Howard P A
Department of Pharmacy Practice, University of Kansas Medical Center, Kansas City 66160, USA.
Ann Pharmacother. 1995 Jun;29(6):596-602. doi: 10.1177/106002809502900609.
To discuss the role of amiodarone for the maintenance of normal sinus rhythm in patients with atrial fibrillation (AF) and review the clinical trial data evaluating the efficacy and safety of amiodarone in patients with AF.
A MEDLINE search was used to identify pertinent literature. Additional references were identified from the articles obtained in the search. Key search terms were atrial fibrillation, amiodarone, and sinus rhythm.
All studies available at the time the article was prepared evaluating the efficacy and safety of amiodarone in AF were included. In addition, review articles discussing the role of amiodarone in AF were selected.
No large, prospective, randomized trials have been performed. Data from 8 nonrandomized and 2 randomized trials are reported. Information derived from review articles is discussed.
In patients with AF, maintenance of normal sinus rhythm is desirable to eliminate symptoms, improve functional capacity, and reduce the risk of thromboembolic complications. Class IA agents traditionally have been used; however, concerns about long-term effects on mortality have focused attention on other agents such as amiodarone. A number of nonrandomized, uncontrolled trials have found amiodarone to be effective for maintaining normal sinus rhythm in patients with AF that is refractory to conventional agents. Two randomized, nonblind trials have found amiodarone's efficacy to be equal to or superior to that of class IA drugs. The findings of these trials must be weighed, however, against the significant potential for toxicity and drug interactions associated with amiodarone. Cardiovascular toxicities, including proarrhythmic effects, appear to be relatively rare. In contrast, noncardiovascular effects are common and potentially serious.
Although the preliminary data using amiodarone in AF are encouraging, many questions remain unanswered. Prospective, randomized trials are needed to evaluate the long-term efficacy and safety of amiodarone in patients with AF. Studies also are needed to determine the optimal dosing regimen. Until these data are available, each patient must be evaluated individually, taking into account the relative benefits and risks of therapy. Amiodarone may be particularly useful in patients with significant risks for proarrhythmia and those whose AF is refractory to traditional therapy.
探讨胺碘酮在维持心房颤动（AF）患者正常窦性心律中的作用，并回顾评估胺碘酮在AF患者中疗效和安全性的临床试验数据。
使用MEDLINE检索来识别相关文献。从检索获得的文章中识别出其他参考文献。关键检索词为心房颤动、胺碘酮和窦性心律。
纳入在撰写本文时所有评估胺碘酮在AF中疗效和安全性的现有研究。此外，选择讨论胺碘酮在AF中作用的综述文章。
尚未进行大规模、前瞻性、随机试验。报告了来自8项非随机试验和2项随机试验的数据。讨论了从综述文章中获得的信息。
在AF患者中，维持正常窦性心律有助于消除症状、改善功能状态并降低血栓栓塞并发症的风险。传统上使用IA类药物；然而，对死亡率长期影响的担忧使人们将注意力集中在其他药物如胺碘酮上。一些非随机、无对照试验发现胺碘酮对维持常规药物难治性AF患者的正常窦性心律有效。两项随机、非盲试验发现胺碘酮的疗效等同于或优于IA类药物。然而，这些试验的结果必须与胺碘酮相关的显著毒性和药物相互作用可能性相权衡。心血管毒性，包括促心律失常作用，似乎相对少见。相比之下，非心血管作用常见且可能严重。
尽管使用胺碘酮治疗AF的初步数据令人鼓舞，但许多问题仍未得到解答。需要进行前瞻性、随机试验来评估胺碘酮在AF患者中的长期疗效和安全性。还需要研究确定最佳给药方案。在获得这些数据之前，必须对每位患者进行个体评估，同时考虑治疗的相对益处和风险。胺碘酮在有显著促心律失常风险的患者以及AF对传统治疗难治的患者中可能特别有用。
