1. Blood. 2015 Oct 19. pii: blood-2015-07-659656. [Epub ahead of print]
High-dose dexamethasone versus prednisone for treatment of adult immune
thrombocytopenia: a prospective multicenter randomized trial.
Wei Y(1), Ji XB(1), Wang YW(1), Wang JX(2), Yang EQ(3), Wang ZC(4), Sang YQ(5),
Bi ZM(6), Ren CA(7), Zhou F(8), Liu GQ(9), Peng J(1), Hou M(10).
(1)Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
(2)Department of Hematology, Liaocheng People's Hospital, Liaocheng, China;
(3)Department of Hematology, People's Hospital of Rizhao, Rizhao, China;
(4)Department of Hematology, Central Hospital of Zibo, Zibo, China; (5)Department
of Hematology, Heze Municipal Hospital, Heze, China; (6)Department of Hematology,
Zibo First Hospital, Zibo, China; (7)Department of Hematology, Weifang People's
Hospital, Weifang, China; (8)Department of Hematology, Jinan Military General
Hospital, Jinan, China; (9)Department of Hematology, Shengli Oilfield General
Hospital, Dongying, China. (10)Department of Hematology, Qilu Hospital, Shandong
University, Jinan, China; firstname.lastname@example.org.
This study compared the efficacy and safety of high-dose dexamethasone (HD-DXM)
and conventional prednisone (PDN) on the largest cohort to date as first-line
strategies for newly diagnosed adult primary immune thrombocytopenia (ITP).
Patients enrolled were randomized to receive dexamethasone 40 mg/d for four days
(n = 95, non-responders received an additional four-day course of dexamethasone),
or prednisone 1.0 mg/kg daily for four weeks and then tapered (n = 97). One or
two courses of HD-DXM resulted in a higher incidence of overall initial response
(82.1% vs. 67.4%, P = 0.044) and complete response (50.5% vs. 26.8%, P = 0.001)
compared to prednisone. Time to response was shorter in the HD-DXM arm (P <
0.001), and a baseline bleeding score ≥ 8 was associated with a decreased
likelihood of initial response. Sustained response was achieved by 40.0% of
patients in the HD-DXM arm and 41.2% in the PDN arm (P = 0.884). Initial complete
response was a positive indicator of sustained response, whereas presence of
anti-platelet autoantibodies was a negative indicator. High-dose dexamethasone
was generally tolerated better. We concluded that high-dose dexamethasone could
be a preferred corticosteroid strategy for first-line management of adult primary
ITP. This study is registered at http://clinicaltrials.gov as NCT01356511.
Copyright © 2015 American Society of Hematology.
PMID: 26480931 [PubMed - as supplied by publisher
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