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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.
- Source :
-
Toxicon : official journal of the International Society on Toxinology [Toxicon] 2012 Feb; Vol. 59 (2), pp. 344-55. Date of Electronic Publication: 2011 Nov 29. - Publication Year :
- 2012
-
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.<br /> (Copyright © 2011 Elsevier Ltd. All rights reserved.)
- Subjects :
- Adolescent
Animals
Blood Coagulation
Blood Coagulation Disorders drug therapy
Caprylates pharmacology
Chemical Fractionation methods
Chromatography, Ion Exchange methods
Colombia
Crotalid Venoms metabolism
Double-Blind Method
Drug Evaluation
Female
Fibrinogen analysis
Hemorrhage drug therapy
Humans
Immunoglobulin Fab Fragments therapeutic use
Immunoglobulin G therapeutic use
Incidence
Male
Pepsin A metabolism
Treatment Outcome
Antivenins therapeutic use
Bothrops metabolism
Drug-Related Side Effects and Adverse Reactions metabolism
Snake Bites drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1879-3150
- Volume :
- 59
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Toxicon : official journal of the International Society on Toxinology
- Publication Type :
- Academic Journal
- Accession number :
- 22146491
- Full Text :
- https://doi.org/10.1016/j.toxicon.2011.11.017