Crotaline snake bite in the Ecuadorian Amazon: randomised double blind comparative trial of three South American polyspecific antivenoms.
OBJECTIVE
To compare the efficacy and safety of three polyspecific antivenoms for bites by pit vipers.


METHODS
Randomised double blind comparative trial of three antivenoms.


METHODS
Shell, Pastaza, southeastern Ecuador.


METHODS
210 patients with incoagulable blood were recruited from 221 consecutive patients admitted with snake bite between January 1997 and December 2001.


METHODS
One of three antivenoms manufactured in Brazil, Colombia, and Ecuador, chosen for their preclinical potency against Ecuadorian venoms.


METHODS
Permanent restoration of blood coagulability after 6 and 24 hours.


RESULTS
The snakes responsible for the bites were identified in 187 cases: 109 patients (58%) were bitten by Bothrops atrox, 68 (36%) by B bilineatus, and 10 (5%) by B taeniatus, B brazili, or Lachesis muta. Eighty seven patients (41%) received Colombian antivenom, 82 (39%) received Brazilian antivenom, but only 41 (20%) received Ecuadorian antivenom because the supply was exhausted. Two patients died, and 10 developed local necrosis. All antivenoms achieved the primary end point of permanently restoring blood coagulability by 6 or 24 hours after the start of treatment in > 40% of patients. Colombian antivenom, however, was the most effective after initial doses of 20 ml (two vials), < 70 ml, and any initial dose at both 6 and 24 hours. An initial dose of 20 ml of Colombian antivenom permanently restored blood coagulability in 64% (46/72) of patients after 6 hours (P = 0.054 compared with the other two antivenoms) and an initial dose of < 70 ml was effective at 6 hours (65%, P = 0.045) and 24 hours (99%, P = 0.06). Early anaphylactoid reactions were common (53%, 73%, and 19%, respectively, for Brazilian, Colombian, and Ecuadorian antivenoms, P < 0.0001) but only three reactions were severe and none was fatal.


CONCLUSIONS
All three antivenoms can be recommended for the treatment of snakebites in this region, though the reactogenicity of Brazilian and Colombian antivenoms is a cause for concern.
Smalligan
Roger
R
Hospital Vozandes del Oriente, Shell, Pastaza, Ecuador.
Cole
Judy
J
Brito
Narcissa
N
Laing
Gavin D
GD
Mertz
Bruce L
BL
Manock
Steven
S
Maudlin
Jeffrey
J
Quist
Brad
B
Holland
Gary
G
Nelson
Stephen
S
Lalloo
David G
DG
Rivadeneira
Gonzalo
G
Barragan
Maria Elena
ME
Dolley
Daniel
D
Eddleston
Michael
M
Warrell
David A
DA
Theakston
R David G
RD
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D000997:Antivenins / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D003105:Colombia; D003435:Crotalid Venoms; D017839:Crotalus; D004311:Double-Blind Method; D004484:Ecuador; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012909:Snake Bites / Q000628:therapy*; D016896:Treatment Outcome
D000997:Antivenins; D003435:Crotalid Venoms