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伊拉地平与非洛地平缓释制剂治疗等效剂量的安全性和有效性。

Safety and efficacy of therapeutically equivalent doses of sustained-release formulations of isradipine and felodipine.

作者信息

Ganz Michael B, Saska Brett A

机构信息

Cleveland Clinic Foundation, Meridia Health System, Department of Medicine, Cleveland, OH 44112, USA.

出版信息

Congest Heart Fail. 2003 Nov-Dec;Suppl 2:1-4. doi: 10.1111/j.1527-5299.2003.03252.x.

DOI:10.1111/j.1527-5299.2003.03252.x
PMID:14688501
Abstract

This open-label, drug substitution study was conducted to determine if subjects receiving sustained-release isradipine (SR-I) can be safely switched to sustained-release felodipine (SR-F) and to assess whether SR-I provides better 24-hour blood pressure (BP) control than SR-F. Forty-one men receiving either SR-F 5 mg or SR-F 10 mg once daily for at least 6 months were switched to an equivalent dose of SR-I; BP was measured 2, 4, and 6 weeks after substitution. Significant reductions in systolic BP were seen in the SR-I 10 mg group after 4 weeks and they remained significantly lower through 6 weeks (p< or =0.05). Diastolic BP was reduced, but not significantly. After 6 weeks, SR-F therapy was reinstated, and BP returned toward baseline values. No serious adverse events were reported. SR-I can be safely substituted for SR-F and may provide better 24-hour control of BP than SR-F.

摘要

这项开放标签的药物替代研究旨在确定接受缓释伊拉地平(SR-I)的受试者是否可以安全地换用缓释非洛地平(SR-F),并评估SR-I是否比SR-F能更好地控制24小时血压(BP)。41名每天服用一次5毫克或10毫克SR-F至少6个月的男性被换用等量的SR-I;换药后2、4和6周测量血压。4周后,SR-I 10毫克组的收缩压显著降低,至6周时仍显著低于换药前(p≤0.05)。舒张压有所降低,但不显著。6周后,恢复SR-F治疗,血压恢复至基线值。未报告严重不良事件。SR-I可以安全地替代SR-F,并且可能比SR-F能更好地控制24小时血压。

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引用本文的文献

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Comparison of blood pressure control with amlodipine and controlled-release isradipine: an open-label, drug substitution study.氨氯地平和控释异搏定在血压控制方面的比较:一项开放标签的药物替代研究。
J Clin Hypertens (Greenwich). 2005 Apr;7(4 Suppl 1):27-31. doi: 10.1111/j.1524-6175.2005.04450.x.