Lablanche J M, Bauters C, Leroy F, Bertrand M E
Hôpital Cardiologique, Université de Lille II, France.
J Cardiovasc Pharmacol. 1992;20 Suppl 3:S82-5. doi: 10.1097/00005344-199206203-00014.
The efficacy of nicorandil was compared with that of nifedipine in 13 patients with vasospastic angina enrolled in a randomized, placebo-controlled, crossover study. All patients had a coronary spasm during coronary arteriography, either spontaneously or ergometrine-induced. During two consecutive periods of 2 days, patients received active drugs or placebo in a randomized order. Each patient received single oral doses of 30 mg nicorandil, 10 mg nifedipine, and, on 2 days, a placebo. One hour after drug intake, patients underwent an ergometrine test with increasing doses of Methergin (ergometrine) (0.05, 0.10, 0.20, and 0.40 mg every 5 min). After placebo, the tests always were positive, and the ECG changes occurred at the same +/- 1 dose of ergometrine in 10 cases, showing good reproducibility. After nicorandil, the tests were negative in nine patients and positive for a higher or lower dose of ergometrine in three and one patient, respectively (p = 0.0034 vs. placebo). After nifedipine, the tests were negative in five patients and positive for a higher or the same dose of ergometrine in four and four patients, respectively (p = 0.0039 vs. placebo). Nifedipine (10 mg) and nicorandil (30 mg) were equally effective in eight patients; in the remaining five patients, nicorandil had better results (p = 0.06). Nicorandil (30 mg) prevents ergometrine-induced coronary spasm. This compound may be beneficial in patients with vasospastic angina.
在一项随机、安慰剂对照、交叉研究中，对13例血管痉挛性心绞痛患者比较了尼可地尔与硝苯地平的疗效。所有患者在冠状动脉造影期间均出现冠状动脉痉挛，痉挛可自发出现或由麦角新碱诱发。在连续两个2天的周期内，患者按随机顺序接受活性药物或安慰剂。每位患者分别单次口服30mg尼可地尔、10mg硝苯地平，并在2天内服用安慰剂。服药1小时后，患者接受麦角新碱试验，递增剂量静脉注射甲基麦角新碱（麦角新碱）（每5分钟0.05、0.10、0.20和0.40mg）。服用安慰剂后，试验总是呈阳性，10例患者在相同的±1剂量麦角新碱时出现心电图改变，显示出良好的可重复性。服用尼可地尔后，9例患者试验呈阴性，3例和1例患者分别在较高或较低剂量麦角新碱时试验呈阳性（与安慰剂相比，p = 0.0034）。服用硝苯地平后，5例患者试验呈阴性，4例和4例患者分别在较高或相同剂量麦角新碱时试验呈阳性（与安慰剂相比，p = 0.0039）。硝苯地平（10mg）和尼可地尔（30mg）在8例患者中疗效相当；在其余5例患者中，尼可地尔效果更好（p = 0.06）。尼可地尔（30mg）可预防麦角新碱诱发的冠状动脉痉挛。该化合物可能对血管痉挛性心绞痛患者有益。
