Clinical experience with heterologous serum products
Abstract
Keywords
About the Authors
O. V. PerelyginaRussian Federation
Head of the Laboratory of Toxoids and Antitoxic Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
E. I. Komarovskaya
Russian Federation
1st professional category expert of the Laboratory of Toxoids and Antitoxic Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
A. V. Mukhacheva
Russian Federation
Leading expert of the Laboratory of Viral Vaccines of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
L. V. Sayapina
Russian Federation
Chief expert of the Division for Expert Evaluation of Antibacterial Medicinal Immunobiological Products of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences, professor
Yu. I. Obukhov
Russian Federation
Head of the Division for Expert Evaluation of Antibacterial Medicinal Immunobiological Products of the Centre for Evaluation and Control of Medicinal Immunobiological Products
V. P. Bondarev
Russian Federation
Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences, professor
References
1. State Register of Medicines. Russian Federation Ministry of Health [official site]. Available from: http://grls.rosminzdrav.ru (in Russian).
2. International travel and health. Vaccines: rabies. WHO [official site]. Available from: http://www.who.int/topics/rabies/ru.
3. Rabies. Fact Sheet ¹ 99. WHO; 2016. Available from: http:// www.who.int/mediacentre/factsheets/fs099/en.
4. Borisevich IV, Chernikova NK, Markov VI, Krasnyanskiy VP, Borisevich SV, Rozhdestvenskiy EV. An experience in the clinical use of specific immunoglobulin from horse blood serum for prophylaxis of Ebola haemorrhagic fever. Voprosy virusologii 2017; 62(1): 25–9 (in Russian).
5. Borisevich IV, Potryvayeva NV, Melnikov SA, Yevseyev AA, Krasnyansky VP, Maksimov VA. Design of equine serum-based Marburg virus immunoglobulin. Voprosy virusologii 2008; 53(1): 39–41 (in Russian).
6. Krasnyansky VP, Gradoboev VN, Borisevich IV, Potryvaeva NV, Lebedinskaya EV, Chernikova NK, Timankova GD. Development and study of the properties of immunoglobulin against Lassa fever. Voprosy virusologii 1997; 42(4): 168–71 (in Russian).
7. Mikhaylov VV, Borisevich IV, Timankova GD, Krasnyansky VP, Potryvaeva NV, Lebedinskaya EV, Chernikova NK. The preparation containing immunoglobulin against Ebola fever from horse blood serum liquid (immunoglobulin Ebola). Patent RUS 2130318 C1; 1996 (in Russian).
8. Krasnyansky VP, Mikhaylov VV, Lukin EP, Borisevich IV, Potryvaeva NV, Melnikov SA, et al. The preparation containing immunoglobulin against VEE from horse blood serum liquid (immunoglobulin against VEE from horse blood serum). Patent RUS 2261113 C1; 2003 (in Russian).
9. Khmelev AL, Borisevich IV, Chernikova NK, Makhlay AA, Mikhaylov VV, Yakovlev AK, at al. Evaluation of safety of prophylactic use of immunoglobulins against viral hemorrhagic fevers from horse blood sera. Zhurnal mikrobiologii, epidemiologii, immunobiologii 2012; (6): 103–6 (in Russian).
10. Khmelev AL, Borisevich IV, Pantyukhov VB, Pirozhkov AP, Syromyatnikova SI, Shatokhina IV, et al. Use of guinea pigs to evaluate the efficacy of a heterological immunoglobulin against Bolivian hemorrhagic fever. Voprosy virusologii 2009; 54(4): 42–4 (in Russian).
11. Borisevich IV, Mikhaylov VV, Khamitov RA, Krasnyansky VP, Chernikova NK, Evseev AA, Mironov AN. Use of monkeys for the preclinical evaluation of specific means of prevention and treatment of hemorrhagic fevers Ebola and Lassa. In: Organisms and environment: Human livelihoods protection in extreme conditions. Mater. Ross. Konf. 2000. P. 210 (in Russian).
12. WHO Model Lists of Essential Medicines. Geneva: WHO, 2015. Available from: https://goo.gl/Phv1iv.
13. Essential medicines and health products: Essential medicines. WHO. Available from: https://goo.gl/mnOZB0.
14. Government Decree of 26 Decemder 2015, ¹ 2724-ð. Available from: https://goo.gl/3soXwG (in Russian).
15. Komissarov AV, Zhuchikhin YuS, Vasilyiv PG, Klimov VI, Lub MYu, Nesterov YuE, et al. Comparative study of quality of anthrax immune globulin preparations obtained by the establishment of production at the Institute of Microbiology of the Russian Defense Ministry and released earlier in the Tbilisi Institute of Vaccines and Serum. In: Diagnosis, treatment and prevention of infectious diseases. Veterinary. Biotechnology. Mat. Yubil nauch konf, posvyashchennoy 50-letiyu Tsentra voenno-tekhnicheskich problem boil zashchity NII mikrobiologii MO RF. 1999. P. 95–6 (in Russian).
16. Pimenov EV, Komissarov AV, Lub MYu, Vasilyiv PG, Zhuchikhin YuS, Komosko GV, et al. The development and improvement of production technology against anthrax globulin equine liquid for medical purposes. In: Diagnosis, treatment and prevention of infectious diseases. Biotechnology. Veterinary. Mat. Yubil nauch konf, posvyashchennoy 70-letiyu NII mikrobiologii MO RF. 1998. P. 326–7 (in Russian).
17. Komissarov AV, Komosko GV, Leshchenko AA, Lub MYu, Pimenov EV, Darmov IV, et al. The sterilizing filtration of horse anti-anthrax liquid globulin preparation. Biotechnologiya 2002. (2): 66–74 (in Russian).
18. Shevtsov AN, Borisevich IV, Darmov IV, Kozhukhov VV, Lub MYu, Kozlova TN, et al. Serum immunobiological preparation for prophylaxis and therapy of anthrax. Biotechnologiya 2011; (1): 42–6 (in Russian).
19. European Centre for Disease Prevention and Control (ECDC). [official site]. Available from: https://goo.gl/yh6aMt.
20. European Centre for Disease Prevention and Control (ECDC). [official site]. Available from: https://goo.gl/ngzNRm.
21. Federal Service for Surveillance on Consumer Rights Protection anf Human Wellbeing [official site]. Available from: http://www.rospotrebnadzor.ru (in Russian).
22. Federal State Statistics Service. Russuin Federation [official site]. Available from: https://goo.gl/VMI1C0(in Russian).
23. European Centre for Disease Prevention and Control (ECDC). [official site]. Available from: https://goo.gl/o7ZTSA.
24. U. S. Food&Drug Administration. U. S. Department of Health and Human Services [official site]. Available from: https://goo.gl/ FLZTwP.
25. U. S. Food &Drug Administration. U. S. Department of Health and Human Services [official site]. Available from: https://goo.gl/ Zqwuvt.
26. Gordinskaya NM, Duka AM, Akmajkina NZ. Experience and features of the organization and conduct of anti-epidemic measures in cases of suspected anaerobic infection in hospitals. Far-Eastern J Infect Dis. 2008; (12): 153–5 (in Russian).
27. Prevention and management of wound infection. Techinical and Guadelines. WHO. Available from: https://goo.gl/ljYVmX.
28. Centers of Disease Control and Prevention. US Department of Health and Human Services [official site]. Available from: https:// goo.gl/FC1DeP.
29. Begg N. Manual for the Management and Control of Diphtheria in the European Region. Expanded Programme on Immunization. Copenhagen: WHO; 1994.
30. Centers for Disease Control and Prevention. Corynebacterium diphtheriae. In: Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. 2015. Available from: https://goo.gl/v2EE5U.
31. Logina I, Donaghy M. Diphtheritic polyneuropathy: a clinical study and comparison with Guillain-Barré syndrome. J Neurol Neurosurg Psychiatry. 1999; 67(4): 433–8. Available from: http://d x.doi.org/10.1136/jnnp.67.4.433.
32. Both L, White J, Mandal S, Efstratiou A. Access to diphtheria antitoxin for therapy and diagnostics. Euro Surveill. 2014; 19(24): pii: 20830. Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20830.
33. ECDC Epidemic Intelligence Information System for Vaccine Preventable Diseases (EPIS-VPD) [official site]. Available from: https://goo.gl/a4Uylb.
34. Immunization, Vaccines and Biologicals. Diphtheria. WHO. Available from: https://goo.gl/GCkhB6.
35. Korzhenkova MP, Malyshev NA, Berko AI, Arsen’ev VA. Diphtheria (clinic, diagnostics, treatment). Guidelines. Moscow. 2008 (in Russian).
36. Trihleb VI, Palatnaja LO, Vygovskaja OV, Trohimovich LP, Arsent’eva NV. Botulism: features of the modern trend. Cases from practice. Curr Infectology 2015; 4(9): 88–93 (in Russian).
37. Ivanova LA, Garas MN, Boltenkov VL, Guk LI. The case of foodborne botulism in adolescents. Curr Infectology 2015; 3(8): 56–63 (in Russian).
38. Bogadel’nikov IV, Prokudina LI, Bobrysheva AV, Bezdol’naja TN, Hamid Fazel’, Krjuger EA, et al. Tetanus is forgotten, but not gone. Child Health 2012; 2(37): 42–9 (in Russian).
39. Gordinskaja NM, Duka AM, Akmajkina NZ. Experience and features of the organization and conduct of anti-epidemic measures in cases of suspected anaerobic infection in hospitals. Far-Eastern J Infect Dis. 2008; 12: 153–5 (in Russian).
40. Borisevich IV, Avdeeva ZhI, Alpatova NA, Davydov DS, Gayderova LA, Gorbunov MA, et al. Medical immunobiological preparations. Directory. V. 2. Human immunoglobulins, sera and heterologous immunoglobulins, monoclonal antibodies, probiotics, bacteriophages, allergens, cytokines (administered to humans). Moscow. 2011. P. 81–103 (in Russian).
41. Supotnitsky MV, Elapov AA, Borisevich IV, Kudasheva EYu, Klimov VI, Lebedinskaya EV, et al. Blood preparations of humans and animals in terms of their quality, efficacy and safety. Biopreparations. Prevention, Diagnosis, Treatment 2015; (3): 33–48 (in Russian).
42. Snegireva II, Romanov BK, Ozereckovskij NA. The safety of blood products according to the post-marketing monitoring. Uspekhi sovr estestvoznaniya 2015; (5): 146–51 (in Russian).
43. The State Pharmacopoeia of the Russian Federation. 13th edition. V. 3. Moscow; 2015. Available from: http://www.femb.ru/feml (in Russian).
44. Borisevich IV, Kudasheva EYu, Perelygina OV, Mironov AN, Merkulov VA, Bondarev VP, et al. State of the problem of standardization of specific immunoglobulins and antitoxic sera. Meditsinskaya immunologiya 2015; 17(5): 379 (in Russian).
Review
For citations:
Perelygina O.V., Komarovskaya E.I., Mukhacheva A.V., Sayapina L.V., Obukhov Yu.I., Bondarev V.P. Clinical experience with heterologous serum products. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(1):41-47. (In Russ.)