上海交通大学学报（医学版）

›› 2009, Vol. 29 ›› Issue (11): 1359-.

• 论著（临床研究） • 上一篇    下一篇

国产奥美沙坦酯片治疗轻、中度高血压的疗效和安全性

胡亚蓉1, 陈绍行1, 张 瑾1, 王佩蓉2, 孔 燕1, 朱鼎良1, 李松华3, 徐荣良3, 吴宗贵4   

  1. 1. 上海交通大学 医学院瑞金医院 高血压科, 上海 200025；2. 上海信谊百路达药业有限公司, 上海 200233；3. 第二军医大学 长海医院心内科, 上海 200433；4.第二军医大学 长征医院 心内科, 上海 200003
  • 出版日期:2009-11-25 发布日期:2009-11-24
  • 通讯作者: 陈绍行, 电子信箱: chenshaoxing2@yahoo.com.cn。
  • 作者简介:胡亚蓉（1970—）, 女, 副主任医师, 硕士生；电子信箱: huyarongma@yahoo.com.cn。

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

HU Ya-rong1, CHEN Shao-xing1, ZHANG Jin1, WANG Pei-rong2, KONG Yan1, ZHU Ding-liang1, LI Song-hua3,
XU Rong-liang3, WU Zong-gui4   

  1. 1. Department of Hypertension, Ruijin Hospital, School of Medicine,Shanghai Jiaotong University, Shanghai 200025, China；2. Shanghai Sine Promod Pharmaceutical Co.Ltd, Shanghai 200023, China；3. Department of Cardiology, Changhai Hospital, The Second Military Medical University, Shanghai 200433, China；4. Department of Cardiology, Changzheng Hospital, The Second Military Medical University, Shanghai 200003, China
  • Online:2009-11-25 Published:2009-11-24

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摘要：

目的 通过与氯沙坦比较，评价国产奥美沙坦单药治疗轻、中度原发性高血压的疗效和安全性。方法 采用随机、双盲、双模拟、阳性对照、多中心和平行方法进行研究。237例轻、中度原发性高血压患者分为奥美沙坦组（口服奥美沙坦20 mg+氯沙坦50 mg安慰剂）和氯沙坦组（氯沙坦50 mg+奥美沙坦20 mg安慰剂），治疗期为8周。治疗4周末，若坐位舒张压≥90 mmHg（1 mmHg=0.133 kPa），则药物剂量加倍；每2周随访1次，观察降压效果和不良反应。另选32例轻、中度原发性高血压患者单纯服用奥美沙坦，观察治疗前和治疗后8周的动态血压变化。结果 与治疗前比较，治疗8周后奥美沙坦组和氯沙坦组收缩压分别下降（15.2±13.3）mmHg和（19.5±11.8）mmHg(均P<0.001)，舒张压分别下降（15.9±7.48）mmHg和（16.2±5.95）mmHg（均P<0.01），两组间比较差异无统计学意义（P>0.05)。奥美沙坦组与氯沙坦组降压总有效率和不良反应发生率比较（86.9% vs 93.7%和7.63% vs 5.88%），差异均无统计学意义（P> 0.05)。动态血压监测显示，收缩压和舒张压的谷峰比值分别为86%和71%。结论 国产奥美沙坦治疗轻、中度高血压与氯沙坦等效，降压平稳，安全性好。

关键词: 抗高血压药, 疗效, 安全性, 奥美沙坦, 氯沙坦

Abstract:

Objective To evaluate the efficacy and safety of domestic olmesartan in treatment of mild to moderate essential hypertension in comparison with losartan. Methods Two hundred and thirty-seven 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 (olmesartan 20 mg+losartan 50 mg placebo) and losartan group (losartan 50 mg+olmesartan 20 mg placebo) for a 8-week therapy. Four weeks after treatment, dosages of drugs were doubled in patients with seated diastolic blood pressure ≥90 mmHg (1 mmHg=0.133 kPa). All patients were followed up every two weeks, and the efficacy and adverse effects were observed. Another 32 patients with mild to moderate essential hypertension were enrolled and given olmesartan only, and ambulatory blood pressure monitoring was performed before and 8 weeks after treatment. Results Compared with those before treatment, both systolic blood pressure and diastolic blood pressure significantly decreased in olmesartan group and losartan group 8 weeks after treatment [(15.2±13.3）mmHg and (19.5±11.8) mmHg, respectively for systolic blood pressure (P<0.001); (15.9±7.48) mmHg and (16.2±5.95) mmHg, respectively for diastolic blood pressure (P<0.01)], while there was no significant difference between these two groups (P>0.05). There was no significant difference in total effective rate and incidence of adverse effect between these two groups (86.9% vs 93.7% and 7.63% vs 5.88%, P>0.05). Ambulatory blood pressure monitoring demonstrated that trough to peak ratios of systolic blood pressure and diastolic blood pressure were 86% and 71%, respectively. Conclusion Domestic olmesaratan provides an effective, safe and long action in the treatment of mild to moderate essential hypertension.

Key words: antihypertensive agents, efficacy, safety, olmesartan, losartan