Silke B, Tennet H, Fischer-Hansen J, Keller N, Heikkila J, Salminen K
Department of Therapeutics and Pharmacology, Queen's University of Belfast, Northern Ireland.
Eur Heart J. 1992 Aug;13(8):1092-100. doi: 10.1093/oxfordjournals.eurheartj.a060320.
The effects of flosequinan and enalapril on exercise capacity (bicycle exercise duration), quality-of-life symptomatology (visual analogue scales) and New York Heart Association (NYHA) grading, were compared in 61 patients with chronic heart failure (NYHA, grade III). Bicycle exercise duration improved similarly with flosequinan (+27%) and enalapril (+18%); in patients completing the study, flosequinan produced a significantly greater increase in exercise time at week 12, compared with enalapril (P = 0.02). Improvements in visual analogue scores relating to general health, energy and vitality, ability to perform physical activities and breathing performance, were equivalent for both drugs. Changes in NYHA classification showed that 27 (55%) of 49 patients completing the study had improved by at least one NYHA grade (15 (68%) patients on flosequinan; 12 (44%) on enalapril). The overall safety and tolerability of the two treatments was similar; 18 patients reported adverse effects while on flosequinan, compared with 19 patients on enalapril. Neither treatment was associated with any clinically important changes in haematological or biochemical variables, although some treatment-related effects were observed. This study confirms that flosequinan achieved similar efficacy to enalapril in the symptomatic relief of chronic heart failure. The effect of flosequinan on survival in chronic heart failure has not been tested; pending such studies, our data suggest that it may prove a useful alternative therapy in patients where ACE inhibitors are contraindicated or poorly tolerated.
在61例慢性心力衰竭(纽约心脏协会[NYHA]Ⅲ级)患者中,比较了氟司喹南和依那普利对运动能力(自行车运动持续时间)、生活质量症状(视觉模拟评分)和NYHA分级的影响。氟司喹南(+27%)和依那普利(+18%)使自行车运动持续时间得到了相似程度的改善;在完成研究的患者中,与依那普利相比,氟司喹南在第12周时使运动时间有显著更大幅度的增加(P = 0.02)。两种药物在与总体健康、精力和活力、进行体力活动的能力以及呼吸功能相关的视觉模拟评分改善方面相当。NYHA分级的变化显示,49例完成研究的患者中有27例(55%)至少改善了一个NYHA分级(服用氟司喹南的患者中有15例[68%];服用依那普利的患者中有12例[44%])。两种治疗的总体安全性和耐受性相似;服用氟司喹南时有18例患者报告有不良反应,服用依那普利时有19例患者报告有不良反应。尽管观察到了一些与治疗相关的效应,但两种治疗均未引起血液学或生化指标的任何具有临床意义的变化。本研究证实,氟司喹南在慢性心力衰竭的症状缓解方面与依那普利疗效相似。氟司喹南对慢性心力衰竭患者生存率的影响尚未得到检验;在进行此类研究之前,我们的数据表明,在血管紧张素转换酶(ACE)抑制剂禁忌或耐受性差的患者中,它可能是一种有用的替代疗法。