JAMA:ACE抑制剂可改善外周动脉疾病患者无痛行走和身体功能

　　据发表在2月6日出版的《美国医学会杂志》上的一则研究披露，在罹患外周动脉疾病及间歇性跛行(即在小腿肚中常常在行走时会感到的时有时无的疼痛)的患者中, 进行为期24周的血管紧张素转换酶(ACE)抑制剂雷米普利的治疗与无痛和最长步行时间及身体健康方面的生活品质改善有关。

　　“欧洲和北美有大约2700万人患有外周动脉疾病(PAD)。PAD病人中大约三分之一的人会发生间歇性跛行,他们常常表现为在步行时会出现腿部肌肉群疼痛而在休息时这种情况又得到了缓解。”

　　澳大利亚墨尔本Baker IDI心脏与糖尿病研究所的Anna A. Ahimastos, Ph.D. 及其同事开展了一项研究，旨在检查与一个服用安慰剂的更大、更一般PAD人群相比，雷米普利治疗对步行距离及健康相关性生活品质的关系。这一随机的、以安慰剂作为对照的试验包括了212名患有外周动脉疾病（平均年龄65.5岁）的患者；试验于2008年5月开始，在2011年8月结束。病人被随机指派每日服用10毫克的雷米普利 (n = 106) 或匹配的安慰剂 (n = 106) 达24周。该研究主要的检测结果是在标准跑步机测试中所记录的最长无痛步行时间。研究人员用步行损害问卷（WIQ）及36健康调查短表（SF-36）来分别评估步行能力及生活品质。

　　研究人员发现，与安慰剂相比，雷米普利与无痛步行时间平均增加了75秒而且最长步行时间增加了255秒（无痛步行时间及最长步行时间分别增加了77% 和123%）有关。与安慰剂相比，雷米普利还与WIQ评分（距离、速度评分以及爬楼梯的中位数）以及总体SF-36的机体健康概括评分中位数的改善有关。

　　文章的作者写道：“WIQ评分的增加提示，雷米普利改善了病人所感到的进行正常日常活动的能力。雷米普利治疗还与属于生理健康部分的SF-36分数的适度改善有关。重要的是，这些相关性独立于那些由全科医生或血管专科医生通过标准临床管理所取得的疗效。进一步的裨益还可能通过包括遵循戒烟、经常运动等建议的生活方式以及对心血管风险因子进行更积极的内科管理而获得。”

　　“就我们所知，这是第一个具有足够统计功效的证明在PAD病人中雷米普利治疗与跑步机步行表现改善有关的随机试验。 ”

Effect of Ramipril on Walking Times and Quality of Life Among Patients With Peripheral Artery Disease and Intermittent Claudication

A Randomized Controlled Trial

Importance  

Approximately one-third of patients with peripheral artery disease experience intermittent claudication, with consequent loss of quality of life.

Objective  

To determine the efficacy of ramipril for improving walking ability, patient-perceived walking performance, and quality of life in patients with claudication.

Design, Setting, and Patients  

Randomized, double-blind, placebo-controlled trial conducted among 212 patients with peripheral artery disease (mean age, 65.5 [SD, 6.2] years), initiated in May 2008 and completed in August 2011 and conducted at 3 hospitals in Australia.

Intervention  

Patients were randomized to receive 10 mg/d of ramipril (n = 106) or matching placebo (n = 106) for 24 weeks.

Main Outcome Measures  

Maximum and pain-free walking times were recorded during a standard treadmill test. The Walking Impairment Questionnaire (WIQ) and Short-Form 36 Health Survey (SF-36) were used to assess walking ability and quality of life, respectively.

Results  

At 6 months, relative to placebo, ramipril was associated with a 75-second (95% CI, 60-89 seconds) increase in mean pain-free walking time (P < .001) and a 255-second (95% CI, 215-295 seconds) increase in maximum walking time (P < .001). Relative to placebo, ramipril improved the WIQ median distance score by 13.8 (Hodges-Lehmann 95% CI, 12.2-15.5), speed score by 13.3 (95% CI, 11.9-15.2), and stair climbing score by 25.2 (95% CI, 25.1-29.4) (P < .001 for all). The overall SF-36 median Physical Component Summary score improved by 8.2 (Hodges-Lehmann 95% CI, 3.6-11.4; P = .02) in the ramipril group relative to placebo. Ramipril did not affect the overall SF-36 median Mental Component Summary score.

Conclusions and Relevance  

Among patients with intermittent claudication, 24-week treatment with ramipril resulted in significant increases in pain-free and maximum treadmill walking times compared with placebo. This was associated with a significant increase in the physical functioning component of the SF-36 score.