ChinJClinPharmacol

391　

Vol125No15September2009(SerialNo1121)

论著

复方尼群洛尔片治疗原发性高血压的随机双盲平行

对照多中心临床试验

OrginalArticle

Randomized,double2blind,parallelcontrolled,multicentreclinicaltrialoffixedcombinationofnitrendipineandatenololinthetreatmentofmildtomoderateessentialhypertension

黄高忠,汤晔华,顾兴建,吴宗贵,

3145

蔡乃绳,魏　盟,戴秋艳,徐　标,

678

宫剑滨,洪小苏,吴小庆

(11上海交通大学附属第六人民医院老年科,上海　200233;21上海长征医院心内科,上海　200003;31上海中山医院,上海　200032;41上海交通大学附属第一人民医院,上海　200080;51南京鼓楼医院,南京　210005;61南京军区南京总医院,南京　210002;71苏州大学附属第二医院,江苏　苏州　215004;81无锡第一医院,江苏　无

)锡　214002

1222

摘要:目的　评价复方尼群洛尔片(钙拮抗剂,抗高血压药)治疗轻中度原发性高血压的疗效和安全性。方法　用随机双盲平行对照多中心临床试验方法,共入选437例原发性高血压患者,随机分成试验组和对照组(3∶1),分别服用复方尼群洛尔片(每片含尼群地平5mg和阿替洛尔10mg)每日2片或阿替洛尔片

(每片25mg)每月1片,疗程8周。结果　治疗8周后,试验组血压下降幅度大(1117±于对照组,2组DBP分别下降(1510±616)、518)mmHg(P<0101),2组(1518±SBP分别下降(1818±1014)、1011)mmHg(<P<0105);降压总有

效率,试验组大于对照组,881710101)。试验组和对照组1221(05),可自行缓解,实、中度原发性高血压疗效确切、中图分类号:5441;R97213　　　文献标识码:A文章编号:1001-6821(2009)05-0391-04

HUANGGao2zhong,TANGYe2hua,

22

GUXing2jian,WUZong2gui,

31

CAINai2sheng,WE,

45

DAIQiu2yan,

7

GONGJian28

WUXiao2qing

(11DepartmentofGerontology,TheSixthPeo2ple’sHospital,ShanghaiJiaotongUniversity,Shanghai200233,China;21CardiologyDepart2ment,ShanghaiChangzhengHospital,Shang2hai200003,China;31ShanghaiZhongshanHospital,Shanghai200025,China;41TheFirstPeople’sHospital,ShanghaiJiaotongUniver2sity,Shanghai200080,China;51NanjingGu2louHospital,Nanjing210005,China;61NanjingGeneralHospitalofNanjingMilitaryArea,Nanjing210002,China;71TheSecondAffiliatedHospitalofSuzhouUniversity,Suzhou215004,China;81TheFirstHospitalofWuxi,Wuxi214002,China)

12

Abstract:Objective　Toevaluatetheefficacyandsafetyofthefixedcombinationofatenololandnitrendipineinpatientswithmildtomoderateessentialhypertension1Methods　Thisisarandomized,double-blind,parallelcontrolled,multicenterclinicaltrial1Atotalof437eligiblesub2jectswererandomizedat3∶1ratiotoreceivethefixedcombinationofatenololandnitrendipine(10mg/5mg,trialgroup)oratenolol(25mg,controlgroup)for8weeks1Results　Aftertreatment,thereductioninDBP[(15103±6155)mmHgvs(1117±518)mmHg,P<0101]andSBP[(1818±1014)mmHgvs(1518±1011)mmHg,0101<P<0105]frombaselineweresignificantlygreaterintrialgroupthanthatincontrolgrouprespectively1Thepercentageofrespondersintrialgroup(8819%)wasstatisticallyhigherthanthatincontrolgroup(7116%,P<0101)1Theincidenceofadversedrugreactionsintrialgroup(2216%)wassimilarasthatincontrolgroup(3013%,P>0105)1Mostofwitchwasmildandtransient1Therewasnoabnormalityinbio2chemicalexaminations1Conclution　Thisstudyshowsthatthefixedcombinationofatenololandnitrendipinewaseffectiveandsafeforthetreatmentofmildtomoderateessentialhypertension1

Keywords:hypertension;fixedcombinationofnitrendipineandatenolol

收稿日期:2008-11-10

修回日期:2009-07-02

作者简介:黄高忠(1964-),男,博士,主任医

师,硕士生导师,主要从事老年心血管疾病的基础和临床研究

通讯作者:吴宗贵,主任医师,教授,博士生导师

Tel:(021)81886999-885291E2mail:zgwu@medmail1com1cn