下肢间歇性负压治疗间歇性跛行。治疗 24 周后的随访。
Lower Extremity Intermittent Negative Pressure for Intermittent Claudication. Follow-Up after 24 Weeks of Treatment.
机构信息
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.
出版信息
Ann Vasc Surg. 2021 Aug;75:253-258. doi: 10.1016/j.avsg.2021.03.016. Epub 2021 Apr 4.
BACKGROUND
Treatment with lower extremity intermittent negative pressure (INP) of -40 mm Hg for one hour twice daily for 12 weeks, increases walking capacity in patients with intermittent claudication (IC). However, the effects of INP treatment beyond 12 weeks have not been elucidated. The aim of the present study was to investigate the clinical effects of INP treatment after 24 weeks in patients with IC.
METHODS
This was a follow-up study after a randomized sham-controlled trial, where patients randomized to the active treatment group were offered to continue treatment for 12 additional weeks (24 weeks in total). Treatment with -40 mm Hg INP was applied in a pressure chamber sealed around the lower leg, and the patients were instructed to treat themselves at home one hour in the morning and one hour in the evening. Pain free walking distance (PWD), maximal walking distance (MWD), resting ankle-brachial index (ABI) and post exercise ABI were measured at baseline, after 12 and 24 weeks.
RESULTS
Ten out of 32 patients (31%) from the active treatment group in the initial trial were included in this follow-up study. At baseline, PWD was (mean ±SD) 151 ± 91 m and MWD was 362 ±159 m. There was a significant increase in both PWD and MWD after 24 weeks of treatment, compared to baseline (ANOVA; P= 0.006 and P= 0.012, respectively). Post hoc tests revealed that PWD increased significantly from baseline to 12 weeks (mean 81 m; 95% CI [6, 156]; P = 0.032), and that MWD increased significantly from 12 to 24 weeks (mean 145 m; 95% CI [22, 268]; P = 0.018). There were no significant changes in resting ABI or post exercise ABI during the 24-week treatment period (ANOVA; P= 0.157 and P= 0.450, respectively).
CONCLUSION
Both PWD and MWD improved after treatment with - 40 mm Hg INP for one hour twice daily for 24 weeks, compared to baseline. The main improvement in PWD occurred during the first 12 weeks of treatment, whereas the main improvement in MWD occurred between 12 and 24 weeks of treatment.
背景
下肢间歇性负压（INP）治疗，每天两次，每次 -40mmHg 持续 1 小时，共 12 周，可增加间歇性跛行（IC）患者的步行能力。然而，INP 治疗超过 12 周的效果尚未阐明。本研究旨在探讨 IC 患者 INP 治疗 24 周后的临床效果。
方法
这是一项随机假对照试验的随访研究，其中随机分配至主动治疗组的患者被提议再接受 12 周的治疗（共 24 周）。使用密封小腿的压力室施加 -40mmHg 的 INP，患者被指导在家中每天上午和晚上各治疗 1 小时。在基线时、治疗 12 周和 24 周时测量无痛行走距离（PWD）、最大行走距离（MWD）、静息踝肱指数（ABI）和运动后 ABI。
结果
初始试验中主动治疗组的 32 例患者中有 10 例（31%）纳入本随访研究。基线时，PWD 为（均值±标准差）151±91m，MWD 为 362±159m。与基线相比，24 周治疗后 PWD 和 MWD 均显著增加（方差分析；P=0.006 和 P=0.012）。事后检验显示，PWD 从基线到 12 周显著增加（平均增加 81m；95%置信区间[6，156]；P=0.032），MWD 从 12 周到 24 周显著增加（平均增加 145m；95%置信区间[22，268]；P=0.018）。24 周治疗期间，静息 ABI 或运动后 ABI 无显著变化（方差分析；P=0.157 和 P=0.450）。
结论
与基线相比，每天两次、每次 1 小时 -40mmHg INP 治疗 24 周后，PWD 和 MWD 均改善。PWD 的主要改善发生在治疗的前 12 周，而 MWD 的主要改善发生在 12 周至 24 周的治疗期间。
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