Di Napoli P, Taccardi A A, Barsotti A
Department of Cardiology, Intensive Care Unit, Casa di Cura Villa Pini d'Abruzzo, Chieti, Italy.
Heart. 2005 Feb;91(2):161-5. doi: 10.1136/hrt.2003.031310.
To investigate the long term effects of trimetazidine in patients with dilated ischaemic cardiomyopathy. The effects of trimetazidine on left ventricular function as well as its tolerability profile and potential anti-inflammatory effects were studied.
61 patients were randomly assigned either to receive trimetazidine (20 mg thrice daily) in addition to their conventional treatment or to continue their usual drug treatment for 18 months. Patients were evaluated at baseline and at 6, 12, and 18 months with a clinical examination, echocardiography, and biochemical analysis (C reactive protein).
Trimetazidine added to the usual treatment significantly improved the patients' functional status (assessed by New York Heart Association functional class). The functional improvement of trimetazidine treated patients was associated with a significant increase in left ventricular ejection fraction (30 (6)%, 32 (8)%, 38 (7)%, and 37 (6)% v 31 (8)%, 30 (7)%, 28 (6)%, and 26 (9)% in control patients at baseline and at 6, 12, and 18 months, respectively) and with a significant effect on ventricular remodelling. C reactive protein plasma concentrations remained stable throughout the study in patients receiving trimetazidine (2.5 (1.0), 2.7 (2.0), 2.7 (3.0), and 3.0 (2.0) mg/l at baseline and at 6, 12, and 18 months, respectively) but increased significantly in the control group (2.4 (1.0), 3.4 (1.2), 6.0 (4.0), and 7.0 (5.0) mg/l, respectively). No significant adverse event or changes in clinical or biochemical parameters were detected.
Treatment with trimetazidine added to the usual treatment for up to 18 months was well tolerated and induced a functional improvement in patients with dilated cardiomyopathy. Trimetazidine treatment was associated with a significant improvement of left ventricular function and the remodelling process. Results also suggest that the inflammatory response was limited in patients treated with trimetazidine.
研究曲美他嗪对扩张型缺血性心肌病患者的长期影响。研究曲美他嗪对左心室功能的影响及其耐受性和潜在的抗炎作用。
61例患者被随机分为两组,一组在常规治疗基础上加用曲美他嗪(每日3次,每次20毫克),另一组继续其常规药物治疗,为期18个月。在基线时以及6个月、12个月和18个月时对患者进行临床检查、超声心动图检查和生化分析(C反应蛋白)评估。
在常规治疗基础上加用曲美他嗪显著改善了患者的功能状态(根据纽约心脏协会心功能分级评估)。曲美他嗪治疗的患者功能改善与左心室射血分数显著增加相关(基线时以及6个月、12个月和18个月时,曲美他嗪治疗组患者分别为30(6)%、32(8)%、38(7)%和37(6)%,对照组患者分别为31(8)%、30(7)%、28(6)%和26(9)%),并且对心室重构有显著影响。接受曲美他嗪治疗的患者在整个研究过程中C反应蛋白血浆浓度保持稳定(基线时以及6个月、12个月和18个月时分别为2.5(1.0)、2.7(2.0)、2.7(3.0)和3.0(2.0)毫克/升),而对照组显著升高(分别为2.4(1.0)、3.(1.2)、6.0(4.0)和7.0(5.0)毫克/升)。未检测到显著的不良事件或临床及生化参数变化。
在常规治疗基础上加用曲美他嗪治疗长达18个月耐受性良好,并能使扩张型心肌病患者的功能得到改善。曲美他嗪治疗与左心室功能和重构过程的显著改善相关。结果还表明,接受曲美他嗪治疗的患者炎症反应受到限制。