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乐卡地平片与氯沙坦片治疗轻至中度原发性高血压疗效及耐受性的随机、双盲、双模拟对照研究

A randomised, double-blind, double-dummy comparison of the efficacy and tolerability of lercanidipine tablets and losartan tablets in patients with mild to moderate essential hypertension.

作者信息

James I G V, Jones A, Davies P

机构信息

Spring House Surgery, Bolton, Lancashire, UK.

出版信息

J Hum Hypertens. 2002 Aug;16(8):605-10. doi: 10.1038/sj.jhh.1001430.

DOI:10.1038/sj.jhh.1001430
PMID:12149668
Abstract

A double-blind, double-dummy, randomised, multicentre study to compare the efficacy and tolerability of lercanidipine with losartan. Patients with mild to moderate hypertension (supine diastolic blood pressure (DBP) 95-115 mm Hg) were enrolled and underwent a placebo run-in period of 14-30 days before random allocation to lercanidipine tablets 10 mg once-daily (n = 234) or losartan tablets 50 mg once-daily (n = 231) during the assessment period (approximately 16 weeks). Titration to lercanidipine 20 mg once-daily (two 10 mg tablets) or losartan 100 mg once-daily (two 50 mg tablets) was allowed after 8 weeks, if necessary. At the end of the study, 71% of patients who received lercanidipine tablets had achieved normalised DBP (ie, < or =90 mm Hg) and 81% had responded to treatment (ie, DBP < or =90 mm Hg or a decrease in DBP > or =10 mm Hg). The corresponding numbers in the losartan tablets group were 65% and 78%, respectively. In those patients who required dose titration, there was evidence of a greater response with lercanidipine tablets than with losartan tablets. Both treatments were well tolerated with a low incidence of adverse drug reactions and a low withdrawal rate. In conclusion, the antihypertensive effects of lercanidipine tablets were comparable with those of losartan tablets; both treatments gave a high response rate for an antihypertensive monotherapy and were very well tolerated.

摘要

一项双盲、双模拟、随机、多中心研究,旨在比较乐卡地平与氯沙坦的疗效和耐受性。纳入轻度至中度高血压患者(仰卧位舒张压(DBP)95 - 115 mmHg),在随机分配至乐卡地平片10 mg每日一次(n = 234)或氯沙坦片50 mg每日一次(n = 231)进行评估期(约16周)之前,先经历14 - 30天的安慰剂导入期。如有必要,8周后允许将乐卡地平滴定至20 mg每日一次(两片10 mg片剂)或氯沙坦滴定至100 mg每日一次(两片50 mg片剂)。研究结束时,接受乐卡地平片治疗的患者中71%的DBP恢复正常(即≤90 mmHg),81%对治疗有反应(即DBP≤90 mmHg或DBP下降≥10 mmHg)。氯沙坦片组的相应数字分别为65%和78%。在那些需要剂量滴定的患者中,有证据表明乐卡地平片比氯沙坦片有更大的反应。两种治疗耐受性均良好,药物不良反应发生率低,停药率低。总之,乐卡地平片的降压效果与氯沙坦片相当;两种治疗作为单一降压疗法均有较高的反应率,且耐受性良好。

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