目的 系统评价参松养心胶囊治疗心房颤动射频消融术后早期复发的有效性和安全性.方法 检索中国知网数据库(CNKI)、万方数据库(WanFang)、维普数据库(VIP)、中国生物医学文献数据库(SinoMed)及PubMed、Web of Science、Cochrane Library等数据库自建库至2023年7月收录的参松养心胶囊治疗心房颤动射频消融术后的随机对照试验(RCT),按照纳入排除标准进行文献筛选,使用RevMan5.3软件进行Meta分析,采用GRADE证据等级评价系统对结局指标进行评价.结果 共纳入9项RCT,涉及患者1315例,试验组657例,对照组658例.Meta分析结果显示:参松养心胶囊可以降低术后心房颤动复发率(RR=0.54,95％CI:0.42～0.69,P＜0.00001)、左房内径(LAD,MD=-1.93,95％CI:-2.90～-0.96,P＜0.0001)、左室舒张末内径(LVEDD,MD=-3.38,95％CI:-3.93～-2.83,P＜0.00001)、左室收缩末内经(LVESD,MD=-1.81,95％CI:-2.28～-1.34,P＜0.00001)、血清N末端脑钠肽前体(NT-proBNP,MD=-88.07,95％CI:-122.77～-53.36,P＜0.00001)水平;提高临床总有效率(RR=1.17,95％CI:1.02～1.34,P=0.02)、左室射血分数(LVEF,MD=2.43,95％CI:1.95～2.90,P＜0.00001)、舒张早期二尖瓣血流速度与舒张晚期二尖瓣血流速度比值(E/A,MD=0.24,95％CI:0.13～0.35,P＜0.0001)以及心房颤动患者生活质量量表评分(AFEQT,MD=9.34,95％CI:4.70～13.98,P＜0.0001),且安全性良好(RD=0.01,95％CI:-0.01～0.03,P=0.51).结论 参松养心胶囊治疗心房颤动射频消融术后在降低术后早期复发率优于常规西药治疗,且安全性良好.受纳入研究数量和质量的限制,尚需要更多大样本、多中心、高质量的临床随机对照试验予以验证.
Abstract
Objective To review systematically the effectiveness and safety of Shensong Yangxin Capsules in treatment of early recurrence of atrial fibrillation(ERAF)after radiofrequency ablation(RFA).Methods The databases of CNKI,WanFang,VIP,SinoMed,PubMed,Web of Science and Cochrane Library were retrieved for collecting RCT of Shensong Yangxin Capsules in treatment of ERAF after RFA from the inception of the databases until 2023.The literatures were screened according to inclusion and exclusion criteria,given a Meta-analysis by using RevMan 5.3 software,and outcome indicators were reviewed by using GRADE evidence rating evaluation system.Results There were totally 9 RCT included with 1315 patients,and there were 657 in test group and 658 in control group.The results of Meta-analysis showed that Shensong Yangxin Capsules decreased AF recurrence rate(RR=0.54,95％CI:0.42～0.69,P＜0.00001),left atrial diameter(LAD,MD=-1.93,95％CI:-2.90～-0.96,P＜0.0001),left ventricular end-diastolic diameter(LVEDD,MD=-3.38,95％CI:-3.93～-2.83,P＜0.00001),left ventricular end-systolic diameter(LVESD,MD=-1.81,95％CI:-2.28～-1.34,P＜0.00001),and N-terminal pro-brain natriuretic peptide(NT-proBNP,MD=-88.07,95％CI:-122.77～-53.36,P＜0.00001).Shensong Yangxin Capsules increased the total clinical efficacy(RR=1.17,95％CI:1.02～1.34,P=0.02),left ventricular ejection fraction(LVEF,MD=2.43,95％CI:1.95～2.90,P＜0.00001),ratio of early diastolic mitral valve flow velocity to late diastolic mitral valve flow velocity(E/A,MD=0.24,95％CI:0.13～0.35,P＜0.0001),and scores of Atrial Fibrillation Effect on Quality-of-Life(AFEQT,MD=9.34,95％CI:4.70～13.98,P＜0.0001).Shensong Yangxin Capsules had higher safety(RD=0.01,95％CI:-0.01～0.03,P=0.51).Conclusion Shensong Yangxin Capsules is superior to conventional Western medicine therapy in reducing ERAF after RFA with higher safety.Due to the limitations of quantity and quality of included studies,the above conclusions still need to be validated by more RCT with larger sample,multicenter and high quality.
维普
万方数据