摘要
２１８例轻、中度高血压病人随机进入研究，２０６例完成研究。其中非洛地平缓释片组（Ｆ组）为１０６例，维拉帕米缓释片组（Ⅴ组）为１００例。病人进入试验，先接受２周安慰剂观察，入选者经随机分组接受单盲给药，即非洛地平缓释片５ｍｇ或维拉帕米缓释片１２０ｍｇ，每日１次服用共２周；若ＤＢＰ≤９０ｍｍＨｇ（１ｍｍＨｇ＝０．１３３ｋＰａ），维持原剂量再服用２周。若ＤＢＰ＞９０ｍｍＨｇ，则剂量加倍，即非洛地平缓释片１０ｍｇ或维拉帕米缓释片２４０ｍｇ治疗２周。结果显示：用非洛地平缓释片５ｍｇ，经２周治疗后，血压得到控制的（即ＤＢＰ≤９０ｍｍＨｇ）病人占５７％（６０／１０６），而用维拉帕米缓释片组（Ⅴ组）则为４２％（４２／１００），两组间差异有显著性（Ｐ＜０．０５）。Ｆ组经４周治疗后降压幅度为２２．４／１５．６ｍｍＨｇ；Ｖ组为１３．９／１１．５ｍｍＨｇ，两组间差异有非常显著性（Ｐ＜０．００１）。同时，Ｆ组治疗后ＤＢＰ≤９０ｍｍＨｇ的病人占７９％，而Ⅴ组仅５４％。两组间差异有显著性（Ｐ＜０．０５）。不良反应多为轻度且一过性。结论提示：非洛地平缓释片与维拉帕米缓释片治疗轻、中度高血压病均有效，而前者５～１０ｍｇ／ｄ较优于后者１２０～?
Twohundredandeighteenpatientswithmildtomoderateessentialhypertension,af-tera2-weekplaceborun-inperiod,wererandomizedtoreceivesingle-blind,oncedailytreatmentofeitherfelodipine-ER5mg(Fgroup)orverapramil-SR120mg(Vgroup)for2weeks.After2weeks,patientswithDBPgreaterthanthetargetof90mmHghadtheirdosedoubledforthenext2weeks.WhereasinpatientswithDBP≤90mmHg,theinitiallowdosewasmaintainedfornext2-weeks.218patientswererandomisedand206patientscompletedthestudy.InFgroup,60/106(57%)patientshadtheirBPcontroledwiththelowdosecomparedto42/100(42%)patientsinVgroup(P<0.05).ThemeanBPinFgroupwasreducedby22.5/15.6mmHg(from162/101mmHgaftertherun-inperiodto139/86mmHg)afterthe4-weekstreatment.InVgroup,thereductionwas13.9/11.5mmHg(from158/102mmHgto145/90mmHg)overthesameperiod.Thedifferencebe-tweenthegroupswashighlystatisticalysignificant(P<0.001).Thereweremorepatients(79%)inFgroupwithcontroledDBPof≤90mmHgattheendofthestudythanthoseinVgroup(54%,P<0.05).Adverseeventsweremostlymildandtransient.Inconclusion,bothfelodipine-ERandver-apamil-SRareeffectiveintreatingmildtomoderateessentialhypertensives,andfelodipine-ER5-10mg/dismoreefectivethantoverapamil-SR120-240mg/d.Bothofthemwereweltolerated.
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
1996年第5期366-369,共4页
Chinese Journal of Cardiology
关键词
非洛地平
维拉帕米
高血压
felodipine-ERverapamil-SRhypertension
