The material includes 17 patients suffering from different degrees of chronic
peripheral arterial disease (11 chronic patients stage III and IV, two patients with acute
arterial occlusion, and four patients stage II). Presence and extent of
arterial occlusion was ascertained by initial arteriography. In twelve of the patients
amputation had been considered. The patients were treated by a series of i.v. infusions of
brinase, a
proteolytic enzyme from Aspergillus oryzae. The
brinase inhibitor capacity in plasma was determined by the azocollagen technique. Dosage of
brinase was calculated to retain a rest-inhibitor capacity in order to avoid free proteolytic activity. In five patients the
enzyme was also given preoperatively by intra-arterial instillation prior to a series of i.v.
brinase infusions. Thirteen patients showed clinical improvement after
brinase treatment. The condition of two patients remained unchanged, and in two patients
amputation could not be avoided. In fourteen patients the treatment results were followed by measurement of peripheral systolic blood pressure. In ten patients obvious increase of the peripheral systolic blood pressure was observed. Cutaneous microcirculation was studied in seven patients by i.v. sequential
fluorescein angiography and signs of improved microcirculation (appearance time, intensity and/or extent of fluorescence) were found in all examined patients. One patient with acute
arterial occlusion of the right leg with obstruction of blood flow from the external iliac artery showed complete disobliteration after a series of i.v.
brinase infusions.
Bleeding complications associated with
brinase treatment were not observed in the material. In three patients
brinase treatment was discontinued because of complications (2
brinase, 1
heparin).