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.
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).
Otero
Rafael
R
Programa de Ofidismo/Escorpionismo, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia. rafaotero@epm.net.co
León
Guillermo
G
Gutiérrez
José María
JM
Rojas
Gustavo
G
Toro
María Fabiola
MF
Barona
Jacqueline
J
Rodríguez
Verónica
V
Díaz
Abel
A
Núñez
Vitelbina
V
Quintana
Juan Carlos
JC
Ayala
Shirley
S
Mosquera
Diana
D
Conrado
Lesdy L
LL
Fernández
Diego
D
Arroyo
Yobana
Y
Paniagua
Carlos A
CA
López
Mercedes
M
Ospina
Carlos E
CE
Alzate
Claudia
C
Fernández
Jorge
J
Meza
Jazmín J
JJ
Silva
Juan F
JF
Ramírez
Patricia
P
Fabra
Patricia E
PE
Ramírez
Eugenio
E
Córdoba
Elkin
E
Arrieta
Ana B
AB
Warrell
David A
DA
Theakston
R David G
RD
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
D000997:Antivenins; D002210:Caprylates; D003435:Crotalid Venoms; D007074:Immunoglobulin G; D011420:Propiolactone; D005340:Fibrinogen; C031492:octanoic acid