Cesarone M R, Belcaro G, Rohdewald P, Pellegrini L, Ledda A, Vinciguerra G, Ricci A, Gizzi G, Ippolito E, Fano F, Dugall M, Cipollone G, Acerbi G, Cacchio M, Del Boccio G, Di Renzo A, Stuard S, Corsi M
Irvine2 Vascular Lab and Physiology, Department of Biomedical Sciences, G D'Annunzio, Chieti-Pescara University, San Valentino Vascular Screening Project, Faculty of Motory Sciences, L'Aquila University, Italy.
Angiology. 2006 Aug-Sep;57(4):431-6. doi: 10.1177/0003319706290318.
The aim of this study was to investigate the clinical efficacy of oral Pycnogenol (Horphag Research Ltd, United Kingdom) in patients with diabetic microangiopathy. Patients without a history of diabetic ulcerations were treated with Pycnogenol. Patients received oral Pycnogenol (50 mg capsules, 3 times daily for a total of 150 mg daily for 4 weeks). A group of 30 patients was included (severe microangiopathy); 30 comparable patients were observed as controls (no treatment during the observation period). All patients (age, 59 years; range, 55-68 years; male:female = 18:12) included in the treatment group completed the 4-week study. Also, all controls completed the follow-up period. There were no drop-outs. All included subjects had signs and symptoms of diabetic microangiopathy. The duration of diabetes-from the first signs/symptoms--was on average 7.5 years (SD = 3). After 4 weeks, microcirculatory and clinical evaluations showed a progressive decrease in skin flux at rest in the foot (indicating an improvement in the level of microangiopathy), a significant decrease in capillary filtration, and a significant improvement in the venoarteriolar response in all treated subjects. There were no visible effects in controls except a slight reduction in skin flux at rest in the foot. Treatment was well tolerated in both groups. In conclusion, this study confirms the clinical efficacy of Pycnogenol in patients with diabetic microangiopathy. The study indicates the clinical role of Pycnogenol in the management, treatment, and control of this common clinical problem. The treatment may be also useful to prevent diabetic ulcerations by controlling the level of microangiopathy.
本研究旨在调查口服碧萝芷（法国沿海松树皮提取物，英国霍法格研究有限公司生产）对糖尿病微血管病变患者的临床疗效。无糖尿病溃疡病史的患者接受碧萝芷治疗。患者口服碧萝芷（50毫克胶囊，每日3次，共150毫克，持续4周）。纳入一组30例患者（重度微血管病变）；观察30例可比患者作为对照（观察期内未治疗）。治疗组所有患者（年龄59岁；范围55 - 68岁；男:女 = 18:12）均完成了为期4周的研究。此外，所有对照组患者均完成了随访期。无患者退出。所有纳入研究的受试者均有糖尿病微血管病变的体征和症状。糖尿病病程（从首次出现症状算起）平均为7.5年（标准差 = 3）。4周后，微循环和临床评估显示，所有接受治疗的受试者足部静息皮肤血流量逐渐下降（表明微血管病变程度改善），毛细血管滤过显著降低，动静脉反应显著改善。对照组除足部静息皮肤血流量略有下降外，无明显效果。两组对治疗的耐受性均良好。总之，本研究证实了碧萝芷对糖尿病微血管病变患者的临床疗效。该研究表明了碧萝芷在管理、治疗和控制这一常见临床问题中的临床作用。该治疗方法通过控制微血管病变程度，可能对预防糖尿病溃疡也有帮助。
