Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome

This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.

This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.

Inclusion Criteria:

• Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
• Baseline platelet counts less than 30×109/L.

Exclusion Criteria:

• Concomitant other systemic autoimmune diseases.
• Other severe complications of Sjogren's syndrome.
• Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL.
• Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
• Active acute or chronic infections.
• History of malignancy.
• Pregnancy or breastfeeding.