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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。
OBJECTIVE: To evaluate the antihypertensive effect and tolerability of lercanidipine, a new calcium channel blocker, in mild to moderate hypertensive patients in China. METHODS: This multicenter, randomized, amlodipine-controlled clinical trial consisted of two phases, the first eight weeks being a double-blind phase and the second 16 weeks being an open trial. Two hundred and forty cases of hypertensive patients with sitting diastolic pressure between 12 and 14.67kPa were randomly assigned to receive either lercanidipine or amlodipine. Double-blind 8-week treatment at the end of sitting diastolic blood pressure ≤ 11.33kPa who continue to maintain the original treatment of drugs and doses to 24 weeks of treatment. Results: Fifty-two patients in the lercanidipine group and 60 patients in the amlodipine group actually completed the 24-week treatment. At the end of treatment, significant and similar decreases in blood pressure were observed in patients receiving lercanidipine and amlodipine, which were 2.77 / 2.11 kPa and 2.79 / 2.17 kPa, respectively (P> 0.05) The drop is similar (2.50 / 1.99kPa and 2.40 / 2.04kPa). In 8 weeks of treatment-effective patients, 42.3% of patients in the lercanidipine group and 41.3% of patients in the amlodipine group experienced adverse events, manifested as dizziness, palpitations and edema, all of which were mild. Conclusions: Lecadipine is similar to amlodipine and has a stable and well tolerated antihypertensive efficacy in patients with mild to moderate hypertension in our country.