Results of a prospective open observational study of the use of dornase alfa as part of complex therapy for patients with cystic fibrosis-Reference-Cited by-同舟云学术

Results of a prospective open observational study of the use of dornase alfa as part of complex therapy for patients with cystic fibrosis

Published:2024-03-11 Issue:2 Volume:34 Page:206-217
ISSN:2541-9617
Container-title:PULMONOLOGIYA
language:
Short-container-title:Pulʹmonologiâ (Mosk.)

Author:

Shadrina V. V.¹^ORCID,Kondratyeva E. I.²^ORCID,Voronkova A. Yu.²^ORCID,Zhekaite E. K.²^ORCID,Krasovskiy S. A.³^ORCID,Amelina E. L.³^ORCID,Orlov A. V.⁴^ORCID,Pinegina Yu. S.⁵,Lavrova A. E.⁶,Trishina S. V.⁷^ORCID,Abdulganieva D. I.⁸^ORCID,Semykin S. Yu.⁹,Vlasova A. V.¹⁰^ORCID

Affiliation:

1. Federal State Budgetary Scientific Institution “Research Centre for Medical Genetics”, Ministry of Science and Higher Education of the Russian Federation; Federal State Budgetary Educational Institution of Higher Education “Perm State Medical University named after academician E.A.Wagner” of the Ministry of Health of the Russian Federation

2. Federal State Budgetary Scientific Institution “Research Centre for Medical Genetics”, Ministry of Science and Higher Education of the Russian Federation; State Budgetary Healthcare Institution of the Moscow region “Research Clinical Institute of Childhood”, Healthcare Ministry of Moscow Region

3. Federal State Budgetary Institution “Pulmonology Scientific Research Institute” under Federal Medical and Biological Agency of Russian Federation

4. St. Petersburg State Budgetary Institution of Health Care “Children’s City Hospital of St. Olga”; Federal State Budgetary Educational Institution of Higher Education “North-Western State Medical University named after I.I.Mechnikov”, Ministry of Health of the Russian Federation

5. State Budgetary Healthcare Institution of the Novosibirsk region “State Novosibirsk Regional Clinical Hospital”

6. Federal State Budgetary Educational Institution of Higher Education “Privolzhsky Research Medical University” of the Ministry of Health of the Russian Federation

7. Medical Academy named after S.I.Georgievskiy is the structural unit of the Federal State Autonomous Educational Institution of Higher Education “Crimean Federal University named after V.I.Vernadskiy” of the Ministry of Science and Higher Education of the Russian Federation

8. Federal State Budgetary Educational Institution of Higher Education “Kazan’ State Medical University” of the Ministry of Health of the Russian Federation

9. Separate Structural Unit “Russian Children’s Clinical Hospital” of the Federal State Autonomous Educational Institution of Higher Education “N.I.Pirogov Russian National Research Medical University” of the Ministry of Health of the Russian Federation

10. State Budgetary Healthcare Institution “Morozov Children’s City Clinical Hospital of the Moscow Health Department”

Abstract

The article discusses results of a prospective observational study of long-term use of the biosimilar dornase alfa (Tigerase) (Generium, Russia) as part of complex therapy in patients with cystic fibrosis in real clinical practice.The aim was to analyze the outcomes of long-term use of the dornase alfa dornase alfa as part of complex therapy in patients with CF (protocol #DRN-CFR-N01).Methods. The study included patients (n = 165) aged 5 years and older from 11 centers for treatment of cystic fibrosis in the Russian Federation with a confirmed diagnosis of cystic fibrosis who were prescribed dornase alfa by their attending physician.Results. The analysis revealed that exacerbations of chronic pulmonary disease during the treatment with dornase alfa were observed in 29 (17.58%) patients included in the study. At the same time, there were no statistically significant changes in FEV1 and FVC (%) against baseline during the treatment in the study population. Adverse events related to the study drug were recorded in 9 (5.45%) patients.Conclusion. Biosimilar dornase alfa demonstrated a favorable efficacy and safety profile in routine clinical practice, which confirms the results of previously published studies.

Publisher

Scientific and Practical Reviewed Journal Pulmonology

Reference11 articles.

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