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胺碘酮的处方开具:基于证据的临床适应证综述

Prescribing amiodarone: an evidence-based review of clinical indications.

作者信息

Vassallo Patricia, Trohman Richard G

机构信息

Department of Medicine, Section of Cardiology, Electrophysiology, Arrhythmia, and Pacemaker Service, Rush University Medical Center, Chicago, Illinois 60612, USA.

出版信息

JAMA. 2007 Sep 19;298(11):1312-22. doi: 10.1001/jama.298.11.1312.

Abstract

CONTEXT

Although amiodarone is approved by the US Food and Drug Administration only for refractory ventricular arrhythmias, it is one of the most frequently prescribed antiarrhythmic medications in the United States.

OBJECTIVE

To evaluate and synthesize evidence regarding optimal use of amiodarone for various arrhythmias.

EVIDENCE ACQUISITION

Systematic search of MEDLINE to identify peer-reviewed clinical trials, randomized controlled trials, meta-analyses, and other studies with clinical pertinence. The search was limited to human-participant, English-language reports published between 1970 and 2007. Amiodarone was searched using the terms adverse effects, atrial fibrillation, atrial flutter, congestive heart failure, electrical storm, hypertrophic cardiomyopathy, implantable cardioverter-defibrillator, surgery, ventricular arrhythmia, ventricular fibrillation, and Wolff-Parkinson-White. Bibliographies of identified articles and guidelines from official societies were reviewed for additional references. Ninety-two identified studies met inclusion criteria and were included in the review.

EVIDENCE SYNTHESIS

Amiodarone may have clinical value in patients with left ventricular dysfunction and heart failure as first-line treatment for atrial fibrillation, though other agents are available. Amiodarone is useful in acute management of sustained ventricular tachyarrythmias, regardless of hemodynamic stability. The only role for prophylactic amiodarone is in the perioperative period of cardiac surgery. Amiodarone may be effective as an adjunct to implantable cardioverter-defibrillator therapy to reduce number of shocks. However, amiodarone has a number of serious adverse effects, including corneal microdeposits (>90%), optic neuropathy/neuritis (< or =1%-2%), blue-gray skin discoloration (4%-9%), photosensitivity (25%-75%), hypothyroidism (6%), hyperthyroidism (0.9%-2%), pulmonary toxicity (1%-17%), peripheral neuropathy (0.3% annually), and hepatotoxicity (elevated enzyme levels, 15%-30%; hepatitis and cirrhosis, <3% [0.6% annually]).

CONCLUSION

Amiodarone should be used with close follow-up in patients who are likely to derive the most benefit, namely those with atrial fibrillation and left ventricular dysfunction, those with acute sustained ventricular arrhythmias, those about to undergo cardiac surgery, and those with implantable cardioverter-defibrillators and symptomatic shocks.

摘要

背景

尽管胺碘酮仅被美国食品药品监督管理局批准用于治疗难治性室性心律失常,但它却是美国最常被处方的抗心律失常药物之一。

目的

评估并综合有关胺碘酮在各种心律失常中最佳应用的证据。

证据收集

系统检索MEDLINE以识别同行评审的临床试验、随机对照试验、荟萃分析及其他具有临床相关性的研究。检索限于1970年至2007年间发表的以人为参与者的英文报告。使用不良反应、心房颤动、心房扑动、充血性心力衰竭、电风暴、肥厚型心肌病、植入式心脏复律除颤器、手术、室性心律失常、心室颤动以及预激综合征等术语检索胺碘酮。对已识别文章的参考文献目录以及官方学会的指南进行审查以获取更多参考文献。92项已识别研究符合纳入标准并被纳入本综述。

证据综合

对于左心室功能不全和心力衰竭患者,胺碘酮作为心房颤动的一线治疗可能具有临床价值,尽管还有其他药物可用。胺碘酮在持续性室性快速心律失常的急性处理中有用,无论其血流动力学是否稳定。预防性使用胺碘酮的唯一作用是在心脏手术的围手术期。胺碘酮作为植入式心脏复律除颤器治疗的辅助手段可能有效,可减少电击次数。然而,胺碘酮有许多严重不良反应,包括角膜微沉积(>90%)、视神经病变/神经炎(≤1%至2%)、蓝灰色皮肤变色(4%至9%)、光敏反应(25%至75%)、甲状腺功能减退(6%)、甲状腺功能亢进(0.9%至2%)、肺毒性(1%至17%)、周围神经病变(每年0.3%)以及肝毒性(酶水平升高,15%至30%;肝炎和肝硬化,<3%[每年0.6%])。

结论

对于可能从中获益最大的患者,即患有心房颤动和左心室功能不全的患者、患有急性持续性室性心律失常的患者、即将接受心脏手术的患者以及患有植入式心脏复律除颤器且有症状性电击的患者,应在密切随访下使用胺碘酮。

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