摘要
目的评价国产伊布利特与普罗帕酮对治疗心房颤动和扑动的有效性及安全性。方法计算机检索CBM(1978～2011.10)、VIP(1989～2011.10)、CNKI(1994～2011.10)和WanFang Data(1998～2011.10),查找所有有关国产伊布利特与普罗帕酮治疗心房颤动和扑动的临床随机对照试验(RCT)。对符合纳入标准的RCT,由两位评价员按Cochrane系统评价的方法,独立进行资料提取、质量评价并交叉核对后,采用RevMan 5.0软件对数据进行Meta分析。结果最终纳入16个研究,1 196例患者。Meta分析结果显示:与普罗帕酮相比,①在疗效方面:国产伊布利特90 min内、4 h及24 h内房颤、房扑总体转复率更高[OR分别为3.32、2.69、3.08,P均<0.0001],亚组分析结果显示90 min内房颤转复率及90 min内房扑转复率也更高,且差异有统计学意义;转复时间方面更短[MD=–25.12,95%CI(–30.43,–19.82),P<0.000 01];②在安全性方面,两者致心律失常发生率差异有统计学意义[OR=3.15,95%CI(1.97,5.05),P<0.000 01];其他不良反应发生率差异亦有统计学意义[OR=0.16,95%CI(0.08,0.33),P<0.000 01]。结论现有临床证据表明,国产伊布利特与普罗帕酮相比,其治疗房颤、房扑可取得较好疗效,能明显提高转复率,缩短转复时间,致心律失常发生较为常见。由于纳入研究方法学质量、样本量所限,该结论尚需大样本、高质量的随机对照试验进一步证实。
Objective To assess the effectiveness and safety of ibutilide and propafenone in the treatment of atrial fibrillation （AF） and atrial flutter （AFL）. Methods All randomized controlled trials （RCTs） on ibutilide and propafenone for AF and AFL were retrieved from databases including CBM （1978 to October 2011）, VIP （1989 to October 2011）, CNKI （1994 to October 2011） and WanFang Data （1998 to October 2011）. The quality of included RCTs was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions Version 4.2.6, and the Cochrane Collaboration＇s software RevMan 5.0 was used for meta-analysis. Results 16 RCTs involving 1 196 patients were included. Results of meta-analysis showed that： a） About effectiveness： compare with propafenone applied as routine therapy, ibutillide was more effective in the total conversion rate of AF and AFL with regards to the time of 0-90 rain, 0-4 hour and 0-24 hour with significant differences （OR=3.32, OR=2.69, OR=3.08, respectively, P〈0.000 1）; In subgroup analysis, a significant difference was found in the conversion rate of AF or AFL in the time of 0N90min. In the time duration for conversion, there was a significant difference （MD=-25.12, 95%CI -30.43 to -19.82, P〈0.000 01）; and b） About the safety： there was a significant difference between the two groups in the incidence of cardiac arrhythmia （OR=3,15, 95%CI 1.97 to 5.05, P〈0.000 01） and other adverse effects （OR=0.16, 95%CI 0.08 to 0.33, P〈0.000 01）. Conclusion Current evidence shows that ibutilide is more effective than propafenone in converting AF or AFL, with a higher incidence of cardiac arrhythmia than propafenone. However, more high-quality, large-scale RCTs are still needed to confirm the effectiveness and safety of ibutilide and propafenone for AF/AFL because of the limitation of the methodological quality and sample size of the included studies.
出处
《中国循证医学杂志》
CSCD
2012年第7期770-776,共7页
Chinese Journal of Evidence-based Medicine
作者简介
秦静，女（1972年-），硕士，副主任医师，主要从事急危重病的临床和基础研究。E-mail：icuqinjing@163．com
通讯作者，E-mail：malill05@126．com
