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股动脉穿刺介入术后应用动脉止血贴压迫止血的多中心随机对照研究
Percutaneous collagen hemostasis device(V+Pad) with conventional manual compression after interventional procedures:multi-center randomized controlled study
【摘要】 目的 评估股动脉穿刺介入术后使用动脉止血贴压迫止血的安全性及临床有效性。方法 本试验采用多中心、随机、对照的研究方法,在3个分中心选取经股动脉穿刺进行介入造影或治疗的患者,随机分为试验组(止血贴组)和对照组(手工压迫组)。比较2组的压迫止血时间、制动时间和血管并发症发生率等指标。结果 3个分中心共入组患者1 158例(试验组和对照组各579例),2组患者年龄、性别构成比与血压差异均无统计学意义(P>0.05)。试验组与对照组比较,压迫时间及下肢制动时间均显著缩短[(4.69±1.15) min vs(6.15±2.74)min,(4.96±2.35)h vs(19.07±6.47)h,P值均<0.01];介入治疗后,试验组并发症发生率为3.4%,对照组3.3%,差异无统计学意义(P>0.05)。结论 止血贴可有效缩短按压止血时间及下肢制动时间,并发症的发生率与传统压迫止血方法相似。
【Abstract】 Objective To evaluate V+Pad and manual compression(MC) on efficacy of hemostasis,complication rate and safety of early mobilization after interventional procedures.Methods The prospective trial was performed in three centers.The patients who admitted diagnosis and therapeutic catheterization via femoral approach were assigned randomly into test group(V+Pad group)or controlled group(MC group).Compression time,bed rest time and vascular complication rate in two groups were compared.Results Three centers in 1 158 patients were enrolled in the study with 579 patients in each group.There was no significant difference between two groups as respect to age,gender ratios and blood pressure.The compression time and bed rest time in test group were shorter than those in the controlled group [(4.69± 1.15) min vs.(6.15 ± 2.74) min,(4.96 ± 2.35) hours vs.(19.07 ± 6.47)hours,P<0.01].Vascular complication rate in two groups had no statistical difference(3.4% vs.3.3%,P>0.05).Conclusion After interventional procedures,there is no difference in safety between V+Pad and MC,while V+ Pad usage can reduce the compression time,bed rest time with effective hemostasis and more comfortable.V+Pad is the preferred method of arterial closure after femoral catheterization.
【Key words】 hemostasis; femoral artery hemostasis sticking; interventional radiology;
- 【文献出处】 实用放射学杂志 ,Journal of Practical Radiology , 编辑部邮箱 ,2012年06期
- 【分类号】R543.5
- 【下载频次】3