Immune Thrombocytopenia Clinical Trial
Official title:
The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Single-arm, open-lable, multicentre study to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroidresistant/relapsed ITP.
Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients
achieve remission from first-line therapies. However, the underlying mechanism of
corticosteroid-resistant or relapsed ITP is not well understood; thus, treatment remains a
great challenge. Atorvastatin was shown to enhance bone marrow endothelial cell function and
N-acetylcysteine (NAC) was shown to inhibit PLT binding to endothelial cell.
A multicentre prospective study was performed in non-splenectomized ITP patients who were
either resistant to a standard dose of corticosteroids or had relapsed. Patients were
randomized to atorvastatin, acetylcysteine plus danazol with danazol monotherapy group.
Platelet count, bleeding and other symptoms were evaluated before and after treatment.
Adverse events are also recorded throughout the study, in order to compare the efficacy and
safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with
corticosteroid-resistant/relapsed ITP.
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