Rehn D, Unkauf M, Klein P, Jost V, Lücker P W
Zyma GmbH, Medizin und Entwicklung, Munich, Germany.
Arzneimittelforschung. 1996 May;46(5):483-7.
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.
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。