Efficacy of antihypertensive drugs given once a day: the calcium antagonists revisited
Efficacy of antihypertensive drugs given once a day: the calcium antagonists revisited
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每天一次的降压药的疗效：钙拮抗剂的再探讨
DOI：
10.1097/00004872-199412001-00020
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发表时间：
1994
期刊：
影响因子：
--
通讯作者：
A. Amery
中科院分区：
文献类型：
--
作者：
J. Staessen;H. Celis;L. Thijs;R. Fagard;A. Amery
背景：大量的降压药已被批准每天给药一次或两次，但没有标准化的证据来证明降压作用持续超过24小时。目的验证第二代钙拮抗剂长期作用的说法的有效性。方法文献检索。已报道的研究中的缺陷大多数研究依赖于动态血压监测。然而，有一些报告很难解释，原因是(1)研究不是盲目或随机的；(2)统计分析不适合研究设计；(3)分析仅限于24小时、日间和夜间血压的平均值；(4)没有基线调整或正式的统计检验；(5)患者在治疗后被细分为有效和无效患者；(6)没有明确的时间框架将药物摄入与观察到的降压效果联系起来。这些文章的作者总结说，氨氯地平、尼群地平和地尔硫卓、伊拉地平、硝苯地平和维拉帕米的改良(缓释)制剂降低了常规(临床)和24小时血压水平。在一些研究中，分别给出了白天(清醒)和夜间(睡眠)的结果；一些研究调查了剂量间隔结束时血压的降低；一些研究比较了不同药物治疗的每日血压曲线。然而，这些报告给出了不同的结果，表明至少在某些研究条件下，尼群地平和缓释地尔硫卓、伊拉地平和硝苯地平的作用不能完全覆盖每天一次的24小时。结论通过动态血压监测对长效降压药的研究进行解释，如果在使用常规血压测量的临床研究中采用相同的标准，将更容易得到解释。
Background A large number of antihypertensive drugs have been approved for administration once or twice a day, but no standardized evidence is required to demonstrate that the reduction in blood pressure is sustained over 24 h. Aim To test the validity of claims of a long duration of action for second-generation calcium antagonists. Method Literature search. Flaws in reported studies Most studies relied on ambulatory blood pressure monitoring. However, several reports were difficult to interpret because (1) the study was not blinded or random; (2) the statistical analysis was inappropriate for the study design; (3) analyses were confined to the means of 24-h, daytime and night-time blood pressure; (4) there was no baseline adjustment or formal statistical testing; (5) patients were subdivided into responders and non-responders after treatment; (6) there was no specified time frame linking drug intake to the observed antihypertensive effects. Claims not substantiated The authors of the articles reviewed concluded that amlodipine, nitrendipine and modified (slow-release) formulations of diltiazem, isradipine, nifedipine and verapamil reduced both conventional (clinic) and the 24-h blood pressure levels. In some studies separate results were presented for the daytime (awake) and night-time (sleeping) periods; some investigated the reduction in blood pressure at the end of the dose interval; and some compared the diurnal blood pressure profiles with different drug treatments. However, these reports gave discrepant results, suggesting that at least under certain study conditions the effect of nitrendipine and of slow-release diltiazem, isradipine and nifedipine did not give full 24-h cover with a single daily dose. Conclusions We conclude that the interpretation of studies on long-acting antihypertensive agents using ambulatory blood pressure monitoring would be easier if the same standards were applied as required in clinical studies using conventional blood pressure measurements.