Real-world safety and effectiveness of intravenous fomepizole in patients with ethylene glycol and methanol poisoning in Japan: results of a 7-year post-marketing surveillance study.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-22 DOI:10.1080/14740338.2024.2372410
Toshiharu Yoshioka, Momoha Koyanagi, Naoki Yoshida
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引用次数: 0

Abstract

Background: Fomepizole is a competitive alcohol dehydrogenase inhibitor used for the treatment of ethylene glycol and methanol poisoning. We evaluated the safety and effectiveness of fomepizole in patients with ethylene glycol or methanol poisoning in Japan.

Research design and methods: This retrospective post-marketing surveillance study conducted in Japan registered patients who received fomepizole intravenous infusion per the package insert (January 2015-June 2022). Endpoints included adverse drug reactions/infections (ADRs), arterial blood pH, and treatment outcomes.

Results: Of 147 patients registered (91 institutions), 131 and 126 were included in the safety and effectiveness analysis sets, respectively. Mean age was 43.6 years, and 66.4% were male. Mean time from poison ingestion to treatment was 15.1 hours; 66.4% received concomitant hemodialysis. No serious ADRs were reported. ADRs were reported in seven patients; the most-reported ADR was vomiting (2.3%). Seven patients died, 105 survived without sequelae, and 19 survived with sequelae. Most common sequelae were renal failure or renal dysfunction. Mean arterial blood pH increased to 7.4 by 4 hours of treatment, remaining stable for 24 hours post-treatment.

Conclusions: Fomepizole is well tolerated and helps improve clinical outcomes in patients with ethylene glycol or methanol poisoning in Japan.

Trial registration: Japanese Pharmaceutical Information Center (JapicCTI-152817).

日本乙二醇和甲醇中毒患者静脉注射福美匹唑的实际安全性和有效性:上市后 7 年监测研究的结果。
背景:福美匹唑是一种竞争性乙醇脱氢酶抑制剂,用于治疗乙二醇和甲醇中毒。我们评估了福美匹唑在日本乙二醇或甲醇中毒患者中的安全性和有效性:这项在日本开展的回顾性上市后监测研究登记了根据包装说明书接受福美匹唑静脉注射的患者(2015年1月至2022年6月)。终点包括药物不良反应/感染(ADR)、动脉血pH值和治疗结果:在注册的 147 名患者(91 家机构)中,分别有 131 名和 126 名患者被纳入安全性和有效性分析集。平均年龄为 43.6 岁,66.4% 为男性。从中毒到接受治疗的平均时间为 15.1 小时;66.4% 的患者同时接受了血液透析。无严重不良反应报告。有 7 名患者报告了不良反应;报告最多的不良反应是呕吐(2.3%)。7 名患者死亡,105 名患者存活下来但没有后遗症,19 名患者存活下来但有后遗症。最常见的后遗症是肾衰竭或肾功能障碍。平均动脉血pH值在治疗4小时后升至7.4,并在治疗后24小时内保持稳定:结论:日本乙二醇或甲醇中毒患者对福美唑的耐受性良好,有助于改善临床疗效:试验注册:日本药品信息中心(JapicCTI-152817)。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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