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A Randomized Multicenter Trial of Crotalinae Polyvalent Immune Fab (Ovine) Antivenom for the Treatment for Crotaline Snakebite in the United States
Richard C. Dart, MD, PhD;
Steven A. Seifert, MD;
Leslie V. Boyer, MD;
Richard F. Clark, MD;
Edward Hall, MD;
Patrick McKinney, MD;
Jude McNally, RPh;
Craig S. Kitchens, MD;
Steven C. Curry, MD;
Gregory M. Bogdan, PhD;
Suzanne B. Ward, PharmD;
R. Stephen Porter, PharmD
Arch Intern Med. 2001;161:2030-2036.
Background Current therapy for crotaline snakebite includes antivenin (Crotalidae)
polyvalent, an antivenom with numerous adverse effects. We compared the efficacy
and safety of 2 dosing regimens with a new antivenom, Crotalinae polyvalent
immune Fab (Fab AV).
Methods A single dose of Fab AV alone (as-needed [PRN] group) was compared with
an initial dose plus repeated treatments during 18 hours (scheduled group)
in a multicenter randomized trial. The study included patients with minimal
or moderate envenomation by a crotaline snake within the preceding 6 hours,
aged 10 years or older, in whom worsening of the envenomation syndrome was
observed before Fab AV treatment. After treatment with Fab AV to achieve initial
control, patients were randomized to the scheduled or PRN treatment group.
Scheduled group patients received additional doses of Fab AV every 6 hours
for 3 doses. The PRN group received no planned additional doses of antivenom.
Results The mean severity score of the 31 patients decreased from 4.35 to 2.39
points (P<.001); there was no difference between
scheduled and PRN groups. No patient in the scheduled group received unplanned
Fab AV doses, but 8 of 16 patients in the PRN group received unplanned doses
(P = .002). Acute reactions occurred in 6 patients
(19%), and serum sickness occurred in 6 (23%) of 26 patients who returned
for follow-up.
Conclusions In the first randomized trial of antivenom in the United States, Fab
AV effectively terminated venom effects. Since the unplanned use of Fab AV
in the PRN group was common, the treatment regimen may require more than 1
initial dose.
From the Rocky Mountain Poison and Drug Center, Denver Health Authority,
Denver, Colo (Drs Dart and Bogdan); University of Colorado Health Sciences
Center, Denver (Dr Dart); Department of Emergency Medicine, Kino Community
Hospital, Tucson, Ariz (Dr Seifert); Department of Pediatrics, University
of Arizona, Tucson (Dr Boyer); Division of Medical Toxicology, University
of California–San Diego Medical Center and the San Diego Division of
the California Poison Control System (Dr Clark); Department of Surgery, John
D. Archbold Memorial Hospital, Thomasville, Ga (Dr Hall); Department of EmergencyMedicine
and the New Mexico Poison Center, University of New Mexico Health Sciences
Center, Albuquerque (Dr McKinney); Arizona Poison and Drug Information Center,
School of Pharmacy, University of Arizona, Tucson (Mr McNally); Department
of Medicine, Veterans Affairs Hospital, Gainesville, Fla (Dr Kitchens); Department
of Medical Toxicology, Good Samaritan Regional Medical Center, Phoenix, Ariz,
and Division of Clinical Medicine, University of Arizona College of Medicine,
Tucson (Dr Curry); and Therapeutic Antibodies Inc, Nashville, Tenn (Drs Ward
and Porter).
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