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目的 研究新型钙拮抗剂乐卡地平在我国治疗高血压患者中的疗效和安全性。方法采用多中心、随机、双盲、氨氯地平对照方法 ,2 40例患者按 1∶1随机分入乐卡地平组或氨氯地平组 ,每天一次口服乐卡地平 10mg或氨氯地平 5mg ,4周或 6周后若患者坐位舒张压 >85mmHg(1mmHg= 0 13 3kPa)则增加剂量至乐卡地平 2 0mg或氨氯地平 10mg ,共治疗 8周。 结果 8周末 ,两组患者坐位平均收缩压和舒张压均较治疗前有显著下降 ,乐卡地平组收缩压 /舒张压下降幅度为 17 2 /11 9mmHg ,氨氯地平组为 16 5/ 12 4mmHg ,P >0 0 5,两组的降压总有效率分别为 73 4%和77 3 % (P =0 50 6) ,副作用发生率分别为 41 2 %和 3 7 0 % ,主要表现为头痛、头晕、心悸等 ,程度较轻。对 2 2例乐卡地平组患者作动态血压资料分析 ,8周末 ,2 4h、白天和夜间平均收缩压 /舒张压均比治疗前显著下降 ,收缩压和舒张压的谷峰比值分别为 56%和 51%。结论 乐卡地平控制血压的疗效和耐受性与氨氯地平相似 ,每天一次服药能平稳控制高血压患者 2 4h血压
Objective To study the efficacy and safety of the new calcium antagonist lercanidip in treating hypertensive patients in China. Methods A multicenter, randomized, double-blind, amlodipine-based approach was used. Two hundred and forty patients were randomized to either lercanidipine or amlodipine at a 1: 1 dose of either 10 mg of lercanidipine or 5 mg of amlodipine once daily. After 4 weeks or 6 weeks, if the patient’s sitting diastolic blood pressure> 85mmHg (1mmHg = 0133kPa), the dose was increased to 20mg lercanidipine or amlodipine 10mg for 8 weeks. Results At the end of the 8th week, the average systolic and diastolic blood pressures decreased significantly in both groups compared with those before treatment. The systolic blood pressure and diastolic blood pressure were decreased by 17 2/11 9mmHg in the lercanidipine group and 16 5 / 124mmHg in the amlodipine group , P> 0.05. The total effective rates of the two groups were 73.4% and 77.3%, respectively (P = 0 50 6). The incidence rates of side effects were 41.2% and 37.0% respectively. The main symptoms were headache , Dizziness, palpitations, etc., to a lesser extent. In 22 cases of lercanidipine group of patients with ambulatory blood pressure data analysis, 8 weekend, 24 h, day and night mean systolic blood pressure / diastolic blood pressure were significantly lower than before treatment, systolic blood pressure and diastolic blood pressure were 56% And 51%. Conclusions The efficacy and tolerability of lercanidipine in controlling blood pressure are similar to that of amlodipine. The daily administration of lercanidipine can control the blood pressure of 24 hours in hypertensive patients