Gibelli G, Negrini M, Mazzocchi F, Prina L, Pollavini P, De Ponti C
G Ital Cardiol. 1986 Nov;16(11):904-8.
The antianginal efficacy of nitroglycerin (NTG), given in a new transdermal therapeutic system (TTS), was compared with that of nifedipine and verapamil, both in slow-release (SR) formulation, in a randomized, double-blind, placebo-controlled study, carried out in 8 patients with stable exercise-induced angina pectoris. TTS NTG 40 cm2 (releasing 20 mg of NTG over 24 hours), nifedipine 20 mg SR, verapamil 120 mg SR and placebo were given once on 4 consecutive days according to a 4 X 4 latin-square design, twice replicated. A cycloergometric symptom-limited exercise test was performed 4 and 8 hours after the administration of each drug. Four hours post-dosing, mean exercise duration was 407 sec. after placebo and 523 (+28%) and 485 (+ 19%) sec. after TTS NTG and nifedipine SR respectively, while at the 8th hour it was 375 sec. after placebo, and 515 (+ 37%) and 457 (+ 21%) sec. after TTS NTG and nifedipine SR. Exercise duration after verapamil was similar to that after placebo. In comparison with placebo maximal workload and total work performed were significantly higher on TTS NTG and on nifedipine at both times of observation, but no significant differences were seen after verapamil. Peak exercise systolic blood pressure was nearly identical after all the treatments tested. Peak exercise heart rate and pressure rate product were both significantly higher on TTS NTG, as well as on nifedipine, in comparison with placebo, while values after verapamil did not differ from those after placebo.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项针对8例稳定型运动诱发型心绞痛患者的随机、双盲、安慰剂对照研究中,将新型透皮治疗系统(TTS)给药的硝酸甘油(NTG)的抗心绞痛疗效与缓释(SR)制剂的硝苯地平和维拉帕米进行了比较。根据4×4拉丁方设计,连续4天每天一次给予TTS NTG 40 cm²(24小时释放20 mg NTG)、硝苯地平20 mg SR、维拉帕米120 mg SR和安慰剂,重复两次。在每次给药后4小时和8小时进行症状限制的运动平板试验。给药后4小时,安慰剂组的平均运动持续时间为407秒,TTS NTG组和硝苯地平SR组分别为523秒(增加28%)和485秒(增加19%);而在第8小时,安慰剂组为375秒,TTS NTG组和硝苯地平SR组分别为515秒(增加37%)和457秒(增加21%)。维拉帕米后的运动持续时间与安慰剂组相似。与安慰剂相比,在两个观察时间点,TTS NTG和硝苯地平的最大工作量和总做功均显著更高,但维拉帕米后未见显著差异。所有测试治疗后的运动高峰收缩压几乎相同。与安慰剂相比,TTS NTG和硝苯地平的运动高峰心率和压力心率乘积均显著更高,而维拉帕米后的数值与安慰剂后无差异。(摘要截短至250字)