Lipo-PGE1, a new lipid-encapsulated preparation of prostaglandin E1: placebo-and prostaglandin E1-controlled multicenter trials in patients with diabetic neuropathy and leg ulcers.

摘要: Several clinical trials have shown that prostaglandin E1 (PGE1) is effective in treating peripheral occlusive vascular disease, but not definitely for diabetic neuropathy. We developed a new preparation of PGE1 incorporated lipid microspheres (lipo-PGE1) was designed to accumulate at lesions. The effect lipo-PGE1 (10 micrograms/day) compared with placebo and the normal dose free (PGE1-CD, 40 two studies (double-blind well-controlled) which enrolled 364 patients neuropathy and/or leg ulcers. drugs were given intravenously (bolus or drip infusion) 4 weeks. Clinical improvement noted 61.6% group 30.0% Trial 1 (p < 0.01), while figures 58.3% 37.1% PGE1-CD 2 0.01). Leg ulcers became smaller groups both In 2, motor conduction velocity improved = 0.016). Side effects occurred few receiving placebo, more local side Thus, bolus intravenous injection minimal effects.