title: Efficacy and safety of two whole IgG polyvalent antivenoms, refined by caprylic acid fractionation with or without beta-propiolactone, in the treatment of Bothrops asper bites in Colombia.
abstract: The efficacy and safety of two whole IgG polyvalent antivenoms (A and B) were compared in a randomised, blinded clinical trial in 67 patients systemically envenomed by Bothrops asper in Colombia. Both antivenoms were fractionated by caprylic acid precipitation and had similar neutralising potencies, protein concentrations and aggregate contents. Antivenom B was additionally treated with beta-propiolactone to lower its anticomplementary activity. Analysing all treatment regimens together, there were no significant differences between the two antivenoms (A=34 patients; B=33 patients) in the time taken to reverse venom-induced bleeding and coagulopathy, to restore physiological fibrinogen concentrations and to clear serum venom antigenaemia. Blood coagulability was restored within 6-24 h in 97% of patients, all of whom had normal coagulation and plasma fibrinogen levels 48 h after the start of antivenom treatment. Two patients (3.0%) had recurrent coagulopathy and eight patients suffered recurrence of antigenaemia within 72 h of treatment. None of the dosage regimens of either antivenom used guaranteed resolution of venom-induced coagulopathy within 6 h, nor did they prevent recurrences. A further dose of antivenom at 6 h also did not guarantee resolution of coagulopathy within 12-24 h in all patients. The incidence of early adverse reactions (all mild) was similar for both antivenoms (15% and 24%; P>0.05).
authors.affiliation: Programa de Ofidismo/Escorpionismo, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia. rafaotero@epm.net.co
authors.forename: Rafael
authors.initials: R
authors.lastname: Otero
authors.forename: Guillermo
authors.initials: G
authors.lastname: León
authors.forename: José María
authors.initials: JM
authors.lastname: Gutiérrez
authors.forename: Gustavo
authors.initials: G
authors.lastname: Rojas
authors.forename: María Fabiola
authors.initials: MF
authors.lastname: Toro
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Barona
authors.forename: Verónica
authors.initials: V
authors.lastname: Rodríguez
authors.forename: Abel
authors.initials: A
authors.lastname: Díaz
authors.forename: Vitelbina
authors.initials: V
authors.lastname: Núñez
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Quintana
authors.forename: Shirley
authors.initials: S
authors.lastname: Ayala
authors.forename: Diana
authors.initials: D
authors.lastname: Mosquera
authors.forename: Lesdy L
authors.initials: LL
authors.lastname: Conrado
authors.forename: Diego
authors.initials: D
authors.lastname: Fernández
authors.forename: Yobana
authors.initials: Y
authors.lastname: Arroyo
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Paniagua
authors.forename: Mercedes
authors.initials: M
authors.lastname: López
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Ospina
authors.forename: Claudia
authors.initials: C
authors.lastname: Alzate
authors.forename: Jorge
authors.initials: J
authors.lastname: Fernández
authors.forename: Jazmín J
authors.initials: JJ
authors.lastname: Meza
authors.forename: Juan F
authors.initials: JF
authors.lastname: Silva
authors.forename: Patricia
authors.initials: P
authors.lastname: Ramírez
authors.forename: Patricia E
authors.initials: PE
authors.lastname: Fabra
authors.forename: Eugenio
authors.initials: E
authors.lastname: Ramírez
authors.forename: Elkin
authors.initials: E
authors.lastname: Córdoba
authors.forename: Ana B
authors.initials: AB
authors.lastname: Arrieta
authors.forename: David A
authors.initials: DA
authors.lastname: Warrell
authors.forename: R David G
authors.initials: RD
authors.lastname: Theakston
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000997:Antivenins / Q000097:blood / Q000737:chemistry / Q000627:therapeutic use*; D001778:Blood Coagulation Disorders / Q000188:drug therapy / Q000209:etiology; D017837:Bothrops; D002210:Caprylates / Q000494:pharmacology; D005591:Chemical Fractionation / Q000379:methods; D002648:Child; D002675:Child, Preschool; D003435:Crotalid Venoms / Q000097:blood*; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D006801:Humans; D007074:Immunoglobulin G; D008297:Male; D051379:Mice; D008875:Middle Aged; D011420:Propiolactone / Q000494:pharmacology; D012008:Recurrence; D012909:Snake Bites / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome; D014914:Whole Blood Coagulation Time
chemical_list: D000997:Antivenins; D002210:Caprylates; D003435:Crotalid Venoms; D007074:Immunoglobulin G; D011420:Propiolactone; D005340:Fibrinogen; C031492:octanoic acid