| アブストラクト | INTRODUCTION: Up to 5% of individuals exposed to low-dose methotrexate (MTX) (i.e., </=30mg/week) may develop cytopenia. However, MTX-induced cytopenia have been poorly described. MATERIAL AND METHODS: All cases of cytopenia (i.e., anaemia, leukopenia, thrombocytopenia, bi- or pancytopenia) in patients receiving low-dose MTX reported to the French pharmacovigilance database during 2006-2016 were analysed. Three groups were defined: cytopenia due to MTX medication errors (e.g., daily rather than weekly administration), cytopenia in people receiving several medications including MTX, cytopenia in people receiving only MTX. RESULTS: 433 cases were analysed. Eighty-four cases (19.4%) were due to medication errors, 180 (41.6%) occurred in individuals exposed both to MTX and other drugs, and 169 (39.0%) occurred in individuals only exposed to MTX. By comparison to other patients, those with cytopenia due to medication errors were older (74+/-13 vs 69+/-15years, p=0.002), received more frequently MTX orally (92.9% vs 65.3%, p<0.001) and had more frequently pancytopenia (71.4% vs 54.4%, p=0.005). By comparison to individuals exposed to multiple drugs (n=180), those exposed only to MTX (n=169) were older (71+/-15 vs 67+/-14, p=0.02), and had more often pancytopenia (62.7% vs 46.7%, p=0.001). Among those only exposed to MTX, most cases (n=140, 82.8%) were considered as toxic rather than idiosyncratic reactions and a trigger (e.g. diarrhoea) was found in 59.3% of those cases. Overall 30 (6.9%) deaths occurred, including 8 in the "medication error" group and 8 in the "MTX only" group. CONCLUSION: These data may be useful for defining optimal biological monitoring of patients prescribed low-dose MTX. |
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| ジャーナル名 | European journal of internal medicine |
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| 投稿日 | 2019/7/28 |
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| 投稿者 | Lalevee, Sophie; Lebrun-Vignes, Benedicte; Simon, Corinne; Laugier, Delphine; Fardet, Laurence |
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| 組織名 | Department of Dermatology, Hopital Henri-Mondor, AP-HP, 94000 Creteil, France.;Regional Pharmacovigilance Centre, Hopital Pitie-Salpetriere, AP-HP, 75013 Paris,;France; EA 7379 EpiDermE, Universite Paris Est Creteil, 94000 Creteil, France.;Regional Pharmacovigilance Center Centre Val de Loire, CHRU Tours, 37000 Tours,;France.;Regional Pharmacovigilance Centre of Marseille Provence Corse, Departement of;clinical Pharmacology and Pharmacovigilance, AP-HM, 13000 Marseille, France.;Department of Dermatology, Hopital Henri-Mondor, AP-HP, 94000 Creteil, France; EA;7379 EpiDermE, Universite Paris Est Creteil, 94000 Creteil, France. Electronic;address: laurence.fardet@aphp.fr. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/31350129/ |
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