Drug-induced tubulointerstitial nephritis in a retrospective study using spontaneous reporting system database.
Drug-induced tubulointerstitial nephritis in a retrospective study using spontaneous reporting system database.
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DOI：
10.2147/tcrm.s168696
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发表时间：
2018
影响因子：
2.8
通讯作者：
Iwanaga K
中科院分区：
文献类型：
--
作者：
Oyama S;Hosohata K;Inada A;Niinomi I;Mori Y;Yamaguchi Y;Uchida M;Iwanaga K
肾小管间质性肾炎（TIN）是一个问题，在临床设置，因为药物治疗是在大多数情况下的原因。患者通常会出现非特异性症状，这可能会导致疾病诊断和治疗的延误。本研究的目的是使用自发报告系统数据库阐明TIN与致病药物相关性的排序。数据摘自日本药品和医疗器械管理局（日本）的日本药物不良事件报告数据库。基于5，195，890份所有不良反应报告，我们获得了3，088份由所有药物引起的TIN报告，并计算了TIN的报告比值比（ROR）和95%CI。ROR最高的5种药物是格列齐特（ROR，30.5; 95% CI，17.4-53.2），甲苯磺酸妥舒沙星水合物（ROR，29.5; 95% CI，21.3-41.0），哌拉西林-他唑巴坦（ROR，24.3; 95%CI，19.4-30.5）、头孢特仑酯（ROR，23.5; 95%CI，12.5-44.2）和甲芬那酸（ROR，22.5; 95%CI，13.4-37.7）。药物诱导的TIN未观察到性别相关差异。大多数关于使用罪魁祸首药物后发生TIN的报告都是在12周内记录的。基于结果，使用药物警戒数据库进行的综合研究使我们能够确定最常诱发TIN的药物，因此在临床实践中应谨慎使用这些药物以避免TIN。
Tubulointerstitial nephritis (TIN) is a problem in clinical settings because drug therapy is the cause in most cases. Patients often present with nonspecific symptoms, which can lead to delays in the diagnosis and treatment of the disease. The purpose of this study was to clarify the rank-order of the association of TIN with the causative drugs using a spontaneous reporting system database. Data were extracted from the Japanese Adverse Drug Event Report database of the Pharmaceuticals and Medical Devices Agency (Japan). Based on 5,195,890 reports of all adverse reactions, we obtained 3,088 reports of TIN caused by all drugs and calculated the reporting odds ratio (ROR) and 95% CI for TIN. The 5 drugs with the highest RORs were gliclazide (ROR, 30.5; 95% CI, 17.4–53.2), tosufloxacin tosilate hydrate (ROR, 29.5; 95% CI, 21.3–41.0), piperacillin–tazobactam (ROR, 24.3; 95% CI, 19.4–30.5), cefteram pivoxil (ROR, 23.5; 95% CI, 12.5–44.2), and mefenamic acid (ROR, 22.5; 95% CI, 13.4–37.7). No sex-related difference was observed in drug-induced TIN. Most of the reports about TIN onset following the administration of culprit drugs were recorded within 12 weeks. Based on the results, a comprehensive study using a pharmacovigilance database enabled us to identify the dugs that most frequently induced TIN, so these drugs should be used carefully in clinical practice to avoid TIN.