新型国产血管封堵器的临床安全性及有效性的应用研究

Assessment of safety and efficacy of homemade vascular hemostasis device

目的通过与人工压迫止血方法相比,评价在冠状动脉造影及介入治疗后应用国产新型血管封堵器的安全性及有效性。方法选择2006年7月至2007年3月299例行冠状动脉造影及介入治疗的患者,随机分为血管封堵器组和人工压迫止血组。主要的观察指标为止血时间、下床活动时间和主要血管并发症。结果血管封堵器组与人工压迫止血组相比显著缩短止血时间和制动时间,(5.2±4.7)minvs(15.1±12.6)min,(187.4±125.6)minvs(324.8±212.4)min(P<0.001),但其与人工压迫止血组的血管并发症发生率差异无统计学意义。结论冠状动脉造影或治疗的患者术后可以立即撤出鞘管应用国产血管封堵器。与人工压迫止血相比,前者可以显著地缩短止血及制动时间而不增加血管并发症。

Objective To determine the safety and efficacy of the homemade extravascular hemostasis device in comparison with standard manual compression after diagnostic and interventional coronary procedures. Methods Two hundred and ninety-nine patients who underwent diagnostic or interventional coronary procedures were randomized to the homemade extravascular hemostasis device or standard manual compression. The primary study end points were time to hemostasis and ambulation and the incidence of major vascular complications. Results Both time to hemostasis and ambulation were significantly reduced in the homemade extravascular hemostasis device, respectively （5.2±4.7） min vs （15.1±12.6） min,（187. 4±125. 6） min vs （324.8±212.4） min （ P〈0. 001）. But the incidence of vascular complications was similar between the homemade extravascular hemostasis device group and manual compression group. Conclusion The homemade extravascutar bemostasis device allows immediate arterial sheath removal after both diagnostic and interventional procedures, dramatically reducing time to hemostasis and patient ambulation without compromising patient safety in comparison with standard comoression techniques.