Analysis of high-dose dexamethasone in different cycles on efficacy and safety of newly diagnosed ITP

doi:10.12047/j.cjap.5673.2018.099

Abstract

Abstract: Objective: To compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in monocycle, di-cycle, tri-cycle. Methods: Divided by the ratio of 1:1:1, 93 newly diagnosed patients were randomly accepted monocycle (Group A:dexamethasone 40 mg once a day, from day1 to day4), dicycle (Group B:dexamethasone 40 mg once a day, from day 1 to day 4, day 15 to day 18), tri-cycle (Group C:dexamethasone 40 mg once a day, from day 1 to day 4, day 15 to day 18, day 29 to day 32) of high-dose dexamethasone treatment. Its efficacy and safety on the patients in three groups were compared. Results: Ninety-three newly patients with new-diagnosed ITP were divided into Group A, B, and C, 31 patients in each group. In terms of short-term benefits, there was no statistically significant difference among the 7th and 14th day complete response rate after end of treatment. However, there was statistically significant difference after the end of treatment on the 7th day response rate (41.9% vs 70.0% vs 90.0%, P<0.01) and the 14th day response rate (16.1% vs 36.70% vs 63.3%, P< 0.01); in terms of long-term benefits, there was no statistically significant difference among the 120-day response rate, the complete response rate within the treatment on the 60th, 90th and 120th day and the relapse rate at 90th and 120th day; however, there was statistically significant difference among the 60- day response rate (10.0% vs 26.6% vs 53.3%, P<0.01), 90-day(0.0% vs 13.3% vs 30.0%, P<0.01) and 60-day relapse rate(88.9% vs 73.3% vs 46.7%, P<0.01). Mostly of the treatment-related adverse reactions in the three groups were mild, and most patients are tolerable. Conclusion: Although the complete response rate of ITP patients did not improved by increasing the cycle of high-dose dexamethasone, but improved response rate in three months, and adverse reactions were tolerable, which could be used as a reference for clinical use.

Key words: thrombocytopenia, primary, dexamethasone, efficacy, safety

XIAO Yue, LI Tang-fei. Analysis of high-dose dexamethasone in different cycles on efficacy and safety of newly diagnosed ITP[J]. CJAP, 2018, 34(5): 436-440.

References

[1] 中华医学会血液学分会止血与血栓学组. 成人原发免疫性血小板减少症诊断与治疗中国专家共识(2016年版)[J]. 中华血液学杂志, 2016, 37(2):89-93.
[2] 侯明, 秦平. 成人原发免疫性血小板减少症诊治的中国专家共识(2016版)解读[J]. 临床血液学杂志, 2016, 29(4):523-527.
[3] Naithani R, Mahapatra M, Kumar R, et al. High dose dexamethasone therapy shows better responses in acute immune thrombocytopenia than in chronic immune thrombocytopenia[J]. Platelets, 2010, 21(4):270-273.
[4] 秦平, 侯明. 2012版成人原发免疫性血小板减少症诊治的中国专家共识解读[J]. 临床血液学杂志, 2013, 26(2):151-155.
[5] Chen JF, Yang LH, Chang LX, et al. The clinical significance of circulating B cells secreting anti-glycoprotein Ⅱb/Ⅲa antibody and platelet glycoprotein Ⅱb/Ⅲa in patients with primary immune thrombocytopenia[J]. Hematology, 2012, 17(5):283-290.
[6] Semple JW. Bregging rights in ITP[J]. Blood, 2012,120(16):3169.
[7] Li X, Zhong H, Bao W, et al. Defective regulatory B-cell compartment in patients with immune thrombocytopenia[J]. Blood, 2012, 120(16):3318-3325.
[8] Zufferey A, Kapur R, Semple JW. Pathogenesis and therapeutic mechanisms in immune thrombocytopenia (ITP)[J]. J Clin Med, 2017, 6(2):76-84.
[9] Qiu J, Liu X, Li X, et al. CD8(+) T cells induce platelet clearance in the liver via platelet desialylation in immune thrombocytopenia[J]. Sci Rep, 2016, 6:27445.
[10] Zhao C, Li X, Zhang F, et al. Increased cytotoxic T-lymphocyte-mediated cytotoxicity predominant in patients with idiopathic thrombocytopenic purpura without platelet autoantibodies[J]. Haematologica, 2008, 93(9):1428-1430.
[11] Swiecki M, Colonna M. The multifaceted biology of plasmacytoid dendritic cells[J]. Nat Rev Immunol, 2015, 15(8):471-485.
[12] Panda SK, Kolbeck R, Sanjuan MA. Plasmacytoid dendritic cells in autoimmunity[J]. Curr Opin Immunol, 2017, 44:20-25.
[13] Catani L, Fagioli ME, Tazzari PL, et al. Dendritic cells of immune thrombocytopenic purpura (ITP) show increased capacity to present apoptotic platelets to T lymphocytes[J]. Exp Hematol, 2006, 34(7):879-887.
[14] Emmons RV, Reid DM, Cohen RL, et al. Human thrombopoietin levels are high when thrombocytopenia is due to megakaryocyte deficiency and low when due to increased platelet destruction[J]. Blood, 1996, 87(10):4068-4071.
[15] Wang S, Yang R, Zou P, et al. A multicenter randomized controlled trial of recombinant human thrombopoietin treatment in patients with primary immune thrombocytopenia[J]. Int J Hematol, 2012, 96(2):222-228.
[16] Saleh MN, Bussel JB, Cheng G, et al. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia:results of the long-term, open-label EXTEND study[J]. Blood, 2013, 121(3):537-545.
[17] Cheng Y, Wong RS, Soo YO, et al. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone[J]. N Engl J Med, 2003, 349(9):831-836.
[18] Wei Y, Ji XB, Wang YW, et al. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia:a prospective multicenter randomized trial[J]. Blood, 2016, 127(3):296-302.