IL-6R抑制剂和胃肠道穿孔:药监测研究和预测性诺莫格拉姆
Shupeng Zou1, Mengling Ouyang1, Qian Cheng1
1Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
干白素-6受体 (IL-6R) 抑制剂,如托西利祖马布和沙利祖马布,与胃肠道穿孔 (GIP) 的风险增加有关. 诸如女性性别,40岁以上的年龄和同时使用NSAID或葡萄皮质激素等因素会增加这种风险.
科学领域:
- 药物监督 药物监督 药物监督
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
背景情况:
- 干白素-6受体 (IL-6R) 抑制剂对于治疗炎症性疾病至关重要,在COVID-19大流行期间使用量增加.
- 越来越多的报道表明IL-6R抑制剂和胃肠道穿孔 (GIP) 之间存在潜在的关联.
研究的目的:
- 使用美国FDA不良事件报告系统 (FAERS) 全面分析IL-6R抑制剂和GIP之间的关联.
- 量化风险信号并确定与IL-6R抑制剂使用相关的GIP的预测因素.
主要方法:
- 使用两个算法检测IL-6R抑制剂的GIP信号的不成比例分析.
- 后勤回归分析以评估风险并开发GIP风险预测模型.
主要成果:
- 在FAERS数据库中,共有994例与IL-6R抑制剂 (托西利祖马布,沙利祖马布) 相关的GIP病例被确定.
- 对托西利祖马布 (ROR 6.86) 和沙利祖马布 (ROR 4.03) 发现了显著的GIP信号,十二指甲孔穿孔显示了最强的关联.
- GIPs的独立风险因素包括女性性别,年龄≥40岁,同时使用葡萄糖皮质类药物和NSAIDs. 风险预测模型表现良好.
结论:
- IL-6R抑制剂可能会增加GIP的风险,特别是在女性和中年患者中.
- 同时使用NSAIDs和葡萄糖皮质类药物进一步增加了患者服用IL-6R抑制剂的GIPs的风险.
- 医疗保健提供者应考虑这些风险因素,并在IL-6R抑制剂治疗期间监测胃肠道并发症.
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