title: Comparative study of the efficacy and safety of two polyvalent, caprylic acid fractionated [IgG and F(ab')2] antivenoms, in Bothrops asper bites in Colombia.
abstract: The efficacy and safety of two polyvalent horse-derived antivenoms in Bothrops asper envenomings were tested in a randomized, double-blind, clinical trial performed in Colombia. Both antivenoms were manufactured from the same pool of hyperimmune plasma. Antivenom A was made of F(ab')2 fragments, generated by pepsin digestion and caprylic acid precipitation, whereas antivenom B consisted of whole IgG molecules produced by caprylic acid precipitation followed by ion-exchange chromatography. Besides the different nature of the active substance, antivenom B had higher protein concentration, slightly higher turbidity and aggregate content. No significant differences were observed in the efficacy of antivenoms. Both halted local and systemic bleeding (P = 0.40) within 6-12 h of treatment in 100% of the cases, and restored blood coagulation (P = 0.87) within 6-24 h in 84.7% of patients, and within 48 h in all of them, in agreement with restoration of plasma fibrinogen concentration. Venom concentrations in serum dropped significantly (P < 0.001), to very low levels, 1 h after antivenom infusion. Nevertheless, eight patients (11.1%), four for each antivenom, presented recurrence of venom antigenaemia at different times, from 6 to 96 h, with clinical significance (recurrent coagulopathy) only in one group B patient (2.9%). Serum creatine kinase (CK) activity was increased, as a consequence of local myonecrosis. There was no significant difference (P = 0.51) in the incidence of early adverse reactions to antivenom administration (28.9% for patients of group A and 20.6% for patients of group B), most of the reactions being mild, mainly cutaneous. The most frequent complications were cellulitis (16.7%), abscess formation (5.6%), acute renal failure (8.3%), and compartmental syndrome (5.6%). In conclusion, IgG and F(ab')2 antivenoms, prepared by caprylic acid fractionation, presented similar efficacy and safety profiles for the treatment of B. asper envenomings in Colombia.
authors.affiliation: Facultad de Medicina, Universidad de Antioquia, A.A. 1226, Medellín, Colombia. rafaotero@une.net.co
authors.forename: Rafael
authors.initials: R
authors.lastname: Otero-Patiño
authors.forename: Alvaro
authors.initials: A
authors.lastname: Segura
authors.forename: María
authors.initials: M
authors.lastname: Herrera
authors.forename: Yamileth
authors.initials: Y
authors.lastname: Angulo
authors.forename: Guillermo
authors.initials: G
authors.lastname: León
authors.forename: José María
authors.initials: JM
authors.lastname: Gutiérrez
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Barona
authors.forename: Sebastián
authors.initials: S
authors.lastname: Estrada
authors.forename: Andrés
authors.initials: A
authors.lastname: Pereañez
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Quintana
authors.forename: Leidy J
authors.initials: LJ
authors.lastname: Vargas
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Gómez
authors.forename: Abel
authors.initials: A
authors.lastname: Díaz
authors.forename: Ana María
authors.initials: AM
authors.lastname: Suárez
authors.forename: Jorge
authors.initials: J
authors.lastname: Fernández
authors.forename: Patricia
authors.initials: P
authors.lastname: Ramírez
authors.forename: Patricia
authors.initials: P
authors.lastname: Fabra
authors.forename: Monica
authors.initials: M
authors.lastname: Perea
authors.forename: Diego
authors.initials: D
authors.lastname: Fernández
authors.forename: Yobana
authors.initials: Y
authors.lastname: Arroyo
authors.forename: Dalila
authors.initials: D
authors.lastname: Betancur
authors.forename: Lady
authors.initials: L
authors.lastname: Pupo
authors.forename: Elkin A
authors.initials: EA
authors.lastname: Córdoba
authors.forename: C Eugenio
authors.initials: CE
authors.lastname: Ramírez
authors.forename: Ana Berta
authors.initials: AB
authors.lastname: Arrieta
authors.forename: Alcides
authors.initials: A
authors.lastname: Rivero
authors.forename: Diana Carolina
authors.initials: DC
authors.lastname: Mosquera
authors.forename: Nectty Lorena
authors.initials: NL
authors.lastname: Conrado
authors.forename: Rosina
authors.initials: R
authors.lastname: Ortiz
mesh_terms: D000293:Adolescent; D000818:Animals; D000997:Antivenins / Q000627:therapeutic use*; D001777:Blood Coagulation; D001778:Blood Coagulation Disorders / Q000188:drug therapy; D017837:Bothrops / Q000378:metabolism*; D002210:Caprylates / Q000494:pharmacology; D005591:Chemical Fractionation / Q000379:methods; D002852:Chromatography, Ion Exchange / Q000379:methods; D003105:Colombia; D003435:Crotalid Venoms / Q000378:metabolism; D004311:Double-Blind Method; D004341:Drug Evaluation; D064420:Drug-Related Side Effects and Adverse Reactions / Q000378:metabolism*; D005260:Female; D005340:Fibrinogen / Q000032:analysis; D006470:Hemorrhage / Q000188:drug therapy; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use; D007074:Immunoglobulin G / Q000627:therapeutic use; D015994:Incidence; D008297:Male; D010434:Pepsin A / Q000378:metabolism; D012909:Snake Bites / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000997:Antivenins; D002210:Caprylates; D003435:Crotalid Venoms; D007140:Immunoglobulin Fab Fragments; D007074:Immunoglobulin G; D005340:Fibrinogen; D010434:Pepsin A; C031492:octanoic acid