Clinical analysis of 207 patients who developed renal disorders during or after treatment with edaravone reported during post-marketing surveillance.
Clinical analysis of 207 patients who developed renal disorders during or after treatment with edaravone reported during post-marketing surveillance.
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DOI：
10.1007/s10157-007-0495-2
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发表时间：
2007-12-01
影响因子：
2.3
通讯作者：
Hishida, Akira
中科院分区：
文献类型：
--
作者：
Hishida, Akira
背景：依达拉奉的上市后监测报告了严重的不良反应，包括肾脏和肝脏疾病。肾脏疾病是最常报告的严重/重要不良反应，这导致了依达拉奉对其因果关系、严重程度和肾功能恢复的评估。方法：对207例因依达拉奉治疗而发生肾脏疾病的急性卒中日本患者进行了回顾性分析。结果：在17例患者（8.2%）中，除依达拉奉外，未发现其他特殊因素是肾脏疾病的可能原因。在91.8%的评价患者中，依达拉奉以外的因素与肾脏疾病的发生相关。全身状态严重恶化（例如，严重感染或血压降低）被认为是135例患者（65.2%）在依达拉奉治疗前或治疗期间发生的肾脏疾病的极可能原因。59例患者（28.5%）接受了血液净化治疗（BPT）。在其余148例无BPT的患者中，93例患者（44.9%）随访期间血清肌酐（SCr）峰值水平≥ 3 mg/dl，55例患者（26.6%）低于3 mg/dl。207例患者中，73.3%的患者肾功能为中重度，43%的患者肾功能恢复正常。结论：早期发现肾功能异常，应及时停止依达拉奉治疗，以减少依达拉奉治疗期间严重肾功能异常的发生。应在未来评价依达拉奉在肾脏疾病发病机制中的确切作用。
BACKGROUND: The post-marketing surveillance of edaravone has reported serious adverse reactions, including renal and hepatic disorders. Renal disorders were the most frequently reported serious/important adverse reactions, which led to the evaluation of their causation by edaravone, their severity, and the recovery of renal function.METHODS: A retrospective review was carried out of 207 Japanese patients with acute stroke who developed renal disorders on edaravone treatment.RESULTS: No particular factor other than edaravone was found as a possible cause of the renal disorders in 17 patients (8.2%). In 91.8% of the patients evaluated, factors other than edaravone were associated with the development of renal disorders. Severe deterioration of systemic status (e.g., a severe infection or a decrease in blood pressure) was considered to be a highly probable cause of renal disorders that occurred before or during treatment with edaravone in 135 patients (65.2%). Fifty-nine patients (28.5%) underwent blood purification treatment (BPT). In the remaining 148 patients without BPT, the peak serum creatinine (SCr) level during follow-up was 3 mg/dl or more in 93 patients (44.9%) and less than 3 mg/dl in 55 patients (26.6%). The severity of renal disorders was moderate to severe in 73.3% of the 207 patients, and renal function recovered in 43%.CONCLUSIONS: Appropriate treatment of deteriorated systemic status and the discontinuation of edaravone administration following the early discovery of renal disorders are recommended to reduce the development of severe renal disorders during edaravone treatment. The precise role(s) of edaravone in the pathogenesis of renal disorders should be evaluated in the future.