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24小时动态血压监测期间硝苯地平两种制剂的比较。

Comparison of two formulations of nifedipine during 24-hour ambulatory blood pressure monitoring.

作者信息

Granberry M C, Gardner S F, Schneider E F, Carter I R

机构信息

Department of Pharmacy Practice, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock 72205, USA.

出版信息

Pharmacotherapy. 1996 Sep-Oct;16(5):932-6.

PMID:8888089
Abstract

STUDY OBJECTIVE

To determine if one commercial extended-release formulation of nifedipine (Adalat CC) is as effective as another (procardia XL) in controlling blood pressure over 24 hours.

DESIGN

Open-label, randomized, crossover study.

SETTING

University-affiliated family medicine clinic.

PATIENTS

Fifteen patients with stage 1-4 primary hypertension.

INTERVENTIONS

Procardia XL or Adalat CC once/day was titrated to achieve blood pressure control. The effective dose was continued for 4 weeks, washed out for 1 week, and reinstituted with other study drug.

MEASUREMENTS AND MAIN RESULTS

Twenty-four-hour ambulatory blood pressure was recorded the conclusion of each treatment phase. Treatment phases were compared for mean 24-hour blood pressure, mean daytime (6:00 A.M.-10:00 P.M.) and mean nighttime blood pressure, and mean blood pressure load (percentage of blood pressure measurements > 140/90 mm Hg daytime and > 120/80 mm Hg nighttime). Thirteen patients completed the study. No statistically significant difference was seen in mean 24-hour blood pressure (138/86 mm Hg for Procardia XL vs 137/85 mm Hg for Adalat CC), daytime or nighttime blood pressure, or blood pressure load. Two patients experienced clinically significant adverse effects while taking Adalat CC.

CONCLUSIONS

In these patients with primary hypertension, Adalat CC was as effective as Procardia XL at controlling blood pressure for 24 hours. Blood pressure, heart rate, and adverse effects should be monitored 2-4 weeks after any exchange of Adalat CC for Procardia XL.

摘要

研究目的

确定一种硝苯地平缓释制剂(拜新同控释片)在24小时内控制血压的效果是否与另一种(络活喜)相同。

设计

开放标签、随机、交叉研究。

地点

大学附属医院家庭医学诊所。

患者

15例1 - 4期原发性高血压患者。

干预措施

每日一次服用络活喜或拜新同控释片,进行滴定以实现血压控制。有效剂量持续服用4周,停药1周,然后换用另一种研究药物。

测量指标及主要结果

在每个治疗阶段结束时记录24小时动态血压。比较各治疗阶段的24小时平均血压、日间(上午6:00至晚上10:00)平均血压和夜间平均血压,以及平均血压负荷(日间血压测量值>140/90 mmHg和夜间血压测量值>120/80 mmHg的百分比)。13例患者完成了研究。在24小时平均血压(络活喜为138/86 mmHg,拜新同控释片为137/85 mmHg)、日间或夜间血压或血压负荷方面,未观察到统计学上的显著差异。2例患者在服用拜新同控释片时出现了具有临床意义的不良反应。

结论

在这些原发性高血压患者中,拜新同控释片在24小时内控制血压的效果与络活喜相同。在将拜新同控释片换为络活喜后的2 - 4周内,应监测血压、心率和不良反应。

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