title: Efficacy and safety of topical hirudin (Hirudex): a double-blind, placebo-controlled study.
abstract: Hirudin, a thrombin inhibitor isolated from the leech Hirudo medicinalis, has been long known for its anticoagulant effects. In 1990, the former German BGA has published a monograph on Hirudo medicinalis extract (containing Hirudin and Eglin), stating that its local use is indicated in bruises with or without hematoma. The aim of this double-blind, placebo-controlled clinical trial was to evaluate the efficacy and safety of a Hirudin-containing cream (Hirudex cream; Hirudo medicinalis extract 280 UI/100 g) in patients affected with bruises with or without hematoma. 60 men and women between the ages of 18 and 65 years with a unilateral acute musculoskeletal injury (bruise) with or without hematoma were included. Dosage schedule and application route for both treatments were the following: 3-4 daily applications for 5 days for a total of 15-20 administrations during the whole study period. In the Hirudin group, a highly statistically and clinically significant improvement were noted. Although a statistical improvement was also seen in patients treated with placebo, this was less pronounced, and a highly significant between-group difference was noted for all three major efficacy parameters at each follow-up visit in favour of Hirudin. Both the patients and the investigator considered the overall assessment of efficacy at the end of the study to be significantly better (p < 0.001) in the Hirudin group than in the placebo group. Results of this study suggest that Hirudin is an effective local treatment in patients with mild to moderate bruises.
authors.affiliation: Clinic of Dermatological Disease, Queen Joanna Hospital, Sofia, Bulgaria.
authors.forename: P K
authors.initials: PK
authors.lastname: Stamenova
authors.forename: T
authors.initials: T
authors.lastname: Marchetti
authors.forename: I
authors.initials: I
authors.lastname: Simeonov
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D016001:Confidence Intervals; D003288:Contusions / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006406:Hematoma / Q000188:drug therapy; D024764:Hirudin Therapy; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D018709:Statistics, Nonparametric
chemical_list: D005343:Fibrinolytic Agents; D006629:Hirudins; D009824:Ointments