Conocimientos básicos sobre la toxina botulínica para una utilización terapéutica segura

  • María Victoria Morales Salucoop, Hospital General de Medellín.
  • Kelly Payares Universidad de Antioquia
  • Andrés Zuluaga Universidad de Antioquia
Palabras clave: biológicos, toxina botulínica tipo A, margen de seguridad, margen terapéutico, migración.

Resumen

El conocimiento específico de las diferentes características moleculares, fisicoquímicas y farmacológicas de cada producto biológico de toxina botulínica tipo A (BoNTA), disponible en nuestro mercado, es indispensable para asegurar una adecuada prescripción con el mínimo de eventos adversos.

La BoNTA tiene indicaciones en múltiples condiciones clínicas, las cuales están autorizadas por agencias reguladoras de importancia como FDA (del inglés, Food and Drug Administration) en Estados Unidos o EMA (del inglés European Medicine Agency) en Europa, e INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) en Colombia.


Al comparar las características generales de los diferentes productos disponibles de BoNTA, se puede concluir que son entidades biológicas similares, no idénticas, con potencias diferentes, las cuales determinan un perfil de eficacia y seguridad específica para cada producto. Por esta razón no son intercambiables, y el uso clínico debe ser individualizado según la condición clínica del paciente, además del producto a utilizar y de la experiencia en el método de inyección utilizado por el médico tratante.

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Biografía del autor/a

María Victoria Morales, Salucoop, Hospital General de Medellín.
Salucoop, Hospital  General   de  Medellín.
Kelly Payares, Universidad de Antioquia
Profesora titular. Grupo Rehabilitación en Salud, Departamento de Medicina Física y Rehabilitación. Facultad de Medicina.
Andrés Zuluaga, Universidad de Antioquia
Profesor asociado. GRIPE (Grupo Investigador de Problemas en Enfermedades Infecciosas), Departamento de Farmacología y Toxicología, Facultad de Medicina.

Referencias bibliográficas

1. Kleinberg M, Mosdell KW. Current and Future Consideration for the New classes biological. American Journal of Health System Pharmacy 2004;61:695-708.

2. Wenzel R, Jones D, Borrego JA. Comparing two botulinum toxin type A formulation using manufacturers’ products summaries. Journal Of clinical Pharmacy and Therapeutic 2007;32: 387-402.

3. Von Ventre PF, Kempe LL. Phisiology of toxin production by Clostridium botulinum types A; B. Action of toxin. J Bacteriol 1960;79:24-32.

4. Charles PD. Botulinum Neurotoxin Serotype A: a clinical update on non cosmetic uses. American Journal of Health System Pharmacy 2004;S6:S11-S23.

5. Aoky KR. Pharmacology and Inmunology of botulinum Neurotoxin. International Ophtalmology. Clinics 2005;45:25-37.

6. Akerman A, Aoki KR. Productos biológicos Terapias únicas. Septiembre 2008.

7. Hambleton P, Cpael B, Bailey N, et al. Production, Purification and toxoiding of Clostridium Botulinum type A toxin In: Lewis JRG, Angel PS eds: Biomedical aspect of botulism. New York NY, Academic Press, 247-260.

8. Hambleton P, Picket AM. Potency Equivalence the Botulinum Toxin Preparation Journal of the Royal Society of Medicine1994; 87: 719.

9. First ER, Pearce LB, Borodic GE. Dose Standardizations of Botulinum toxin. Lancet 1994;343:1035.

10. Aoky KR. Preclinical Update on BOTOX® (botulinum toxin type A)purified neurotoxin complex relative to other botulinum neurotoxin preparation. European Journal of Neurology 1999;6 S4)S3-S10.

11. Foster KA, Bigalke H, Aoki KR. Botulinum Neurotoxin From Laboratory to Bedside. Neurotoxicity Research 2006;9:133-140.

12. Aoky KR, Ranoux D, Wissel J. Using translational medicine to understand clinical differences between botulinum toxin formulation: European Journal of Neurology
2006;13:10-19.

13. Rosales RL, Bigalke H, Dressler D. Pharmacology of botulinum toxin: differences between type A preparations.
European Journal of Neurology 2006; 13:2-10.

14. Dolly O. Synaptic Transmission:Inhibition of Neurotransmitter release by botulinum toxins. Headache 2003;43:S16- S24.

15. De Pavia A, Meunier FA, Molgo J, Aoki KR, Dolly JO. Functional repair of motor endplates alter botulinum neurotoxin type A poisoning: Biphasic switch of synaptic activity between nerve sprouts and their parent terminals.
Proc Natl Acad Sci US 1999;96:3200-3205.

16. Borodic G, Ferrante R, Pearce LB et al. Histologic Assesment of dose related diffusion and muscle fiber response after therapeutic botulinum A toxin injection. Movement disorder 1994;9:31-39.

17. Sandeep C, St Helier NHS Trust. Different formulations of botulinum toxin type A have different migration characteristics. Journal of Cosmetic Dermatology 2008;7: 50-54.

18. Dutton JJ. Botulinum A toxin in the treatment craniocervical muscle spam: short and Long term local and sy st emic ef fects. Sur v Ophat almol 19 96;41:51-65. American Academy of Dermatology. 2006, Meeting, July 26-30. San Diego CA.

19. Kessler KR, Skutta M, Benecke R. Long term treatment of cervical dystonia with botulinum toxin A: efficacy, safety, and antibody frequency. J Neurol 1999;246:265-274.

20. Foster KA; Bigalke H, Aoki KR. Botulinum Neurotoxin From Laboratory to bedside. Neurotox Res 2006;9:133-140.

21. Barclay L. Respiratory compromise, death may be linked tobotulinum toxin. Medical alerts.February 8, 2008
Available at:http:// www.medscape.com. Accessed March 14.

22. Cherington M. Clinical spectrum of botulism. Muscle Nerve 1998;21:701-710.

23. Shapiro RL, Hatheway C, Swerdlow DL. Botulism in the UnitedStates: a clinical and epidemiologic review. Ann Intern Med 1998;129:221-228.

24. Girlanda P, Vita G, Nicolosi C, et al. Botulinum toxin therapy: distant effects on neuromuscular transmission and
autonomic nervous system. J Neurol Neurosurg Psychiatry
1992;55:844-845.

25. Volker Mall et al. Botulinum Toxin in Adductor Spasticity. Developmental Medicine & Child Neurology 2006;48:10-
13.

26. Comella CL, Jankovic J, Daggett S, Mordaunt J, Brin MF. Interim results of an observational study of neutralizing antibody formation with the current preparation of botulinum toxin type A treatment for cer vical dystonia. Neurology 2004;62(S5):A511.

27. Yablon SA, Brashear A, Gordon MF, Elovic EP, Turkel CC,
Daggett S, et al. Formation of neutralizing antibodies in
patients receiving botulinum toxin type A for treatment of
postclinical trials. Clin Ther 2007;29:683-690.

28. Bakheit AMO; Fedorova NV, Skoromets AA. The beneficial antiespasticity effect of botulinum toxin type A is maintained after repeated treatmen cycles. J Neurol Neurosurg Psychiatry 2004;75:1558-1561.

29. Atassi MZ, Oshima M. Structure activity and immune (T and B cell) recognition of botulinum neurotoxin. Critical Review in Inmunology 1999;19:219-260.

30. Aoky KR. Botulinum neurotoxin serotypes A and B prepaartion have different safety margin in preclinical models of muscle weakening ef f icacy and sy stemic safety.
Toxicon 2002;40:923-928.

31. Sampaio C, Costa J, Ferreira J. Clinical Comparability of
Marketed Formulation of Botulinum Toxin. Movement Disorders 2004;19(S4):129-136.

32. Marcheti A, Magar R, Findley L, et al. Retrospective Evaluation of the Dose of Dy spor t® and BOTOX® in the Management of Cer vical Dystonia and Blepharospasm: The REAL DOSE Study. Movement Disorders 2005;20(8):937-944.

33. Ranoux D, Gury C, Fondarai J, Mas JL, Zuber M. Respective potencies of BOTOX® and Dysport®: a double blind, randomised, crossover study in cervical dystonia. J Neurol Neurosurg Psychiatry 2002;72:459-462.

34. Bihari K. Safety effectiveness and duration of effect of
BOTOX® after switching from Dy spor t® for blepharospasm, cer vical dystonia and hemifacial spam. Current Medical Research and opinion 2005;21(3): 433-
438.

35. Nussgens Z, Roggenkamper P. Comparison of two botulinumtoxin preparations in the treatment of essential
blepharospasm. Graefes Arch Clin Exp Ophthalmol 1997;
235:197-199.

36. Durif F. Clinical bioequivalence of the current commercial preparations of botulinum toxin. Eur J Neurol 1995;2(S3): S17-S18.

37. Sampaio C, Ferreira JJ, Simoes F, et al. DYSBOT: a singleblind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type ADysport® and BOTOX® assuming a ratio of 4:1. Mov Disord 1997;12:1013-1018.

38. Sampaio C, Costa J, Ferreira JJ. Clinical Comparability of
Marketed Formulations of Botulinum Toxin. Movement Disorders 2004;19(S8):S129-S136.

39. Chapman MA, Barron R, Tanis DC; Gill CH, Charles PD. Comparison of Botulinum Neurotoxin Preparations for the Treatment of Cervical Dystonia. Clinical Therapeutics 2007;29:1325-1337.

40. Lu CS, Chen RS, Tsai CH. Double-blind, placebocontrolledstudy of botulinum toxin injections in the
treatment of cer vical dystonia. J Formos Med Assoc 1995;94: 189-192.

41. Wissel J, Kanovsky P, Ruzicka E, et al. Efficacy and safety of a standardised 500 unit dose of Dysport® -(Clostridium botulinum toxin type A haemaglutinin complex) in a heterogeneous cer vical dystonia population: results of a prospective, multicentre, randomised, doubleblind, placebocontrolled, parallel group study. J Neurol 2001;248:1073- 1078.

42. Molho E, Jankovic J, Lew M. Role of Botulinum Toxin in the Treatment of Cervical Dystonia. Neurol Clin 2008;26(S1):43-53.

43. Ostergaard L, Fuglsang-Frederiksen A, Werdelin L, Sjo O, Winkel H. Quantitative EMG in botulinum toxin treatment
of cervical dystonia. A double-blind placebo controlled study. Electroencephalogr Clin Neurophysiol 1994;93:434-439.

44. Novak I, Campbell L, Boyce M and Fung V. S. C. Botulinum toxin assessment, intervention and aftercare for cervical dystonia and other causes of hypertonia of the neck: internationalconsensus statement. European Journal of Neurology 2010;17(S2):94-108.

45. Gil C. Rodríguez MF, Berrocal N y cols. Blefaroespasmo y Espasmo hemifacial: tratamiento a largo plazo con toxina botulínica. Neurología 2012;003-009 (www.elsevier.es / Neurología).

46. Kikuta H. Distonías faciales. De enfoque terapéutico, 2012, edición 15:29-33.

47. Bell MS, Vermeulen LC, Sperling KB. Pharmacotherapy with botulinum toxin: harnessing nature’s most potent neurotoxin. Pharmacotherapy 2000;20:1079-1091.

48. Esquenazi A. Falls and fractures in older poststroke patients with spasticity: consequences and drug treatment considerations. Clinical Geriatrics 2004;12:27-35.

49. Richardson D, Sheean G, Werring D, et al. Evaluating the role of botulinum toxin in the management of focal hypertonia in adults. J Neurol Neurosurg Psychiatry 2000;69:499-506.

50. Wissel J, et al. Consensus on botulinum toxin type A in
adult spasticity. J Rehabil Med 2009;41:13-25.

51. Pascual-Pascual SI y col. Guía terapéutica de la espasticidad infantil con toxina botulínica. Rev Neurol 2007;44:303- 309.

52. Comella CL, Pullman SL. Botulinum toxins in neurological disease. Muscle Nerve 2004;29:628-644.

53. Maillard H, Briand N, Bara C, Celerier P. Efficacy of botulinum toxin in the treatment of axillary and palmar
hyperhidrosis: 10 cases. Ann Dermatol Venereol 2003;130:511-513.

54. Talarico S, Mendonc A M. A Double-Blind, Randomized, Comparative Study of Two Type A Botulinum Toxins in the Treatment of Primary Axillary Hyperhidrosis. Dermatol Surg
2007;33:S44-S50.

55. Guyer BM. Mechanism of botulinum toxin in the relief of chronic pain. Curr Rev Pain 1999;3:427-431.

56. Rodriguez A. Botulinum Toxin For Spasmodic Dysphonia.
Phisical Medicine and Rehabilitation; Clinics North American 2003;14:767-779.

57. Gilles K , Denys P, et al. Botulinum Toxin A (BOTOX®), intradetrusor injection in adult with neurogenic detrusor overactive/ overactive bladder: a Systematic Literature
Review. European Urology 2008;53:275-287.

58. Lim M, Mace A, Reza Nouraei, SA, Sandhu G. Botulinum toxin in the management of sialorrhoea: a systematic review. Clinical Otolaryngology 2006;31:267-272.

59. Long H, Liao Z, Wang Y, Liao L, Lai W. Efficacy of botulinum toxins on bruxism: an evidencebased review.
International Dental Journal 2012;62:1-5.

60. Lee SJ, McCall WD, Kim YK, Chung SC, Chung JW. Effect of botulinum toxin injection on nocturnal bruxism: A randomized controlled trial. Am J Phys Med Rehabil 2010;89:16-23.

61. Información para los profesionales de la salud: OnabotulinumtoxinA (comercializada como BO TOX®/ BOTOX® Cosmetic), Abobotulinumtoxin A (comercializada
como Dysport®) y Rimabotulinumtoxin B (comercializada
como Myobloc) Alerta de la FDA [08/2009]

62. Dysport® Abobotulinumtoxin A, Insert Package. April 2009.

63. Brashear A. Clinical Comparisons of botulinum Neurotoxin Formulation. The Neurologist 2008;14(5):289-298.

64. Lew MF. Review of the FDA-Approved Uses of Botulinum Toxins, Including Dat a Suggesting Efficacy in Pain Reduction. The Clinical Journal of Pain 2002;18:S142-S146.
Publicado
2013-12-15
Cómo citar
Morales, M. V., Payares, K., & Zuluaga, A. (2013). Conocimientos básicos sobre la toxina botulínica para una utilización terapéutica segura. Revista Colombiana De Medicina Física Y Rehabilitación, 23(2), 106-118. Recuperado a partir de https://revistacmfr.org/index.php/rcmfr/article/view/71
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