Cai H C, Wang S J, Fu L, Wang X M, Hou M, Qin P, Chen F P, Zhang X H, Huang H, He J S, Wu R H, Ma J Y, Yang R C, Liu X F, Tian Y, Liu A J, Wu J S, Zhu W W, Zhou Y H, Liu W B, Hu Y, He W J, Li Y, Pan D, Zhao Y Q
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830001, China.
Zhonghua Xue Ye Xue Za Zhi. 2017 May 14;38(5):379-383. doi: 10.3760/cma.j.issn.0253-2727.2017.05.005.
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. Treatment was started with a daily administration of rhTPO (300 U/kg) for 2 consecutive weeks. Patients who attained stable PLT≥50×10(9)/L were enrolled to maintenance therapy starting with every other day administration of rhTPO, then adjusted dose interval to maintain platelet count (30-100) ×10(9)/L. 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≥30×10(9)/L for 12 weeks. The percentage of patients with a platelet response (PLT≥30×10(9)/L) at 4(th) week, 8(th) week and 12(th) 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) ×10(9)/L. The overall incidence of rhTPO-related adverse events was 7.7%. All the adverse events were generally mild. 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.
评估在原发性免疫性血小板减少症（ITP）患者中，每日给予重组人血小板生成素（rhTPO）后血小板（PLT）计数达到稳定状态时，使用降低剂量的rhTPO进行维持治疗的疗效和安全性。治疗开始时，连续2周每日给予rhTPO（300 U/kg）。血小板计数稳定≥50×10⁹/L的患者开始接受维持治疗，起始为隔日给予rhTPO，然后调整给药间隔以维持血小板计数在（30 - 100）×10⁹/L。共纳入91例符合条件的患者。14例患者因不依从（12/14）和研究者决定（2/14）而退出研究。在完成研究的77例患者中，38例隔日或更少次数给予rhTPO的患者能够维持血小板计数≥30×10⁹/L达12周。维持治疗第4周、第8周和第12周时血小板反应（PLT≥30×10⁹/L）的患者百分比分别为92.6%（63/68）、82.7%（43/52）和85.0%（34/40）。血小板计数中位数维持在（70 - 124）×10⁹/L范围内。rhTPO相关不良事件的总体发生率为7.7%。所有不良事件一般均为轻度。延长rhTPO的给药间隔对于维持ITP患者稳定的血小板计数是可行的，但最佳给药间隔尚不确定，且可能因人而异。
