罗普司亭用于消化系统肿瘤难治性化疗相关血小板减少的疗效与安全性分析OA
Efficacy and Safety of Romiplostim for Refractory Chemotherapy-Induced Thrombocytopenia in Digestive System Cancer
目的 评估罗普司亭治疗消化系统肿瘤难治性化疗相关血小板减少症(CIT)的疗效与安全性.方法 采用单中心回顾性研究,纳入 2025 年 4 月—2026 年 1 月于华中科技大学同济医学院附属同济医院消化肿瘤科就诊的难治性 CIT 患者 40 例.所有患者既往经重组人白细胞介素-11、重组人血小板生成素或口服小分子血小板生成素受体激动剂治疗后,血小板恢复不佳,予以罗普司亭250 μg皮下注射,每周 1 次.主要终点为血小板计数(PLT)恢复至≥75×109•L-1或较基线升高≥50×109•L-1所需时间;次要终点为14 d内 PLT 恢复率以及安全性.采用 Cox 回归分析 PLT 恢复时间的影响因素.结果 PLT 中位恢复时间为10.0 d[95%CI=(8.8,11.2)],14 d内总体恢复率为82.5%(33/40).多因素分析显示,基线 PLT 是其恢复时间的独立影响因素(HR= 2.468,P<0.05).按体重计算剂量亚组分析显示,罗普司亭剂量>4 μg•kg-1组中位 PLT 恢复时间为8 d,2~4 μg•kg-1组为10 d,呈现起效更快趋势,但差异无统计学意义;不同体重亚组疗效与安全性均无显著差异.治疗期间仅 2 例(5.0%)患者进行了挽救性血小板输注,未发生血栓事件及药物相关不良事件.结论 罗普司亭治疗消化系统肿瘤难治性 CIT 表现出较好的疗效与可控的安全性,基线 PLT 或可作为预测治疗效果的独立指标.增加罗普司亭剂量有加速 PLT 恢复的趋势,且短期安全性可控,可作为难治性 CIT 的二线治疗选择.
Objective To evaluate the efficacy and safety of romiplostim in the treatment of refractory chemotherapy-induced thrombocytopenia(CIT)in patients with digestive system malignancies.Methods A single-center retrospective study was performed.Forty patients with refractory CIT were enrolled at the Department of Gastrointestinal Oncology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology from April 2025 to January 2026.All patients had previously received treatment with recombinant human interleukin-11,recombinant human thrombopoietin,or oral small-molecule thrombopoietin receptor agonists,yet exhibited inadequate platelet recovery.Romiplostim 250 μg was administered subcutaneously once weekly.The primary endpoint was the time to platelet count(PLT)recovery to≥75×109·L-1 or increase by≥50×109·L-1 relative to baseline.Secondary endpoints included the platelet response rate within 14 days and safety.Cox proportional hazards regression was used to analyze factors associated with the time to PLT recovery.Results The median time to PLT recovery was 10.0 days[95%CI=(8.8,11.2)],and the overall response rate within 14 days was 82.5%(33/40).Multivariate analysis demonstrated that baseline PLT was an independent factor influencing the time to platelet recovery(HR=2.468,P<0.05).Weight-based dose subgroup analysis showed that the median time to PLT recovery was 8 days in the>4 μg·kg-1 group and 10 days in the 2~4 μg·kg-1 group,indicating a trend toward faster onset of effect without statistical significance.There were no significant differences in efficacy or safety among different weight subgroups.Only 2 patients(5.0%)received platelet transfusion during treatment.No thrombotic events or drug-related adverse events occurred.Conclusion Romiplostim demonstrated promising efficacy and controllable safety in the treatment of refractory CIT in patients with digestive system malignancies,and baseline PLT may serve as an independent predictive indicator of treatment response..A higher dose of romiplostim shows a trend toward accelerated platelet recovery with manageable short-term safety.Romiplostim may be considered as a second-line treatment option for refractory CIT.
邱萍;戴宇翃
荆州市中心医院肿瘤科,荆州 434020华中科技大学同济医学院附属同济医院肿瘤科,武汉 430030
医药卫生
罗普司亭消化系统肿瘤难治性化疗相关血小板减少临床疗效安全性
RomiplostimGastrointestinal malignanciesRefractory chemotherapy-induced thrombocytopeniaClinical efficacySafety
《医药导报》 2026 (8)
1355-1360,6
湖北省自然科学基金面上项目(2023AFB1059)湖北省自然科学基金联合基金项目(2025AFD780).
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