People's Hospital Peking University, Institute of Hematology, Xicheng District, Beijing, People's Republic of China.
Clin Drug Investig. 2011;31(2):135-41. doi: 10.1007/BF03256939.
Delayed recovery of platelets can be found in recipients of related donor haploidentical haematopoietic stem cell transplantation (HSCT). The objective of this study was to evaluate the safety of recombinant human thrombopoietin (rhTPO) administration prior to engraftment in patients who received related donor haploidentical HSCT.
Nineteen patients with haematological malignancies received rhTPO prior to platelet engraftment after related donor haploidentical HSCT. Safety and tolerability levels together with the influence of rhTPO on the outcome of transplantation were evaluated.
Slight elevations in ALT and/or AST were observed in five patients; in two other patients, bilirubin levels increased slightly. No significant changes in routine examination findings and no allergic reactions were observed during the study period. Eighteen patients achieved platelet engraftment at a median of 16 (range 11-34) days. The cumulative ± SD incidence of acute graft-versus-host disease (GVHD) grade 1-4 at +100 days was 68.4 ± 10.7%, and that of chronic GVHD at 3 years was 24.7 ± 10.7%. Nine (47.4%) patients survived free of relapse, with a median follow-up of 1631 (1550-1734) days after transplantation.
Early administration of rhTPO prior to engraftment was safe and well tolerated in patients receiving related donor haploidentical HSCT.
在接受相关供体单倍体造血干细胞移植（HSCT）的受者中可发现血小板恢复延迟。本研究的目的是评估在接受相关供体单倍体 HSCT 的患者中，在植入前给予重组人血小板生成素（rhTPO）的安全性。
19 例血液系统恶性肿瘤患者在相关供体单倍体 HSCT 后血小板植入前接受 rhTPO。评估安全性和耐受性水平以及 rhTPO 对移植结果的影响。
5 例患者出现 ALT 和/或 AST 轻度升高；另外 2 例患者胆红素水平略有升高。在研究期间，常规检查结果无明显变化，未观察到过敏反应。18 例患者在中位数为 16 天（范围 11-34 天）达到血小板植入。+100 天时急性移植物抗宿主病（GVHD）1-4 级的累积发生率为 68.4%±10.7%，3 年时慢性 GVHD 的发生率为 24.7%±10.7%。9 例（47.4%）患者无复发存活，移植后中位随访时间为 1631 天（1550-1734 天）。
在接受相关供体单倍体 HSCT 的患者中，在植入前早期给予 rhTPO 是安全且耐受良好的。
