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    Home > Active Ingredient News > Blood System > Lancet Haemat: All-trans retinoic acid + high-dose dexamethasone may become a new first-line therapy for primary immune thrombocytopenia!

    Lancet Haemat: All-trans retinoic acid + high-dose dexamethasone may become a new first-line therapy for primary immune thrombocytopenia!

    • Last Update: 2021-10-10
    • Source: Internet
    • Author: User
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    High-dose dexamethasone is immune standard initial treatment of thrombocytopenia in patients, but many patients will relapse, requiring further treatment
    .


    All-trans retinoic acid has been shown to have immunomodulatory effects and can promote platelet production


    immunity

    This study aimed to evaluate the activity and safety of all-trans retinoic acid combined with high-dose dexamethasone as the first-line treatment for newly diagnosed patients with immune thrombocytopenia
    .

    diagnosis

    This is a multi-center, open-label, randomized controlled phase 2 trial conducted in 6 medical centers in different regions of China, recruiting untreated, newly diagnosed primary immune thrombocytopenia over 18 years of age Patients with disease (platelet count <30x109/L or platelet count <50x109/L and clinically significant bleeding)
    .


    The test patients were randomly divided into two groups 1:1, and received all-trans retinoic acid (10 mg, oral, 2/day, continuous use for 12 weeks) + high-dose dexamethasone (40 mg/day, intravenous infusion, continuous use for 4 days ) Or only high-dose dexamethasone


    Continuous remission rate at 6 months

    Continuous remission rate at 6 months

    From January 1, 2020 to June 30, 2020, a total of 132 patients were randomly assigned to the all-trans retinoic acid + high-dose dexamethasone group (n=66) or the high-dose dexamethasone group (n=66) )
    .


    Three patients did not receive their planned treatment, so 129 patients were included in the safety analysis set


    At the 6th month, the proportion of patients with sustained remission in the all-trans retinoic acid + high-dose dexamethasone group was significantly higher than that in the high-dose dexamethasone group at the 6th month, all-trans retinoic acid + high-dose dexamethasone The proportion of patients with sustained remission in the group was significantly higher than that in the high-dose dexamethasone group

    Adverse reactions

    Adverse reactions

    The most common adverse reactions in the combination treatment group were dry skin (48%), headache (19%) and insomnia (19%).
    The most common adverse reactions in the high-dose dexamethasone group were insomnia (15%) and anxiety or mood disorders.
    (12%)
    .


    Both groups were well tolerated, and there were no adverse events of grade 4 or above


    In summary, the combination of all-trans retinoic acid and high-dose dexamethasone is safe for the treatment of newly diagnosed patients with primary immune thrombocytopenia and can provide a sustained response
    .


    This program may become a first-line treatment option for such patients, but further research is needed to verify its effectiveness and safety


    All-trans retinoic acid combined with high-dose dexamethasone is safe in the treatment of newly diagnosed patients with primary immune thrombocytopenia, and can provide continuous remission.


    Original source:

    Qiu-Sha Huang, et al.


    All-trans retinoic acid plus high- dose dexamethasone as first-line treatment for patients with newly diagnosed immune thrombocytopenia: a multicentre, open-label, randomised, controlled, phase 2 trial in this message
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