内科理论与实践

内科理论与实践 ›› 2025, Vol. 20 ›› Issue (02): 126-131.doi: 10.16138/j.1673-6087.2025.02.05

• 论著 • 上一篇    下一篇

海曲泊帕治疗实体肿瘤化疗所致血小板减少症的疗效及安全性回顾性研究

陈勇1, 陈子漩1, 武文娟2, 王晓庆3, 陈小军4, 李颖1, 汪瑞1, 李悦1   

  1. 1.扬州大学附属医院肿瘤内科，江苏 扬州 225009
    2.苏北人民医院肿瘤内科，江苏 扬州 225012
    3.高邮市中医院肿瘤内科，江苏 扬州 225699
    4.扬州大学附属江都人民医院肿瘤内科，江苏 扬州 225200
  • 收稿日期:2024-10-09 出版日期:2025-04-28 发布日期:2025-07-08
  • 基金资助:
    扬州市医学重点学科培育对象（肿瘤治疗学）项目(YZYXZDXK-013);扬州市科技计划项目(YZ2024077);江苏省产学研合作项目(BY20221106)

Retrospective study of efficacy and safety of hetrombopag in treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors

CHEN Yong1, CHEN Zixuan1, WU Wenjuan2, WANG Xiaoqing3, CHEN Xiaojun4, LI Ying1, WANG Rui1, LI Yue1   

  1. 1. Department of Oncology, Affiliated Hospital of Yangzhou University, Yangzhou 225009, China
    2. Department of Oncology, the People’s Hospital of Subei, Yangzhou 225012, China
    3. Department of Oncology, Gaoyou Traditional Chinese Medical Hospital, Yangzhou 225699, China
    4. Department of Oncology, the Affiliated Jiangdu People’s Hospital of Yangzhou University, Yangzhou 225200, China
  • Received:2024-10-09 Online:2025-04-28 Published:2025-07-08

RichHTML

0

PDF (PC)

2

摘要：

目的：评估海曲泊帕治疗实体肿瘤化疗所致血小板减少症（chemotherapy-induced thrombocytopenia，CIT）的疗效及安全性。方法：回顾性纳入2021年9月至2022年6月包括扬州大学附属医院在内的4所医院接受海曲泊帕治疗的57例CIT患者，比较海曲泊帕不同治疗方案[单药和联合重组人血小板生成素（recombinant human thrombopoietin，rhTPO）/重组人白介素(recombinant human interleukin, rhIL)-11]和不同治疗剂量的疗效差异。观察血小板输注情况及不良事件发生率。结果：单药组12例，其中Ⅰ~Ⅱ级CIT占83.3%；联合组45例，其中Ⅰ~Ⅱ级CIT占64.5%。联合组既往升血小板药物使用率显著高于单药组（66.7%比0.0%，P<0.001）。海曲泊帕治疗总体有效率为89.5％，治疗后7、14、21 d有效率分别为40.4％、77.2％、87.7％。单药组有效率与联合治疗组差异无统计学意义（91.7％比88.9％，P=1.000）。联合组治疗后中位血小板计数峰值显著高于单药组（151.5×109/L比126.0×109/L，P=0.013）。单药治疗2.5 mg/d和5.0 mg/d剂量组有效率分别为100.0%和85.7%；联合治疗2.5、5.0、7.5 mg/d剂量组有效率分别为71.4%、91.7%和100.0%。单药组及联合组内不同海曲泊帕剂量有效率相比差异无统计学意义（P>0.05）。治疗期间共1例接受血小板输注，联合治疗组4例出现血小板增多。结论：海曲泊帕治疗CIT疗效确切且安全，其中单药治疗轻中度CIT疗效确切，联合rhTPO/rhIL-11治疗中重度及难治性CIT同样具有较好疗效，但最佳治疗剂量及联合方案仍需进一步验证。

关键词: 海曲泊帕, 化疗所致血小板减少症, 实体肿瘤, 疗效, 安全性

Abstract:

Objective To evaluate efficacy and safety of hetrombopag in the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients with solid tumors. Methods From September 2021 and June 2022, patients with CIT who were treated with hetrombopag from four hospitals were enrolled. The clinical efficacy of either hetrombopag monotherapy or hetrombopag combined with recombinant human thrombopoietin (rhTPO)/ recombinant human interleukin (rhIL)-11 and the efficacy of different doses of hetrombopag were analyzed. The frequency of platelet transfusions and the incidence of adverse events were also analyzed. Results A total of 57 patients were included, in which 12 patients were in the monotherapy group (83.3% with Ⅰ-Ⅱ CIT) and 45 patients were in the combination group (64.5% with Ⅰ-Ⅱ CIT). The proportion of patients who received thrombopoietic therapy during the CIT period was significantly higher in the combination group compared to the monotherapy group (66.7% vs. 0.0%, P < 0.001). The overall responses rate was 89.5%, and responses rates at 7, 14 and 21 days after treatment were 40.4%, 77.2% and 87.7%, respectively. The responses rate was 91.7% in the monotherapy group and 88.9% in the combination group, which had no significant difference between the two groups (P = 1.000). The median peak platelet count after treatment was significantly higher in the combination group compared to the monotherapy group (151.5×10⁹/L vs. 126.0×10⁹/L, P = 0.013). In the monotherapy groups, the responses rates of 2.5 mg/d and 5 mg/d were 100.0% and 85.7%, respectively. In the combination therapy groups, the responses rates of 2.5, 5 and 7.5 mg/d were 71.4%, 91.7% and 100.0%, respectively. The response rates had no significant differences among different doses of hetrombopag in both the monotherapy and combination therapy groups (P > 0.05). After treatment, one patient need a platelet transfusion, and 4 patients in the combination group developed thrombocytosis. Conclusions Hetrombopag is effective and safe for treating CIT, in which monotherapy shows significant efficacy in mild to moderate cases, and hetrombopag combin with rhTPO or rhIL-11 is effectiveness in moderate to severe or refractory cases. However, the optimal dosage and combination regimen still need further investigation.

Key words: Hetrombopag, Chemotherapy-induced thrombocytopenia, Solid tumor, Efficacy, Safety

中图分类号: