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口服异波帕胺对轻度心力衰竭患者的影响——与速尿的双盲安慰剂对照比较。异波帕胺研究组。

The effects of oral ibopamine in patients with mild heart failure--a double blind placebo controlled comparison to furosemide. The Ibopamine Study Group.

作者信息

Parker J O

机构信息

Cardiovascular Laboratory, Kingston General Hospital, Ontario, Canada.

出版信息

Int J Cardiol. 1993 Jul 15;40(3):221-7. doi: 10.1016/0167-5273(93)90004-z.

DOI:10.1016/0167-5273(93)90004-z
PMID:8225657
Abstract

The effect of ibopamine and furosemide in 130 patients with NYHA Class I and II heart failure were studied in a parallel, double-blind, randomized placebo-controlled multi-centre trial. Ibopamine 200 mg b.i.d. was compared to furosemide 40 mg q.d. and placebo. A 1- to 2-week single-blind run-in period was followed by an 8-week double-blind treatment period. Reproducible treadmill exercise test times with the modified Naughton-Balke protocol were required for randomization. Exercise times increased significantly in comparison to the placebo group after 8 weeks of therapy for both the furosemide group (1.2 min, P < 0.035) and the ibopamine group (1.3 min, P < 0.025). Neither furosemide nor ibopamine affected quality of life assessments. Adverse clinical experiences were generally mild and similar in frequency amongst the three treatment groups. The results of this study show the usefulness of both ibopamine and furosemide as monotherapy in patients with mild congestive heart failure.

摘要

在一项平行、双盲、随机、安慰剂对照的多中心试验中,研究了异波帕明和呋塞米对130例纽约心脏协会(NYHA)心功能I级和II级心力衰竭患者的疗效。将每日两次服用200毫克异波帕明与每日一次服用40毫克呋塞米及安慰剂进行比较。在为期1至2周的单盲导入期后,进行为期8周的双盲治疗期。随机分组要求采用改良的诺顿-巴尔克方案进行可重复的跑步机运动试验。治疗8周后,呋塞米组(增加1.2分钟,P<0.035)和异波帕明组(增加1.3分钟,P<0.025)的运动时间与安慰剂组相比均显著增加。呋塞米和异波帕明均未影响生活质量评估。不良临床事件一般较轻,且在三个治疗组中的发生频率相似。本研究结果表明,异波帕明和呋塞米作为单一疗法对轻度充血性心力衰竭患者均有用。

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