К вопросу об отсутствии взаимозаменяемости лекарственных препаратов ботулинического токсина типа А
https://doi.org/10.21518/2079-701X-2015-5-112-123
Аннотация
Об авторах
А. Р. Артеменко
Первый Московский государственный медицинский университет им. И.М. Сеченова
Россия
Россия
А. Л. Куренков
Научный центр здоровья детей, Москва
Россия
Россия
К. В. Беломестова
Первый Московский государственный медицинский университет им. И.М. Сеченова
Россия
Россия
Список литературы
1. Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. Ophthalmology, 1980, 87(10): 1044-1049.
2. Information for Healthcare Professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc) [веб-страница]. Silver Spring, MD: US Food and Drug Administration; 2013. Доступно по адресу: http//www.fda.gov/ Drugs/DrugSafety/PostmarketDrugSafetyInform ationforPatientsandProviders/ DrugSafetyInformationforHeathcare-Professionals/ucm174949.htm
3. Sakaguchi G, Kozaki S, Ohishi I. Structure and function of botulinum toxins. In: Alouf JE, editor. Bacterial Protein Toxins. London: Academic Press, 1984: 435-443.
4. Hatheway C. Bacterial sources of clostridial neurotoxins. In: Simpson LL, editor. Botulinum Neurotoxin and Tetanus Toxin. San Diego, CA: Academic Press, 1989: 4-24.
5. Schantz EJ, Johnson EA. Properties and use of botulinum toxin and other microbial neurotox-ins in medicine. Microbiol Rev., 1992, 56(1): 80-99.
6. Das Gupta BR, Sugiyama H. Role of a protease in natural activation of Clostridium botulinum neurotoxin. Infect Immun., 1972, 6(4): 587-590.
7. WHO international biological reference preparations [веб-страница]. Geneva: World Health Organization. Доступно по адресу: http://www. who.int/biologicals/reference_preparations/en
8. Schantz E.J., Johnson E.A. Botulinum toxin: the story of its development for the treatment of human disease. Perspect Biol Med., 1997, 40(3): 317-327.
9. Schantz EJ, Johnson EA. Properties and use of botulinum toxin and other microbial neurotox-ins in medicine. Microbiol Rev, 1992, 56(1): 80-99.
10. BOTOX® (onabotulinumtoxinA) [prescribing information]. Irvine, CA: Allergan, Inc., 2013.
11. Zhang L, Lin WJ, Li S, Aoki KR. Complete DNA sequences of the botulinum neurotoxin complex of Clostridium botulinum type A-Hall (Allergan) strain. Gene, 2003, 315: 21-32.
12. Fernandez-Salas E, Wang J, Molina Y, Nelson JB, Jacky BP, Aoki KR. Botulinum neurotoxin sero-type A specific cell-based potency assay to replace the mouse bioassay. PLoS One, 2012, 7(11): e49516.
13. Lietzow MA, Gielow ET, Le D, Zhang J, Verhagen MF. Subunit stoichiometry of the Clostridium botulinum type A neurotoxin complex determined using denaturing capillary electrophore-sis. Protein J., 2008, 27(7-8): 420-425.
14. Hambleton P. Clostridium botulinum toxins: a general review of involvement in disease, structure, mode of action and preparation for clinical use. J Neurol., 1992, 239(1): 16-20.
15. Panjwani N, O'Keeffe R, Pickett A. Biochemical, functional and potency characteristics of type A botulinum toxin in clinical use. Botulinum J., 2008, 1(1): 153-166.
16. Ipsen, Ltd. Dysport Summary of Product Characteristics [веб-страница]. Surrey, UK: Datapharm Communications Ltd; 2013. Доступно по адресу: http//www.medicines. org.uk/emc/medicine/870
17. Dysport® (abobotulinumtoxinA) [prescribing information]. Boulogne-Billancourt: Ipsen Biopharm Ltd, 2012.
18. Center for Drug Evaluation and Research. Center for Drug Evaluation and Research (CDER). Application #125274. Chemistry reviews. BLA STN 125286/0. Reloxin (Botulinum Toxin Type A). Silver Spring, MD: Center for Drug Evaluation and Research; 2009. Доступно по адресу: http//www.accessdata.fda.gov/ drugsatfda_docs/nda/2009/125274s000_ ChemR.pdf
19. Roggenkamper P, Jost WH, Bihari K, Comes G, Grafe S; NT 201 Blepharospasm Study Team. Efficacy and safety of a new Botulinum Toxin Type A free of complexing proteins in the treatment of blepharospasm. J Neural Transm., 2006, 113(3): 303-312.
20. Xeomin (incobotulinumtoxinA) [prescribing information]. Frankfurt am Main: Merz Pharmaceuticals, LLC, 2013.
21. Frevert J, Dressler D. Complexing proteins in botulinum toxin type A drugs: a help or a hindrance? Biologics, 2010, 4: 325-332.
22. Dressler D, Mander G, Fink K. Measuring the potency labelling of onabotulinumtoxinA (Botox® and incobotulinumtoxinA (Xeomin (®)) in an LD50 assay. J Neural Transm., 2012, 119(1): 13-15.
23. Инструкция по применению лекарственного препарата Лантокс. Регистрационный номер ЛСР-001587/08, 12.09.2008.
24. Yinchun W. The structure, function and the hot points in clinical use of botulinum toxin (including the quality of BTXA). BTXA Congress, Beijing, China, 2007. Congress proceedings: P. 60-71.
25. Инструкция по применению лекарственного препарата для медицинского применения Релатокс® № ЛП 001593 - 190312, 2012.
26. Schellekens H. When biotech proteins go off-patent. Trends Biotechnol., 2004, 22(8): 406-410.
27. Schellekens H. Follow-on biologics: challenges of the "next generation". Nephrol Dial Transplant., 2005, 20(Suppl. 4): iv31-iv36.
28. Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov., 2007, 6(6): 437-442.
29. Ledford H. Biotechs go generic: the same but different. Nature, 2007, 449(7160): 274-276.
30. Genzyme Corporation. Genzyme provides details of October Myozyme (alglucosidase alfa) Advisory Panel meeting and additional regulatory updates [press release]. Cambridge, MA: Genzyme Corporation; September 23, 2008. Доступно по адресу: http//news.genzyme. com/press-release/genzyme-provides-details-october-myozyme-alglucosidase-alfa-advisory-panel-meeting-and
31. Sakaguchi G., Kozaki S., Ohishi I. Structure and function of botulinum toxins. In: AIouf JE, editor. Bacterial Protein Toxins. London: Academic Press, 1984: 435-443.
32. Inoue K, Fujinaga Y, Watanabe T, Ohyama T, Takeshi K, Moriishi K et al. Molecular composition of Clostridium botulinum type A progenitor toxins. Infect Immun., 1996, 64(5): 1589-1594.
33. Ohishi I, Sugii S, Sakaguchi G. Oral toxicities of Clostridium botulinum toxins in response to molecular size. Infect Immun., 1977, 16(1): 107109.
34. Wagman J, Bateman JB. Botulinum type A toxin: properties of a toxic dissociation product. Arch Biochem Biophys., 1953, 45(2): 375-383.
35. Cai S, Sarkar HK, Singh BR. Enhancement of the endopeptidase activity of botulinum neurotox-in by its associated proteins and dithiothreitol. Biochemistry, 1999, 38(21): 6903-6910.
36. Eisele KH, Fink K, Vey M, Taylor HV. Studies on the dissociation of botulinum neurotoxin type A complexes. Toxicon., 2011, 57(4): 555-565.
37. Scopes RK. Protein Purification: Principles and Practice. 3rd ed. New York: Springer, 1994.
38. Chen F, Kuziemko GM, Amersdorfer P, Wong C, Marks JD, Stevens RC. Antibody mapping to domains of botulinum neurotoxin serotype A in the complexed and uncomplexed forms. Infect Immun., 1997, 65(5): 1626-1630.
39. Goschel H, Wohlfarth K, Frevert J, Dengler R, Bigalke H. Botulinum A toxin therapy: neutralizing and nonneutralizing antibodies - therapeutic consequences. Exp Neurol., 1997, 147(1): 96-102.
40. Kukreja R, Chang TW, Cai S, Lindo P, Riding S, Zhou Y et al. Immunological characterization of the subunits of type A botulinum neurotoxin and different components of its associated proteins. Toxicon., 2009, 53(6): 616-624.
41. Joshi SG, Elias M, Singh A, Al-Saleem FH, Ancharski D, Nasser Z et al. Modulation of bot-ulinum toxin-induced changes in neuromuscu-lar function with antibodies directed against recombinant polypeptides or fragments. Neuroscience, 2011, 179: 208-222.
42. Mcbellan K, Das RE, Ekong TA, Sesardic D. Therapeutic botulinum type A toxin: factors affecting potency. Toxicon., 1996, 34(9): 975-985.
43. Hunt T, Clarke K. Potency evaluation of a formulated drug product containing 150-kd botu-linum neurotoxin type A. Clin Neuropharmacol., 2009, 32(1): 28-31.
44. Sesardic D, Leung T, Gaines Das R. Role for standards in assays of botulinum toxins: international collaborative study of three preparations of botulinum type A toxin. Biologicals, 2003, 31(4): 265-276.
45. Brown M, Nicholson G, Ardila MC, Satorius A, Broide RS, Clarke K et al. Comparative evaluation of the potency and antigenicity of two distinct BoNT/A-derived formulations. J Neural Transm., 2013, 120(2): 291-298.
Рецензия
Для цитирования:
Артеменко А.Р., Куренков А.Л., Беломестова К.В. К вопросу об отсутствии взаимозаменяемости лекарственных препаратов ботулинического токсина типа А. Медицинский Совет. 2015;(5):112-123. https://doi.org/10.21518/2079-701X-2015-5-112-123
For citation:
Artemenko A.R., Kurenkov A.L., Belomestova K.V. On the absence of interchangeability of botulinum toxin type A drugs. Meditsinskiy sovet = Medical Council. 2015;(5):112-123. (In Russ.) https://doi.org/10.21518/2079-701X-2015-5-112-123
Просмотров: 371
Послать статью по эл. почте 