背景:慢性静脉功能不全(CVI)是静脉瓣膜回流和/或静脉血流阻塞以及下肢静脉高压的结果。这项前瞻性补充注册研究的目的是评估压力袜或碧萝精®在控制CVI症状和水肿方面的功效及其对微循环参数的功效。
方法:两组比较的30名CVI患者观察4个月。
结果:弹性压缩的耐受性低于Bycnogenol®,有12名受试者无法遵循常规压缩。没有观察到由于补充的副作用;补充的耐受性是最佳的。纳入时的动态静脉压(AVP)和再填充时间(RT)表明静脉压和反流显着增加(再填充时间<16秒)。4个月后AVP和RT没有改变。两组之间的微循环和临床测量结果具有可比性。4个月后,与压缩相比,碧萝精®可显著改善皮肤静息通量(RF)和皮肤PO2-PCO2(P<0.05).摄入碧萝精®后,皮肤PO2的显著增加和PCO2的减少归因于异常高的皮肤静息通量的减少,更好的灌注和皮肤营养供应的标志。碧萝精®减少腿部体积,晚上平均减少18.3%,而压缩减少4.4%(P<0.05),对水肿有重要影响。与压迫相比,碧萝皂苷组的静脉临床严重程度评分(VCSS)和复合症状评分(CSS)显着降低,表明与压缩相比,补充碧萝精®可更好地改善微循环灌注和营养供应。与压缩相比,碧萝醇®显着改善了微循环和临床症状。与压缩相比,碧萝精®降低了远踝周围区域的局部氧化应激(OS)(P<0.05)。较低的局部OS是更好的毛细血管灌注和更好的营养交换的重要代谢指标。在注册研究结束时,在压迫组中观察到4个小溃疡和4个肢体(最大直径在3至5毫米之间)的皮肤破裂。在Pycnogenol®组中没有观察到溃疡或皮肤破裂。
结论:碧萝精®缓解水肿,改善CVI患者的微循环,减少静止,与压缩相比,间质液。CVI的大多数症状与间质水潴留有关;肢体组织中多余液体的存在改变了灌注和营养供应。Pycnogenol®补充剂减少了CVI肢体中的水和液体积累,改善了微循环和局部氧化应激,从而显示出重要的抗水肿作用。
BACKGROUND: Chronic venous insufficiency (CVI) is the consequence of venous valve reflux and/or venous flow obstruction and resulting venous hypertension in the lower extremities. The aim of this prospective supplement registry study was to evaluate the efficacy of compression stockings or Pycnogenol® in controlling symptoms and edema in CVI and their efficacy on microcirculatory parameters.
METHODS: Two comparable groups of 30 subjects with CVI were observed for 4 months.
RESULTS: Elastic compression was less tolerated than Pycnogenol® with 12 subjects being unable to follow the compression routine. No side effects due to supplementation were observed; tolerability of the supplementation was optimal. Ambulatory venous pressure (AVP) and refilling time (RT) at inclusion indicated a significant increase in venous pressure and reflux (refilling time <16 seconds). AVP and RT did not change after 4 months. Microcirculatory and clinical measurements were comparable at inclusion between the 2 groups. After 4 months, skin resting flux (RF) and skin PO
2-PCO
2 were significantly improved with Pycnogenol® compared to compression (P<0.05). The significant increase in skin PO
2 and the decrease in PCO
2 after Pycnogenol® intake were ascribed to the decrease in the abnormally high skin resting flux, a sign of better perfusion and skin nutritional supply. Pycnogenol® reduced leg volume, on average by 18.3% in the evening compared to 4.4% of reduction with compression (P<0.05) showing an important effect on edema. The venous Clinical Severity Score (VCSS) and the composite symptom score (CSS) decreased significantly in the Pycnogenol® group compared to compression, indicating a better improvement in microcirculatory perfusion and nutritional supply produced by the supplementation of Pycnogenol® in comparison with compression. Pycnogenol® significantly improved
microcirculation and clinical symptoms in comparison with compression. The decrease in local oxidative stress (OS) at the distal perimalleolar region with Pycnogenol® was significant in comparison with compression (P<0.05). A lower local OS is an important metabolic indication of a better capillary perfusion with better nutritional exchanges. At the end of the registry study, four small ulcerations and skin breaks in four limbs (between 3 and 5 mm of maximum diameters) were observed in the compression group. No ulcerations or skin breaks were observed in the Pycnogenol® group.
CONCLUSIONS: Pycnogenol® relieved edema, improved
microcirculation in CVI patients and reduced stationary, interstitial fluid in comparison with compression. Most symptoms of CVI are associated with interstitial water retention; the presence of extra fluid in limb tissues alters perfusion and nutrient supply. Pycnogenol® supplementation reduced water and fluid accumulation in CVI limbs and improved
microcirculation and local oxidative stress thus showing important anti-edema effects.