Department of Biomedical Sciences, G D'Annunzio, Chieti-Pescara University, Faculty of Motory Sciences, L'Aquila University, Italy.
Phytomedicine. 2010 Sep;17(11):835-9. doi: 10.1016/j.phymed.2010.04.009. Epub 2010 Jun 25.
The aim of this study was to evaluate the clinical efficacy of standardized French maritime pine bark extract Pycnogenol in patients with severe chronic venous insufficiency (CVI). 98 subjects with symptomatic CVI and edema were randomly assigned to one group treated with 150 mg Pycnogenol a day only, another group with stockings only and a third group with both Pycnogenol and elastic stockings. The average ambulatory venous pressure (AVP) at inclusion was 58+/-7 mm Hg (range 48-60 mm Hg) with a refilling time (RT)<12 s (average 7+/-2 s). The duration of the disease was on average 6.0+/-3.1 years. There were no differences in AVP or RT among the 3 groups at inclusion and microcirculatory and clinical evaluations were comparable. After 8 weeks treatment there was a significant decrease of rate of ankle swelling, resting flux, transcutaneous pO(2) and clinical symptom scores in all groups with significantly better results for the combination treatment. Pycnogenol alone was more effective than compression alone for all parameters (p<0.05). No side-effects were observed; compliance and tolerability were very good. This study corroborates a significant clinical role for Pycnogenol in the management, treatment and control of CVI also in combination with compression.
本研究旨在评估标准化法国沿海松树皮提取物碧萝芷(Pycnogenol)对严重慢性静脉功能不全(CVI)患者的临床疗效。98 例有症状的 CVI 和水肿患者被随机分为三组:一组仅服用 150 毫克碧萝芷,一组仅穿弹力袜,一组同时服用碧萝芷和弹性袜。纳入时平均步行静脉压(AVP)为 58±7mmHg(范围 48-60mmHg),再充盈时间(RT)<12s(平均 7±2s)。疾病持续时间平均为 6.0±3.1 年。纳入时三组间 AVP 或 RT 无差异,且微循环和临床评估相当。经过 8 周的治疗,所有组的踝肿胀率、休息流量、经皮 pO2 和临床症状评分均显著下降,联合治疗的效果明显更好。碧萝芷单独治疗在所有参数上均优于单独压缩治疗(p<0.05)。未观察到不良反应;依从性和耐受性非常好。这项研究证实了碧萝芷在 CVI 的管理、治疗和控制方面具有显著的临床作用,联合使用压缩治疗效果更佳。