anti-MDA5 antibody-positive dermatomyositis
Conditions
Interventions
experimental group:High-dose glucocorticoid + cyclophosphamide + calcineurin inhibitor
control group:High-dose glucocorticoid + cyclophosphamide or calcineurin inhibitor
Sponsors
First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Meet ENMC or Sontheimer's classification criteria for dermatomyositis; 2. Serum western blotting was positive for anti-MDA5 antibody; 3. Aged >=18 years, no gender limit; 4. CROSS model evaluation score >=3 points (total score: 6); 5. Glucocorticoid shock therapy and immunosuppressive therapy were not used; 6. The patient voluntarily signed informed consent and agreed to use the triple therapy/classical regimen.
Exclusion criteria
Exclusion criteria: 1. Patients with pulmonary interstitial lesions caused by other autoimmune diseases or other causes; 2. Patients with RP-ILD at enrollment (including but not limited to type I or type II respiratory failure, HRCT affected area exceeding 50% of the total volume of both lungs); 3. Patients with definite infections (including but not limited to bacterial or fungal infections found by smears or cultures of bodily fluids such as peripheral blood, sputum, alveolar lavage fluid, bone marrow and cerebrospinal fluid); 4. Patients with severe cardiopulmonary, liver and kidney dysfunction who could not use triple therapy regimen after researchers' evaluation; 5. Pregnant or lactating patients; 6. Patients formally participating in other drug clinical trials or intervention studies; 7. Patients with poor treatment compliance or other patients deemed unsuitable to participate in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of rapidly progressing interstitial lung disease (RP-ILD) after 6 months of treatment; | — |
Countries
China
Contacts
Public ContactTan Wenfeng
Outcome results
None listed