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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 effect of domestic olmesartan medoxomil on the antihypertensive efficacy, blood pressure morning peak (MBPS) and blood pressure at the end of 6 h in patients with mild or moderate essential hypertension by 24 h ambulatory blood pressure monitoring (ABPM). Methods A randomized, double-blind, double-dummy active drug control clinical trial was conducted. Twenty-four patients in the experimental group were given either olmesartan medoxomil 20 mg plus Japanese-made olmesartan medoxomil (placebo) Tamsulosin placebo 1 tablets, observed before and after treatment ambulatory blood pressure, blood pressure morning peak and medication at the end of 6 h blood pressure changes. Results After 8 weeks of treatment, the decrease of blood pressure in the experimental group and the control group was (8.8 ± 3.0) / (10.8 ± 2.8) vs (8.9 ± 4.0) / (9.2 ± 5.2) mm Hg for 24 h (10.5 ± 10.9 / 12.2 ± 8.1) vs (11.2 ± 8.4 / 12.6 ± 8.5) mm Hg, respectively, which were significantly lower than those before treatment (P <0.01). There was no significant difference between the two groups (P> 0.05) The morning peak decreased significantly 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 (P <0.01). Conclusion Domestic olmesartan medoxomil treatment of mild to moderate essential hypertension patients can effectively reduce 24 h blood pressure, morning peak blood pressure and medication at the end of 6 h blood pressure, the antihypertensive rate was no significant difference compared with the proud Tanzania.