马来酸左旋氨氯地平与苯磺酸氨氯地平治疗轻中度原发性高血压

Comparison of Effects and Safety of L-amlodipine Maleate and Amlodipine Besylate in Patients with Mild to Moderate Primary Hypertension

目的评价马来酸左旋氨氯地平治疗轻中度原发性高血压的有效性和安全性。方法符合标准的轻中度原发性高血压患者共204例,按随机、双盲、对照的原则,经2周的安慰剂导入期后,分为马来酸左旋氨氯地平组(初始剂量2.5mg/d,n=101)、苯磺酸氨氯地平组(初始剂量5mg/d,n=103),4周后达目标血压者(坐位血压<140/90mmHg),继续服用至试验结束,未达目标血压者加量1倍,即左旋氨氯地平5mg/d,氨氯地平10mg/d,继续观察4周。总观察期为10周。受试者中随机选择69例分别于双盲治疗前后查24h动态血压(ABPM)。结果 4和8周后总有效率:马来酸左旋氨氯地平组分别为67.01%,91.58%,苯磺酸氨氯地平组分别为66.67%,88.42%,两组疗效的差异无统计学意义(P>0.05)。通过ABPM计算出两种药物收缩压及舒张压的谷峰比值和平滑指数,结果显示两药在收缩压及舒张压的谷峰比值均>50%,平滑指数均>1,两组间的差异均无统计学意义(均P>0.05)。药物相关的不良事件发生率分别为马来酸左旋氨氯地平组10.89%、苯磺酸氨氯地平组14.56%,两组发生率差异无统计学意义,无严重不良事件。结论马来酸左旋氨氯地平与苯磺酸氨氯地平对轻中度原发性高血压均具平稳长效的降压疗效,具有相同的安全性。

Objective To evaluate the effectiveness and safety of L-amlodipine maleate in patients with mild to moderate essential hypertension. Methods A total of 204 mild to moderate essential hypertensives was enrolled and randomized into two groups and were given L-amlodipine maleate (Xuan Ning) and amlodipine besylate(Norvasc) on the principle of double-blind and placebo control. After 2 weeks placebo washing out,both amlodipines were given for 4 weeks. The initial dose of L-amlodipine was 2.5 mg/d (n=101) and amlodipine besylate was 5 mg/d (n=103). For those whose target blood pressure was achieved at sitting blood pressure 0.05). The systolic and diastolic blood pressure trough peak ratio and smoothness index based on ABPM showed that the trough/peak ratio of the systolic blood pressure and diastolic blood pressure were >50%,and smoothness index was >1 in both of the drugs treated groups. No statistically significant difference of trough/peak ratio and smoothness index between two groups were found(all P>0.05). Drug-related adverse events rates were 10.89% in L-amlodipine and 14.56% in amlodipine besylate group (P>0.05),and no serious adverse events were found. Conclusion BothL-amlodipine maleate and amlodipine besylate have a stable and long-lasting antihy-pertensive effect in mild to moderate essential hypertension with the comparable safety.