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学科主题: 临床医学
题名:
A multicenter randomized controlled trial of recombinant human thrombopoietin treatment in patients with primary immune thrombocytopenia
作者: Wang, Shujie1,2; Yang, Renchi2,3; Zou, Ping4; Hou, Ming5; Wu, Depei6; Shen, Zhixiang7; Lu, Xijing8; Li, Yan9; Chen, Xiequn10; Niu, Ting11; Sun, Hui12; Yu, Li13; Wang, Zhao14; Zhang, Yin15; Chang, Naibai16; Zhang, Gaokui17; Zhao, Yongqiang1,2
关键词: Primary immune thrombocytopenia (ITP) ; Thrombopoietin (TPO) ; Recombinant human thrombopoietin (rhTPO)
刊名: INTERNATIONAL JOURNAL OF HEMATOLOGY
发表日期: 2012-08-01
DOI: 10.1007/s12185-012-1124-8
卷: 96, 期:2, 页:222-228
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Hematology
研究领域[WOS]: Hematology
关键词[WOS]: C-MPL LIGAND ; GROWTH-FACTORS ; DOUBLE-BLIND ; PURPURA ; MEGAKARYOCYTOPOIESIS ; STIMULATION ; ELTROMBOPAG ; ANTIBODIES
英文摘要:

This multicenter, randomized trial assessed the efficacy and safety of a recombinant human thrombopoietin (rhTPO) in patients with persistent primary immune thrombocytopenia (ITP) who had failed glucocorticosteroid treatment. A total of 140 eligible patients were randomized to receive rhTPO + danazol (rhTPO group, 73 patients) or danazol (control group, 67 patients) alone. During the first phase, the increase in the mean maximal platelet counts (101.2 x 10(9)/L) and the area under curve (749.6) in the rhTPO group were significantly higher compared to control (33.3 x 10(9)/L and 316.2; P = 0.0060 and 0.0000, respectively). The major response rate (MRR) and total response rate (TRR) in the rhTPO group were 38.4 and 60.3 %, respectively, significantly higher than in control (MRR 7.9 %, P = 0.0003; TRR 36.5 %, P = 0.0104). In the control group, 45 patients with platelet counts < 20 x 10(9)/L were given rhTPO during the second phase and achieved MRR 31.1 % and TRR 66.7 %. The mean platelet counts in the rhTPO group were still approximately 50 x 10(9)/L on day 28 of the study. The overall incidence of rhTPO-related adverse events was 13.6 %. All the adverse events were generally mild. This study demonstrated that rhTPO was well tolerated, and it markedly increased platelet counts in chronic ITP patients. Stimulation of platelet production by rhTPO may provide a new therapeutic option for patients with ITP.

语种: 英语
所属项目编号: 200802031
项目资助者: Ministry of Health People&prime ; s Republic of China
WOS记录号: WOS:000307764900011
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/61128
Appears in Collections:北京大学第二临床医学院_血液科_期刊论文

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作者单位: 1.Chinese Acad Med Sci, Peking Union Med Coll Hosp, Beijing 100730, Peoples R China
2.Peking Union Med Coll, Beijing 100730, Peoples R China
3.Chinese Acad Med Sci, Blood Dis Hosp, Beijing 100730, Peoples R China
4.Huazhong Univ Sci & Technol, Affiliated Union Hosp, Wuhan 430074, Peoples R China
5.Shandong Univ, Qilu Hosp, Jinan 250100, Peoples R China
6.Suzhou Univ, Affiliated Hosp 1, Suzhou 215006, Peoples R China
7.Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Shanghai 200030, Peoples R China
8.Peking Univ, Peoples Hosp, Inst Hematol, Beijing 100871, Peoples R China
9.China Med Univ, Affiliated Hosp 1, Shenyang, Peoples R China
10.Fourth Mil Med Univ, Xijing Hosp, Xian 710032, Peoples R China
11.Sichuan Univ, W China Hosp, Chengdu 610064, Peoples R China
12.Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou, Peoples R China
13.Chinese Peoples Liberat Army, Gen Hosp, Beijing, Peoples R China
14.Henan Prov Peoples Hosp, Zhengzhou, Peoples R China
15.Beijing Hosp, Minist Hlth, Beijing, Peoples R China
16.Beijing DMS Pharma Ltd, Beijing, Peoples R China
17.Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China

Recommended Citation:
Wang, Shujie,Yang, Renchi,Zou, Ping,et al. A multicenter randomized controlled trial of recombinant human thrombopoietin treatment in patients with primary immune thrombocytopenia[J]. INTERNATIONAL JOURNAL OF HEMATOLOGY,2012,96(2):222-228.
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