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| 国产复方非洛地平缓释片治疗原发性高血压的疗效和安全性 | |
| 引用本文： | HUANG Gaozhong,黄高忠,吴宗贵,陈绍行,张昀昀,吴士尧,章建梁.国产复方非洛地平缓释片治疗原发性高血压的疗效和安全性[J].中国临床药学杂志,2008,17(3):148-151. |
| 作者姓名： | HUANG Gaozhong 黄高忠 吴宗贵 陈绍行 张昀昀 吴士尧 章建梁 |
| 作者单位： | 1. 上海交通大学附属第六人民医院老年科,上海,200233 2. 中国人民解放军第二军医大学附属长征医院心内科,上海,200003 3. 上海交通大学医学院瑞金医院心内科,上海,200025 4. 上海交通大学医学院第九人民医院心内科,上海,200011 5. 中国人民解放军第二军医大学附属长海医院心内科,上海,200433 |
| 摘 要： | 目的 评价国产复方非洛地平缓释片治疗轻、中度原发性高血压的疗效和安全性.方法 采用多中心、随机、双盲双模拟、前瞻性平行对照方法,从321例高血压患者中筛选出经非洛地平(5mg)单药治疗4wk、血压不能满意控制者217例,随机分为试验组和对照组,继续治疗8wk,分别服用复方非洛地平缓释片(由马来酸依那普利和缓释非洛地平组成,5mg/5mg)1片和非洛地平缓释片(5mg)、马来酸依那普利片(5mg)各1片.双盲治疗4wk后DBP不低于90mm Hg(1mm Hg=0.133kPa)者剂量加倍.结果 前4wk非洛地平单药治疗的有效率32.4%,降压无效而人组者血压平均下降(5.4±3.3/2.7±1.9)mm Hg.后8wk联合用药降压的总有效率试验组和对照组分别为88.3%和92.2%,血压分别进一步下降16.2/10.5mm Hg和14.8/11.4mm Hg.单药的不良反应主要为头痛、头晕、头胀、面部潮红等(12.0%).双盲试验期不良反应总发生率试验组和对照组分别为19.4%和14.7%,其中干咳发生率分别占6.5%和8.3%.结论 国产复方非洛地平缓释片治疗轻、中度原发性高血压安全、有效. |
| 关 键 词： | 复方制剂 非洛地平 高血压 临床试验 复方非洛地平缓释片 继续治疗 原发性高血压 疗效和安全性 essential hypertension patients tablets felodipine compound safety 干咳 发生率 双盲试验 面部潮红 头痛 不良反应 单药 组分 总有效率 联合用药 |
| 文章编号： | 1007-4406(2008)03-0148-04 |
| 修稿时间： | 2007年6月15日 |
Efficacy and safety of compound felodipine sustained-release tablets in patients with essential hypertension |
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| HUANG Gaozhong,WU Zonggui,CHEN Shaoxing,ZHANG Yunyun,WU Shiyao,ZHANG Jianliang.Efficacy and safety of compound felodipine sustained-release tablets in patients with essential hypertension[J].Chinese Journal of Clinical Pharmacy,2008,17(3):148-151. | |
| Authors: | HUANG Gaozhong WU Zonggui CHEN Shaoxing ZHANG Yunyun WU Shiyao ZHANG Jianliang |
| Institution: | HUANG Gaozhong1,WU Zonggui2,CHEN Shaoxing3,ZHANG Yunyun1,WU Shiyao4,ZHANG Jianliang5(1Department of Gerontology,Sixth People\' s Hospital,Shanghai Jiaotong University,Shanghai 200233,China,2 Department of Cardiology,Changzheng Hospital,Second Military Medical University of PLA,Shanghai 200003,3 Department of Cardiology,Ruijin Hospital,School of Medicine,Shanghai 200025,4Department of Cardiology,Ninth People\'s Hospital,... |
| Abstract: | AIM To evaluate the efficacy and safety of compound felodipine sustained-release tablets(domestic product) in patients with mildto-moderate essential hypertension.METHODS This was a double-blind,randomized,controlled multicenter clinical trial.Patients with essential hypertension (n=321) were treated with placebo for 2 wk,then felodipine sustained-release tablets for 4 wk.Those patients whose blood pressure were still not lower than 140/90 mm Hg(1 mm Hg=0.133 kPa) were randomly assigned to receive compound ... |
| Keywords: | compound preparation felodipine hypertension clinical trial |
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