奥美沙坦酯治疗原发性高血压的疗效及安全性

Efficacy and safety of olmesartan medoxomil in patients with mild to moderate essential hypertension

目的观察血管紧张素Ⅱ受体拮抗剂奥美沙坦酯治疗轻、中度原发性高血压(EH)的疗效和安全性。方法采用前瞻性、随机双盲、阳性药物对照研究方法,将40例轻、中度EH患者随机分为奥美沙坦酯组(n=20)与氯沙坦组(n=20),分别经安慰剂洗脱2周后,患者每天口服1次奥美沙坦酯20mg或氯沙坦50mg,若4周后患者坐位舒张压(DBP)≥90mmHg,则剂量加倍后治疗至8周。每2周观察血压、心率变化及不良反应的发生情况;比较治疗前后血尿常规、血生化指标及心电图改变。结果治疗8周后,与基线血压比较,奥美沙坦酯组与氯沙坦组血压均显著下降(P<0.01),但两组间降压幅度无统计学差异(P>0.05);两组降压总有效率分别为64.21%和60.0%,无统计学差异(P>0.05)。两组治疗前后心率及血生化指标均无显著改变(P>0.05),亦无不良反应发生。结论奥美沙坦酯能有效降低轻、中度EH患者的血压,疗效与氯沙坦相似,具有良好的安全性。

Objective To investigate the efficacy and safety of olmesartan medoxomil in patients with mild to moderate essential hypertension. Methods In the prospective double-blind randomized controlled study, 40 patients with sitting DBP≥ 90 mmHg at the end of 2-week placebo wash-out period were randomized to olmesartan medoxomil （ n = 20） or losartan group （n = 20）. The enrolled patients received olmesartan medoxomil 20 mg or losartan 50 mg once daily for 4 weeks. For the patients with an unsatisfactory blood pressure response （sitting DBP≥90 mmHg） , the dosage of medicine was doubled until the 8th week in both groups. Blood pressure and heart rate were measured every 2 weeks, and blood and urine routine, biochemical indexes and electrocardiogram were assessed at baseline and end of the treatment. Results Eight weeks after treatment, the blood pressure was significantly decreased from baseline in both groups（P 〈0.01）. However, there was no significant difference in the therapeutic effect between the two groups （ P 〉 0.05 ）. The total effective rates were 64.21% in olmesartan medoxomil group and 60.0% in losartan group with no significant difference between the two groups （P〉0.05）. No significant changes were found in laboratory tests and heart rate（P 〉0.05）, and no adverse events were observed in both groups. Conclusion Like losartan, olmesartan medoxomil has a favorable antihypertensive effect and is safe in the treatment of mild to moderate essential hypertension.