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BMJ 2004;329:1129 (13 November), doi:10.1136/bmj.329.7475.1129
Roger Smalligan, hospital director1, Judy Cole1, Narcissa Brito, senior hospital technician1, Gavin D Laing, research scientist2, Bruce L Mertz, clinician1, Steven Manock, clinician1, Jeffrey Maudlin, clinician1, Brad Quist, clinician1, Gary Holland, clinician1, Stephen Nelson, clinician1, David G Lalloo, clinical senior lecturer2, Gonzalo Rivadeneira, doctor3, Maria Elena Barragan, herpetologist4, Daniel Dolley, human biology student5, Michael Eddleston, Wellcome Trust career development fellow5, David A Warrell, professor of tropical medicine and infectious diseases5, R David G Theakston, professor of medical biology2
1 Hospital Vozandes del Oriente, Shell, Pastaza, Ecuador, 2 Alistair Reid Venom Research Unit, Liverpool School of Tropical Medicine, Liverpool L3 5QA, 3 Ministry of Health, Guayaquil, Ecuador, 4 Fundacion Herpetologica Gustavo Orcés, Quito, Ecuador, 5 Nuffield Department of Clinical Medicine, University of Oxford, John Radcliffe Hospital, Headington, Oxford OX3 9DU
Correspondence to: D A Warrell david.warrell{at}clinical-medicine.oxford.ac.u
Objective To compare the efficacy and safety of three polyspecific antivenoms for bites by pit vipers.
Design Randomised double blind comparative trial of three antivenoms.
Setting Shell, Pastaza, southeastern Ecuador.
Participants 210 patients with incoagulable blood were recruited from 221 consecutive patients admitted with snake bite between January 1997 and December 2001.
Intervention One of three antivenoms manufactured in Brazil, Colombia, and Ecuador, chosen for their preclinical potency against Ecuadorian venoms.
Main outcome measures 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.
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