| Popis: |
A large-scale clinical trial was conducted, according to World Health Organization Good Clinical Practice guidelines, in 7 centres in North Cameroon to determine the safety and efficacy of a polyvalent antivenom composed of purified F(ab')2. This study included 223 patients presenting clinically with an obvious snake bite, predominantly due to #Echis ocellatus$ (viper), the most abundant species in this savannah region. Clinical surveillance was maintained for 5 d in all patients and until the twenty-sixth day in 74% of cases. Two 10 mL ampoules of polyvalent F(ab')2 equine antivenom (Ipser Africa (TM)) were administered to each patient by intravenous infusion. If necessary, treatment was repeated 1 h after the end of the first infusion, and then with a frequency determined by the patient's clinical condition. Before initiation of antivenom treatment, the main clinical disorders observed on admission were oedema (93.7%) and haemorrhage (48.9%), with a clotting time longer than 30 min in 65.4% of patients. Clincal cure was obtained in 213 patients (96.8%). No amputation was necessary, and the case fatality rate was only 1.3%. On average, 4.6 (+ or - 3.7) ampoules were administered per patient ; 43% of subjects recovered after only a single infusion of 2 ampoules. Early adverse reactions, of varying degrees of severity, were observed in 6.3% of patients. A severe early reaction, anaphylactic shock, was observed in only one patient (0.4%). Serum sickness was observed in another patient. Polyvalent F(ab')2 equine antivenom given by repeated 20 mL intravenous infusions is a safe and effective treatment for envenomation caused by African vipers. (Résumé d'auteur) |
