Wang X, Gong L, Guo J, Wang X, Liu Y, Ye X, Zhang G, Yang P
Shanghai Institute of Hypertension, Riu Jin Hospital, Shanghai Second Medical University, China.
J Hypertens Suppl. 1998 Sep;16(4):S43-7.
To compare the blood pressure effects of two dihydropyridine calcium channel blockers, amlodipine and nitrendipine, in 488 patients with essential hypertension.
The study used a randomized, single-blind design of 4 weeks' duration conducted at four medical centres in China. Patients were randomized to receive either amlodipine monotherapy (5-10 mg once daily; n = 334) or nitrendipine (10 mg twice or three times daily; n = 1 54). Blood pressure was evaluated by standard blood pressure measurements before and after treatment, and by 24 h ambulatory blood pressure monitoring in a subgroup of patients (n = 18).
Both systolic and diastolic blood pressures were reduced from baseline after 4 weeks of amlodipine and nitrendipine monotherapy. Diastolic blood pressure was reduced by 14.4% in the amlodipine group, which was significantly better than the 13.0% reduction in the nitrendipine group (P< 0.05). In addition, blood pressure response rates were significantly better with amlodipine monotherapy than with nitrendipine monotherapy. In the subgroup of patients undergoing 24 h ambulatory blood pressure monitoring, both systolic and diastolic blood pressure were reduced from baseline in the amlodipine and nitrendipine groups. Adverse effects were generally mild, with dizziness, flushing, palpitation, headache, drowsiness and ankle oedema being the most common. Rushing and headache were more frequent in the nitrendipine group than in the amlodipine group (P< 0.05 for flushing and P<0.01 for headache).
Amlodipine monotherapy reduced blood pressure more effectively than nitrendipine monotherapy in patients with essential hypertension and was associated with fewer adverse events.
比较两种二氢吡啶类钙通道阻滞剂氨氯地平和尼群地平对488例原发性高血压患者的血压影响。
本研究采用随机、单盲设计，在中国的四个医疗中心进行，为期4周。患者被随机分为接受氨氯地平单药治疗组（5 - 10毫克，每日一次；n = 334）或尼群地平组（10毫克，每日两次或三次；n = 154）。治疗前后通过标准血压测量评估血压，并在一组亚组患者（n = 18）中通过24小时动态血压监测进行评估。
氨氯地平和尼群地平单药治疗4周后，收缩压和舒张压均较基线水平降低。氨氯地平组舒张压降低了14.4%，显著优于尼群地平组的13.0%降低幅度（P < 0.05）。此外，氨氯地平单药治疗的血压反应率显著优于尼群地平单药治疗。在接受24小时动态血压监测的亚组患者中，氨氯地平和尼群地平组的收缩压和舒张压均较基线水平降低。不良反应一般较轻，最常见的是头晕、潮红、心悸、头痛、嗜睡和踝部水肿。尼群地平组的潮红和头痛比氨氯地平组更频繁（潮红P < 0.05，头痛P < 0.01）。
在原发性高血压患者中，氨氯地平单药治疗比尼群地平单药治疗更有效地降低血压，且不良事件更少。
