斯福米辛相关的不良事件:FDA不良事件报告系统的不成比例分析
Luxuan Yang1, Wenyong Zhang1, Xiujuan Shen1
1Department of Infection Disease, The Fifth People's Hospital of Suzhou, Suzhou, Jiangsu, China.
斯福米辛的使用与不良事件 (AE) 有关,特别是在女性和某些地区. 胃肠道和皮肤疾病很常见,早期发病,强调需要仔细监测.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 抗微生物耐药性 抗微生物耐药性
背景情况:
- 斯福米提供了一种独特的机制来对抗耐药细菌.
- 药物选择有限增加了对现有治疗的依赖,可能会增加不良事件 (AE) 风险.
- 了解氏素的AE概况对于安全的临床使用至关重要.
研究的目的:
- 使用美国FDA不良事件报告系统 (FAERS) 数据调查与氏素相关的不良事件 (AE).
- 为了告知临床安全和药监督实践.
- 为了确定与氏素相关的AE的模式和风险因素.
主要方法:
- 美国FDA不良事件报告系统 (FAERS) 数据库的数据挖掘.
- 分析了796个报告的与菌素相关的副作用.
- 统计分析包括报告赔率比率 (RORs) 和发病时间 (TTO).
主要成果:
- 不良事件 (AE) 在女性中更频繁 (61.90%) 并在2018-2019年达到峰值.
- 胃肠道疾病 (16.29%),受伤/中毒/手术并发症 (13.50%),皮肤疾病 (11.26%) 是最常见的.
- 观察到早期发病 (中位数TTO2天) 和与非标签使用,腹和恶心相关.
结论:
- 与素相关的副作用需要仔细监测,特别是在女性患者和高报告率地区.
- 确定的AE概况可能与现有的安全数据有所不同,需要重新评估.
- 这些研究结果支持加强药物监测,并改进了福米辛治疗的临床管理.
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