电邮这篇文章 Comparative assessment of tolerability and risk of pharmacotherapy with botulinum toxin type a drugs in children with cerebral palsy with severe spasticity syndrome
- 作者: Arkhipov V.1, Goryachev D.2, Chebanenko N.3, Solovyova A.2
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隶属关系:
- Federal State Budgetary Institution “Scientific Center for Examination of Medical Devices” of the Ministry of Health of the Russian Federation
- Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medical Use Products" of the Ministry of Health of the Russian
- Federal State Budgetary Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education" of the Ministry of Healthcare of the Russian Federation
- 期: 卷 26, 编号 1 (2020)
- 页面: 33-40
- 栏目: Clinical pharmacology and pharmaceuticals
- URL: https://journals.rcsi.science/0869-2106/article/view/25838
- DOI: https://doi.org/10.18821/0869-2106-2020-26-1-33-40
- ID: 25838
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详细
This paper presents a comprehensive assessment of safety monitoring of the use of botulinum toxin type A (BTA) drugs in the WHO databases (VigiBase) and automated information system (AIS) “Roszdravnadzor-Pharmacovigilance”, as well as a comparison of the dynamics of receipt of messages.
The authors present a post-marketing study of domestic experience in the use of BTA drugs (Dysport, Botox, and Xeomin) based on a retrospective clinical and pharmacological analysis of 169 medical records of children with cerebral palsy in whom these drugs were used to treat spasticity syndrome.
Analysis of the spectrum of adverse events, which were mentioned in 10 (5.9%) medical records, showed that their nature corresponded to the data set out in the instructions for medical use. Serious adverse reactions according to the criteria of severity “death” and “threat to life”, with a high degree of reliability of cause-and-effect relationship were not revealed during the study, which confirms a sufficiently high safety profile of these drugs.
This paper focuses on improving the methodology for assessing the effectiveness and safety of BTA drugs for the treatment of spasticity syndrome in children and the need to identify and report all adverse drug reactions.
作者简介
Vladimir Arkhipov
Federal State Budgetary Institution “Scientific Center for Examination of Medical Devices” of the Ministry of Health of the Russian Federation
编辑信件的主要联系方式.
Email: arkhipov2005@rambler.ru
ORCID iD: 0000-0002-1441-3418
MD, PhD, DSc
俄罗斯联邦, 8/2 Petrovsky Blvd, Moscow 127051Dmitry Goryachev
Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medical Use Products" of the Ministry of Health of the Russian
Email: Gorachev@expmed.ru
ORCID iD: 0000-0001-8583-2372
MD, PhD, DSc
俄罗斯联邦, 8/2 Petrovsky Blvd, Moscow 127051Natalia Chebanenko
Federal State Budgetary Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education" of the Ministry of Healthcare of the Russian Federation
Email: nataqwe@yndex.ru
ORCID iD: 0000-0002-7231-0249
MD, PhD, associate Professor of the Department of children's neurology
俄罗斯联邦, 2/1, Barrikadnayast., Moscow, 125993Anna Solovyova
Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medical Use Products" of the Ministry of Health of the Russian
Email: Soloviova@expmed.ru
ORCID iD: 0000-0001-9244-8934
俄罗斯联邦, 8/2 Petrovsky Blvd, Moscow 127051
参考
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- Romanov B.K., Olefir Yu.V., Alyautdin R.N., Glagolev S.V., Polivanov V.A., Ilienko L.I. et al. The safety of the use of drugs in children – international monitoring data for 50 years. Safety and risk of pharmacotherapy. 2019; 7(2): 57-64. (in Russian) doi: 10.30895/2312-7821-2019-7-2-57-64.
- Treatment and Rehabilitation of Children with Spastic Forms of Cerebral Palsy. Methodical recommendations. No. 26. [Lechenie i Reabilitatsiya Detei so Spasticheskimi Formami Tserebral’nogo Paralicha. Metodicheskie rekomendatsii № 26.] Moscow: 2016. (in Russian)
- Kurenkov A. L., Bursagova B. I., Kuzenkova L. M., Petrova S.A. Use of botulinum toxin type A in spastic forms of cerebral palsy, effective pharmacotherapy. Effektivnaya farmakoterapiya. 2013; (3): 14-20. (in Russian)
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