海南医学
海南醫學
해남의학
HAINAN MEDICAL JOURNAL
2014年
16期
2458-2462,2463
,共6页
郭宗文%王丹丹%王徐乐%黄从新
郭宗文%王丹丹%王徐樂%黃從新
곽종문%왕단단%왕서악%황종신
决奈达隆%心房颤动%心房扑动%Meta分析%随机对照试验
決奈達隆%心房顫動%心房撲動%Meta分析%隨機對照試驗
결내체륭%심방전동%심방복동%Meta분석%수궤대조시험
Dronedarone%Atrial fibrillation%Atrial flutter%Meta-analysis%Randomized controlled trial
目的：评价决奈达隆治疗心房颤动、心房扑动的疗效及安全性。方法计算机检索PubMed、Embase、the Cochrane Collaboration Database，查找建库至2014年2月28日期间发表的所有关于决奈达隆治疗房颤、房扑的英文随机对照试验(RCT)。由两位研究者按照纳入排除标准进行文献筛选、资料提取和方法学质量评价后，采用RevMan 5.2软件进行Meta分析。结果最终纳入6个RCT，共计9377例患者。Meta分析结果显示：与安慰剂比较，决奈达隆能显著降低房颤、房扑的复发率[OR=0.55，95%CI(0.43,0.72)，P<0.00001]和心室率[MD=-12.25，95%CI (-17.09，-7.40)，P<0.00001]；与安慰剂相比比较，决奈达隆增加了患者的心血管事件住院率[OR=1.17，95%CI(0.43,3.21)，P=0.76]，降低了患者的总死亡率[OR=0.95，95%CI(0.76，1.20)，P=0.67]，但差异均无统计学意义；与安慰剂比较，决奈达隆增加了总的不良反应发生率[OR=1.48，95%CI(1.06,2.05)，P=0.02]，但未显著增加严重不良反应发生率[OR=1.17，95%CI(0.79，1.72)，P=0.43]。结论决奈达隆对于房颤、房扑患者疗效显著且耐受良好，但要慎用于有严重器质性心脏病的永久性房颤患者。由于纳入研究数量及质量有限，需要开展更多高质量随机对照临床试验进一步确认。
目的：評價決奈達隆治療心房顫動、心房撲動的療效及安全性。方法計算機檢索PubMed、Embase、the Cochrane Collaboration Database，查找建庫至2014年2月28日期間髮錶的所有關于決奈達隆治療房顫、房撲的英文隨機對照試驗(RCT)。由兩位研究者按照納入排除標準進行文獻篩選、資料提取和方法學質量評價後，採用RevMan 5.2軟件進行Meta分析。結果最終納入6箇RCT，共計9377例患者。Meta分析結果顯示：與安慰劑比較，決奈達隆能顯著降低房顫、房撲的複髮率[OR=0.55，95%CI(0.43,0.72)，P<0.00001]和心室率[MD=-12.25，95%CI (-17.09，-7.40)，P<0.00001]；與安慰劑相比比較，決奈達隆增加瞭患者的心血管事件住院率[OR=1.17，95%CI(0.43,3.21)，P=0.76]，降低瞭患者的總死亡率[OR=0.95，95%CI(0.76，1.20)，P=0.67]，但差異均無統計學意義；與安慰劑比較，決奈達隆增加瞭總的不良反應髮生率[OR=1.48，95%CI(1.06,2.05)，P=0.02]，但未顯著增加嚴重不良反應髮生率[OR=1.17，95%CI(0.79，1.72)，P=0.43]。結論決奈達隆對于房顫、房撲患者療效顯著且耐受良好，但要慎用于有嚴重器質性心髒病的永久性房顫患者。由于納入研究數量及質量有限，需要開展更多高質量隨機對照臨床試驗進一步確認。
목적：평개결내체륭치료심방전동、심방복동적료효급안전성。방법계산궤검색PubMed、Embase、the Cochrane Collaboration Database，사조건고지2014년2월28일기간발표적소유관우결내체륭치료방전、방복적영문수궤대조시험(RCT)。유량위연구자안조납입배제표준진행문헌사선、자료제취화방법학질량평개후，채용RevMan 5.2연건진행Meta분석。결과최종납입6개RCT，공계9377례환자。Meta분석결과현시：여안위제비교，결내체륭능현저강저방전、방복적복발솔[OR=0.55，95%CI(0.43,0.72)，P<0.00001]화심실솔[MD=-12.25，95%CI (-17.09，-7.40)，P<0.00001]；여안위제상비비교，결내체륭증가료환자적심혈관사건주원솔[OR=1.17，95%CI(0.43,3.21)，P=0.76]，강저료환자적총사망솔[OR=0.95，95%CI(0.76，1.20)，P=0.67]，단차이균무통계학의의；여안위제비교，결내체륭증가료총적불량반응발생솔[OR=1.48，95%CI(1.06,2.05)，P=0.02]，단미현저증가엄중불량반응발생솔[OR=1.17，95%CI(0.79，1.72)，P=0.43]。결론결내체륭대우방전、방복환자료효현저차내수량호，단요신용우유엄중기질성심장병적영구성방전환자。유우납입연구수량급질량유한，수요개전경다고질량수궤대조림상시험진일보학인。
Objective To assess the effectiveness and safety of dronedarone in the treatment of atrial fibrilla-tion (AF) and atrial flutter (AFL). Methods All randomized controlled trials (RCTs) examining dronedarone for the treatment of AF and AFL were retrieved from databases, including PubMed, the Cochrane Collaboration Database and Embase, from the database' s initial construction to February 28, 2014. After the quality of included RCTs was assessed, the Cochrane Collaboration's software RevMan 5.2 was used for meta-analysis. Results 6 RCTs involving 9 377 pa-tients were included. Meta analysis showed that, compared with placebo, dronedarone reduced recurrence of atrial fi-brillation and atrial flutter [OR=0.55, 95%CI (0.43, 0.72), P<0.000 01] and ventricular rate during onset of atrial fibril-lation and atrial flutter [MD=-12.25, 95%CI (-17.09,-7.40), P<0.000 01]. Compared with placebo, dronedarone didn't significantly increase the hospitalization rate due to cardiovascular events [OR=1.17, 95%CI (0.43, 3.21), P=0.76] and didn't significantly reduce all-cause mortality [OR=0.95, 95%CI (0.76, 1.20, P=0.67]. Dronedarone was well tolerat-ed. Compared with placebo, dronedarone increased the incidence of all adverse drug reactions [OR=1.48, 95% CI (1.06, 2.05),P=0.02], but didn't significantly increase serious adverse drug reactions [OR=1.17, 95%CI (0.79,1.72), P=0.43]. Conclusion Dronedarone is effective and well-tolerated in treating AL and AFL. Because of the limited quantity and amount of the included studies, this conclusion has to be further proved by more high-quality RCTs.
