5-year control and treatment of edema and increased capillary filtration in venous hypertension and diabetic microangiopathy using o-(β-hydroxyethyl)-rutosides:: A prospective comparative clinical registry

5-year control and treatment of edema and increased capillary filtration in venous hypertension and diabetic microangiopathy using o-(β-hydroxyethyl)-rutosides:: A prospective comparative clinical registry
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DOI:
10.1177/0003319707312683
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发表时间:
2008-02-01
期刊:
影响因子:
2.8
通讯作者:
Grossi, Maria Giovanna
Grossi, Maria Giovanna
中科院分区:
医学3区
文献类型:
--
作者:
Belcaro, Gianni;Cesarone, Maria Rosaria;Grossi, Maria Giovanna

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这项独立的前瞻性对照试验评估了O-(β -羟乙基)-rutosides (HR)在5年给药期间对体征和症状以及微循环障碍进一步退化的疗效。评估了HR在预防静脉溃疡等终点并发症中的保护作用。本研究是基于水肿和毛细血管滤过率(CFR)与临床评分量表的评估。患者有严重程度的慢性静脉功能不全(CVI)和静脉微血管病,并完成至少5年的治疗。考虑以下4组:A组(CVI合并糖尿病患者,给予1500mg /d HR), B组(CVI合并糖尿病患者,给予2g /d HR), C组(对照组,不接受药物或压迫治疗),d组(仅使用弹性压迫袜的患者)。所有患者都接受了“最佳”治疗。无不良反应或不耐受,依从性良好(> 85%)。在A组,5年随访期间CFR有统计学意义的下降。13组CFR的下降幅度大于a组,5年内水肿、肿胀和CFR均显著减少,接近正常水平。在5年内,HR对治疗静脉水肿和高血压以及防止远端静脉系统恶化是有效的。HR预防溃疡是另一个重要的观察结果。HR的效果似乎部分与剂量相关,耐受性和依从性良好。
This independent prospective controlled trial evaluates the efficacy of O-(beta-hydroxyethyl)-rutosides (HR) during 5 years of administration against signs and symptoms and further degeneration of microcirculatory disturbances. The protective effect of HR in preventing end-point complications such as venous ulceration is evaluated. This study is based on evaluation of edema and the capillary filtration rate (CFR) in association with a clinical score scale. Patients having a severe degree of chronic venous insufficiency (CVI) and venous microangiopathy and completing at least 5 years of treatment are included. The following 4 groups are considered: group A (patients with CVI but without diabetes mellitus, receiving 1500 mg/d of HR), group B (patients with CVI and diabetes mellitus, receiving 2 g/d of HR), group C (control subjects receiving no pharmacologic or compression treatment), and group D (patients using elastic compression stockings only). All patients received the "best" available treatment. No adverse effects or intolerance is noted, with good compliance (> 85%). In group A, there is a statistically significant decrease in the CFR during 5 years of follow-up. In group 13, the decrease in the CFR is greater than that in group A. Reductions in edema, swelling, and the CFR during 5 years are notable, and values approach normal levels. During 5 years, HR is effective in treating venous edema and hypertension and in preventing deterioration of the distal venous system. The prevention of ulcerations with HR is another important observation. The effects of HR seem to be partially dose related, and tolerability and compliance are good.