Department of Biomedical Sciences, West Virginia School of Osteopathic Medicine, Lewisburg, WV, USA.
Sci Rep. 2021 Jan 13;11(1):1035. doi: 10.1038/s41598-020-80569-7.
Adverse outcomes associated with the treatment of Toxoplasma gondii infections in patients with various health backgrounds have not been characterized. The aim of this study was to identify the adverse outcomes and adverse events associated with the current clinical treatments of Toxoplama gondii infections using real world data reported to the FDA adverse event reporting system (FAERS). Data submitted to FAERS between 2013 and 2019 was retrieved and analyzed. Reporting odds ratio of death was calculated for the drugs having ≥ 25 reports of adverse outcomes. The adverse event profiles for the same drugs were analyzed and the reporting odds ratio was calculated relative to all other drugs used in the treatment of Toxoplasma infections. There were 503 cases reporting the treatment of Toxoplasma infections in the FAERS database. Death (DE) was the adverse outcome in 102 reports, of which 23 (22.5%) anti-Toxoplasma drugs were listed as the primary suspect drug (PS). Clindamycin (2.04; 1.07-3.90) followed by pyrimethamine (1.53; 0.99-2.36) were the most likely to be associated with death. Adverse events analysis suggest that sulfonamides formulations may have a less favorable safety profile. Our study represents the first real-world analysis of adverse outcomes and events associated with the treatment of Toxoplasma infections. Our findings support the need to better understand the current first-line agents for Toxoplasma infections, in addition to underscoring the need to identify safer regimens.
尚未明确与治疗不同健康背景患者的弓形虫感染相关的不良结局和不良事件。本研究旨在使用向 FDA 不良事件报告系统 (FAERS) 报告的真实世界数据，确定当前弓形虫感染临床治疗相关的不良结局和不良事件。检索并分析了 2013 年至 2019 年 FAERS 中提交的数据。对于不良结局报告数≥25 的药物，计算了死亡的报告比值比 (ORR)。分析了相同药物的不良事件谱，并计算了相对于用于治疗弓形虫感染的所有其他药物的报告比值比 (ORR)。FAERS 数据库中共有 503 例报告了弓形虫感染的治疗情况。在 102 例报告中，有 102 例（102/503，20.3%）不良结局为死亡 (DE)，其中 23 例（23/102，22.5%）抗弓形虫药物被列为主要怀疑药物（PS）。克林霉素（2.04；1.07-3.90）和乙胺嘧啶（1.53；0.99-2.36）最有可能与死亡相关。不良事件分析表明磺胺类药物制剂可能具有不太有利的安全性特征。我们的研究代表了对与弓形虫感染治疗相关的不良结局和事件的首次真实世界分析。我们的研究结果支持有必要更好地了解当前治疗弓形虫感染的一线药物，此外还强调需要确定更安全的治疗方案。
