Karetová Debora, Suchopár Josef, Bultas Jan
Vnitr Lek. 2020 Spring;66(2):97-103.
With the advent of novel monocomponent venoactive drugs containing the flavonoid diosmin, the need has arisen to answer the question of therapeutic equivalence of the widely used micronized purified flavonoid fraction (MPFF) contained in Detralex and of the currently introduced monocomponent venoactive drugs. Experimental work provides evidence that each of the two dominant components, i.e. diosmin and hesperidin, has its specific and distinctive pharmacodynamic effect. There is also evidence of a mutual synergistic effect, e.g. in antiexudative action. Clinical studies have been carried out with MPFF for the most part, and effect has clearly been established in this particular form. Conversely, the results of studies documenting the effect of diosmin alone have been conflicting. Mutual comparisons failed to confirm equivalence of MPFF and monocomponent diosmin in any of the studies. This fact is clearly reflected in the relevant guidelines where the use of MPFF in chronic venous disease is recommended unequivocally (level of evidence 1 and strength of evidence B) while, in the case of monocomponent diosmin, it is stated that treatment can be considered (2C). It can be concluded that both experimental and clinical studies document that only a complex of biologically active flavonoids - a micronized purified flavonoid fraction - has evidence of effect and is recommended by relevant guidelines.
随着含黄酮类地奥司明的新型单组分血管活性药物的出现,有必要回答以下问题:广泛使用的Detralex中所含的微粉化纯化黄酮类成分(MPFF)与目前推出的单组分血管活性药物在治疗上是否等效。实验工作表明,两种主要成分,即地奥司明和橙皮苷,各自都有其特定且独特的药效学作用。也有证据表明存在相互协同作用,例如在抗渗出作用方面。大部分临床研究是针对MPFF进行的,并且这种特定形式的效果已得到明确证实。相反,记录单独使用地奥司明效果的研究结果相互矛盾。在任何一项研究中,相互比较都未能证实MPFF和单组分地奥司明的等效性。这一事实在相关指南中得到了明确体现,其中明确推荐在慢性静脉疾病中使用MPFF(证据级别1,证据强度B),而对于单组分地奥司明,则表明可以考虑进行治疗(2C)。可以得出结论,实验和临床研究均表明,只有生物活性黄酮类成分的复合物——微粉化纯化黄酮类成分——有效果证据且被相关指南推荐。