免疫检查点抑制剂诱导的肌肉骨不良事件:一项大规模的药监测研究
1Department of Orthopedics, Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, China.
Frontiers in pharmacology
|October 26, 2023
概括
免疫检查点抑制剂 (ICI) 可以导致各种肌肉骨问题,包括肌肉,关节和骨问题. 这项研究确定了特定的毒性,并证实组合治疗不会显著增加风险.
科学领域:
- 在瘤学瘤学.
- 类风湿病学 类风湿病学
- 药物监督 药物监督 药物监督
背景情况:
- 免疫检查点抑制剂 (ICI) 越来越多地使用,但它们对肌肉骨的毒性未被充分认识到.
- 需要进行系统的调查,以确定ICI诱导的肌肉骨不良事件的谱和特征.
- 了解这些不良事件对于优化患者管理至关重要.
研究的目的:
- 系统地调查免疫检查点抑制剂 (ICI) 的肌肉骨毒性概况.
- 描述ICI诱导的主要肌肉骨不良事件的临床特征和并发症.
- 为了比较ICI单疗法和组合疗法之间肌肉骨不良事件的风险.
主要方法:
- 利用FDA不良事件报告系统数据库 (2010年1月至2021年3月) 获取不良事件数据.
- 采用报告几率比率和贝叶斯信心传播神经网络算法来识别疑似ICI诱导的肌肉骨不良事件.
- 分析了临床特征,并发症,并使用后勤回归和 Ω 收缩模型比较单一疗法与组合疗法风险.
主要成果:
- ICI肌肉骨毒性影响肌肉,关节,脊柱和骨,PD-1抑制剂如pembrolizumab显示较高的风险.
- 确定了主要不良事件,包括肌肉炎,神经肌肉病,关节炎,骨折,脊髓炎,脊柱狭窄,Sjogren综合征,炎,肌炎,肌病,类风湿性肌痛和肌肉.
- 与单一治疗相比,联合治疗 (nivolumab和ipilimumab) 并没有显著增加肌肉骨重大不良事件的风险.
结论:
- 免疫检查点抑制剂 (ICI) 的使用与各种肌肉骨不良事件有关.
- 具体的毒性包括肌肉,神经肌肉结节,肌,关节,脊柱和骨.
- 这些不良事件的管理策略需要在临床实践中进行优化.
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