A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis

A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy

To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.

Inclusion Criteria:

• diagnosed as myasthenia gravis (MG) by clinical diagnosis
• QMG scores ≥7 at the time of enrollment
• basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient

Exclusion Criteria:

• receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study
• QMG swallowing function score ≥ 2 points or QMG vital capacity = 3
• abnormal hepatic functions
• uncontrolled diabetes patients
• hyperkalemia patients
• immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of HIV infection
• patients who are allergic to Tacrolimus or macrolide antibiotics
• receiving other immuno-inhibitors within 12 weeks