High-dose dexamethasone plus recombinant human thrombopoietin versus high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia:a prospective, multicenter, randomized trial.
机构：[1]Department of Hematology,[2]Department of pediatrics, the Second Hospital of Shandong University, Jinan, China.[3]Department of Hematology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.[4]Department of Hematology, Binzhou Medical University Hospital, Binzhou, China.[5]Department of Hematology, The First Affiliated Hospital of Xinjiang Medical University, China.[6]Department of Hematology, Liaocheng People's Hospital, Liaocheng, China.[7]Department of Hematology, Xinjiang Uiger Municipal People's Hospital, Urumqi, China.[8]Department of Hematology, Shengli Oilfield Central Hospital, Dongying, China.[9]Department of Hematology, Yantai Yuhuangding Hospital, Yantai, China.[10]Department of Hematology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.[11]Department of Hematology, The Second Affiliated Hospital of Guangzhou Medical University, Guangdong, China.[12]Department of Hematology, Military General Hospital, Jinan, China.[13]Department of Hematology, Taian City Central Hospital, Taian, China.[14]Department of Hematology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.[15]Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.[16]Department of Hematology, Zibo Central Hospital, Zibo, China.[17]Department of Hematology, Weifang People's Hospital, Weifang, China.[18]Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China.[19]Department of Hematology, Qingdao Municipal Hospital, Qingdao, China.[20]Department of Hematology, Linyi People's Hospital, Linyi, China.[21]Department of Hematology, Shandong Provincial Qianfoshan Hospital, Jinan, China.[22]Department of Hematology, Jinan Central Hospital, Jinan, China.[23]Department of Hematology, Qilu Hospital (Qingdao), Shandong University, Qingdao, China.[24]Department of Hematology, Shandong Provincial Hospital of Traditional Chinese Medicine, Jinan, China.[25]Department of Hematology, Weihai Municipal Hospital, Weihai, China.[26]Department of Hematology, Zhejiang Provincial Hospital of TCM, Hangzhou, China.[27]Shandong Province Key Laboratory of Hematology/Immunology, Creative Studio of Scientific and Technologic Leading Talents, Qilu Hospital, Shandong University, Jinan, China.
We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO) versus HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs. 66.7%, P < 0.001) and complete response (CR, 75.0% vs. 42.7%, P < 0.001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs. 36.5%, P = 0.02; sustained CR: 46.0% vs. 32.3%, P = 0.043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as clinicaltrials.gov identifier: NCT01734044. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.
基金：
National Natural Science Foundation of China,
Grant/Award Numbers: 81770114, 81900121,
81900124, 81973994; Natural Science
Foundation of Shandong Province, Grant/
Award Number: 2019GSF108240; Taishan
Scholar Foundation of Shandong Province,
Grant/Award Number: ts201511095; Young
Taishan Scholar Foundation of Shandong
Province, Grant/Award Number:
tsqn201909175
通讯机构：[1]Department of Hematology,[27]Shandong Province Key Laboratory of Hematology/Immunology, Creative Studio of Scientific and Technologic Leading Talents, Qilu Hospital, Shandong University, Jinan, China.[*1]Shandong Province Key Laboratory of Hematoimmunology, Creative Studio of Scientific and Technologic Leading Talents, Qilu Hospital, Cheeloo College of Medicine, Shandong University, 107 West Wenhua Road, Jinan, Shandong, 250012, China[*2]Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, 250012, China
推荐引用方式(GB/T 7714)：
Yu Yafei,Wang Miaomiao,Hou Yu,et al.High-dose dexamethasone plus recombinant human thrombopoietin versus high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia:a prospective, multicenter, randomized trial.[J].AMERICAN JOURNAL OF HEMATOLOGY.2020,95(12):1542-1552.doi:10.1002/ajh.25989.
APA：
Yu Yafei,Wang Miaomiao,Hou Yu,Qin Ping,Zeng Qingshu...&Hou Ming.(2020).High-dose dexamethasone plus recombinant human thrombopoietin versus high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia:a prospective, multicenter, randomized trial..AMERICAN JOURNAL OF HEMATOLOGY,95,(12)
MLA：
Yu Yafei,et al."High-dose dexamethasone plus recombinant human thrombopoietin versus high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia:a prospective, multicenter, randomized trial.".AMERICAN JOURNAL OF HEMATOLOGY 95..12(2020):1542-1552
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