CAJ | 학술논문

目的以日本产奥美沙坦酯(傲坦)为对照,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血压变异(BPV)的影响.方法随机双盲双模拟活性药对照临床试验.试验组每日口服国产奥美沙坦酯20 mg+傲坦安慰剂1片,对照组口服傲坦20 mg+奥美沙坦酯安慰剂1片.2周后如诊室坐位血压＜ 140/90 mmHg(1 mmHg=0.133 kPa),维持原剂量;血压未达标者加量至奥美沙坦酯40 mg+傲坦安慰剂2片,或傲坦40 mg+奥美沙坦酯安慰剂2片,服药至8周末.在第0周和8周时分别进行24 h动态血压监测(ABPM),观察治疗前后动态血压和BPV的变化.结果 (1)治疗8周后,试验组和对照组24 h血压均较治疗前有显著下降(P＜0.01),降幅分别为(9±3)/(11±3)mmHg和(9±4)/(9±5) mmHg,差异无统计学意义(P＞0.05).(2)两组治疗前和治疗8周后的BPV的变化差异均无统计学意义(P＞0.05),试验组治疗前后的24 h血压标准差分别为(10±2)/(11 ±3) mmHg和(10±3)/(12±2) mmHg,对照组分别为(10±3)/(11±3) mmHg和(12±3)/(12 ±4) mmHg.(3)两组不良反应发生率分别为10.42％和8.33％,差异无统计学意义(P＞0.05).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24h血压,其降压幅度与傲坦差异无统计学意义.二者对BPV均无显著影响,其对BPV带来的变化差异无统计学意义.
목적 이일본산오미사탄지(오탄)위대조,평개국산오미사탄지대경、중도원발성고혈압환자적강압료효급혈압변이(BPV)적영향.방법 수궤쌍맹쌍모의활성약대조림상시험.시험조매일구복국산오미사탄지20 mg+오탄안위제1편,대조조구복오탄20 mg+오미사탄지안위제1편.2주후여진실좌위혈압＜ 140/90 mmHg(1 mmHg=0.133 kPa),유지원제량;혈압미체표자가량지오미사탄지40 mg+오탄안위제2편,혹오탄40 mg+오미사탄지안위제2편,복약지8주말.재제0주화8주시분별진행24 h동태혈압감측(ABPM),관찰치료전후동태혈압화BPV적변화.결과 (1)치료8주후,시험조화대조조24 h혈압균교치료전유현저하강(P＜0.01),강폭분별위(9±3)/(11±3)mmHg화(9±4)/(9±5) mmHg,차이무통계학의의(P＞0.05).(2)량조치료전화치료8주후적BPV적변화차이균무통계학의의(P＞0.05),시험조치료전후적24 h혈압표준차분별위(10±2)/(11 ±3) mmHg화(10±3)/(12±2) mmHg,대조조분별위(10±3)/(11±3) mmHg화(12±3)/(12 ±4) mmHg.(3)량조불량반응발생솔분별위10.42％화8.33％,차이무통계학의의(P＞0.05).결론 국산오미사탄지치료경、중도원발성고혈압환자능유효강저24h혈압,기강압폭도여오탄차이무통계학의의.이자대BPV균무현저영향,기대BPV대래적변화차이무통계학의의.
Objective To evaluate the effect of olmesartan medoxomil tablets (olmesartan) in comparison with Olmetec on 24 h ambulatory blood pressure (ABPM) and blood pressure variability (BPV)in patients with mild to moderate hypertension.Methods A randomized,double-blind,double-mimic controlled trial was performed.Forty-eight patients with mild to moderate essential hypertension were randomly into treatment group (olmesartan) and control group (Olmetec) for eight weeks.The ABPM was taken before and at the end of the trial.Results After eight weeks,treatment with olmesartan induced a significant reduction in ABPM in patients [(9 ± 3)/(11 ± 3) mmHg (1 mmHg =0.133 kPa)],which is similar with the reduction by Olmetec [(9 ± 4) / (9 ± 5) mmHg],P ＞ 0.05.This situation holds for BPV with the standard deviations of 24 h,systolic blood pressure/diastolic blood pressure of pre-treatment and pro-treatment were (10 ± 2)/(11 ± 3) mmHg vs (10 ± 3)/(12 ± 2) mmHg in olmesartan group,and (10 ± 3)/(11 ±3) mmHg vs (12 ±3)/(12 ±4) mmHg in Olmetec group.(3) There is no difference in the rate of adverse event between olmesartan (10.42％) and Olmetec (8.33％) treatment(P ＞ 0.05).Conclusion Similar to Olmetec,treatment with olmesartan once daily can significantly reduce ABPM in patients with mild to moderate essential hypertension.