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拉西地平与阿替洛尔治疗原发性高血压的疗效及安全性双盲比较。英国拉西地平研究组。

A double-blind comparison of the efficacy and safety of lacidipine with atenolol in the treatment of essential hypertension. The United Kingdom Lacidipine Study Group.

出版信息

J Cardiovasc Pharmacol. 1991;17 Suppl 4:S27-30.

PMID:1726002
Abstract

Thirty-one centers in the U.K. recruited 637 patients (aged 21 to 75 years) with mild-to-moderate essential hypertension [diastolic blood pressure (DBP) of 95 to 115 mm Hg, and systolic blood pressure (SBP) less than or equal to 200 mm Hg on three occasions]. After a 4-week placebo run-in period, 533 patients were randomized to receive double-blind 4 mg of lacidipine once daily (n = 268) or 50 mg of atenolol once daily (n = 265). If blood pressure was not controlled after 1 month (control = DBP less than or equal to 90 mm Hg, or less than or equal to 95 mm Hg if reduced by greater than or equal to 15 mm Hg from baseline), dosages were increased to 6 mg of lacidipine once daily or 100 mg of atenolol once daily. Hydrochlorothiazide (HCTZ, 25 mg once daily) was added after 2 months of active treatment if required for blood pressure control. Both lacidipine and atenolol reduced blood pressure to a similar degree over the 5 months of double-blind active treatment. The reduction achieved was maintained for the duration of the open phase of the study (to month 14). The incidence of adverse events was also similar for both drugs, and serious adverse events were rare and thought to be unrelated to the study drug therapy. The results indicate that lacidipine once daily for mild-to-moderate hypertension has an efficacy and safety similar to that of atenolol.

摘要

英国的31个中心招募了637名年龄在21至75岁之间的轻度至中度原发性高血压患者[舒张压(DBP)为95至115毫米汞柱,收缩压(SBP)在三次测量中均小于或等于200毫米汞柱]。经过4周的安慰剂导入期后,533名患者被随机分配接受双盲治疗,其中268名患者每日一次服用4毫克拉西地平,265名患者每日一次服用50毫克阿替洛尔。如果1个月后血压未得到控制(控制标准为DBP小于或等于90毫米汞柱,或者如果较基线水平降低大于或等于15毫米汞柱,则DBP小于或等于95毫米汞柱),则将拉西地平的剂量增加至每日一次6毫克或阿替洛尔的剂量增加至每日一次100毫克。如果在积极治疗2个月后仍需要控制血压,则添加氢氯噻嗪(HCTZ,每日一次25毫克)。在双盲积极治疗的5个月中,拉西地平和阿替洛尔降低血压的程度相似。在研究的开放阶段(至第14个月),血压降低的效果得以维持。两种药物的不良事件发生率也相似,严重不良事件很少见,且被认为与研究药物治疗无关。结果表明,每日一次服用拉西地平治疗轻度至中度高血压的疗效和安全性与阿替洛尔相似。

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引用本文的文献

1
Lacidipine: a review of its use in the management of hypertension.拉西地平:用于高血压管理的综述
Drugs. 2003;63(21):2327-56. doi: 10.2165/00003495-200363210-00008.
2
Dose linearity of lacidipine pharmacokinetics after single and repeated oral doses in healthy volunteers.健康志愿者单次及多次口服拉西地平后药代动力学的剂量线性关系。
Clin Pharmacokinet. 2003;42(1):99-106. doi: 10.2165/00003088-200342010-00004.
3
Lacidipine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in the treatment of hypertension.
拉西地平。对其药效学、药代动力学特性及治疗高血压的潜力的综述。
Drugs. 1994 Aug;48(2):274-96. doi: 10.2165/00003495-199448020-00010.