Wollersheim H, Thien T, van 't Laar A
Department of Medicine, St. Radboud University Hospital, Nijmegen, The Netherlands.
J Clin Pharmacol. 1987 Nov;27(11):907-13. doi: 10.1002/j.1552-4604.1987.tb05587.x.
In 16 patients with Raynaud's phenomenon a placebo-controlled single-dose study was performed on the hemodynamic effects of 10 mg nifedipine, sublingually administered, followed by an open eight-week study on the therapeutic efficacy of chronic oral nifedipine, 10 mg qid. After the acute sublingual nifedipine administration, a pronounced objective improvement of finger skin (P = .013) and forearm muscle blood flow (P = .04) during a standard finger-cooling test was found. During the chronic oral study the improvement in objective efficacy parameters disappeared, except for laser Doppler estimated shunt flow (P = .07). The acute hemodynamic effects did not predict the long-term results in individual patients. Patients with systemic sclerosis reacted as well as patients with primary Raynaud's phenomenon. This study shows that orally administered nifedipine does not convey long-term objective benefit to patients with Raynaud's phenomenon. The apparent increase in vasodilation during acute administration suggests that sublingual nifedipine prophylactically or during a vasospastic attack may be more useful.
对16例雷诺现象患者进行了一项安慰剂对照单剂量研究,观察舌下含服10 mg硝苯地平的血流动力学效应,随后进行了一项为期8周的开放性研究,观察口服硝苯地平(10 mg,每日4次)的治疗效果。急性舌下含服硝苯地平后,在标准手指冷却试验中发现手指皮肤(P = 0.013)和前臂肌肉血流(P = 0.04)有明显的客观改善。在慢性口服研究期间,除激光多普勒估计的分流血流外(P = 0.07),客观疗效参数的改善消失。急性血流动力学效应并不能预测个体患者的长期结果。系统性硬化症患者与原发性雷诺现象患者的反应相同。本研究表明,口服硝苯地平对雷诺现象患者没有长期的客观益处。急性给药期间血管舒张的明显增加表明,舌下含服硝苯地平在预防或血管痉挛发作期间可能更有用。