Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Vascular Surgery, Oslo University Hospital, Oslo, Norway; Otivio AS, Oslo, Norway.
Department of Surgery, Sørlandet Hospital, Kristiansand, Norway; Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.
J Vasc Surg. 2021 May;73(5):1750-1758.e1. doi: 10.1016/j.jvs.2020.10.024. Epub 2020 Oct 22.
We investigated the effects of lower extremity intermittent negative pressure (INP) treatment for 1 hour two times daily for 12 weeks on the walking distance of patients with intermittent claudication (IC).
Patients with IC were randomized to treatment with -40 mm Hg INP (treatment group) or -10 mm Hg INP (sham control group). Pain-free walking distance (PWD) and maximal walking distance (MWD) on a treadmill, resting and postexercise ankle-brachial index, resting and postischemic blood flow (plethysmography), and quality of life (EQ-5D-5L and Vascuqol-6) were measured at baseline and after 12 weeks of treatment.
A total of 72 patients were randomized, and 63 had data available for the intention-to-treat analyses. The between-group comparisons showed a significant change in the PWD, favoring the treatment group over the sham control group (estimated treatment effect, 50 m; 95% confidence interval [CI], 11-89; P = .014). The PWD had increased by 68 m (P < .001) in the treatment group and 18 m (P = .064) in the sham control group. No significant difference was found in the change in the MWD between the two groups (estimated treatment effect, 42 m; 95% CI, -14 to 97; P = .139). The MWD had increased by 62 m (P = .006) in the treatment group and 20 m (P = .265) in the sham control group. For patients with a baseline PWD of <200 m (n = 56), significant changes had occurred in both PWD and MWD between the two groups, favoring the treatment group (estimated treatment effect, 42 m; 95% CI, 2-83; P = .042; and estimated treatment effect, 62 m; 95% CI, 5-118; P = .032; respectively). Both overall and for the group of patients with a PWD <200 m, no significant differences were found in the changes in the resting and postexercise ankle-brachial index, resting and postischemic blood flow, or quality of life parameters between the two groups.
Treatment with -40 mm Hg INP increased the PWD compared with sham treatment in patients with IC. For the patients with a baseline PWD of <200 m, an increase was found in both PWD and MWD compared with sham treatment.
我们研究了每日 2 次、每次 1 小时的下肢间歇性负压（INP）治疗 12 周对间歇性跛行（IC）患者步行距离的影响。
将 IC 患者随机分为-40mmHg INP 治疗组（治疗组）或-10mmHg INP 假治疗组（假治疗组）。在基线和 12 周治疗后，使用跑步机测量无痛步行距离（PWD）和最大步行距离（MWD）、静息和运动后踝臂指数、静息和缺血后血流（体积描记法）以及生活质量（EQ-5D-5L 和 Vascuqol-6）。
共纳入 72 例患者，63 例患者完成意向治疗分析。组间比较显示，PWD 有显著变化，治疗组优于假治疗组（治疗效果估计，50m；95%置信区间[CI]，11-89；P=.014）。治疗组 PWD 增加 68m（P<.001），假治疗组增加 18m（P=.064）。两组间 MWD 的变化无显著差异（治疗效果估计，42m；95%CI，-14 至 97；P=.139）。治疗组 MWD 增加 62m（P=.006），假治疗组增加 20m（P=.265）。对于基线 PWD<200m 的患者（n=56），两组 PWD 和 MWD 均有显著变化，治疗组更优（治疗效果估计，42m；95%CI，2-83；P=.042；治疗效果估计，62m；95%CI，5-118；P=.032）。两组的静息和运动后踝臂指数、静息和缺血后血流以及生活质量参数的变化均无显著差异。
与假治疗相比，-40mmHg INP 治疗可增加 IC 患者的 PWD。对于基线 PWD<200m 的患者，与假治疗相比，PWD 和 MWD 均有增加。
