Naafs M A, de Boer A C, Koster R W, Klazen C W, Dunning A J
Eur Heart J. 1984 Sep;5(9):705-9. doi: 10.1093/oxfordjournals.eurheartj.a061730.
Transdermally delivered nitroglycerin (TTS-NTG) through a rate-controlling membrane yields stable blood levels for 24 h. We studied the effect of TTS-NTG (25 mg per 10 cm2) on exercise induced angina in 10 patients with stable angina pectoris, all in NYHA class III, who were not under treatment with other cardiac drugs. In a pre-study exercise test, all patients had angina pectoris and more than one mm ST depression. The study was placebo controlled and double blind with a randomized cross-over. Exercise tests were carried out on a treadmill according to the Bruce-protocol, 12 to 16 h after administration of TTS-NTG or of an identical placebo. After a 48 h wash-out period, the procedure was repeated after application of a plaster with the alternative content. A significant improvement was seen on TTS nitroglycerin compared with placebo in the total duration of exercise (7.2 +/- 3.6 min (mean +/- SD) vs 6.2 +/- 3.8 min; P less than 0.002). In 7 patients, the time to onset of angina was extended by TTS nitroglycerin. Maximal ST depression (lead V4 and V6) was significantly lower on TTS nitroglycerin (1.85 +/- 1 mm) compared with placebo (2.2 +/- 1 mm; P less than 0.05). It is concluded that 12 to 16 h after administration, transdermally delivered nitroglycerin improves exercise capacity and reduces maximal ST depression in patients with stable angina.
通过控速膜经皮递送的硝酸甘油(TTS-NTG)可产生持续24小时的稳定血药浓度。我们研究了TTS-NTG(每10平方厘米25毫克)对10例稳定型心绞痛患者运动诱发心绞痛的影响,这些患者均为纽约心脏协会(NYHA)III级,且未接受其他心脏药物治疗。在一项预研究运动试验中,所有患者均有心绞痛且ST段压低超过1毫米。该研究采用安慰剂对照、双盲随机交叉设计。在给予TTS-NTG或相同安慰剂12至16小时后,根据布鲁斯方案在跑步机上进行运动试验。经过48小时的洗脱期后,使用含替代成分的贴剂重复该过程。与安慰剂相比,TTS硝酸甘油组的总运动持续时间有显著改善(7.2±3.6分钟(平均值±标准差)对6.2±3.8分钟;P<0.002)。7例患者中,TTS硝酸甘油延长了心绞痛发作时间。与安慰剂(2.2±1毫米)相比,TTS硝酸甘油组的最大ST段压低(V4和V6导联)显著更低(1.85±1毫米;P<0.05)。结论是,给药12至16小时后,经皮递送的硝酸甘油可改善稳定型心绞痛患者的运动能力并降低最大ST段压低。