Registration Number
0225U000342,
(0122U000545)
, R & D reports
Title
To study the effectiveness of combination therapy with first- and second-line drugs and to develop optimal treatment regimens for patients with refractory sarcoidosis
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Вивчити ефективність комбінованої терапії препаратами першої та другої лінії і розробити оптимальні схеми лікування хворих на рефрактерний саркоїдоз легень
Head
Havrysiuk Volodymyr K., д.мед.н.
Registration Date
09-01-2025
Organization
State organization "National scientific center of phthisiatry, pulmonology and allergology named after F. G. Yanovskyi National academy of medical sciences of Ukraine"
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To develop optimal treatment regimens for patients with refractory pulmonary sarcoidosis based on the study of the effectiveness and tolerability of combination therapy with first- and second-line drugs and evaluation of treatment results
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Study object – 250 patients with newly diagnosed pulmonary sarcoidosis after monotherapy and combination therapy with methylprednisolone (MP) and methotrexate (MTX), 49 patients with refractory course.
Aim – to develop optimal regimens of treatment of patients with refractory pulmonary sarcoidosis based on effectiveness and tolerability study with first- and second-line drugs and assessment of follow-up outcomes of treatment.
Methods – clinical, laboratory, chest computed tomography, lung ventilation and diffusion capacity tests.
It was established that the refractory disease was in 10,8 % of all pulmonary sarcoidosis patients in Ukraine. It was determined that in refractory pulmonary sarcoidosis patients a stage 3 of the disease was significantly more prevalent –
14.8 %. Same was true for extrapulmonary disease. It was determined that the rate of regression after 6 months therapy with hydroxychloroquine (HC) in combination with MTX (62.5 %) was higher than pentoxifylline (PP) + (MP) (28.6 %). It was established that serious side effects, causing discontinuation of HC in combination with MTX were observed in 4 cases (12.9 %). It was found that the relapses of the disease in terms 6-12 months since the completion of therapy were registered in 38.5 % of cases. It was established that combination therapy MTX+PP was not effective and was not recommended for clinical use. IT was determined that despite effective use of HC+MTX and PP+MP combinations, high rate of side effects was observed in a majority of patients and required an individual approach to the treatment. There was developed the technology of management of pulmonary sarcoidosis, which allowed to achieve higher effectiveness of diagnosis and personificated treatment by 15.0 % and lower the rate of side effects by 17.0 %, and the technology of management of refractory pulmonary sarcoidosis, which use helps to achieve 52.0 % effectiveness of treatment.
Sphere of application – pulmonology, phthysiology.
Product Description
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Havrysiuk Volodymyr K.
Dziublyk Yaroslav O.
Merenkova Yevhniia O.
Morska Nataliia D.
Pendalchuk Nataliia V.
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2025-01-09