Sabri Mohammad-Reza, Zolfi-Gol Ali, Ahmadi Alireza, Haghjooy-Javanmard Shaghayegh
Isfahan University of Medical Sciences, Isfahan, Iran.
Pediatr Cardiol. 2016 Jan;37(1):55-61. doi: 10.1007/s00246-015-1238-x. Epub 2015 Jul 28.
Better postoperative management of patients who have undergone single ventricle (SV) Fontan procedure could potentially reduce long-term complications and improve the quality of life for patients. The present study determined the effect of tadalafil on myocardial and endothelial function and exercise performance after modified Fontan operation. Patients who had undergone SV modified Fontan operation were enrolled in this clinical trial. The demographic characteristics of the patients were recorded. Before administration of tadalafil and after the trial, ventricular function (MPI, EF, FS, E/A, VTI), exercise performance, and endothelial function were evaluated for sonographic and biochemical markers (FMD, IMT, ICAM, VCAM, NO) using echocardiography, exercise testing, vascular ultrasonography, and biochemical measurements, respectively. A single dose of tadalafil of 1 mg/kg was administered daily for 6 weeks, and the functional class of the patients before and after tadalafil was determined. A total of 15 patients completed this clinical trial. Tadalafil was shown to have a significant effect on myocardial function, exercise performance, and improvement in NYHA functional class (p < 0.05) of study population. It had no significant effect on the biochemical variables and endothelial function except for IMT (p > 0.05), which decreased significantly after tadalafil administration (p < 0.05). The findings indicate that tadalafil is a safe, well-tolerated agent for the use after modified Fontan operation to improve myocardial function and exercise performance and possibly reduce long-term morbidity and mortality of patients. More conclusive results could be obtained from further study with a larger sample size and long-term follow-up.
对接受单心室(SV)Fontan手术的患者进行更好的术后管理,可能会减少长期并发症并提高患者的生活质量。本研究确定了他达拉非对改良Fontan手术后心肌和内皮功能以及运动能力的影响。接受SV改良Fontan手术的患者被纳入该临床试验。记录患者的人口统计学特征。在给予他达拉非之前和试验结束后,分别使用超声心动图、运动测试、血管超声检查和生化测量方法,评估心室功能(心肌表现指数、射血分数、缩短分数、E/A比值、心室流出道时间积分)、运动能力和内皮功能的超声和生化标志物(血流介导的血管舒张功能、内膜中层厚度、细胞间黏附分子、血管细胞黏附分子、一氧化氮)。每天给予1mg/kg的他达拉非单剂量,持续6周,并确定患者在服用他达拉非前后的功能分级。共有15名患者完成了该临床试验。结果显示,他达拉非对研究人群的心肌功能、运动能力和纽约心脏协会功能分级的改善有显著影响(p<0.05)。除内膜中层厚度外,它对生化变量和内皮功能没有显著影响(p>0.05),服用他达拉非后内膜中层厚度显著降低(p<0.05)。研究结果表明,他达拉非是一种安全、耐受性良好的药物,可用于改良Fontan手术后改善心肌功能和运动能力,并可能降低患者的长期发病率和死亡率。通过更大样本量的进一步研究和长期随访可获得更确凿的结果。