purin 反代谢物与 Pneumocystis jirovecii 肺炎相关
Lipin Lukose1, Pawar Mansi Shantaram1, Alan Raj2
1Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.
这项研究确定了氨酸抗代谢物可能导致Pneumocystis jirovecii肺炎 (PJP) 的安全信号. 该分析强调了自身免疫和癌症患者,特别是儿童的风险,强调了需要进一步研究的必要性.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床流行病学临床流行病学
背景情况:
- 纯素抗代谢物 (PAs) 用于治疗各种疾病,包括自身免疫性疾病和癌症.
- 肺炎 (PJP) 是一种严重的机会性感染,可以发生在免疫受损的个体中.
- 检测潜在的药物安全信号对于患者保护至关重要.
研究的目的:
- 研究与Pneumocystis jirovecii肺炎 (PJP) 相关的纯素抗代谢物 (PAs) 的潜在安全信号.
- 分析PAs和PJP在FDA不良事件报告系统 (FAERS) 数据库中的不成比例.
- 为了探索不同患者群体的信号强度.
主要方法:
- 对FAERS数据库 (2004Q1-2021Q3) 的回顾性案例/非案例不成比例性分析.
- 使用AERSmine软件进行数据挖掘.
- 员工报告几率比率 (ROR) 和比例报告比率 (PRR) 具有确定的值 (ROR-1.96SE > 1,PRR ≥ 2,X2 ≥ 4) 来识别安全信号.
主要成果:
- 总共分析了7073份PJP报告,其中899份与PA相关.
- 对PA和PJP检测到一个显著的原始信号 (ROR 15.76).
- 对于fludarabine和thioguanine,观察到的信号强度最高. 在自身免疫 (ROR 3.33) 和癌症 (ROR 2.93) 群体中注意到风险增加,儿童的风险增加了近两倍 (ROR 11.57).
结论:
- 有证据表明,与氨酸抗代谢剂使用相关的PJP的安全信号,特别是在自身免疫和癌症患者中.
- 与信号相关的特定PA包括阿扎西奥普林,默卡普托普林,提奥瓜宁,克拉德里宾,弗鲁达拉宾和克洛法拉宾.
- 需要在特定人群中进行进一步的流行病学研究来验证这些发现并为临床实践提供信息.
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