奥美沙坦酯片治疗轻中度原发性高血压的疗效和安全性

Effects and safety of mild and moderate primary hypertension treated with olmesartan medoxomil tablet

目的评价国产奥美沙坦酯片治疗轻中度原发性高血压的疗效和安全性。方法用随机双盲双模拟多中心活性药对照的试验设计,符合入选条件的221例轻中度原发性高血压患者随机分为奥美沙坦酯组和氯沙坦组,治疗8周,观察2组治疗前后的血压、心率、心电图和血尿实验室检查的变化。动态血压用开放试验方法,分别在安慰剂末期和治疗期结束时(未停药),做24h动态血压监测。结果奥美沙坦组与氯沙坦组比较,平均坐位收缩压和舒张压降低程度都有显著性差异,分别为17.22vs11.02mmHg,(P<0.01);13.41vs11.18mmHg(P<0.05)。奥美沙坦组降压总有效率为82.41%;每日1次服用奥美沙坦酯片作用可持续24h,药物降低收缩压和舒张压的谷峰比值均>50%。2组药物不良反应发生率分别为3.5%,5.4%,2组比较无显著性差别。结论国产奥美沙坦酯片治疗轻中度原发性高血压患者,能24h平稳降压,谷峰比满意,且耐受性较好。

Objective To evaluate the effect and safety of olmesartan medoxomil in the treatment of patients with mild to moderate primary hypertension. Methods A randomized, double- blind, double- mimic controlled trial was performed. Two hundreds twenty - one patients with mild to moderate primary hypertension were randomly into olmesartan group and losartan group. The changes of blood pressure, heart rate,electrocardiogram, blood and urinary laboratory examination were observed. Open method was used in the clinical trial of ambulatory blood pressure. The 24 - hour ambulatory blood pressure monitoring was investigated at the end of placebo and treatment period. Results ITT analysis, reduction in both systolic and diastolic blood pressure has significantly difference between two groups. In olmesartan and losartan group, the reduction of systolic blood pressure was 17.22 mmHg and 11.02 mmHg,separately. The reduction of diastolic blood pressure was 13.41 mmHg and 11.18 mmHg, separately. Normotension was achieved in 82.41% in olmesartan group. The antihypertensive effect of olmesartan can cover over 24 hours. The trough to peak ratios for systolic and diastolic blood pressure by olmesartan were all more than 50%. Adverse reactions were observed in 3.57%, 5.4% of patients in the two groups （ P 〉 0. 05 ）.Conclusion The effect of olmesartan once daily can maintain for 24 hours. The trough to peak ratio is satisfied. Olmesartan is safe and effective for the treatment of mild to moderate hypertension.