Shortell C K, Queiroz R, Johansson M, Waldman D, Illig K A, Ouriel K, Green R M
Division of Vascular Surgery, Department of Radiology, University of Rochester School of Medicine and Dentistry, NY 14621, USA.
J Vasc Surg. 2001 Nov;34(5):854-9. doi: 10.1067/mva.2001.118589.
The purposes of this study were to evaluate the safety and efficacy of limited-dose tissue plasminogen activator (t-PA) in patients with acute vascular occlusion and to compare these results with those obtained in equivalent patients receiving urokinase.
We compared the results of 60 patients receiving catheter-directed urokinase from November 1997 to November 1998 (240,000 units/h x 4 h, 120,000 units/h thereafter for a maximum of 48 h) with those of 45 patients receiving catheter-directed t-PA from November 1998 to August 2000 (2 mg/h, total dose < or =100 mg) for acute arterial occlusion (AAO) and acute venous occlusion (AVO). Interventional approaches such as cross-catheter and coaxial techniques were used to reduce the dose of lytic agent needed to achieve pre-lysis-treatment goals (eg, complete lysis of all thrombus/unmasking graft stenosis or establishing outflow target). Statistical analysis was performed using Student t test and Fisher exact test.
The urokinase and t-PA groups were comparable with regard to age, comorbidities (coronary artery disease, hypertension, diabetes, renal insufficiency, smoking), duration of ischemic or occlusive symptoms, location of occlusive process, pretreatment with warfarin, and thrombotic versus embolic and native versus graft occlusion in patients with AAO. In patients with AAO and in those with AVO, t-PA was equivalent to or better than urokinase with regard to percent of clot lysis, incidence of major bleeding complications, limb salvage, and mortality. Achievement of pretreatment goals (arterial patients only) was 50% for urokinase patients and 76% for t-PA patients (P =.02). Analysis of success in individual pretreatment-goal achievement showed urokinase and t-PA to be equivalent in unmasking stenoses (85% and 84%, respectively; P = NS), whereas t-PA was superior to urokinase in the more critical task of establishing run-off (39% versus 81% for urokinase and t-PA, respectively; P =.001). Additional interventions, either endovascular or surgical, were required in 60% and 51% (P = NS) of patients receiving urokinase and t-PA, respectively, for AAO, and in 54% and 62% (P = NS) of patients receiving urokinase and t-PA, respectively, for AVO.
Limited-dose t-PA is a safe and effective therapy for AAO and AVO when administered by experienced teams using innovative but well-established interventional techniques.
本研究旨在评估低剂量组织型纤溶酶原激活剂（t-PA）治疗急性血管闭塞患者的安全性和有效性，并将这些结果与接受尿激酶治疗的同等患者的结果进行比较。
我们比较了1997年11月至1998年11月期间接受导管定向尿激酶治疗的60例患者（240,000单位/小时×4小时，此后120,000单位/小时，最长48小时）与1998年11月至2000年8月期间接受导管定向t-PA治疗的45例患者（2毫克/小时，总剂量≤100毫克）治疗急性动脉闭塞（AAO）和急性静脉闭塞（AVO）的结果。采用交叉导管和同轴技术等介入方法来减少达到溶栓前治疗目标所需的溶栓剂剂量（例如，所有血栓完全溶解/揭示移植血管狭窄或建立流出道目标）。使用学生t检验和Fisher精确检验进行统计分析。
在年龄、合并症（冠状动脉疾病、高血压、糖尿病、肾功能不全、吸烟）、缺血或闭塞症状持续时间、闭塞过程位置、华法林预处理以及AAO患者的血栓形成与栓塞以及天然血管与移植血管闭塞方面，尿激酶组和t-PA组具有可比性。在AAO患者和AVO患者中，就血栓溶解百分比、大出血并发症发生率、肢体挽救率和死亡率而言，t-PA等同于或优于尿激酶。尿激酶患者达到预处理目标（仅动脉患者）的比例为50%，t-PA患者为76%（P = 0.02）。对个体预处理目标达成情况的成功分析表明，在揭示狭窄方面尿激酶和t-PA相当（分别为85%和84%；P = 无显著性差异），而在建立血流方面这一更关键的任务中t-PA优于尿激酶（尿激酶和t-PA分别为39%和81%；P = 0.001）。对于AAO，接受尿激酶和t-PA治疗的患者分别有60%和51%（P = 无显著性差异）需要额外的血管内或外科干预；对于AVO，接受尿激酶和t-PA治疗的患者分别有54%和62%（P = 无显著性差异）需要额外干预。
当由经验丰富的团队使用创新但成熟的介入技术给药时，低剂量t-PA是治疗AAO和AVO的安全有效疗法。
