Feldman Arthur M, Silver Marc A, Francis Gary S, De Lame Paul-André, Parmley William W
Department of Medicine, Jefferson Medical College, 1025 Walnut Street, Philadelphia, PA 19607, USA.
J Card Fail. 2005 Apr;11(3):240-5. doi: 10.1016/j.cardfail.2004.10.001.
Enhanced external counterpulsation (EECP) treatment can improve exercise tolerance in patients with ischemic heart disease; however, the possible benefits of EECP in patients with stable heart failure (HF) and left ventricular dysfunction (LVD) are unclear. An open pilot study showed significant increases in exercise tolerance in HF patients undergoing EECP. Thus a larger, controlled study of EECP in patients with stable HF (New York Heart Association [NYHA] classes II and III) and LVD was undertaken.
The PEECH trial is a controlled, randomized, single-blind, parallel-group, multicenter study of 187 patients with symptomatic but stable HF (NYHA classes II and III) and an LV ejection fraction < or =35% was designed to assess the efficiency of EECP in patients with stable HF. Medical therapy is optimized in all patients based on the recommendations of the Heart Failure Society of America ("Usual Care"), and then randomized between 2 treatment groups; UC or EECP (35 hours over 7 weeks).
Efficacy measures include standard exercise tolerance tests on a treadmill (modified Naughton protocol), with measurements of peak oxygen uptake and exercise duration time; quality of life questionnaires; NYHA classification; and neurohormonal markers of HF.
增强型体外反搏(EECP)治疗可改善缺血性心脏病患者的运动耐量;然而,EECP对稳定型心力衰竭(HF)和左心室功能不全(LVD)患者的潜在益处尚不清楚。一项开放性试点研究表明,接受EECP治疗的HF患者运动耐量显著提高。因此,针对稳定型HF(纽约心脏协会[NYHA]II级和III级)和LVD患者开展了一项更大规模的EECP对照研究。
PEECH试验是一项针对187例有症状但病情稳定的HF(NYHA II级和III级)且左室射血分数≤35%患者的对照、随机、单盲、平行组、多中心研究,旨在评估EECP对稳定型HF患者的疗效。根据美国心力衰竭学会的建议(“常规治疗”),对所有患者进行优化药物治疗,然后随机分为两个治疗组;常规治疗组或EECP组(7周内进行35小时治疗)。
疗效评估指标包括采用改良诺顿方案在跑步机上进行的标准运动耐量测试,测量峰值摄氧量和运动持续时间;生活质量问卷;NYHA分级;以及HF的神经激素标志物。