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伊洛前列素与阿司匹林治疗血栓闭塞性脉管炎所致严重肢体缺血的试验。TAO研究。

Trial of iloprost versus aspirin treatment for critical limb ischaemia of thromboangiitis obliterans. The TAO Study.

作者信息

Fiessinger J N, Schäfer M

机构信息

Service de Pathologie Vasculaire, Hôpital Broussais, Paris, France.

出版信息

Lancet. 1990 Mar 10;335(8689):555-7. doi: 10.1016/0140-6736(90)90346-7.

DOI:10.1016/0140-6736(90)90346-7
PMID:1689791
Abstract

152 patients with thromboangiitis obliterans (Buerger's disease) and pain from critical leg ischaemia were randomly allocated to receive iloprost, a chemically stable prostacyclin analogue, or low-dose aspirin, for 28 days in a double-blind trial. On review, 19 patients did not fulfil the stringent entry criteria. Of the other 133 patients, 98 also had leg ulcers. After 21-28 days, 58 (85%) of 68 iloprost-treated patients showed ulcer healing or relief of ischaemic pain, compared with 11 (17%) of 65 in the aspirin-treated group. 43 (63%) on iloprost treatment had complete relief of pain, compared with 18 (28%) on aspirin. Ulcers healed completely in 18 of 52 (35%) who received iloprost compared with 6 of 46 (13%) who received aspirin. 6 months after the start of treatment, the response rate was 45 of 51 (88%) patients treated with iloprost compared with 12 of 44 (21%) patients treated with aspirin.

摘要

152例血栓闭塞性脉管炎(伯格氏病)且因严重下肢缺血而疼痛的患者被随机分配接受伊洛前列素(一种化学性质稳定的前列环素类似物)或小剂量阿司匹林治疗,进行为期28天的双盲试验。复查时,19例患者不符合严格的入选标准。在其余133例患者中,98例还患有腿部溃疡。21至28天后,68例接受伊洛前列素治疗的患者中有58例(85%)溃疡愈合或缺血性疼痛缓解,相比之下,阿司匹林治疗组65例患者中有11例(17%)。接受伊洛前列素治疗的43例(63%)患者疼痛完全缓解,相比之下,阿司匹林治疗组为18例(28%)。接受伊洛前列素治疗的52例患者中有18例(35%)溃疡完全愈合,相比之下,接受阿司匹林治疗的46例患者中有6例(13%)。治疗开始6个月后,接受伊洛前列素治疗的51例患者中有45例(88%)有反应,相比之下,接受阿司匹林治疗的44例患者中有12例(21%)。

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