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) mmHg;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)mmHg,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)mmHg降至(20.3±9.2)mmHg和(33.4±13.1)mmHg降至(24.1±10.4)mmHg,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。
Abstract
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) mmHg and (8.9±4.0)/(9.2±5.2) mmHg, 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) mmHg, respectively, with no significant differences between the two groups. In both groups, the MBPS was significantly reduced after treatment(from (31.3±10.2) mmHg to (20.3±9.2) mmHg and (33.4±13.1) mmHg to (24.1±10.4) mmHg, 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.
关键词
奥美沙坦酯 /
高血压 /
动态血压监测 /
晨峰血压 /
服药末6 h血压
{{custom_keyword}} /
Key words
olmesartan /
hypertension /
ambulatory blood pressure monitoring /
morning blood pressure surge /
blood pressure 6 h after dosing
{{custom_keyword}} /
中图分类号：
R969.4
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
BLIZIOTIS I A, DESTOUNIS A, STERGIOU G S. Home versus ambulatory and office blood pressure in predicting target organ damage in hypertension: A systematic review and meta-analysis . J Hypertens, 2012, 30(7): 1289-1299.
Writing Group of 2010 Chinese Guidlines for the Management of Hypertension.2010 Chinese Guidelines for the Management of hypertension. Chin Hypertens J(中华高血压杂志), 2011, 19(8): 701-743.
WILLIAMS B, GOSSE P, LOWE L, et al. The prospective, randomized investigation of the safety and efficacy of telmisartan versus ramipril using ambulatory blood pressure monitoring(PRISMA I). J Hypertens,2006,24(1):193-200.
LACOURCIRE Y, NEUTEL J M, SCHUMACHER H. Comparison of fixed-dose combinations of telmisartan/hydrochlorothiazide 40/12.5 mg and 80/12.5 mg and a fixed-dose combination of losartan/hydrochlorothiazide 50/12.5 mg in mild to moderate essential hypertension: Pooled analysis of two multicenter, prospective, randomized, open-label, blinded-end point (PROBE) trials.Clin Ther,2005,27(11):1795-1805.
MANCIA G, FAGARD R, NARKIEWICZ K,et al. 2013 ESH/ESC practice guidelines for the management of arterial hypertension. Blood Press,2014,23(1):3-16.
MAHMOUD K D, DE SMET B J, ZIJLSTRA F, et al. Sudden cardiac death: Epidemiology, circadian variation, and triggers. Curr Probl Cardiol,2011,36(2):56-80.
SATOH M, KIKUYA M, OHKUBO T, et al. Aldosterone-to-renin ratio and nocturnal blood pressure decline in a general population: The Ohasama study. J Hypertens,2011,29(10):1940-1947.
SMITH D H, DUBIEL R, JONES M. Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: A comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Am J Cardiovasc Drugs,2005,5(1):41-50.
ZHOU Y M, DONG Y L, DONG W H, et al. The logic regression analysis about antihypertensive drug utilization and influence factors of hospitalized patients. Chin Pharm J(中国药学杂志),2009,44(1):67-69.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
PDF(666 KB)
