Kalis B
J Mal Vasc. 1984;9(2):133-6.
A double-blind therapeutic trial was undertaken in 40 subjects with large venous ulcers and distributed on a homogeneous basis. They were treated with naftidrofuryl by intravenous infusions for one week followed by oral treatment for three months, in comparison with a placebo (infusions of saline and lactose tablets). All the patients received the same local treatment. Results were assessed not only clinically (changes in ulcer) but also objectively by the measurement of TcPO2. TcPO2 by the measurement of transcutaneous tissue oxygenation is an indicator of the state of the microcirculation and hence the trophic condition of the tissues. Study of the results (Student t) showed that in the treated group and at the ulcer site there was a significant (p less than 0.05) difference from D7 onwards, which increased further during treatment (p less than 0.02 at 3 months). For the placebo group, significance occurred only at D90 (p less than 0.05). The intergroup course difference was itself significant at D45 and D90. The tolerance of naftidrofuryl in both of its forms was unremarkable. Clinical study showed a good correlation between improvement in PO2 and ulcer healing. This trial confirmed the efficacy of naftidrofuryl in the treatment of venous ulcers.
对40名患有大面积静脉溃疡的受试者进行了一项双盲治疗试验,并将他们进行了均匀分组。与安慰剂(生理盐水输注和乳糖片)相比,他们接受了一周的萘呋胺酯静脉输注治疗,随后进行了三个月的口服治疗。所有患者均接受相同的局部治疗。不仅通过临床(溃疡变化)评估结果,还通过测量经皮氧分压(TcPO2)进行客观评估。通过测量经皮组织氧合来测定TcPO2是微循环状态的指标,因此也是组织营养状况的指标。结果研究(Student t检验)表明,治疗组从第7天起在溃疡部位与安慰剂组有显著差异(p<0.05),在治疗期间差异进一步增大(3个月时p<0.02)。对于安慰剂组,仅在第90天出现显著差异(p<0.05)。组间病程差异在第45天和第90天本身具有显著性。萘呋胺酯两种剂型的耐受性均无异常。临床研究表明,PO2改善与溃疡愈合之间具有良好的相关性。该试验证实了萘呋胺酯治疗静脉溃疡的疗效。