背景:棘球白素属于第四代抗真菌药,并且没有关于其凝血功能障碍风险的系统研究;这项研究将使用美国食品和药物管理局不良事件报告系统(FAERS)数据库预测棘白菌素类凝血功能障碍的风险。
方法:2004年1月至2024年3月的数据来自FAERS。我们检查了凝血功能障碍事件的临床特征,并通过使用报告优势比(ROR)进行了不相称性分析,以将棘白菌素与完整数据库进行比较。
结果:有313例报告称与棘白菌素作为主要可疑(PS)药物有关的凝血功能障碍。发生凝血功能障碍的中位时间为3天(四分位距[IQR]1-9天)。与三唑和多烯相比,棘白菌素具有更强的凝血功能障碍信号(ROR3.18,95CI2.81-3.51,p<0.01)。与卡泊芬净和米卡芬净相比,Anidulafungin具有更强的信号(ROR6.84,95CI4.83-9.70,p<0.01)。对应于弥散性血管内凝血(DIC)的最强信号,血小板计数下降,血小板减少症,胃肠道出血,脑出血,肺出血和血栓性血小板减少性紫癜(TTP)是米卡芬净(ROR27.19,95CI18.49-39.98),米卡芬净(ROR3.50,95CI2.36-5.19),Anidulafungin(ROR9.75,95CI5.22-18.19),米卡芬净(ROR3.17,95CI2.02-4.97),米卡芬净(ROR4.95,95CI2.81-8.72),卡波芬金(ROR20.76,95CI11.77-36.59),米卡芬净(ROR20.43,95CI8.49-49.14),分别。
结论:对于凝血功能障碍,我们发现棘白菌素的信号比三唑和多烯更强,Anidulafungin的信号比米卡芬净和卡泊芬净更强。使用相应的药物时,应密切监测凝血参数。
BACKGROUND: Echinocandins belong to the fourth generation of antifungals, and there are no systematic studies on their risk in coagulation dysfunction; this study will predict the risk of coagulation dysfunction of echinocandins using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
METHODS: Data from January 2004 to March 2024 were obtained from FAERS. We examined the clinical characteristics of the coagulation dysfunction events and conducted disproportionality analysis by using reporting odds ratios (ROR) to compare echinocandins with the full database.
RESULTS: There were 313 reports of coagulation dysfunction related to echinocandins as the primary suspect (PS) drug. The median time to incident for coagulation dysfunction was 3 (interquartile range [IQR] 1-9) days. Compared to triazoles and polyenes, echinocandins have a stronger signal (ROR 3.18, 95%CI 2.81-3.51, p < 0.01) of coagulation dysfunction. Compared to caspofungin and micafungin,
anidulafungin has a stronger signal (ROR 6.84, 95%CI 4.83-9.70, p < 0.01). The strongest signal corresponding to disseminated intravascular coagulation (DIC), platelet count decreased, thrombocytopenia, gastrointestinal haemorrhage, cerebral haemorrhage, pulmonary haemorrhage and thrombotic thrombocytopenic purpura (TTP) is micafungin (ROR 27.19, 95%CI 18.49-39.98), micafungin (ROR 3.50, 95%CI 2.36-5.19),
anidulafungin (ROR 9.75, 95%CI 5.22-18.19), micafungin (ROR 3.17, 95%CI 2.02-4.97), micafungin (ROR 4.95, 95%CI 2.81-8.72), caspofungin (ROR 20.76, 95%CI 11.77-36.59), micafungin (ROR 20.43, 95%CI 8.49-49.14), respectively.
CONCLUSIONS: For coagulation dysfunction, we found stronger signals for echinocandins than triazoles and polyenes, and stronger signals for
anidulafungin than micafungin and caspofungin. Coagulation parameters should be closely monitored while using the respective drugs.