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Application of vasoactive substances in one option to improve symptoms in patients with arterial occlusive disease in stage II. To estimate the efficiency of drug therapy, the improvement of the pain-free walking distance is usually utilized. Transcutaneous oxygen tension (tcPO2) may allow a more objective estimation of drug therapy effects in contrast to the pain-free walking distance.
22 patients at the mean age of 61 years were included in a controlled, prospective double-blind study to show the efficacy of therapy with naftidrofuryl. 12 patients were treated with naftidrofuryl (2x300 mg/die p.o.) and 10 patients with a placebo over a period of 12 weeks. Both collectives did not differ significantly in regard to age, sex, cardiovascular morbidity and vascular status. Initially doppler, oscillography and transcutaneous oxygen tension measurements were carried out. Measurement of the transcutaneous oxygen tension before and at exercise was registered five times before and after therapy.
In the placebo group, there was an increase of the pain-free walking distance from 177 to 242 m (mean) and in the naftidrofuryl group from 186 to 257 m (difference 23,5 vs 38,2%; not significant). Comparison of the transcutaneously measured pO2 before and after therapy did not show significant differences (neither during rest nor during exercise) between the collectives. The closest, but negative correlation, was found between the pain-free walking distance and the O2 index foot (tcPO2 on the foot during exercise divided by tcPO2 on the foot at rest in mmHg).
Our study showed a slight increase in the pain-free walking distance in both the placebo and naftidrofuryl therapy group. Due to the subjective nature of the pain-free walking distance, its use is limited for determining therapy efficacy. However, transcutaneous PO2 measurement also could not show a significant difference between verum and placebo. It is still to be discussed whether spot check tcPO2 measurement can reflect the therapy course satisfactory. Further investigations with a larger patient collective may be necessary to confirm beneficial therapy results using naftidrofuryl, which could not be identified in our study.