Weisbort J, Meshulam N, Binjamini M, Zerikier F, Brunner D
Z Kardiol. 1986;75 Suppl 3:96-9.
The efficacy of a once daily transdermally applied nitroglycerin system and of sustained release nitroglycerin capsules was assessed by ergometer stress testing in 12 patients with stable angina pectoris in a double-blind crossover study. In the morning the patients received transdermally applied nitroglycerin (TDS) which delivered 5.0 mg nitroglycerin in 24 hours together with a placebo capsule, respectively 1 nitroglycerin (NTR) capsule of 2.5 mg together with a plaster placebo. In the evening the first treatment group received 2 placebo capsules, and the second group 1 NTR capsule and 1 placebo capsule. Each period lasted 14 days. The patients performed a pre-medication ergometer stress test and repeated the test on the first and 14th day of each treatment period, 1 and 24 hours after medication. At the end of the second period all patients continued in an open study with TDS once a day for a further three months. Minor degrees of ST-segment depression, and in fewer patients, were observed at comparable workloads in the treatment tests compared with the pre-medication tests. The improvement after TDS on the first and last day of each period, 1 and 24 hours after medication, was significant and more marked than with NTR. The latter did not reach significance. Furthermore, increase of work capacity and elevation of angina threshold was greater with TDS than with NTR. Similar results were found at the end of the open study after 3 months' treatment with TDS. No development of tolerance was observed.
在一项双盲交叉研究中,通过测力计应激试验评估了每日一次经皮应用硝酸甘油系统和缓释硝酸甘油胶囊对12例稳定型心绞痛患者的疗效。早晨,患者分别接受24小时释放5.0毫克硝酸甘油的经皮应用硝酸甘油(TDS)及安慰剂胶囊,或2.5毫克硝酸甘油胶囊及安慰剂贴剂。晚上,第一治疗组接受2粒安慰剂胶囊,第二组接受1粒硝酸甘油(NTR)胶囊和1粒安慰剂胶囊。每个疗程持续14天。患者在用药前进行测力计应激试验,并在每个治疗疗程的第1天和第14天、用药后1小时和24小时重复该试验。在第二疗程结束时,所有患者继续进行开放研究,每天使用TDS,持续三个月。与用药前试验相比,在治疗试验中,在相当的工作量下观察到较小程度的ST段压低,且出现这种情况的患者较少。每个疗程用药后1小时和24小时的第一天和最后一天,TDS后的改善显著且比NTR更明显。后者未达到显著水平。此外,TDS使工作能力的增加和心绞痛阈值的提高比NTR更大。在开放研究结束时,经过3个月的TDS治疗也发现了类似结果。未观察到耐受性的发展。