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-PatiñoDepartamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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

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

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V NunezDepartamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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A DiazDepartamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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

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

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A SierraDepartamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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

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

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

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N CastañedaDepartamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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

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M MurciaDepartamento de Pediatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia.

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

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W D Dias da SilvaDepartamento 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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