PDF(Pubmed)
Abstract：
Azole antifungal drugs are commonly used to treat vulvovaginal candidiasis (VVC). The nephrotoxicity and developmental toxicity of azole drugs have not been systematically analyzed in the real world. We used the FDA Adverse Event Reporting System (FAERS) to investigate the adverse events (AEs) associated with imidazole therapy for VVC. FAERS data (from quarter 1 2004 to quarter 3 2022) were retrieved using OpenVigil 2.1, and AEs were retrieved and standardized according to the Medical Dictionary for Regulatory Activities (MedDRA). In the top 10 System Organ Class (SOC), all four drugs have been found to have kidney and urinary system diseases and pregnancy. We found significant signals, including clotrimazole [bladder transitional cell carcinoma, (report odds ratio, ROR = 291.66)], [fetal death, (ROR = 10.28)], ketoconazole[nephrogenic anemia (ROR = 22.1)], [premature rupture of membranes (ROR = 22.91 46.45, 11, 3)], Miconazole[hematuria (ROR = 19.03)], [neonatal sepsis (ROR = 123.71)], [spontaneous abortion (ROR = 5.98)], Econazole [acute kidney injury (ROR = 4.41)], [spontaneous abortion (ROR = 19.62)]. We also discovered new adverse reactions that were not reported. Therefore, when using imidazole drugs for treatment, it is necessary to closely monitor the patient\'s renal function, pay attention to the developmental toxicity of the fetus during pregnancy, and be aware of potential adverse reactions that may occur.
摘要：
唑类抗真菌药物通常用于治疗外阴阴道念珠菌病（VVC）。在现实世界中尚未系统地分析唑类药物的肾毒性和发育毒性。我们使用FDA不良事件报告系统（FAERS）来调查与咪唑治疗VVC相关的不良事件（AE）。使用OpenVigil2.1检索FAERS数据（从2004年第1季度到2022年第3季度），并根据监管活动医学词典（MedDRA）检索和标准化AE。在前10个系统器官类（SOC）中，所有四种药物都被发现患有肾脏和泌尿系统疾病以及怀孕。我们发现了重要的信号,包括克霉唑[膀胱移行细胞癌，(报告赔率比，ROR=291.66)],[胎儿死亡，(ROR=10.28)],酮康唑[肾性贫血（ROR=22.1）]，[胎膜早破（ROR=22.9146.45，11，3）]，咪康唑[血尿（ROR=19.03）]，[新生儿败血症（ROR=123.71）]，[自然流产(ROR=5.98)],益康唑[急性肾损伤（ROR=4.41）]，[自然流产(ROR=19.62)]。我们还发现了未报告的新的不良反应。因此,当使用咪唑药物进行治疗时，有必要密切监测患者的肾功能，注意胎儿在怀孕期间的发育毒性，并意识到可能发生的潜在不良反应。
