Galley P, Thiollet M
Service de Médecine Interne, Hôpital de Pessac, France.
Int Angiol. 1993 Mar;12(1):69-72.
The efficacy and safety of a new veno-active flavonoid fraction (S 5682) consisting of micronized diosmin (90%) and hesperidin (10%) have been studied in 100 patients with symptomatic capillary fragility in a double-blind, randomized, placebo-controlled trial. Treatment lasted 6 weeks and consisted of 2 daily tablets of either S 5682 or placebo. Patients were examined at weeks 0, 2, 4 and 6. Compared to placebo, capillary resistance, assessed by the negative suction cup method, was significantly higher in the S 5682 group at week 4 (219 +/- 10 mmHg versus 159 +/- 8 mmHg; p < 0.001) and week 6 (261 +/- 12 mmHg versus 163 +/- 9 mmHg; p < 0.001). This resulted in a significant improvement of symptoms of capillary fragility (spontaneous ecchymosis, epistaxis, purpura, petechiae, gingivorrhagia, metrorrhagia and conjunctival haemorrhage) in S 5682 treated patients (p < 0.001). S 5682 was well tolerated. The rate of side-effects spontaneously volunteered by the patients was similar in both groups. We, therefore, conclude that S 5682 increases to a large extent the capillary resistance in patients with abnormal capillary fragility without significant side-effects.
在一项双盲、随机、安慰剂对照试验中，对100例有症状性毛细血管脆性的患者研究了一种由微粉化地奥司明（90%）和橙皮苷（10%）组成的新型静脉活性类黄酮组分（S 5682）的疗效和安全性。治疗持续6周，包括每日服用2片S 5682或安慰剂。在第0、2、4和6周对患者进行检查。与安慰剂相比，通过负压吸引杯法评估的毛细血管阻力在第4周时S 5682组显著更高（219±10 mmHg对159±8 mmHg；p<0.001），在第6周时也是如此（261±12 mmHg对163±9 mmHg；p<0.001）。这导致接受S 5682治疗的患者毛细血管脆性症状（自发性瘀斑、鼻出血、紫癜、瘀点、牙龈出血、子宫出血和结膜出血）有显著改善（p<0.001）。S 5682耐受性良好。两组患者自发报告副作用的发生率相似故我们得出结论，S 5682可在很大程度上提高毛细血管脆性异常患者的毛细血管阻力，且无明显副作用。
