动态血压监测评价国产奥美沙坦酯对轻、中度原发性高血压患者的降压疗效及对血压晨峰的影响

Evaluation of Antihypertensive Effects of Domestic Olmesartan Tablets on Morning Blood Pressure Surge By Ambulatory Blood Pressure Monitoring in Patients with Mild to Moderate Essential Hypertension

目的采用24 h动态血压监测(ABPM)评价国产奥美沙坦酯片对轻、中度原发性高血压患者的降压疗效、血压晨峰(MBPS)和服药末6 h血压的影响。方法随机双盲双模拟活性药对照临床试验,试验组24例患者口服奥美沙坦酯20 mg+日本产奥美沙坦酯(傲坦)安慰剂1片,对照组24例口服傲坦20 mg+奥美沙坦酯安慰剂1片,观察治疗前后动态血压、血压晨峰和服药末6 h血压的变化。结果治疗8周后,试验组、对照组24 h血压降幅分别为(8.8±3.0)/(10.8±2.8)vs(8.9±4.0)/(9.2±5.2)mm Hg;服药末6 h血压降幅为(10.5±10.9/12.2±8.1)vs(11.2±8.4/12.6±8.5)mm Hg,均较治疗前显著降低(P<0.01),两组降幅差异均无显著性(P>0.05);平均血压晨峰分别从(31.3±10.2)mm Hg降至(20.3±9.2)mm Hg和(33.4±13.1)mm Hg降至(24.1±10.4)mm Hg,均显著下降(P<0.01)。结论国产奥美沙坦酯治疗轻、中度原发性高血压患者能有效降低24 h血压、晨峰血压和服药末6 h血压,其降压幅度与傲坦比较差异无统计学意义。

OBJECTIVE To evaluate the effects of domestic olmesartan medoxomil tablets on 24 h ambulatory blood pressure,morning blood pressure surge（ MBPS）,and blood pressure at 6 h after dosing in patients with mild to moderate hypertension. METHODS A randomized,double-blind,double-mimic controlled trial was performed. Forty-eight patients were randomly assigned to treatment group（ domestic olmesartan tablets） or control group（ Olmetec）. The 24 h ambulatory blood pressure was monitored at the end of the trial. RESULTS The mean 24 h systolic / diastolic blood pressures of the treatment and control groups were significantly reduced by（ 8. 8 ± 3. 0） /（ 10. 8 ± 2. 8） mm Hg and（ 8. 9 ± 4. 0） /（ 9. 2 ± 5. 2） mm Hg,respectively,and the mean systolic / diastolic blood pressure at 6 h after dosing significantly reduced by（ 10. 5 ± 10. 9） /（ 12. 2 ± 8. 1） and（ 11. 2 ± 8. 4） /（ 12. 6 ± 8. 5） mm Hg,respectively,with no significant differences between the two groups. In both groups,the MBPS was significantly reduced after treatment（ from（ 31. 3 ± 10. 2） mm Hg to（ 20. 3 ± 9. 2） mm Hg and（ 33. 4 ± 13. 1） mm Hg to（ 24. 1 ± 10. 4） mm Hg,respectively）. CONCLUSION Administration of domestic olmesartan medoxomil tablets once daily can significantly reduce 24 h blood pressure,morning blood surge and blood pressure at 6 h after dosing in patients with mild to moderate essential hypertension.