Surveillance of drugs that most frequently induce acute kidney injury: A pharmacovigilance approach
Surveillance of drugs that most frequently induce acute kidney injury: A pharmacovigilance approach
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DOI：
10.1111/jcpt.12748
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发表时间：
2019-02-01
影响因子：
2
通讯作者：
Iwanaga, Kazunori
中科院分区：
文献类型：
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作者：
Hosohata, Keiko;Inada, Ayaka;Iwanaga, Kazunori
急性肾损伤（Acute kidney injury，阿基）是一种常见于住院患者的疾病，在世界范围内日益严重。最近，临床研究表明，药物诱导的阿基与不良结局（包括慢性肾脏疾病和终末期肾脏疾病的进展）之间存在很强的相关性;然而，关于药物诱导的阿基的数据有限。本研究的目的是使用自发报告系统数据库阐明所有药物与阿基相关性的排序。方法我们使用日本药物不良事件报告（JADER）数据库进行了回顾性药物警戒分析。分析了2004年4月至2017年1月期间提交给药品和医疗器械管理局的不良事件报告。结果和讨论基于5 195 890份所有不良事件的报告，我们获得了12 964份由所有药物引起的阿基报告，并计算了阿基的报告比值比（ROR）和95%置信区间（CI）。最常报告的药物是盐酸伐昔洛韦（ROR，24.88; 95% CI：23.1-26.8），艾地骨化醇（ROR，14.23; 95% CI，11.68-17.33），依达拉奉（ROR，14.03; 95% CI，11.76-16.75），阿昔洛韦（ROR，11.17; 95%CI，9.55-13.1）、哌拉西林-他唑巴坦（ROR，9.23; 95%CI，7.72-11.0）和螺内酯（ROR，7.36; 95%CI，6.12-8.86）。新内容和结论一项使用药物警戒数据库的综合研究使我们能够确定最常诱发阿基的药物，提高医生对潜在肾功能下降患者使用药物的认识。
What is known and objective Acute kidney injury (AKI) often occurs in hospitalized patients, and it is an increasing problem worldwide. Recently, clinical studies have shown that there is a strong association between drug-induced AKI and poor outcomes, including the progression of chronic kidney disease and end-stage renal disease; however, limited data are available on drug-induced AKI. The purpose of this study was to clarify the rank-order of the association of all drugs with AKI using a spontaneous reporting system database. Methods We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report (JADER) database. Adverse event reports submitted to Pharmaceuticals and Medical Devices Agency between April 2004 and January 2017 were analysed. Results and discussion Based on 5 195 890 reports of all adverse events, we obtained 12 964 reports of AKI caused by all drugs and calculated the reporting odds ratio (ROR) and 95% confidence interval (CI) for AKI. The most frequently reported drugs were valaciclovir hydrochloride (ROR, 24.88; 95% CI: 23.1-26.8), eldecalcitol (ROR, 14.23; 95% CI, 11.68-17.33), edaravone (ROR, 14.03; 95% CI, 11.76-16.75), acyclovir (ROR, 11.17; 95% CI, 9.55-13.1), piperacillin-tazobactam (ROR, 9.23; 95% CI, 7.72-11.0), and spironolactone (ROR, 7.36; 95% CI, 6.12-8.86). What is new and conclusion A comprehensive study using a pharmacovigilance database enabled us to identify the drugs that most frequently induce AKI, raising physicians' awareness of the drugs in use for patients with potentially decreased renal function.