Nikolova K
Clinic of Dermatology and Venereology, Higher Medical Institute, Sofia, Bulgaria.
Methods Find Exp Clin Pharmacol. 1994 Oct;16(8):609-13.
The effect of flunarizine in the treatment of post-phlebitic syndrome (PPS) and venous leg ulcers was studied in 42 patients in a double-blind, placebo-controlled trial over a period of 3 months. During the first month the dose of flunarizine or the matching placebo was 1 capsule of 5 mg twice-daily, and during the following 2 months 1 capsule of 5 mg once-daily. Most of the subjective symptoms such as heaviness in the legs, pain, paraesthesia, cramps at night, and swelling of the ankles considerably improved during treatment with flunarizine and were slightly improved in the placebo group. The ulcer surface area decreased after 3 months' treatment with flunarizine by 68.3% (p < 0.001), and after treatment with placebo by 20.5% (p > 0.05). In 15 patients treated with flunarizine and 1 with placebo the ulcers vanished completely. An improvement in the photoplethysmographic record of the lower legs in the flunarizine group was observed, as shown by increase in the index recovery time, while there were no significant changes in the placebo group. The results show that the favorable effect of flunarizine in the treatment of PPS and venous leg ulcers might be due largely to an improvement in subcutaneous circulation of the lower legs. Flunarizine may be an important adjunct to the conservative management of the complications caused by chronic venous insufficiency.
在一项为期3个月的双盲、安慰剂对照试验中,对42例患者研究了氟桂利嗪治疗血栓后综合征(PPS)和下肢静脉溃疡的效果。在第一个月,氟桂利嗪或匹配安慰剂的剂量为每日2次,每次1粒5毫克胶囊,在接下来的2个月中,剂量为每日1次,每次1粒5毫克胶囊。在使用氟桂利嗪治疗期间,大多数主观症状如腿部沉重感、疼痛、感觉异常、夜间痉挛和脚踝肿胀有显著改善,而安慰剂组仅有轻微改善。用氟桂利嗪治疗3个月后溃疡表面积减少68.3%(p<0.001),用安慰剂治疗后减少20.5%(p>0.05)。在15例接受氟桂利嗪治疗的患者和1例接受安慰剂治疗的患者中,溃疡完全消失。观察到氟桂利嗪组小腿光电容积描记图有所改善,表现为指数恢复时间增加,而安慰剂组无显著变化。结果表明,氟桂利嗪治疗PPS和下肢静脉溃疡的良好效果可能主要归因于小腿皮下循环的改善。氟桂利嗪可能是慢性静脉功能不全所致并发症保守治疗的重要辅助药物。