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首页> 外文期刊>Prescrire international >Dronedarone - Atrial fibrillation: Too many questions about long-term adverse effects
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Dronedarone - Atrial fibrillation: Too many questions about long-term adverse effects

机译:决奈达隆-心房颤动:关于长期不良反应的太多问题

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? In patients with atrial fibrillation, a betablocker is generally used initially to prevent recurrence or to slow the heart rate. Amiodarone is a last resort, mainly because of its numerous adverse effects. ? Dronedarone, chemically similar to amiodarone, was recently authorised for this indication in the European Union. ? In a double-blind trial versus amiodarone in 504 patients, the failure rate was significantly higher with dronedarone (75.1% versus 58.8%). ? Two placebo-controlled trials in heart failure patients yielded conflicting results. Dronedarone was associated with a statistically significant increase in mortality in a trial in 627 symptomatic patients free of arrhythmias. However, there was no statistically significant difference in a trial including 4630 patients with atrial fibrillation and a lower risk of cardiovascular events. ? There are no comparative trials versus other antiarrhythmic drugs or heart-rate-lowering agents, including betablockers and calcium channel blockers. ? Like other antiarrhythmic drugs, dronedarone also has arrhythmogenic effects, including bradycardia and QT prolongation. Other adverse effects include diarrhoea, nausea and vomiting, and cutaneous disorders. Transient elevation of creatinine levels is also frequent, and cases of renal failure have been reported. ? In the trial versus amiodarone, dronedarone had a different pattern of short-term adverse effects, including more gastrointestinal disorders but less frequent thyroid disorders, neurological disorders, hypersensitivity reactions, hypertension, and QT prolongation. Little is known of potential long-term adverse effects, especially pulmonary fibrosis. ? In practice, dronedarone is better tolerated but less effective than amiodarone in the short term. When antiarrhythmic drug therapy is needed, it is better to continue to use a betablocker or, as a last resort, amiodarone, a drug with better-documented adverse effects, especially during long-term treatment.
机译:?对于患有房颤的患者,通常最初会使用β受体阻滞剂来预防复发或减慢心律。胺碘酮是不得已的方法,主要是因为其副作用很多。 ?化学上与胺碘酮相似的决奈达隆,最近在欧盟被批准用于这种适应症。 ?在504例患者中,与胺碘酮进行的双盲试验中,决奈达隆的失败率明显更高(75.1%对58.8%)。 ?两项针对心力衰竭患者的安慰剂对照试验得出了相互矛盾的结果。在627例无心律不齐的有症状患者中,决奈达隆与死亡率的统计显着增加相关。但是,这项试验在包括4630例房颤和心血管事件风险较低的患者中,没有统计学差异。 ?没有与其他抗心律不齐药物或降低心率的药物(包括β受体阻滞剂和钙通道阻滞剂)进行比较的试验。 ?与其他抗心律失常药物一样,决奈达隆也具有心律失常作用,包括心动过缓和QT延长。其他不良反应包括腹泻,恶心和呕吐以及皮肤疾病。肌酐水平的短暂升高也很常见,并且有肾衰竭病例的报道。 ?在与胺碘酮的试验中,决奈达隆具有不同的短期不良反应模式,包括更多的胃肠道疾病,但较少见的甲状腺疾病,神经系统疾病,超敏反应,高血压和QT延长。潜在的长期不良反应,尤其是肺纤维化知之甚少。 ?实际上,决奈达隆在短期内比胺碘酮具有更好的耐受性,但效果较差。当需要抗心律不齐药物治疗时,最好继续使用β受体阻滞剂,或作为最后手段使用胺碘酮,这种药物具有较好的不良作用,尤其是在长期治疗期间。

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