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从品牌别嘌醇转换为通用别嘌醇期间缺乏疗效。

Lack of efficacy during the switch from brand to generic allopurinol.

作者信息

De Vuono Antonio, Scicchitano Francesca, Palleria Caterina, Russo Emilio, De Sarro Giovambattista, Gallelli Luca

机构信息

ASP Cosenza, Italy.

出版信息

J Forensic Leg Med. 2013 Jul;20(5):540-2. doi: 10.1016/j.jflm.2013.02.007. Epub 2013 Mar 7.

DOI:10.1016/j.jflm.2013.02.007
PMID:23756530
Abstract

We report for the first time the lack of therapeutic effects after the switch from a brand formulation of allopurinol to a generic one. A 56-year-old man, with a 5 years history of well-treated gout arthropathy with allopurinol (Zyloric(®) 300 mg/die), developed acute gout arthropathy after the switch from the brand formulation of allopurinol to a generic one. Clinical evaluation and laboratory findings confirmed the diagnosis of acute gout arthropathy. Generic formulation of the drug was dismissed and Zyloric(®) was administered with an improvement of both clinical symptoms and laboratory findings. In conclusion, even if generic formulations are considered to have the same effects in comparison to the brand one, more data are necessaries in order to well define their effectiveness and rationale use.

摘要

我们首次报告了从别嘌醇品牌制剂转换为通用制剂后缺乏治疗效果的情况。一名56岁男性,有5年使用别嘌醇(Zyloric®,300毫克/天)治疗痛风性关节炎的良好病史,在从别嘌醇品牌制剂转换为通用制剂后出现了急性痛风性关节炎。临床评估和实验室检查结果证实了急性痛风性关节炎的诊断。停用该药物的通用制剂并给予Zyloric®后,临床症状和实验室检查结果均有所改善。总之,即使通用制剂被认为与品牌制剂具有相同的效果,但仍需要更多数据来明确其有效性和合理使用方法。

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Lack of efficacy during the switch from brand to generic allopurinol.从品牌别嘌醇转换为通用别嘌醇期间缺乏疗效。
J Forensic Leg Med. 2013 Jul;20(5):540-2. doi: 10.1016/j.jflm.2013.02.007. Epub 2013 Mar 7.
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Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial.非布司他与别嘌醇及安慰剂对高尿酸血症和痛风患者降低血清尿酸的作用:一项为期28周的III期随机双盲平行组试验。
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Payer decision-making with limited comparative and cost effectiveness data: the case of new pharmacological treatments for gout.在比较和成本效益数据有限的情况下支付方的决策:以痛风的新药理学治疗为例
Evid Based Med. 2012 Aug;17(4):105-8. doi: 10.1136/ebmed-2011-100065. Epub 2012 Feb 18.

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