| アブストラクト | BACKGROUND: Progressive multifocal leukoencephalopathy (PML) has been reported as the development of drugs with immunomodulatory properties, such as anticancer, immunosuppressive, and biological agents, has accelerated. To clarify an incidence profile of drug-associated PML in real-world clinical practice, we analyzed reported patients with PML using the Japanese Adverse Drug Event Report (JADER) database. METHODS: We analyzed PML reports extracted from the JADER database based on the preferred term of "progressive multifocal leukoencephalopathy" from between 2004 and 2021. This was a retrospective, observational study. We evaluated the effects of causative drugs, underlying diseases, and the age of the patients on the annual number of PML reports. RESULTS: The JADER database contained 773,966 reports published between April 2004 and March 2022, from which we identified 361 PML events. These PML events may include multiple counts of the same case reported by different pathways and patients diagnosed with probable or possible PML. The number of PML reports and reporting ratios have gradually increased over the past decade. The annual number of PML reports associated with biologics, immunosuppressants, and antineoplastic drugs showed an increasing trend. Females aged >/=30 years showed an increase in PML reports; in contrast, there the number of reports for males aged >/=50 years increased. CONCLUSIONS: The number of PML reports and reporting ratios have gradually increased in the past decade in Japan, and it considered that it was related to change in the treatment of malignancies and autoimmune diseases, and the increasing use of biologics, immunosuppressive agents, and antineoplastic agents. |
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| ジャーナル名 | Journal of the neurological sciences |
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| 投稿日 | 2023/11/21 |
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| 投稿者 | Sakurai, Shuji; Maezawa, Mika; Nakao, Satoshi; Hirofuji, Sakiko; Miyasaka, Koumi; Yamashita, Moe; Matsui, Kensuke; Nishida, Shohei; Kobayashi, Ryo; Iguchi, Kazuhiro; Hayashi, Yuichi; Suzuki, Akio; Nakamura, Mitsuhiro |
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| 組織名 | Department of Pharmacy, Gifu University Hospital, Gifu, Japan.;Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.;Department of Pharmacy, Gifu University Hospital, Gifu, Japan; Laboratory of;Advanced Medical Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.;Laboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.;Department of Pharmacy, Gifu University Hospital, Gifu, Japan; Faculty of Nursing;Science, Tsuruga Nursing University, Fukui, Japan.;Electronic address: mnakamura@gifu-pu.ac.jp. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37984106/ |
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