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非洛地平缓释片早晚服用治疗原发性高血压:一项采用24小时动态监测的双盲研究

Evening vs morning isradipine sustained release in essential hypertension: a double-blind study with 24 h ambulatory monitoring.

作者信息

Fogari R, Malacco E, Tettamanti F, Gnemmi A E, Milani M

机构信息

Internal Medicine Department, University of Pavia, Italy.

出版信息

Br J Clin Pharmacol. 1993 Jan;35(1):51-4. doi: 10.1111/j.1365-2125.1993.tb05670.x.

Abstract

A randomized, double-blind, placebo controlled study evaluated the effects on 24 h ambulatory blood pressure (ABP) of isradipine sustained release (I-SRO) administered once daily, in the morning (AM) or in the evening (PM). Eighteen uncomplicated essential hypertensives (10 men, mean age 55 +/- 6 years) with casual sitting DBP 96-110 mm Hg received, according to a triple-way crossover design, I-SRO 5 mg AM, or 5 mg PM, or placebo for 4 weeks. A 24 h ABP monitoring (Spacelabs 90207) was carried out at the end of each treatment. Twenty-four hour BP was 145.3/89.8 mm Hg after randomized placebo. AM and PM I-SRO significantly reduced 24 h BP, by 13.7/8.7 and 12.9/8.2 mm Hg respectively. Daytime (07.00 h-23.00 h) BP significantly decreased by 15.0/9.7 mm Hg with AM and 13.2/8.7 mm Hg with PM regimen; night-time BP (23.00 h-07.00 h) significantly decreased by 11.6/7.1 and 12.3/7.4 mm Hg, respectively. Nocturnal nadir BP values were 132.6/78.1 after randomized placebo, 120.9/71.4 after AM I-SRO and 121.0/72.4 mm Hg after PM I-SRO. Morning peak BP values were 154.6/96.9, 139.5/87.6 and 137.5/85.5 mm Hg, respectively. Mean BP values in the early morning hours (i.e. between 03.00 h and 08.00 h) were significantly decreased by 12.1/7.3 mm Hg after AM and 14.3/7.9 mm Hg after PM intake. No significant differences were detected in the BP lowering effect of the two I-SRO regimens.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

一项随机、双盲、安慰剂对照研究评估了一日一次清晨(AM)或傍晚(PM)服用伊拉地平缓释片(I-SRO)对24小时动态血压(ABP)的影响。18例无并发症的原发性高血压患者(10例男性,平均年龄55±6岁),随机坐位舒张压为96 - 110 mmHg,按照三交叉设计,分别接受清晨5 mg I-SRO、傍晚5 mg I-SRO或安慰剂治疗4周。每种治疗结束时均进行24小时ABP监测(Spacelabs 90207)。随机服用安慰剂后24小时血压为145.3/89.8 mmHg。清晨和傍晚服用I-SRO均显著降低24小时血压,分别降低13.7/8.7 mmHg和12.9/8.2 mmHg。白天(07:00 - 23:00)血压,清晨服用方案显著降低15.0/9.7 mmHg,傍晚服用方案显著降低13.2/8.7 mmHg;夜间血压(23:00 - 07:00)分别显著降低11.6/7.1 mmHg和12.3/7.4 mmHg。随机服用安慰剂后夜间血压最低点值为132.6/78.1 mmHg,清晨服用I-SRO后为120.9/71.4 mmHg,傍晚服用I-SRO后为121.0/72.4 mmHg。清晨血压峰值分别为154.6/96.9 mmHg、139.5/87.6 mmHg和137.5/85.5 mmHg。清晨时段(即03:00至08:00之间)的平均血压值,清晨服用后显著降低12.1/7.3 mmHg,傍晚服用后显著降低14.3/7.9 mmHg。两种I-SRO治疗方案的降压效果未检测到显著差异。(摘要截选至250词)

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