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盐酸奈必洛尔片治疗轻中度原发性高血压有效性及安全性

The efficacy and safety of nebivolol tablet in mild to moderate essential hypertensive patients

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【作者】 荆珊陈源源孙宁玲柯元南赵秀丽羊镇宇华琦张国刚赵水平袁洪李爱华李占全李晓东赵慧颖

【Author】 JING Shan1,CHEN Yuan-yuan1, SUN Ning-ling1,KE Yuan-nan2, ZHAO Xiu-li3,YANG Zhen-yu4, HUA Qi5,ZHANG Guo-gang6, ZHAO Shui-ping7,YUAN Hong8, LI Ai-hua9,LI Zhan-quan10, LI Xiao-dong11,ZHAO Hui-ying12 (1.Department of Cardiology,People′s Hospital of Peking University,Beijing100044,China;2.Sino-Japan Friendship Hospital,Beijing 100029,China;3.Beijing Tongren Hospital,Beijing 100730,China;4.Wuxi People′s Hospital,Wuxi 214023,Jiangsu Province,China;5.Xuanwu Hospital of Capital Medical University,Beijing 100053,China;6.Xiangya Hospital Central South University,Changsha 410008,China;7.The Second Xiangya Hospital of Central South University,Changsha 410011,China;8.The Third Xiangya Hospital of Central South University,Changsha 410013,China;9.Yangzhou No.1 People′s Hospital,Yangzhou 225001,Jiangsu Province,China;10.The People′s Hospital of Liaoning Province,Shenyang 110016,China;11.Shengjing Hospital of China Medical University,Shenyang 110004,China;12.The First Hospital of Jilin University,Changchun 130021,China)

【机构】 北京大学人民医院心内科中日友好医院北京同仁医院无锡市人民医院首都医科大学宣武医院中南大学湘雅医院中南大学湘雅二医院中南大学湘雅三医院扬州市第一人民医院辽宁省人民医院中国医科大学附属盛京医院吉林大学第一医院

【摘要】 目的评价盐酸奈必洛尔片治疗轻、中度原发性高血压的有效性和安全性,同时评价奈必洛尔的降压平稳性。方法用多中心、随机、双盲、阳性药物平行对照设计。经过2周安慰剂导入期,入选315例轻中度高血压受试者,随机分为盐酸奈必洛尔片5 mg.d-1组(试验组)和富马酸比索洛尔片5 mg.d-1组(对照组)。47例受试者进入开放动态血压研究,服用盐酸奈必洛尔片5 mg.d-1,用药前和用药12周后分别行24 h动态血压监测,计算用药前后24 h收缩压和舒张压的谷峰比值。结果治疗12周后,2组受试者的平均坐位舒张压及收缩压较基线有显著下降,2组降压有效率分别为73.4%和69.7%(P>0.05)。动态血压监测治疗后24 h平均收缩压/舒张压、白天及夜间平均收缩压/舒张压与治疗前比较均显著降低,差异有统计学意义(P<0.01);整体法收缩压谷/峰比为78.9%,舒张压谷/峰比为75.3%。2组间不良事件发生率差异无统计学意义(P>0.05)。结论盐酸奈必洛尔能显著降低舒张压和收缩压,其降压作用持续、平稳,其安全性和耐受性良好。

【Abstract】 Objective To evaluate the efficacy,safety and the smooth control effect of nebivolol in mild to moderate essential hypertensive patients.Methods A multicenter,randomized,double-blind,active parallel control design study enrolled 315 subjects with mild to moderate essential hypertension.After 2 weeks of placebo run-in period,subjects were randomized to nebivolol 5 mg daily or bisoprolol 5 mg daily,who were treated with for 12 weeks.24 h ambulatory blood pressure monitoring after and before treatment were taken and T/P radio were counted with 47 subjects.Results Compared with baseline,mean sitting diastolic blood pressure(MSDBP) and systolic blood pressure(MSSBP) of the two groups were reduced significantly after 12 weeks.The total efficacy rate of nebivolol group was 73.4% and the total efficacy rate of bisoprolol group was 69.7%.There were no differences on the decrease of blood pressure and the total efficacy rate between two groups.The rate of drug related adverse event was similar between two groups(P>0.05).Twelve weeks after treatment,compared with baseline,24 hours systolic/ diastolic blood pressure,day systolic/ diastolic blood pressure and night systolic/ diastolic blood pressure have very significantly differences(P<0.01),T/P of systolic blood pressure was 78.9%,T/P of diastolic blood pressure was 75.3%.Conclusion Nebivolol can reduce systolic and diastolic blood pressure effectively and has smoothly control effect.Nebivolol is well tolerated and has better safety.

【关键词】 奈比洛尔原发性高血压疗效谷峰比值
【Key words】 nebivololessential hypertensionefficacyT/P ratio
  • 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2013年02期
  • 【分类号】R544.1
  • 【被引频次】13
  • 【下载频次】330
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