Objective: The optimal dosage of recombinant human thrombopoietin (rhTPO) for enhancing platelet engraftment following allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains undefined. We have crafted a prospective, dose-exploration, controlled clinical study to evaluate the effectiveness and safety of escalating doses rhTPO in facilitating platelet engraftment post-transplantation.
Methods: The study encompassed 57 individuals undergoing allo-HSCT. Commencing day +1 post-transplantation, patients were administered rhTPO therapy. The experimental group, comprising 27 patients, received a continous daily dosage of 22500 U of rhTPO until platelet engraftment was achieved. While the control group, consisting of 30 participants, was given a continuous daily dosage of 15000 U of rhTPO，also until platelet engraftment occurred.
Results: Patients in the experimental group, who received 22,500 U/day rhTPO, achieved a significantly earlier median time to platelet engraftment compared to the control group (12 vs. 13 days, P=0.042, z=4.142) and reached platelet counts of ≥30×109/L more rapidly (13 vs. 16 days, z=3.936, P=0.047). There was a noticeable trend in the experimental group towards earlier attainment of higher platelet thresholds of 50×109/L, 75×109/L, and 100×109/L (15 vs. 20 days, 18 vs. 22 days, 22.5 vs. 28 days). No instances of delayed platelet engraftment were noted in either group. By day 21, the cumulative platelet engraftment rate stood at 96.3% for the experimental group and 83.3% for the control group. By day 60, both groups had achieved a full 100% engraftment rate. Additionally, the experimental group experienced an earlier median time to neutrophil engraftment (11 vs. 12.5 days, z=4.534, P=0.033). During the follow-up period, both groups showed a 100% one-year overall survival rate. The one-year relapse-free survival rates were 96.3% for the experimental group and 93.3% for the control group, indicating no significant disparity. Notably, the cumulative incidence of moderate to severe acute graft-versus-host disease (aGVHD) was significantly lower in the experimental group (14.8% vs. 40.0%, P=0.043). Safety assessments, encompassing evaluations of adverse events such as thrombosis and bleeding, confirmed that the higher dosage of rhTPO was both safe and reliable.
Conclusion: Escalating the dosage of rhTPO injections demonstrates a safe and efficacious approach to enhancing platelet engraftment in patients following allo-HSCT. This strategy not only accelerates the recovery of platelet levels but also contributes to the overall therapeutic regimen without compromising patient safety.
No relevant conflicts of interest to declare.
This feature is available to Subscribers Only
Sign In or Create an Account Close Modal