A randomized, blinded, comparative trial of one pepsin-digested and two whole IgG antivenoms for Bothrops snake bites in Uraba, Colombia. The Regional Group on Antivenom Therapy Research (REGATHER).

R Otero-Patiño Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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J L Cardoso Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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H G Higashi Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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V Nunez Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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A Diaz Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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M F Toro Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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M E Garcia Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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A Sierra Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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L F Garcia Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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A M Moreno Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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M C Medina Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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N Castañeda Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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J F Silva-Diaz Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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M Murcia Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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S Y Cardenas Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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W D Dias da Silva Departamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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The therapeutic efficacy and the incidence of early antivenom reactions (EARs) were compared in a clinical trial performed in 79 patients bitten by Bothrops sp. in Urabá, Colombia. Patients were randomized into three groups according to the antivenom administered: A (n = 30, Butantan polyspecific, pepsin-digested Bothrops antivenom); B (n = 27, Butantan polyspecific, whole IgG Bothrops antivenom); and C (n = 22, Colombian commercial, monovalent, whole IgG Bothrops antivenom). The groups were comparable in all clinical and epidemiologic aspects; 33 patients had mild, 22 moderate, and 24 severe envenoming. At the doses used (two, four, and six vials [10 ml/vial] for mild, moderate, and severe envenomings, respectively) there were no differences between the antivenoms in restoring normal hemostatic parameters within 24 hr. The evolution of local envenoming was comparable in the three groups. Serum venom/antivenom kinetics determined by ELISA showed a complete clearance of venom levels 1 hr after treatment in mild/moderate envenomings. In severe cases, venom levels remained detectable up to 24 hr and recurrence of antigenemia was observed in some cases. Antivenom concentrations remained at high levels up to 24 hr of treatment. The incidence of EARs was significantly different in the groups: A (36.7%), B (11.1.%), and C (81.8%). There were no life-threatening anaphylactic reactions. We conclude that the efficacy of the three antivenoms was similar in neutralizing human Bothrops envenomings and that the production of whole IgG antivenoms by caprylic acid fractionation is a good alternative for reducing the incidence of EARs.

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