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首页> 外文期刊>The American Journal of Cardiology >Bretylium, a Class III Antiarrhythmic, Returns to the Market
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Bretylium, a Class III Antiarrhythmic, Returns to the Market

机译:Bretylium,III类抗真瘤,返回市场

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摘要

Bretylium, with an extensive pharmacologic and medicinal history, was approved by the United States Food and Drug Administration in 1986 for "short-term prevention and treatment of ventricular fibrillation (VF) and treatment of life-threatening ventricular arrhythmias and ventricular tachycardia (VT) unresponsive to adequate doses of a first-line antiarrhythmic agent, such as lidocaine." The NDA sponsor withdrew bretylium from the market in 2011, largely due to unavailability of raw materials required for its production; prior to this, bretylium was removed from the 2000 ACLS Guidelines algorithm for VF/ pulseless VT given the challenges obtaining raw materials for drug manufacture. Recently, bretylium has been reintroduced into the US market by a generic pharmaceutical company with the same indications as before. This article provides a history of the salient trials evaluating the efficacy and safety of bretylium and looks to the future as bretylium finds its place in the modern day management of ventricular arrhythmia. (c) 2020 Elsevier Inc. All rights reserved.
机译:Bretylium具有广泛的药理学和医学历史,1986年被美国食品和药物管理局批准用于“短期预防和治疗室颤(VF),以及治疗对足够剂量的一线抗心律失常剂(如利多卡因)无反应的危及生命的室性心律失常和室性心动过速(VT)”NDA赞助商于2011年从市场上撤回了布雷季铵,主要原因是其生产所需的原材料不可用;在此之前,鉴于获取药物生产原料的挑战,bretylium已从2000年ACLS指南VF/无脉冲VT算法中删除。最近,一家仿制药公司以与以前相同的适应症将布雷季铵重新引入美国市场。这篇文章提供了一个历史的显着试验评估的有效性和安全性,并展望了未来,因为布雷替林找到了在现代室性心律失常管理的位置。(c) 2020爱思唯尔公司版权所有。

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