随机临床试验血管紧张素转换酶抑制剂，雷米普利，在间歇性跛行患者。

Randomized clinical trial of angiotensin-converting enzyme inhibitor, ramipril, in patients with intermittent claudication.

机构信息

Academic Vascular Surgical Unit, Hull York Medical School and University of Hull, Hull, UK.

出版信息

Br J Surg. 2013 Aug;100(9):1154-63. doi: 10.1002/bjs.9198.

DOI:10.1002/bjs.9198

PMID:23842829

Abstract

BACKGROUND

The aim was to investigate the effect of ramipril on clinical parameters in patients with peripheral arterial disease.

METHODS

Patients with intermittent claudication were randomized to receive ramipril or placebo for 24 weeks in a double-blind study. Outcome measures were walking distance, arterial stiffness measurement and quality of life (QoL).

RESULTS

A total of 33 patients were included (25 men; mean(s.d.) age 64.6(7.8) years); 14 received ramipril and 19 placebo. After 24 weeks, ramipril improved maximum treadmill walking distance by an adjusted mean (95 per cent confidence interval, c.i.) of 131 (62 to 199) m (P = 0·001), improved treadmill intermittent claudication distance by 122 (56 to 188) m (P = 0.001) and improved patient-reported walking distance by 159 (66 to 313) m (P = 0.043) compared with placebo. Ramipril reduced carotid femoral pulse wave velocity by -1.47 (95 per cent c.i. -2.40 to -0.57) m/s compared with placebo (P = 0.002). Resting ankle : brachial pressure index (ABPI) improved slightly in both ramipril and placebo groups (0.02 (95 per cent c.i. -0.08 to 0.11) versus 0.03 (-0.05 to 0.10); P = 0.830). Ramipril had a slight, non-significant effect on QoL physical domains compared with placebo.

CONCLUSION

Ramipril improved walking distance in patients with claudication; however, this improvement was not related to improved ABPI but might have been due to ramipril reducing arterial stiffness.

REGISTRATION NUMBER

NCT01037530 (http://www.clinicaltrials.gov).

摘要

背景

本研究旨在探讨雷米普利对周围动脉疾病患者临床参数的影响。

方法

采用双盲研究方法，将间歇性跛行患者随机分为雷米普利组或安慰剂组，治疗 24 周。观察指标包括步行距离、动脉僵硬度测量和生活质量（QoL）。

结果

共纳入 33 例患者（25 例男性；平均（标准差）年龄 64.6(7.8)岁）；14 例患者接受雷米普利治疗，19 例患者接受安慰剂治疗。治疗 24 周后，雷米普利组较安慰剂组最大跑步机步行距离平均增加（95%置信区间，CI）131（62 至 199）m（P = 0·001），跑步机间歇性跛行距离增加 122（56 至 188）m（P = 0.001），患者报告的步行距离增加 159（66 至 313）m（P = 0.043）。雷米普利组较安慰剂组颈动脉-股动脉脉搏波速度降低-1.47（95%CI -2.40 至 -0.57）m/s（P = 0.002）。雷米普利组和安慰剂组的静息踝臂血压指数（ABPI）均略有改善（0.02（95%CI -0.08 至 0.11）与 0.03（-0.05 至 0.10）；P = 0.830）。与安慰剂相比，雷米普利对 QoL 生理领域的影响较小，无统计学意义。