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尿激酶与重组组织型纤溶酶原激活剂治疗中心静脉导管血栓形成的双盲随机试验

Urokinase versus recombinant tissue plasminogen activator in thrombosed central venous catheters: a double-blinded, randomized trial.

作者信息

Haire W D, Atkinson J B, Stephens L C, Kotulak G D

机构信息

Department of Internal Medicine, University of Nebraska Medical Center, Omaha 68198-3330.

出版信息

Thromb Haemost. 1994 Oct;72(4):543-7.

PMID:7878629
Abstract

Fifty dysfunctional central venous catheters proven radiographically to be occluded by thrombus were blindly randomized to be injected with either 2 mg recombinant tissue plasminogen activator (t-PA) or 10,000 units of urokinase (UK) and allowed to incubate for 2 h. A second dose was allowed if catheter function was not restored with the first injection. Repeat radiograph contrast injection was done when catheter function was restored or after 2 doses of study drug were administered, whichever occurred first. Thirteen of 22 catheters randomized to UK had full function restored compared to 25 of 28 randomized to t-PA (p = 0.013). Radiographic contrast injection showed 7 catheters randomized to UK had complete resolution of the thrombus compared to 17 randomized to t-PA (p = 0.042). Four catheters randomized to UK had complete resolution of the thrombus after a single dose compared to 13 randomized to t-PA (p = 0.036). A novel dose of 2 mg of t-PA restored catheter function more reliably and dissolved thrombi faster than twice the standard, FDA-approved dose of UK.

摘要

五十根经影像学证实因血栓堵塞的功能失调中心静脉导管被随机分为两组,一组盲法注射2毫克重组组织型纤溶酶原激活剂(t-PA),另一组注射10000单位尿激酶(UK),并孵育2小时。若首次注射后导管功能未恢复,则允许注射第二剂。当导管功能恢复或给予两剂研究药物后(以先发生者为准),进行重复的影像学造影剂注射。随机分配至UK组的22根导管中有13根功能完全恢复,而随机分配至t-PA组的28根中有25根(p = 0.013)。影像学造影剂注射显示,随机分配至UK组的7根导管血栓完全溶解,而随机分配至t-PA组的有17根(p = 0.042)。随机分配至UK组的4根导管单剂量后血栓完全溶解,而随机分配至t-PA组的有13根(p = 0.036)。与两倍FDA批准的UK标准剂量相比,2毫克t-PA的新剂量更可靠地恢复了导管功能,且更快地溶解了血栓。

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