心房颤动患者抗心律失常药物使用及安全性分析

Abstract

目的 了解国内心房颤动患者中抗心律失常药物使用情况并评价其安全性.方法 选取2011年1月至2013年12月中国心房颤动注册研究中曾使用抗心律失常药物治疗的心房颤动患者4 008例,调查胺碘酮、普罗帕酮、索他洛尔和莫雷西嗪的使用情况,对患者进行定期随访,记录停药及不良反应.结果 所有使用抗心律失常药物的心房颤动患者中,2 579例(64.3％)服用胺碘酮,1 247例(31.1％)服用普罗帕酮者,服用索他洛尔和莫雷西嗪者仅有148例(3.7％)和34例(0.8％).服用胺碘酮的患者合并冠心病[13.5％ (348/2 579)比7.4％ (93/1 247),P＜0.001]、非缺血性心肌病[3.1％ (78/2 579)比0.7％(9/1 247),P＜0.001]和心力衰竭[4.0％(102/2 579)比1.4％(17/1 247,P＜0.001]的比例明显高于服用普罗帕酮患者.服用胺碘酮、普罗帕酮、索他洛尔和莫雷西嗪的心房颤动患者随访24个月过程中停药比例分别为28.8％(743/2 579)、25.1％(313/1 247)、14.2％(21/148)和32.4％(11/34).停用胺碘酮的患者中,563例(75.7％)为遵医嘱停药,126例(17.0％)为自行停药,22例(3.0％)因药物无效停药,仅有32例(4.3％)因出现不良反应停药.出现胺碘酮不良反应的患者中,18例(56.3％)为甲状腺功能异常,4例(12.5％)出现心动过缓,2例(6.2％)出现间质性肺炎及肺间质纤维化,消化道反应、皮疹、转氨酶升高等均为散发病例.结论 我国心房颤动患者中胺碘酮和普罗帕酮是使用最多的抗心律失常药物,医生对于抗心律失常药物处方较规范,基本符合指南推荐;抗心律失常药物治疗中也存在很高处方停药率,反映当前心房颤动治疗领域仍然缺乏理想药物.临床试验注册 中国临床试验注册中心,注册号ChiCTR-OCH-13003729.

Objective To investigate the current status of antiarrhythmic drugs (AADs) use in Chinese patients with atrial fibrillation(AF) and assess the safety of AADs in this patient cohort.Methods From January 2011 to December 2013,a total of 4 008 AF patients treated with AADs was enrolled in this study and patients were followed up for 24 months.Detailed information of prescribed drug,the causes of drug discontinuation and side effects were recorded.Results Amiodarone was prescribed to 64.3％ (2 579cases) and propafenone to 31.1％ (1 247 cases) of the enrolled patients,only 148 patients(3.7％) were treated with sotalol and 34 patients (0.8％) were treated with moracizine.The prevalence of heart failure (4.0％ (102/2 579) vs.1.4％ (17/1 247,P ＜0.001),coronary heart disease (13.5％ (348/2 579) vs.7.4％(93/1 247),P＜ 0.001) and non-ischemic cardiomyopathy (3.1％ (78/2 579) vs.0.7％(9/1 247),P＜ 0.001) was significantly higher in patients treated with amiodarone than in the patients treated with propafenone.During the follow-up period,the discontinuation rate of amiodarone,propafenone,sotalol and moracizine was 28.8％ (743/2 579),25.1％ (313/1 247),14.2％ (21/148) and 32.4％(11/34) respectively.The reasons of discontinuing amiodarone were:follow physicians' decision (75.7％,563 cases),no effect (3.0％,22 cases),side effects (4.3％,32 cases) and patients' own decision (17.0％,126 cases).The side effects of amiodarone included thyroid dysfunction (56.3％,18 cases),bradycardia (12.5％,4 cases),interstitial pneumonitis/pulmonary interstitial fibrosis (6.2％,2 cases) and others (gastrointestinal symptom,rash,hepatic dysfunction,etc.).Conclusions Amiodarone and propafenone are the most common AADs used in Chinese patients with atrial fibrillation.The prescription of AADs is essentially in accordance to the guideline of AF treatment.However,the discontinuation rates of AADs are high in Chinese AF patients.Lacking of better AADs is still a major problem in AF pharmacotherapy.Clinical Trial Registry Chinese Clinical Trial Registry,ChiCTR-OCH-13003729.