[Evaluation of the analgesic effect of naftidrofuryl in permanent ischemia in patients with arterial diseases. Double-blind versus placebo study]

Abstract

Ischemic rest pain, with or without trophic disorders and occurring very frequently at night, is responsible for insomnia and complications such as positional oedema. The pathophysiological mechanisms underlying the analgesic effect of naftidrofuryl led us to evaluate the efficacy of this treatment. 37 selected patients were given 2 daily infusions of 400 mg of naftidrofuryl for 8 days, under double-blind conditions. Evaluation criteria were pain assessment using a visual analogue scale, analgesic consumption considering both the power (WHO scale: level I paracetamol, level II dextropropoxyphene, level III morphine) and the dosage of the analgesic used (analgesic score), index of therapeutic success including the level of pain reduction and the absence of analgesic use. The results showed a significant difference in favour of naftidrofuryl for: reduction of pain, difference in the course of the analgesic score, the distribution of the population according to the index of therapeutic success. Three patients discontinued treatment due to inefficacy, but all 3 belonged to the placebo group. This study demonstrates the benefit of naftidrofuryl in pain reduction which was assessed, in particular, by the reduction of analgesic consumption.