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重组组织型纤溶酶原激活剂与尿激酶治疗外周动脉和移植物闭塞的随机试验

Recombinant tissue-type plasminogen activator versus urokinase in peripheral arterial and graft occlusions: a randomized trial.

作者信息

Meyerovitz M F, Goldhaber S Z, Reagan K, Polak J F, Kandarpa K, Grassi C J, Donovan B C, Bettmann M A, Harrington D P

机构信息

Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115.

出版信息

Radiology. 1990 Apr;175(1):75-8. doi: 10.1148/radiology.175.1.2107563.

DOI:10.1148/radiology.175.1.2107563
PMID:2107563
Abstract

A randomized prospective trial was undertaken to compare intraarterial administration of recombinant human tissue-type plasminogen activator (rt-PA) with urokinase (UK) in 32 patients with peripheral arterial or bypass graft occlusions. Sixteen patients were randomized to receive rt-PA and 16 to receive UK. The rt-PA dose was administered as a 10-mg bolus into the thrombus, followed by 5 mg/h for up to 24 hours. The UK dose was administered as a 60,000 IU bolus into the thrombus, followed by 240,000 IU/h for 2 hours, 120,000 IU/h for 2 hours, and 60,000 IU/h for up to 20 hours. Serial arteriograms were obtained at baseline and at 4, 8 or 16, and 24 hours. The endpoint was defined as 95% of greater clot lysis. The cumulative numbers of patients with successful thrombolysis (rt-PA vs UK) were four vs none at 4 hours, seven vs one at 8 hours, seven vs three at 16 hours, and eight vs six at 24 hours. Lysis occurred more rapidly in the rt-PA group (P = .04). Major bleeding complications occurred in five rt-PA patients and two UK patients (P = .39). At 24 hours, fibrinogen levels were significantly lower in the rt-PA group than in the UK group (P = .01). There was no apparent difference in 30-day clinical success.

摘要

进行了一项随机前瞻性试验,比较重组人组织型纤溶酶原激活剂(rt-PA)与尿激酶(UK)动脉内给药治疗32例外周动脉或旁路移植血管闭塞患者的效果。16例患者随机接受rt-PA治疗,16例接受UK治疗。rt-PA剂量为10mg静脉推注至血栓内,随后以5mg/h持续给药24小时。UK剂量为60,000IU静脉推注至血栓内,随后2小时内以240,000IU/h给药,接下来2小时内以120,000IU/h给药,最多20小时内以60,000IU/h给药。在基线以及4、8或16和24小时时进行系列动脉造影。终点定义为血栓溶解95%或更高。成功溶栓的累积患者数(rt-PA组与UK组)在4小时时为4例对0例,8小时时为7例对1例,16小时时为7例对3例,24小时时为8例对6例。rt-PA组溶栓发生更快(P = 0.04)。5例rt-PA患者和2例UK患者发生了严重出血并发症(P = 0.39)。24小时时,rt-PA组纤维蛋白原水平显著低于UK组(P = 0.01)。30天临床成功率无明显差异。

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