纤维蛋白封闭剂改善外周血管手术中的止血效果：一项随机前瞻性试验。
Fibrin sealant improves hemostasis in peripheral vascular surgery: a randomized prospective trial.
作者信息
Schenk Worthington G, Burks Sandra G, Gagne Paul J, Kagan Steven A, Lawson Jeffrey H, Spotnitz William D
机构信息
Department of Surgery, University of Virginia, Charlottesville, VA 22908, USA.
出版信息
Ann Surg. 2003 Jun;237(6):871-6; discussion 876. doi: 10.1097/01.SLA.0000071565.02994.DA.
OBJECTIVE
To evaluate the efficacy and safety of an investigational fibrin sealant (FS) in a randomized prospective, partially blinded, controlled, multicenter trial.
SUMMARY BACKGROUND DATA
Upper extremity vascular access surgery using polytetrafluorethylene (PTFE) graft placement for dialysis was chosen as a reproducible, clinically relevant model for evaluating the usefulness of FS. The FS consisted of pooled human fibrinogen (60 mg/mL) and thrombin (500 NIH U/mL). Time to hemostasis was measured, and adverse events were monitored.
METHODS
Consenting adult patients (n = 48) undergoing placement of a standard PTFE graft were randomized in a 2:1:1 ratio to the treatment group using FS (ZLB Bioplasma AG, Bern, Switzerland), oxidized regenerated cellulose (Surgicel, Johnson & Johnson, New Brunswick, NJ), or pressure. Patients received heparin (3,000 IU IVP) before placement of vascular clamps. If the treatment was FS, clamps were left in place for 120 seconds after the application of study material to permit polymerization. If treatment was Surgicel, clamps were left in place until the agent had been applied according to manufacturer's instructions. If the treatment was pressure, clamps were released as soon as the investigator was ready to apply compression. Immediately after release of the last clamp, the arterial and venous suture lines were evaluated for bleeding. The time to hemostasis at both the venous and arterial sites was recorded.
RESULTS
Significant (P < or =.005) reduction in time to hemostasis was achieved in the FS group. Thirteen (54.2%) patients randomized to FS experienced immediate hemostasis at both suture lines following clamp removal compared to no patients using Surgicel or pressure. Only one patient (7.1%) in the Surgicel group and no patients in the pressure group experienced hemostasis at 120 seconds from clamp removal, compared to 13 (54.2%) patients for FS. Adverse events were comparable in all groups. There were no seroconversions.
CONCLUSIONS
FS achieved more rapid hemostasis than traditional techniques in this peripheral vascular procedure. FS use appeared to be safe for this procedure.
目的
在一项随机前瞻性、部分盲法、对照、多中心试验中评估一种研究性纤维蛋白密封剂（FS）的疗效和安全性。
总结背景数据
选择使用聚四氟乙烯（PTFE）移植物植入进行透析的上肢血管通路手术作为评估FS效用的可重复、临床相关模型。该FS由混合人纤维蛋白原（60mg/mL）和凝血酶（500NIH U/mL）组成。测量止血时间，并监测不良事件。
方法
同意参与的成年患者（n = 48）接受标准PTFE移植物植入，按2:1:1的比例随机分为使用FS（ZLB Bioplasma AG，伯尔尼，瑞士）、氧化再生纤维素（Surgicel，强生公司，新不伦瑞克，新泽西州）或压迫法的治疗组。患者在放置血管夹前接受肝素（3000IU静脉推注）。如果治疗方法是FS，在应用研究材料后将夹子放置120秒以允许聚合。如果治疗方法是Surgicel，根据制造商说明放置夹子直到应用该制剂。如果治疗方法是压迫法，一旦研究者准备好施加压迫就松开夹子。在松开最后一个夹子后，立即评估动脉和静脉缝合线的出血情况。记录静脉和动脉部位的止血时间。
结果
FS组止血时间显著（P≤0.005）缩短。随机分配到FS组的13名（54.2%）患者在移除夹子后两个缝合线处立即止血，而使用Surgicel或压迫法的患者无此情况。Surgicel组仅1名患者（7.1%）在移除夹子后120秒止血，压迫法组无患者止血，而FS组有13名（54.2%）患者止血。所有组的不良事件相当。无血清转化情况。
结论
在该外周血管手术中，FS比传统技术实现了更快的止血。使用FS似乎对该手术是安全的。
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