A multicentre double-blind, double-dummy, randomised study of recombinant human thrombopoietin versus eltrombopag in the treatment of immune thrombocytopenia in Chinese adult patients

被引:21
作者
Mei, Heng [1 ,2 ,3 ]
Xu, Min [1 ]
Yuan, Guolin [4 ]
Zhu, Feiyue [5 ]
Guo, Jingming [6 ]
Huang, Ruibin [7 ]
Qin, Jun [8 ]
Lv, Tingting [4 ]
Qin, Fangmei [5 ]
Cai, Huili [6 ]
Yin, Ping [9 ]
Qin, Tingting [9 ]
Hu, Yu [1 ,2 ,3 ]
机构
[1] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Inst Haematol, 1277 Jiefang Dadao, Wuhan 430022, Hubei, Peoples R China
[2] Huazhong Univ Sci & Technol, Hubei Clin & Res Ctr Thrombosis & Hemostasis, Wuhan, Peoples R China
[3] Huazhong Univ Sci & Technol, Collaborat Innovat Ctr Hematol, Wuhan, Peoples R China
[4] Hubei Univ Arts & Sci, Dept Hematol, Xiangyang Cent Hosp, Affiliated Hosp, Xiangyang, Hubei, Peoples R China
[5] Loudi Cent Hosp, Inst Haematol, Loudi, Hunan, Peoples R China
[6] Yichang Cent Peoples Hosp, Inst Haematol, Yichang, Hubei, Peoples R China
[7] Nanchang Univ, Inst Haematol, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China
[8] Peoples Hosp, Inst Haematol, Shiyan, Peoples R China
[9] Huazhong Univ Sci & Technol, Tongji Med Coll, Sch Publ Hlth, Dept Epidemiol & Stat, Wuhan, Hubei, Peoples R China
基金
中国国家自然科学基金;
关键词
immune thrombocytopenia; recombinant human thrombopoietin; eltrombopag; platelet counts; thrombopoietin receptor agonists; INTERNATIONAL CONSENSUS REPORT; PURPURA; MANAGEMENT; EFFICACY; RITUXIMAB; CHILDREN; GROWTH; SAFETY;
D O I
10.1111/bjh.17808
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
We performed a double-blind, double-dummy controlled study to compare the efficacy between recombinant human thrombopoietin (rhTPO) and eltrombopag in rapidly increasing the platelet counts in Chinese patients with immune thrombocytopenia (ITP). A total of 96 patients diagnosed with ITP for >= 6 months who had baseline platelet counts of <30 x 10(9)/l were randomly assigned (1:1 ratio) to receive eltrombopag 25 mg/day or rhTPO 300 u/kg for 2 weeks. Compared with the eltrombopag group, a significantly higher proportion of patients in the rhTPO group achieved platelet counts of >= 50 x 10(9)/l [75 center dot 00% (36/48) vs. 43 center dot 75% (21/48), P = 0 center dot 003] or complete response (64 center dot 58% vs. 25 center dot 00%) on day 15. Moreover, a higher proportion of patients in the rhTPO group either had platelet counts that rapidly increased to twice that of baseline and with platelet counts of >= 30 x 10(9)/l, or reached >= 50 x 10(9)/l at least once when analysed on day 9, 12, and 15. However, upon discontinuation of the treatment, the platelet counts reduced to the baseline within 1 week in the rhTPO group, but on the fourth week in the eltrombopag group. Adverse events were similar in patients given rhTPO and eltrombopag. To conclude, rhTPO is superior to eltrombopag at 25 mg/day in rapidly increasing platelet counts in patients with ITP (ClinicalTrials.gov Identifier: NCT03771378).
引用
收藏
页码:781 / 789
页数:9
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