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Vasosealの臨床的有効性ならびに安全性を封筒法による無作為試験により,用手的圧迫法と比較検討した.185例を対象にVagoseal群(V群)93例,用予的圧迫群(M群)92例に振り分けられた.平均止血時間はV群8.1±4.3分,M群25.4±6.3分とV群がM群に比し有意に短く(p<0.05),鎮痛剤ならびに眠剤の使用頻度はそれぞれV群9/93例(9.7%),12/93例(12.9%),M群53/92例(57.6%),63/92例(68.5%)とV群がM群に比し有意に使用頻度が少なかった(p<0.01).合併症として,再出血はV群7/93例(7.5%),M群7/92例(7.6%),血腫形成はV群5/93例(5.3%),M群5/92例(5.4%)と有意差を認めず,穿刺部痛の持続はV群1/93例(1.1%),M群7/92例(7.6%)とV群がM群に比し有意に少なかった(p<0.05).希望調査にて,42/45例(93.3%)がVasosealを次回の止血法として選択し,以前用手的圧迫を経験した患者の自覚症状からみた苦痛度は,Vasosealにより10→3.9±2.1に有意に軽減された(p<0.01).
The purpose of this study was to evaluate the efficacy and safety of the new vascular hemostasis device (Vasoseal) (group-V:n=93) in sealing the femoral artery puncture site after cardiac catheterization and percutaneous coronary angioplasty in comparison with that of conventional manual compression (group-M : n=92). The average compression time was 8.1±4.3 min in group V and 25.4±6.3 min in group-M (p<0.01). The frequency of the use of an anodyne was 9/93 (9.7%) in group-V and in 53/92 (57.6%) in group-M (p<0.01). The frequency of the use of a sleeping drug was obser-ved in 12/93 (12.9%) in group-V and 63/92 (68.4%) in group-M (p<0.01). Rebleeding was observed in 7/93 (7.5%) in group-V and in 7/92 (7.6%) in group-M (p=NS), and hematoma was observed in 5/93 (5.3%) in group -V and in 5/92 (5.4%) in group-M (p=NS). Dis-comfort during the hemostasis procedure was observed in 1/93 (1.1%) in group-V and in 7/92 (7.6%) in group-M p<0.05). There was no surgical intervention in either group and no major complication in group-V. The suh-iective discomfort score during the Vasoseal procedure was improved from the previous 10 to 3.9±2.1 (p<0.01). It is indicated that the vascular hemostasis device (Vasoseal) is an effective and safe device for the management of the arterial puncture site involved in the procedures mentioned above.
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