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奥昔芦丁与欧洲七叶树提取物治疗慢性静脉功能不全患者的临床疗效及耐受性比较

Comparative clinical efficacy and tolerability of oxerutins and horse chestnut extract in patients with chronic venous insufficiency.

作者信息

Rehn D, Unkauf M, Klein P, Jost V, Lücker P W

机构信息

Zyma GmbH, Medizin und Entwicklung, Munich, Germany.

出版信息

Arzneimittelforschung. 1996 May;46(5):483-7.

PMID:8737631
Abstract

Oxerutins (O-(beta-hydroxyethyl)rutosides, HR, Venoruton) and horse chestnut extract (HCE) are active principles of first priority for the pharmacological treatment of chronic venous insufficiency (CVI). The efficacies of both compounds were shown in numerous, double-blind, randomized, placebo controlled clinical trials. Besides the direct comparison of the two compounds the aim of the study was to investigate the initial dose/maintenance dose concept for HR. 137 female, postmenopausal patients with CVI II finished the study according to protocol. Following one week placebo run-in the patients were treated either with 1000 mg/d HR, 600 mg/d HCE or 1000 mg/d for 4 weeks and than with 500 mg/d HR within the initial dose/maintainance dose concept for 12 weeks and observed for further 6 weeks. A main confirmative criterion was the volume reduction of the leg. Subjective criteria were descriptively evaluated. HR (1000 mg/d) was proven to be equivalent or better, reducing the leg volume (AUB0-18) by -5273 +/- 11418 ml.d compared to -3187 +/- 10842 ml.d under HR (1000 mg/d and 500 mg/d), and -3004 +/- 7429 ml.d under HCE-treatment. Both compounds exhibit a substantial carry-over effect. The maintenance posology of HR is able to stabilize the therapeutic obtained under initial dose conditions.

摘要

奥昔芦丁(O-(β-羟乙基)芦丁糖苷,HR,维脑路通)和七叶树提取物(HCE)是慢性静脉功能不全(CVI)药物治疗的首要活性成分。这两种化合物的疗效已在众多双盲、随机、安慰剂对照临床试验中得到证实。除了对这两种化合物进行直接比较外,该研究的目的还在于探究HR的初始剂量/维持剂量方案。137名患有II期CVI的绝经后女性患者按方案完成了该研究。在经过一周的安慰剂导入期后,患者按照初始剂量/维持剂量方案,分别接受1000 mg/d HR、600 mg/d HCE治疗,或先接受1000 mg/d HR治疗4周,然后接受500 mg/d HR治疗12周,并继续观察6周。主要的确证标准是腿部体积的减小。对主观标准进行了描述性评估。结果证明,HR(1000 mg/d)等效或更优,与HR(1000 mg/d和500 mg/d)治疗下腿部体积减小-3187±10842 ml.d以及HCE治疗下腿部体积减小-3004±7429 ml.d相比,其腿部体积减小了-5273±11418 ml.d。两种化合物均表现出显著的延续效应。HR的维持剂量能够稳定初始剂量条件下所获得的治疗效果。

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