Abstract
The objective of this study is to conduct a comparative study of the efficacy and safety of methotrexate (MT) at a dose of 10 mg/week and 15 mg/week in patients with pulmonary sarcoidosis having contraindications to GCS therapy. Material and Methods. The study involved 44 patients with stage II pulmonary sarcoidosis (26 females and 18 males aged 24 to 70) with contraindications to the appointment of therapy glucocorticosteroid (GCS). In group 1 (28 patients), methotrexate was prescribed at a dose of 10 mg/week, in group 2 (16 patients), methotrexate was prescribed at a dose of 15 mg/week. The diagnosis and assessment of the dynamics of sarcoidosis were carried out taking into account clinical symptoms based on the results of high-resolution computed tomography and body plethysmography. The significance of differences in indicators was determined using the Student's t-test and Fisher's exact test. The number of cases of clinical treatment without residual changes of a fibrous nature in the lung parenchyma in patients after treatment with methotrexate at a dose of 15 mg/week significantly increased compared to the same indicator in the group of patients after treatment at a dose of 10 mg/week (81.3% and 42.4% respectively, p=0.025). An increase in the therapeutic dose of methotrexate from 10 mg/week to 15 mg/week leads to a decrease in the time to achieve a clinical cure (10.1±0.5 months and 12.8±0.8 months respectively, р˂0.02), indicating an accelerating rate of regression of sarcoidosis. Immunosuppressive therapy of patients with pulmonary sarcoidosis using the drug at doses of 10 and 15 mg/week is characterized by satisfactory tolerability.
Highlights
IntroductionЕфективність і переносимість метотрексату в дозах 15 мг/тиждень та 10 мг/тиждень у хворих на саркоїдоз легень
Evaluation of the results of MT efficacy showed that successful completion of treatment with the confirmation by CT results was achieved in 18 patients (64.3%) of group 1 and in 14 patients (87.5%) of group 2, but Fisher's exact test (0.160) exceeds the critical level of significance (0.05)
Does not allow us to assert that increasing a dose of MT to 15 mg/week increases the effectiveness of immunosuppressive therapy in patients with pulmonary sarcoidosis
Summary
Ефективність і переносимість метотрексату в дозах 15 мг/тиждень та 10 мг/тиждень у хворих на саркоїдоз легень. Мета роботи ‒ провести порівняльне вивчення ефективності та безпеки метотрексату (МТ) в дозах 10 мг/тиждень і 15 мг/тиждень у хворих на саркоїдоз легень з протипоказаннями до глюкокортикостероїдної терапії. У пацієнтів після лікування метотрексатом у дозі 15 мг/тиждень достовірно збільшується кількість випадків клінічного лікування без залишкових змін фіброзного характеру в паренхімі легень порівняно з аналогічним показником у групі хворих після лікування препаратом у дозі 10 мг/тиждень (81,3% і 42,4% відповідно, р=0,025). The main drugs in the treatment of sarcoidosis are systemic glucocorticosteroids (GCS) [11, 6]. Severe side effects and resistance to GCS therapy, methotrexate (MT), the second-line drug is used [1, 5, 8]
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