Long-Term Intravenous Infusion of PGE₁ in Peripheral Arterial Blood Flow Disorders: Results of an Open Screening Study with Patients in Fontaine’s Stages III and IV

Summary

In all, 151 patients, 41 women and 110 men, average age 72 years (range 22–92 years old), with PAOD in stages III and IV in whom reconstructive vascular surgery, catheter dilation or thrombolytic treatment was not possible, had been refused by the patient or was too perilous, and in whom conventional vasoactive drugs were ineffective, were treated with one intravenous infusion of 40 µg of PGE₁ (alprostadil) twice daily for on average 26.9 ± 21.5 days. In each case PGE₁ was infused in 250 ml of 5% laevulose solution. Each infusion lasted for 2 hours.

The important results were as follows:

• 1. Rest pain was present in 146 of the patients before treatment. After treatment there was no rest pain in 27.1% of all patients, it was reduced in 42.3% and it was unchanged in 30.6%.

• 2. Necrosis was present in 95 patients before treatment. After treatment the areas of necrosis had healed up completely in 21.1%, they had improved in 37.9%, were unchanged in 11.6% and were worse in 29.5%.

• 3. The determination of transcutaneous oxygen partial pressure revealed a highly significant increase of on average 65% in the 20 patients investigated.

• 4. Adverse reactions (nausea, malaise) were only reported by nine patients. In two patients the treatment had to be stopped because of the side-effects.

Retrospective stratification of the patients included in the study showed also that the therapeutic results were better in younger patients with endangiitis and in non-diabetics than in older patients and diabetics. Rest pain responded better than necrosis.

It is clear from the results that PGE₁ is effective not only by the intra-arterial route, but also by intravenous administration, and these results were achieved in an extremely unpromising group of patients.