

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