国产奥美沙坦单药治疗轻、中度原发性高血压的疗效和安全性

Antihypertensive efficacy and safety of domestic olmesartan monotherapy in mild or moderate essential hypertension

目的评价国产奥美沙坦单药治疗轻、中度原发性高血压的疗效和安全性。方法选择68例轻、中度原发性高血压患者,随机、单盲、平行对照分成奥美沙坦组和氯沙坦组,分别口服奥美沙坦(20 mg／次,每天1次)或氯沙坦(50 mg／次,每天1次),治疗4周末若坐位舒张压≥90 mm Hg(1 mm Hg=0．133 kPa),则药物剂量加倍,再治疗4周,即共治疗8周。每2周随访1次,观察国产奥美沙坦的降压效果和不良反应。奥美沙坦组中的14例患者还观察治疗前、后24 h动态血压变化,并计算谷峰比值。结果治疗8周后,奥美沙坦组的收缩压和舒张压分别下降(24．3±9．5)和(17．6±4．9)mm Hg,治疗总有效率为82．4％,与氯沙坦组[(22．1±10．1)和(16．8±14．7)mm Hg,76．5％]的差异无统计学意义(P值均>0．05)。奥美沙坦组患者的24 h动态血压降压曲线平稳,收缩压和舒张压的谷峰比值分别为58．2％和60．1％。奥美沙坦组的不良反应发生率为2．9％,与氯沙坦组(8．8％)的差异无统计学意义(P>0．05)。结论国产奥美沙坦单药治疗(20～40 mg／d)能有效、平稳、持续而安全地降低轻、中度高血压患者的血压。

Objective To assess the antihypertensive efficacy and sai＇ety of domestic olmesartan monotherapy in patients with mild or moderate essential hypertension （EH）. Melhods Sixty-eight patients with mild or moderate EH were allocated with once daily oral treatment of starting dosages of domestic olmesartan 20 mg/d, or losartan 50 mg/d for 8 weeks in a randomized monoblind, paralleded and controlled trial. The dosages of these two drugs were doubled after 4 weeks in the patients whose seated diastolic blood pressure （DBP） were still ≥90 mm Hg （1 mm Hg = 0. 133 kPa）. All patients were followed up every two weeks to observe the efficacy and adverse effects（AEs）. 24 h ambulatory blood pressure monitoring（ABPM） was performed in 14 patients in the domestic olmesartan group before and after the 8 week therapy to calculate the trough-peak ratio. Results After 8-week treatment, 20-40 mg/d domestic olmesartan monotherapy showed significantly decrease of both seated systolic blood pressure by （24.3 ± 9.5） mm Hg and seated DBP by （17.6 ± 4.9） mm Hg with a response rate of 82.4%（P 〈0.01）. The antihypertensive efficacy of 20-40 mg/d domestic olmesartan was similar to that of 50- 100 mg losartan （P 〉 0.05）. In terms of the 24 h ABPM, 20-40 mg/d domestic olmesartan monotherapy exhibited a sustained 24-h BP reduction profile with the trough to-peak ratios of 58. 2% and 60. 1% for SBP and DBP, respectively. The incidence of AEs for domestic olmesartan was 2. 9%, showing no significant difference with losartan. Conclusion The domestic olmesartan monotherapy（20-40 mg/d） provides a safe, effective and stable antihypertensive efficacy in patients with mild-to-moderate EH.