盐酸安他唑啉片治疗室性早搏的随机、双盲、阳性药对照研究  

Therapeutic Effect of Hydrochloride Antazoline for Premature Ventricular Contraction in Patients with Normal Structure Heart:a Single Center,Double-blind,Controlled,Randomized Trial

作　　者：王靖[1] 楚建民[1] 贾玉和[1] 毛克修[1] 陈旭华[1] 陶燕[2] 华伟[1] 张澍[1] 

机构地区：[1]中国医学科学院北京协和医学院阜外心血管病医院心律失常诊治中心,北京100037 [2]北京核工业医院内科,北京100822

出　　处：《中国分子心脏病学杂志》2010年第5期281-284,共4页Molecular Cardiology of China

摘　　要：目的治疗无明显器质性心脏病室性期前收缩(室早)的意义目前尚不清楚,但因室早引发的一系列症状在临床上很常见,此时减少早搏数量成为改善患者生活质量的主要治疗方法。盐酸安他唑啉(安他唑啉)是一种治疗多种心律失常的药物,本研究目的就是观察安他唑啉治疗无明显器质性心脏病患者的安全性与有效性。方法本研究为双盲、随机、阳性药对照研究,对照药物为稳心颗粒。在2009年11月至2010年4月期间入选60例不伴有明显器质性心脏病的室早患者,停用其他抗心律失常药2周后随机分为安他唑啉治疗组和稳心颗粒治疗组。服药治疗第2周进行随访记录不良反应等临床资料,满4周后复查Holter。疗效结果为对比治疗前后24小时室早的数目,安全性指标为治疗前后患者生化检查结果。结果共入选72例患者,男性37例(51.39%),平均年龄(45.06±12.33)岁,实际完成随访67例(研究组34例)。两组间基本临床资料匹配。研究组与对照组服药治疗4周后24小时室早数目均有明显降低,分别为70.11%和67.80%,两组间没有统计学差异(P=0.35)。研究组有88.24%(30/34)的患者24小时室早减少超过75%,对照组为78.79%(26/33),但两组间没有统计学差别(P=0.61)。两组均没有出现严重的不良反应。结论安他唑啉在临床上治疗一些不合并严重心脏疾病的室早具有较好的有效性和较高的安全性。Objective To examine the clinical efficacy and safety of hydrochloride antazoline（antazoline） for premature ventricular contraction（PVC） in patients with normal structure heart.Methods Anticipating 60 patients participated in this single center,double-blind,controlled,and randomized trial from Nov.2009 to Apr.2010.Buchangwenxin granule（wenxin） was selected as control-agent.Patients were divided into 2 groups equally after a wash-out period of two weeks.Antazoline group was given antazoline 0.1 gram three times a day,and wenxin group was given wenxin 9 gram three times a day for at least 28 days.The study compared the results of chemical examination and the number of PVC recorded by holter before and after taking medicines.Results Total 72 patients were recruited（male 51.39%,n=37）,and 67 patients fulfilled follow-up were analyzed at last.The baseline clinical data were matched between the 2 groups.After the treatment,the number of PVCs decreased dramatically in antazoline group and wenxin group,70.11% and 67.80% respectively.But there is no difference between the 2 groups,P =0.35.Effective rate of antazoline group and wenxin group were 88.24% and 78.79%,P=0.61.There are not severe side effects in both 2 groups.Conclusion Antazoline is an effective and safe antiarrhythmia agent for PVC in the patients with normal structure heart.

关 键 词：盐酸安他唑啉 室性期前收缩 有效性 安全性 

分 类 号：R541.7[医药卫生—心血管疾病]