Galderisi M, Petrocelli A, Garofalo M, Celentano A, Alfieri A, de Divitiis O
Clinical Methodology, Federico II University of Naples, Italy.
J Int Med Res. 1995 Jul-Aug;23(4):234-43. doi: 10.1177/030006059502300403.
In this single-blind crossover study the antihypertensive efficacies of two dihydropyridine calcium antagonists, sustained-release isradipine and lacidipine, were compared using clinic and ambulatory blood-pressure measurements. After a 2-week placebo wash-out, 34 patients (19 men, 15 women, mean age 49 years) with mild to moderate hypertension (diastolic blood pressure range 95-110 mmHg) were treated with 5 mg sustained-release isradipine for 4 weeks and 4 mg lacidipine for 4 weeks in a random order. Medications were taken once daily at 08.00 h. Clinic and ambulatory blood pressures were recorded at the end of each placebo or treatment period. Two patients stopped isradipine and six lacidipine because of severe adverse effects. Clinic systolic and diastolic blood pressures decreased by an average of 17/14 mmHg with isradipine and 17/13 mmHg with lacidipine, compared with placebo (P < 0.01 in both cases), without a change in heart rate. Mean ambulatory 24-h and daytime systolic and diastolic blood pressure were significantly reduced by sustained-release isradipine and lacidipine (P < 0.05 and P < 0.01, respectively). At night systolic blood pressure fell compared with placebo (P < 0.05 with both drugs) whereas the reduction in diastolic blood pressure was not statistically significant. Mean 24-h heart rate remained unchanged. Blood-pressure variability did not differ significantly between the two drugs or between either drug and the placebo. The antihypertensive effects of sustained-release isradipine and lacidipine were similar, but the tolerability of isradipine appears to be greater since it caused fewer withdrawals.
在这项单盲交叉研究中，使用临床和动态血压测量方法比较了两种二氢吡啶类钙拮抗剂（缓释伊拉地平与拉西地平）的降压效果。在为期2周的安慰剂洗脱期后，34例轻度至中度高血压患者（19例男性，15例女性，平均年龄49岁，舒张压范围为95 - 110 mmHg）被随机安排接受4周的5 mg缓释伊拉地平治疗和4周的4 mg拉西地平治疗。药物均于每日08:00服用一次。在每个安慰剂或治疗期结束时记录临床和动态血压。2例患者因严重不良反应停用伊拉地平，6例停用拉西地平。与安慰剂相比，伊拉地平使临床收缩压和舒张压平均降低17/14 mmHg，拉西地平降低17/13 mmHg（两种情况P均<0.01），心率无变化。缓释伊拉地平和拉西地平均显著降低动态24小时及日间收缩压和舒张压（分别为P<0.05和P<0.01）。夜间收缩压与安慰剂相比下降（两种药物均P<0.05），而舒张压下降无统计学意义。24小时平均心率保持不变。两种药物之间以及任何一种药物与安慰剂之间的血压变异性无显著差异。缓释伊拉地平和拉西地平的降压效果相似，但伊拉地平的耐受性似乎更好，因为其导致的停药情况较少。
