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中国临床药理学与治疗学 ›› 2013, Vol. 18 ›› Issue (9): 1053-1058.

• 药物治疗学 • 上一篇    下一篇

国产奥美沙坦酯治疗轻中度原发性高血压的单中心疗效和安全性评价

刘文洁, 柯永胜, 杨浩, 蔚有权, 曹蘅   

  1. 皖南医学院弋矶山医院心血管内科, 芜湖 241001,安徽
  • 收稿日期:2013-02-05 修回日期:2013-06-25 发布日期:2013-09-07
  • 作者简介:刘文洁,女,本科,主治医师,研究方向:心血管疾病基础和临床研究。Tel: 13955369423 E-mail:853600954@qq.com; 曹蘅,女,本科,教授,主任医师,硕士生导师,研究方向:心血管疾病基础和临床研究。Tel: 13956196933 E-mail: yjscaoheng@163.com

Efficacy and safety of domestic olmesartan in treatment of mild to moderate essential hypertension

LIU Weng -jie, KE Yong -sheng, YANG Hao, WEI You-quan, CAO Heng   

  1. Department of Cardiology, Yijishan Hospital, Wannan Medical College, Wuhu 241001,Anhui, China
  • Received:2013-02-05 Revised:2013-06-25 Published:2013-09-07

摘要: 目的: 通过与进口奥美沙坦酯(商品名傲坦)比较,单中心评价国产奥美沙坦酯单药治疗轻、中度原发性高血压的疗效和安全性;验证本药与原研药等效。方法: 采用随机、双盲、双模拟、阳性对照方法进行研究。57例轻、中度原发性高血压患者分为奥美沙坦酯组(27人、国产奥美沙坦酯 20 mg+傲坦模拟片1片 20 mg)和傲坦组(30人、傲坦 20 mg+国产奥美沙坦酯模拟片1片 20 mg),治疗期为8周,每2周随访1次,观察降压效果和不良反应;治疗2周后若患者坐位舒张压≥90 mm Hg (1 mm Hg=0.133 kPa)和(或)收缩压≥140 mm Hg,则将剂量加一倍, 至疗程结束。若坐位舒张压<90 mm Hg,则维持原剂量。结果: 与治疗前比较,治疗8周后奥美沙坦酯组和傲坦组收缩压分别下降( 22.5±9.5) mm Hg 和(21.4±9.5) mm Hg (均P<0.001),舒张压分别下降(16.1±5.5) mm Hg 和(14.7±4.4) mm Hg (均P<0.001),两组间比较差异无统计学意义(P>0.05)。国产奥美沙坦酯组与傲坦组降压总有效率(96.30% vs 92.60%)和不良反应发生率比较,差异均无统计学意义(P>0.05)。结论: 国产奥美沙坦酯片20~40 mg,每日1次是治疗轻中度原发性高血压的安全有效药物。

关键词: 国产奥美沙坦酯片, 傲坦, 高血压, 心率

Abstract: AIM: To evaluate the efficacy and safety of domestic olmesartan in treatment of mild to moderate essential hypertension in comparison with Ao tan and to verify its equivalency with the original study medicine.METHODS: 57 patients with mild to moderate essential hypertension were enrolled in a randomized,double-blind, multi-center, paralleded and active-controlled trial, and were divided into olmesartan group (27 patients with domestic olmesartan 20 mg+Ao tan simulated piece 1 piece 20 mg) and Ao tan group (30 patients with Ao tan 20 mg+domestic olmesartan simulated piece 1 piece 20 mg) for a 8-week therapy. All patients were followed up every two weeks, and the efficacy and adverse effects were observed. After treatment for 2 weeks, dosages of drugs were doubled in patients with seated diastolic blood pressure≥90 mm Hg (1 mm Hg=0.133 kPa).RESULTS: Compared with those before treatment, both systolic blood pressure and diastolic blood pressure significantly decreased in domestic olmesartan group and Ao tan group 8 weeks after treatment [(22.5±9.5) mm Hg and (21.4±9.5) mmHg, respectively for systolic blood pressure (P<0.001); (16.1±5.5) mm Hg and ( 14.7±4.4) mm Hg, respectively for diastolic blood pressure (P<0.001) ], while there was no significant difference between these two groups (P>0.05). There was no significant difference in total effective rate (96.30% vs 92.60%) and incidence of adverse effect between these two groups (P>0.05) .CONCLUSION: Domestic olmesartan is very effective in treatment of mild to moderate hypertension in a daily dose of 20-40 mg with good tolerability.

Key words: Domestic olmesartan, Ao tan, Hypertension, Heart rate

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