Streminski J A, de la Haye R, Rettig K, Kuntz G
G.E.M. Gesellschaft für Evaluation und Qualitätssicherung in der Medizin mbH, Kaarst Nycomed Arzneimittel GmbH, München.
Vasa. 1992;21(4):392-402.
In an open, randomized study in patients with peripheral arterial occlusive disease in state IIb according to Fontaine the clinical efficacy and tolerability of Actovegin upon intravenous and intraarterial application was examined compared to vascular training. 30 patients were included in each of the three therapy groups. Over a period of four weeks each patient received daily therapy--except for weekends. Patients of group I received a daily intravenous infusion of 250 ml Actovegin 20% p.i. the patients in group II received this medication by the intraarterial route. The third patient group received standardized vascular training. From a total of 90 patients 73 completed the study according to the study protocol. In all three groups the therapy resulted in the improvement of pain-free and pain-limited walking distances. Upon comparison of relative changes in the intraarterial and intravenous group significant differences turned out: whereas patients in the intravenous group achieved a mean increase in pain-free walking distance of 37.8%, a mean increase in walking distance of 44.9% in the intraarterial group was observed. With respect to maximum walking distances the relative improvements amounted to a mean of 44.0% in the intravenous group, and 64.3% in the intraarterial group. After training over four weeks in the vascular-training group the patients achieved a mean increase in pain-free walking distance of 69.6% and 53.5% in pain-limited walking distance. This meant a significantly greater improvement in pain-free walking distance compared to the intravenous group; the difference compared to the intraarterial group was not significant; however the mean values indicated that the vascular-training group showed greater improvements in pain-free walking distance, and more moderate improvements in maximum walking distance than the intraarterial group. However, these results were significantly modified, if a differentiation was made in the vascular-training group between patients with high and low compliance. In the patients' rating all three therapies were described as throughout beneficial, however, less positive for the intravenous therapy, which is in accordance to the results of changes in walking-distance. The results of the present study are discussed having in mind physical therapy being limited through contraindications and insufficient patient compliance.
在一项针对根据Fontaine分级处于IIb期外周动脉闭塞性疾病患者的开放性随机研究中,将活化素静脉内和动脉内应用时的临床疗效和耐受性与血管训练进行了比较。三个治疗组每组纳入30例患者。在四周的时间里,每位患者每天接受治疗(周末除外)。第一组患者每天静脉输注250ml 20%的活化素;第二组患者通过动脉内途径接受此药物治疗。第三组患者接受标准化的血管训练。90例患者中共有73例按照研究方案完成了研究。在所有三个组中,治疗均使无痛和疼痛受限步行距离得到改善。比较动脉内组和静脉内组的相对变化时,发现了显著差异:静脉内组患者的无痛步行距离平均增加了37.8%,而动脉内组观察到步行距离平均增加了44.9%。关于最大步行距离,静脉内组的相对改善平均为44.0%,动脉内组为64.3%。在血管训练组经过四周训练后,患者的无痛步行距离平均增加了69.6%,疼痛受限步行距离增加了53.5%。这意味着与静脉内组相比,无痛步行距离有显著更大的改善;与动脉内组相比差异不显著;然而,平均值表明血管训练组在无痛步行距离上的改善比动脉内组更大,在最大步行距离上的改善比动脉内组更适度。但是,如果在血管训练组中对依从性高和低的患者进行区分,这些结果会有显著改变。在患者的评价中,所有三种治疗都被描述为总体有益,然而,对静脉内治疗的评价不太积极,这与步行距离变化的结果一致。考虑到物理治疗因禁忌症和患者依从性不足而受到限制,对本研究的结果进行了讨论。