Steffensen R, Melchior T, Bech J, Nissen H, Haastrup B, Grande P, Rasmussen V, Hansen J F, Skagen K, Haghfelt T
The Heart Centre, National University Hospital, Rigshospitalet, Copenhagen, Denmark.
Cardiovasc Drugs Ther. 1997 Nov;11(5):629-35. doi: 10.1023/a:1007726722284.
This study was designed to compare once-daily administration of 5-10 mg amlodipine with two daily doses of 40 mg sustained-release isosorbide dinitrate in 59 patients with stable angina using a randomized, double-blind, crossover study design. Anginal episodes, nitroglycerin consumption, and possible adverse events were recorded in a diary. A maximal symptom-limited bicycle exercise test and 48-hour ambulatory ECG monitoring were performed at baseline and at the end of each 5-week period of therapy. Exercise time, time to angina, time to ST depression, and maximal ST depression were measured during exercise. During ambulatory monitoring, the number of ischemic episodes and the duration per hour of ST depression were assessed. Amlodipine significantly reduced anginal episodes (P < 0.001) when compared with isosorbide dinitrate. Furthermore, amlodipine prolonged time to ST depression (P < 0.001) and time to angina (P < 0.05) when compared with isosorbide dinitrate. The number and duration of ischemic episodes during ambulatory monitoring were significantly reduced with amlodipine when compared with baseline values (P < 0.05), whereas no differences were found between isosorbide dinitrate and baseline. Adverse events were reported more frequently with isosorbide dinitrate than with amlodipine (P < 0.02). Amlodipine appears to be more effective and tolerable than sustained-release isosorbide dinitrate as monotherapy for chronic stable angina.
本研究采用随机、双盲、交叉研究设计，旨在比较59例稳定型心绞痛患者每日一次服用5 - 10毫克氨氯地平和每日两次服用40毫克缓释硝酸异山梨酯的疗效。患者通过日记记录心绞痛发作情况、硝酸甘油服用量及可能出现的不良事件。在基线期以及每5周治疗期结束时，进行一次最大症状限制的自行车运动试验和48小时动态心电图监测。运动期间测量运动时间、心绞痛发作时间、ST段压低时间及最大ST段压低程度。动态监测期间，评估缺血发作次数及每小时ST段压低持续时间。与硝酸异山梨酯相比，氨氯地平能显著减少心绞痛发作次数（P < 0.001）。此外，与硝酸异山梨酯相比，氨氯地平可延长ST段压低时间（P < 0.001）和心绞痛发作时间（P < 0.05）。与基线值相比，氨氯地平可显著减少动态监测期间缺血发作的次数和持续时间（P < 0.05），而硝酸异山梨酯与基线值之间未发现差异。硝酸异山梨酯报告的不良事件比氨氯地平更频繁（P < 0.02）。作为慢性稳定型心绞痛的单一疗法，氨氯地平似乎比缓释硝酸异山梨酯更有效且耐受性更好。
