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氟吡汀的滥用倾向:自发呈报的药物不良反应的意义。

Abuse liability of flupirtine revisited: implications of spontaneous reports of adverse drug reactions.

机构信息

Department of Psychiatry and Psychotherapy III, University Hospital of Ulm, Ulm, Germany.

出版信息

J Clin Pharmacol. 2013 Dec;53(12):1328-33. doi: 10.1002/jcph.164. Epub 2013 Sep 17.

DOI:10.1002/jcph.164
PMID:24037995
Abstract

Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP's agonistic effects at the GABAA receptor might prime addictive behaviors, and literature provides some anecdotal reports on FLP abuse/dependence. To shed more light on this topic we acquired and evaluated data obtained from a national German pharmacovigilance database. We analyzed all reports of FLP abuse/dependence that were recorded in the database of the German Federal Institute for Drugs and Medical Devices (BfArM). A total of n = 48 reports of FLP abuse/dependence could be identified (mean age 45 years, 62.5% female). First reports were submitted to BfArM in 1991 with increasing numbers of annual reports from the year 2006 on. Mean daily FLP dosage was 805 mg (range 200-3,000 mg). Current or previous substance abuse/dependence was reported in 21% and 17%, respectively. Mean duration of FLP abuse/dependence until report to BfArM was 23 months (range 1-84 months). Withdrawal syndromes after discontinuation of FLP were reported in n = 9 (19%). Our findings strengthen the hypothesis that FLP features a potential to cause addictive behaviors. Female sex, age >40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence.

摘要

早期研究表明,中枢作用的非阿片类和非甾体类镇痛药氟吡汀(FLP)没有滥用的潜力。然而,FLP 对 GABA A 受体的激动作用可能会引发成瘾行为,并且文献中提供了一些关于 FLP 滥用/依赖的轶事报道。为了更深入地了解这个问题,我们获取并评估了来自德国国家药物警戒数据库的数据。我们分析了数据库中记录的所有 FLP 滥用/依赖报告,该数据库由德国联邦药物和医疗器械研究所(BfArM)管理。共确定了 n = 48 例 FLP 滥用/依赖报告(平均年龄 45 岁,女性占 62.5%)。第一份报告于 1991 年提交给 BfArM,自 2006 年以来,每年的报告数量呈递增趋势。平均每日 FLP 剂量为 805mg(范围 200-3000mg)。分别有 21%和 17%的报告称存在当前或以前的物质滥用/依赖。从开始滥用 FLP 到向 BfArM 报告的平均时间为 23 个月(范围 1-84 个月)。在停止使用 FLP 后,有 n = 9(19%)报告出现戒断综合征。我们的发现进一步证实了 FLP 具有引发成瘾行为的潜力这一假设。女性、年龄 >40 岁和长期 FLP 治疗可能是 FLP 滥用/依赖发展的潜在风险因素。

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