A prospective study of the efficacy and safety of maintenance therapy with recombinant human thrombopoietin in patients with primary immune thrombocytopenia: a multicenter study
10.3760/cma.j.issn.0253-2727.2017.05.005
- VernacularTitle: 重组人血小板生成素用于原发免疫性血小板减少症维持治疗的有效性和安全性——多中心临床研究
- Author:
Huacong CAI
1
;
Shujie WANG
1
;
Ling FU
2
;
Xiaomin WANG
;
Ming HOU
;
Ping QIN
;
Fangping CHEN
;
Xiaohui ZHANG
;
He HUANG
;
Jingsong HE
;
Runhui WU
;
Jingyao MA
;
Renchi YANG
;
Xiaofan LIU
;
Ying TIAN
;
Aijun LIU
;
Jingsheng WU
;
Weibo ZHU
;
Yuhong ZHOU
;
Wenbin LIU
;
Yu HU
;
Wenjuan HE
;
Yan LI
;
Deng PAN
;
Yongqiang ZHAO
Author Information
1. Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
2. People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830001, China
- Publication Type:Journal Article
- Keywords:
Thrombocytopenia;
Recombinant human thrombopoietin;
Treatment outcome;
Drug toxicity
- From:
Chinese Journal of Hematology
2017;38(5):379-383
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of maintenance therapy with reduced dose of rhTPO in the patients with primary immune thrombocytopenia (ITP) who attained stable platelet (PLT) counts after daily administration of rhTPO.
Methods:Treatment was started with a daily administration of rhTPO (300 U/kg) for 2 consecutive weeks. Patients who attained stable PLT≥50×109/L were enrolled to maintenance therapy starting with every other day administration of rhTPO, then adjusted dose interval to maintain platelet count (30-100) ×109/L.
Results:A total of 91 eligible patients were enrolled. Fourteen patients discontinued the study due to noncompliance (12/14) and investigator decision (2/14) . Among 77 patients who completed the study, 38 patients with the administration of rhTPO at every other day or less could maintain PLT≥30×109/L for 12 weeks. The percentage of patients with a platelet response (PLT≥30×109/L) at 4th week, 8th week and 12th week of maintain therapy was 92.6% (63/68) , 82.7% (43/52) and 85.0% (34/40) , respectively. Median platelet counts remained in the range of (70-124) ×109/L. The overall incidence of rhTPO-related adverse events was 7.7%. All the adverse events were generally mild.
Conclusion:Extending the dose interval of rhTPO is feasible to maintain stable platelet count in the patients with ITP, but the optimal dose interval is uncertain and might vary with individuals.
