Initial evidence of safety and clinical effect of recombinant streptokinase suppository in acute hemorrhoidal disease. Open, proof-of-concept, pilot trial
Abstract
A proof-of-concept, pilot clinical trial was carried out in 2 hospitals, to evaluate the safety of recombinant streptokinase (rSK) administered by the rectal route in patients with acute hemorrhoidal disease (AHD). Suppositories containing 200 000 IU rSK were given every 6 hours, up to 4 applications. The patients, after discharge, were seen daily in follow-up visits up to 10 days. Symptoms, lesion size, edema and inflammation were evaluated. Ten patients were included. The rSK suppository was safe and tolerable. The adverse events reported were minimal (only ardor and anal itching in only one patient), both with minor intensity which did not require treatment, and with low causality relationship of the product since they could be explained by the underlying disease as well. Symptoms disappeared at 24 hours in 7 patients. Complete recovery was achieved in most of the patients (90%) in 5 days. Only one patient needed surgical thrombectomy. rSK suppositories are safe and showed initial efficacy data. It could become a new therapeutic option for hemorrhoidal crisis if results are confirmed in further and controlled studies.
