摘要
目的评价静脉注射伊布利特与普罗帕酮转复持续时间<90d的心房颤动(房颤)、心房扑动(房扑)的有效性及安全性。方法本研究为前瞻性随机单盲对照研究。2003年9月至2004年7月,5个研究中心共入选符合入组条件的患者212例,随机进入普罗帕酮组和伊布利特组。伊布利特组107例,其中房颤75例,房扑32例;普罗帕酮组105例,其中房颤76例,房扑29例。两组分别在持续心电、血压监测下于10min内静脉推注伊布利特1mg或普罗帕酮70mg,如给药结束10min后仍未转复为窦性心律,重复前述治疗1次。观察开始给药后1·5h内房颤/房扑的转复率及4h内不良反应的发生情况。结果(1)伊布利特组房扑的转复率明显高于普罗帕酮组(78·1%vs.48·3%,P<0·05);而房颤的转复率两组比较,差异无统计学意义(54·7%vs.39·5%,P>0·05)。两组房颤和房扑总转复率的差异有统计学意义(伊布利特组和普罗帕酮组分别为61·7%和41·9%,P<0·05)。(2)两组平均转复时间相比,差异无统计学意义(P>0·05)。(3)房颤/房扑持续48h之内者,两组间转复率差异无统计学意义;而房颤/房扑持续3d以上者两组间转复率比较,差异有统计学意义(P<0·05)。(4)伊布利特的主要不良反应为短阵室性心动过速(5例,4·7%)、连发室性过早搏动(4例,3·7%)和一度房室阻滞(1例,0·9%)。普罗帕酮的主要不良反应为交界性心律与低血压(2例,1·9%)、恶心与呕吐(2例,1·9%)。普罗帕酮组发生1例与试验药物无关的严重不良事件。结论与普罗帕酮比较,伊布利特对房扑的转复有明显的优势。房颤/房扑持续3d以上者(<90d)应用伊布利特的转复率明显高于普罗帕酮。两药的不良反应一般无需特殊处理。
Objective To compare the efficacy and safety of ibutilide versus propafenone in immediate cardioversion of atrial fibrillation (AF) and atrial flutter (AFL) lasted less than 90 days. Methods 212 consecutive patients suffering from AF or AFL all lasting less than 90 days that were diagnosed and treated in 5 medical centers were randomly assigned into two groups: ibutilide group (n=107, including 75 AF cases and 32 AFL cases, receiving intravenous injection of ibutilide 1mg over 10 minutes) and propafenone group as control group (n=105, including 76 AF cases and 29 AFL cases, receiving intravenous injection of propafenone 70 mg over 10 minutes). If AF/AFL still persisted 10 minutes after treatment, the above dose was repeated. The conversion rate within 1.5 hours and adverse effects within 4 hours were observed. Results (1) The conversion rate on AFL of the ibutilide group was 78.1%, significantly higher than that of the propafenone group (48.3%,P<0.01), while no significant difference was observed in the conversion rate on AF(54.7% vs. 39.5%,P>0.05)and the mean conversion time (P>0.05). However the overall conversion rate on AFL and AF of the ibutilide group was 61.7%, significantly higher than that of the propafenone group (41.9%,P<0.05). (2) The conversion rate on AF/AFL lasing less than 48 h was 65.9% in the ibutilide group, not significantly different from that of the propafenone group (55.7%), the conversion rate on AF/AFL lasing 3～30 d in the ibutilide group was 66.7%, significantly higher than that of the propafenone group (26.3%, P<0.05), and the conversion rate on AF/AFL lasing 31～88 d was 50%, significantly higher than that of the propafenone group (0, P<0.01). (3) There was no differe4nce in the times needed for conversion between these 2 groups.(4)The most severe adverse effect in the ibutilide group was short run of ventricular tachycardia occurring in 5 cases among which 4 cases recovered simultaneously and one case recovered after accepting a bolus dose of 100 mg lidocaine. The most severe adver
出处
《中华医学杂志》
CAS
CSCD
北大核心
2005年第12期798-801,共4页
National Medical Journal of China
