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Fingolimod: contraindicated in patients with a history of cardiovascular disease

机译:Fingolimod:患有心血管疾病史的患者禁忌

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Fingolimods an orally administered immuno-suppressant, approved for use in adults with multiple sclerosis. In this situation, the first-line treatment is an injectable beta interferon, in the absence of anything better. The harm-benefit balance of other "disease-modifying" drugs is no better, and can even be worse, than that of beta interferon (1). Cardiac adverse effects of fingolimod such as dose-dependent brachycardia were already identified in clinical trials performed before marketing authorisation. Subsequently, cardiovascular deaths (sudden death, myocardial infarction or cardiac rhythm disorders) have been reported (2,3). At the end of 2017, fingolimod became contra-indicated in patients having had, during the previous 6 months, a myocardial infarct, unstable angina, stroke, a transient ischaemic attack, decompensated or class III/IV heart failure, and in patients with cardiac arrhythmia, with 2nd or 3rd degree atrioventricular block, or having a QT interval on the electrocardiogram greater than or equal to 500 msec. This measure was taken following an analysis by the European Pharma-covigilance Risk Assessment Committee (PRAC) of 48 cases of ventricular arrhythmias attributable to fingolimod, of which 9 were fatal. The 9 patients who died all had a history of heart disease (4,5).
机译:Fingolimod批准用于具有多发性硬化的成年人的口服施用免疫抑制剂。在这种情况下,第一线治疗是一种可注射的β干扰素,在没有更好的情况下的情况下。其他“疾病修饰”药物的危害效益平衡并不更好,并且甚至可能比β干扰素(1)更差。在营销授权前进行的临床试验中已经鉴定了Fingolimod如剂量依赖性血糖卡的心脏不良影响。随后,已经报道了心血管死亡(猝死,心肌梗死或心脏节律疾病)(2,3)。截至2017年底,佛教莫德在前6个月,心肌梗塞,不稳定的心绞痛,中风,短暂性缺血性攻击,失代偿或III级/ III型心力衰竭中,对患者进行了矛盾的患者,并在心脏病患者中表明心律失常,具有第二或第3度的房室间块,或者在电磁图上具有Qt间隔,大于或等于500毫秒。在欧洲药物 - 社会风险评估委员会(PRAC)的分析后48例归因于Fingolimod的心间心律失常的分析,其中9例是致命的。所有死亡的9例患者都有心脏病历史(4,5)。

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    《Prescrire international》 |2018年第195期|共1页
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  • 中图分类 药学;
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