【摘要】 目的:评价新型钙通道阻滞剂乐卡地平在中国轻中度高血压患者中的降压疗效和耐受性。方法:本研究为多中心、随机、氨氯地平对照临床试验,由二阶段组成,前8周为双盲阶段,后16周为开放试验。240例导入期末坐位舒张压在12～14.67kPa的高血压患者随机分入乐卡地平组或氨氯地平组接受治疗。双盲8周治疗末坐位舒张压≤11.33kPa者继续按原治疗药物和剂量维持治疗至24周末。结果:乐卡地平组有52例、氨氯地平组有60例患者实际完成24周治疗。在治疗末,乐卡地平组和氨氯地平组患者均获得显著而且相似的血压下降幅度,分别为2.77/2.11kPa和2.79/2.17kPa(P>0.05),各组均与8周末获得的血压下降幅度相似(2.50/1.99kPa和2.40/2.04kPa)。8周治疗有效的患者中,乐卡地平组有42.3％、氨氯地平组有41.3％的患者出现不良事件,具体表现为头晕、心悸和水肿,均为轻度。结论:乐卡地平与氨氯地平相似,在我国轻中度高血压患者中长期应用降压疗效稳定,耐受性好。更多还原

【Abstract】 Objective:To assess the long-term efficacy and tolerability of lercanidipine,a new di-hydropyrimidine, in Chinese with mild to moderate essential hypertension. Methods: There were 2 stages in this multicenter, randomized, and active-controlled study. The first 8 weeks was designed as double blinded and the latter 16 weeks was open-label. 240 patients with a sitting DBP of 12-14.67 kPa at the end of run-in period were recruited into the study. They were randomized to receive lercanidipine or amlodipine, No other agents with influence on blood pressure were permitted to receive. Patients with a sitting DBP≤11. 33kPa in the end of the 8th week were kept on therapy with original a-gents and dosage in the latter 16 weeks. Results:52 patients in lercanidipine group and 60 patients in the control group finished the 24 weeks study. At the end of the study,the sitting SBP and DBP were similar and were significantly decreased by lercanidipine and amldipine. After 24 week therapy, the SBP /DBF ratio was 2. 77/2.11kPa for lercanidipine and 2. 79/2. 17kPa for amlodipine, which were similar to those after 8 week therapy (2. 50/1.99kPa for lercanidipine and 2.40/2.04kPa for amlodipine). Among patients responded to the first 8 week treatment, 94. 2 % of them in lercanidipine group and 93.3% in amlodipine group remained effectiveness (P>0.05).The incidence of adverse events was 42.3% for lercanidipine group and 41.3% for amlodipine group. Conclusion:Similar to amlodip-ine,lercanidipine is effective in long-term treatment of mild to moderate hypertension in Chinese.更多还原