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

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• 作者：Rafael Otero-Patiñ ; o^a ; ^b ; ^{rafaotero@une.net.co} ; &Aacute ; lvaro Segura^c ; Marí ; a Herrera^c ; Yamileth Angulo^c ; Guillermo Leó ; n^c ; José ; Marí ; a Gutié ; rrez^c ; Jacqueline Barona^b ; Sebasti&aacute ; n Estrada^b ; André ; s Pereañ ; ez^b ; Juan Carlos Quintana^b ; Leidy J. Vargas^b ; Juan Pablo Gó ; mez^a ; ^b ; Abel Dí ; az^b ; Ana Marí ; a Su&aacute ; rez^a ; Jorge Fern&aacute ; ndez^d ; Patricia Ramí ; rez^d ; Patricia Fabra^d ; Monica Perea^d ; Diego Fern&aacute ; ndez^e ; Yobana Arroyo^e ; Dalila Betancur^e ; Lady Pupo^e ; Elkin A. Có ; rdoba^f ; C. Eugenio Ramí ; rez^f ; Ana Berta Arrieta^f ; Alcides Rivero^f ; Diana Carolina Mosquera^g ; Nectty Lorena Conrado^g ; Rosina Ortiz^g
• 关键词：Antivenom ; Venom ; Envenoming ; Bothrops asper ; Colombia ; IgG ; F(ab&prime ; )2 ; Caprylic acid fractionation ; Early adverse reactions
• 刊名：Toxicon
• 出版年：2012
• 出版时间：February 2012
• 年：2012
• 卷：59
• 期：2
• 页码：344-355
• 全文大小：660 K

文摘

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.