Belcaro G, Dugall M, Luzzi R, Corsi M, Ledda A, Ricci A, Pellegrini L, Cesarone M R, Hosoi M, Errichi B M, Cornelli U, Cotellese R, Agus G, Feragalli B
Irvine 3 Labs, Circulation Sciences, CH-PE University, Italy.
Int J Angiol. 2017 Sep;26(3):170-178. doi: 10.1055/s-0036-1597756. Epub 2016 Dec 28.
The aim of this registry study was to compare products used to control symptoms of CVI. Endpoints of the study were microcirculation, effects on volume changes, and symptoms (analogue scale). Pycnogenol, venoruton, troxerutin, the complex diosmin-hesperidin, Antistax, Mirtoselect (bilberry), escin, and the combination Venoruton-Pycnogenol (VE-PY) were compared with compressions. No safety or tolerability problems were observed. At inclusion, measurements in the groups were comparable: 1,051 patients completed the registry. : Venoruton, Pycnogenol, and the combination VE-PY produced the best effects on skin flux. These products and the combination VE-PY better improved PO and PCO . The edema score was decreased more effectively with the combination and with Pycnogenol. Venoruton; Antistax also had good results. Considering volumetry, the best performers were the combination PY-VE and the two single products Venoruton and Pycnogenol. Antistax results for edema were also good. The best improvement in symptoms score were obtained with Pycnogenol and compression. A larger decrease in oxidative stress was observed with Pycnogenol, Venoruton, and with the VE-PY combination. Good effects of Antistax were also observed. Parestesias were lower with Pycnogenol and with Antistax. Considering the need for interventions, the best performers were Pycnogenol, VE-PY, and compression. The efficacy of Pycnogenol and the combination are competitive with stockings that do not have the same tolerability in warmer climates. A larger and more prolonged evaluation is suggested to evaluate cost-efficacy (and non-interference with drugs) of these products in the management of CVI. The registry is in progress; other products are in evaluation.
这项注册研究的目的是比较用于控制慢性静脉功能不全（CVI）症状的产品。该研究的终点是微循环、对体积变化的影响以及症状（视觉模拟评分）。将碧萝芷、维脑路通、曲克芦丁、复合地奥司明 - 橙皮苷、脉管复康片、越橘提取物（越橘）、七叶皂苷以及维脑路通 - 碧萝芷组合（VE - PY）与压迫疗法进行比较。未观察到安全性或耐受性问题。纳入研究时，各分组的测量数据具有可比性：1051名患者完成了注册。结果显示：维脑路通、碧萝芷以及VE - PY组合对皮肤血流量产生的效果最佳。这些产品以及VE - PY组合能更好地改善经皮氧分压（PO）和二氧化碳分压（PCO）。组合疗法和碧萝芷能更有效地降低水肿评分。维脑路通和脉管复康片也取得了良好效果。在体积测量方面，表现最佳的是PY - VE组合以及维脑路通和碧萝芷这两种单一产品。脉管复康片在水肿方面的效果也很好。症状评分改善最佳的是碧萝芷和压迫疗法。碧萝芷、维脑路通以及VE - PY组合观察到氧化应激有更大程度的降低。脉管复康片也观察到良好效果。碧萝芷和脉管复康片导致的感觉异常较少。考虑到干预需求，表现最佳的是碧萝芷、VE - PY组合和压迫疗法。碧萝芷及其组合的疗效与在温暖气候下耐受性不同的弹力袜相当。建议进行更大规模、更长期的评估，以评估这些产品在CVI管理中的成本效益（以及对药物无干扰）。注册研究正在进行中；其他产品正在评估。
