国产封堵器与进口封堵器治疗先天性心脏病有效性与安全性的Meta分析

Effectiveness and safety of domestic and imported occluder devices on treating congenital heart diseases: a meta-analysis

目的：评价国产封堵器与进口封堵器介入治疗先天性心脏病的安全性与有效性。方法：检索CBM、CNKI、万方、维普、pubmed和embase数据库,筛选2000~2016年7月国产封堵器与进口封堵器治疗先天性心脏病对照研究的文献,使用Rev Man 5.0软件对数据进行Meta分析。结果：共纳入8个符合条件的非随机对照研究,共1 294例患者。Meta分析结果显示,手术时间、X线曝光时间和手术成功率两组差异无统计学意义,但住院时间和并发症发生率国产组明显减少。结论：国产封堵器的安全性和有效性值得肯定,可以替代进口封堵器在临床中的应用。

Objective： To evaluate the effectiveness and safety of domestic and imported occluder devices on treating congenital heart diseases. Methods： Databases of CBM, CNKI, Wan Fang, VIP, pubmed and embase were searched for domestic and imported occluder devices on treating congenital heart diseases, from 2000 to July 2016.The meta-analysis was performed using Rev Man 5.0 software. Results： Eight non-randomized controlled trials involving 1 294 patients were met the inclusion criteria. Results of the meta-analysis showed that there were not significantly different in success rate, interventional treatment time and X-ray exposure time between two groups. But hospital stay and incidence of postoperative complications in the domestic group were less than those in the imported group. Conclusion： The effectiveness and safety of domestic occluder devices are worthy of recognition, which may replace imported occluder devices in clinical application.