| アブストラクト | BACKGROUND: Acute kidney injury (AKI) is associated with significant increases in short- and long-term morbidity and mortality. Drug-induced AKI is a major concern in the present healthcare system. Our spontaneous reporting system (SRS) analysis assessed links between AKI, along with patients' age, as healthcare-associated risks and administered anti-infectives. We also generated anti-infective-related AKI-onset profiles. METHOD: We calculated reporting odds ratios (RORs) for reports of anti-infective-related AKI (per Medical Dictionary for Regulatory Activities) in the Japanese Adverse Drug Event Report database and evaluated the effect of anti-infective combination therapy. The background factors of cases with anti-infective monotherapy and combination therapy (>/= 2 anti-infectives) were matched using propensity score. We evaluated time-to-onset data and hazard types using the Weibull parameter. RESULTS: Among 534,688 reports (submission period: April 2004-June 2018), there were 21,727 AKI events. The reported number of AKI associated with glycopeptide antibacterials, fluoroquinolones, third-generation cephalosporins, triazole derivatives, and carbapenems were 596, 494, 341, 315, and 313, respectively. Crude RORs of anti-infective-related AKI increased among older patients and were higher in anti-infective combination therapies [anti-infectives, >/= 2; ROR, 1.94 (1.80-2.09)] than in monotherapies [ROR, 1.29 (1.22-1.36)]. After propensity score matching, the adjusted RORs of anti-infective monotherapy and combination therapy (>/= 2 anti-infectives) were 0.67 (0.58-0.77) and 1.49 (1.29-1.71), respectively. Moreover, 48.1% of AKI occurred within 5 days (median, 5.0 days) of anti-infective therapy initiation. CONCLUSION: RORs derived from our new SRS analysis indicate potential AKI risks and number of administered anti-infectives. |
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| ジャーナル名 | BMC pharmacology & toxicology |
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| 投稿日 | 2021/9/1 |
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| 投稿者 | Nakao, Satoshi; Hasegawa, Shiori; Umetsu, Ryogo; Shimada, Kazuyo; Mukai, Ririka; Tanaka, Mizuki; Matsumoto, Kiyoka; Yoshida, Yu; Inoue, Misaki; Satake, Riko; Nishibata, Yuri; Liao, Jun; Nakamura, Mitsuhiro |
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| 組織名 | Laboratory of Drug Informatics, Gifu Pharmaceutical University; Gifu, 1-25-4,;Daigaku-Nishi, Gifu, 501-1196, Japan.;Present Address: Department of Pharmacy, Kyushu University Hospital, Fukuoka,;Japan.;Division of Pharmacy, Kobe City Medical Center General Hospital, Kobe, Hyogo,;Present Address: Micron Inc, Tokyo, Japan.;Present Address: Division of Pharmacy, Japanese Red Cross Wakayama Medical;Center, Wakayama, Japan.;Department of Pharmaceutical Informatics and Biological Statistics, School of;Science, China Pharmaceutical University, Nanjing, China.;Daigaku-Nishi, Gifu, 501-1196, Japan. mnakamura@gifu-pu.ac.jp. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34462002/ |
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