| アブストラクト | 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. |
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| ジャーナル名 | Scientific reports |
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| 投稿日 | 2024/6/25 |
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| 投稿者 | Zhou, Tianyu; Chen, Chongze; Chen, Xiaowei; Wang, Bin; Sun, Feng; Li, Wanfang; Liu, Dong; Jin, Hongtao |
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| 組織名 | Department of Pharmacy, Shaanxi University of Chinese Medicine, Xianyang, China.;Key Laboratory of Pharmacodynamics and Material Basis of Chinese Medicine of;Shaanxi Administration of Traditional Chinese Medicine, Xianyang, China.;Engineering Research Center of Brain Health Industry of Chinese Medicine,;Universities of Shaanxi Province, Xianyang, China.;New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy;of Medical Sciences and Peking Union Medical College, Beijing, China.;Department of Pharmacy, Fuzhou Changle People's District Hospital, Fuzhou,;Fujian, China.;Department of Epidemiology and Biostatistics, School of Public Health, Peking;University, Beijing, China.;NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drug,;Beijing, China.;Beijing Union Genius Pharmaceutical Technology Development Co. Ltd, Beijing,;China.;Center for Drug Evaluation, NMPA, Beijing, China. liud@cde.org.cn.;jinhongtao@imm.ac.cn.;Beijing, China. jinhongtao@imm.ac.cn.;China. jinhongtao@imm.ac.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38914572/ |
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