Cavezzi A, Paccasassi S, Elio C
Vascular Unit, Hippocrates Poliambulatory and Stella Maris Clinic, S. Benedetto del Tronto, Ascoli Piceno, Italy.
Int Angiol. 2013 Aug;32(4):417-23.
The aim of the study was to assess efficacy and safety of a new medical device, based on electric microcurrents and vacuum mechanism, on lymphedema of the lower limbs.
This was an observational clinical and instrumental study was performed on eight patients (2 males and 6 females, mean age 40.5 years), affected by secondary (3) or primary (5) lymphedema of the lower limbs. Ten daily sessions with an electro-sound wave and vacuum medical device were performed. Patients did not discontinue antecedently worn compression stockings. Lymphoscintigraphy of the lower limbs was performed before and after the treatment and an independent observer scored the images. Circumference tape measurement and relative volumetry were calculated before and after the treatment.
Total limb mean volumetry decreased from 9145 cc (±3439 SD) to 8714 (±3307) after 10 sessions (5% improvement); reduction in the lower leg volumetry was 8%. Ankle and mid calf mean circumference (in cm) decreased from 27.7 to 27.2 and from 36.2 to 35.2. Popliteal and inguinal lymph node visualisation at lymphoscintigraphy improved of 72%, 41%, 95% and 192% and of 0%, 33%, 110% and 245% respectively, 5', 45',120' and 180' after the injection. Radiotracer ascension along the leg and the thigh increased respectively of 48% and 33%, 39% and 64%, 50% and 62% and finally of 55% and 78% at the same intervals. Dermal back flow did not significantly vary till 45', whereas it improved of 25% both 120' and 180' after injection. No side effects were highlighted during the treatment.
In this observational study the application of a medical device, based on bioresonance and vacuum mechanisms, on limbs with lymphedema proved to be both safe and effective in terms of limb volume reduction and of lymphoscintigraphy parameters.
本研究旨在评估一种基于微电流和真空机制的新型医疗器械对下肢淋巴水肿的疗效和安全性。
这是一项针对8例下肢继发性(3例)或原发性(5例)淋巴水肿患者(2例男性,6例女性,平均年龄40.5岁)的观察性临床及器械研究。使用一种电声波和真空医疗器械,每天进行10次治疗。患者未停用之前穿着的加压弹力袜。在治疗前后进行下肢淋巴闪烁造影,由一名独立观察者对图像进行评分。在治疗前后计算周长卷尺测量值和相对容积。
经过10次治疗后,全下肢平均容积从9145立方厘米(标准差±3439)降至8714(标准差±3307)(改善了5%);小腿容积减少了8%。脚踝和小腿中部的平均周长(厘米)从27.7降至27.2,从36.2降至35.2。在淋巴闪烁造影中,腘窝和腹股沟淋巴结的显影分别在注射后5分钟、45分钟、120分钟和180分钟时改善了72%、41%、95%和192%,以及0%、33%、110%和245%。放射性示踪剂沿小腿和大腿的上升分别在相同时间间隔内增加了48%和33%、39%和64%、50%和62%,最后增加了55%和78%。皮肤逆流在45分钟之前没有显著变化,而在注射后120分钟和180分钟时均改善了25%。治疗期间未发现明显副作用。
在本观察性研究中,基于生物共振和真空机制的医疗器械应用于淋巴水肿肢体,在减少肢体容积和淋巴闪烁造影参数方面被证明是安全有效的。