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目的 评估罗普司亭N01在肿瘤治疗所致血小板减少症(CTIT)患者中的临床疗效和安全性。方法 回顾性分析江苏大学附属昆山市第一人民医院2024年7月至2025年1月收治的经罗普司亭N01治疗的CTIT患者共46例。患者罗普司亭N01治疗前基线血小板计数低于50×109/L。罗普司亭N01初始剂量3～5μg/kg,每周1次，皮下注射，根据血小板计数水平每周增加1～2μg/kg,最大剂量10μg/kg。隔日复查血常规，血小板恢复至75×109/L以上且较基线时升高30×109/L以上即可停药。记录罗普司亭N01治疗前及治疗后21天内患者血小板计数、有无出血及相关不良反应情况。结果 46例CTIT患者经罗普司亭N01治疗后，完全缓解(CR)38例，部分缓解(PR)4例，微效(MR)3例，无效(NC)1例，客观有效率(ORR)为91.3%(42/46)。其中一线治疗组和二线治疗组ORR分别高达94.1%和90.0%,两组ORR相似，差异无统计学意义(P>0.05)。一线治疗组血小板<50×109/L的持续时间、恢复至75×109/L和恢复至100×109/L的时间均较二线治疗组短，差异均有统计学意义(P<0.05)。患者总体不良反应较轻，主要表现为轻中度肌肉关节疼痛、头痛、头晕、失眠等。结论 罗普司亭N01对CTIT疗效确切，且只需要每周注射1次，甚至对重组人血小板生成素(rhTPO)、重组人白细胞介素-11(rhIL-11)以及第一代血小板生成素受体激动剂(TPO-RA)等治疗失败的患者亦有效，不良反应轻，未增加血栓风险，其可推荐作为3级以上CTIT患者的一线治疗方案，或其他升血小板治疗失败后的挽救治疗方案。
Abstract：Objective To evaluate the clinical efficacy and safety of romiplostim N01 in patients with cancer therapy induced thrombocytopenia(CTIT). Methods A total of 46 patients with CTIT treated with romiplostim N01 in Kunshan First People's Hospital from July 2024 to January 2025 were retrospectively analyzed. The baseline platelet count was lower than 50×109/L, and the initial dose of romiplostim N01 was 3-5 μg/kg, once a week, subcutaneously injected, and the dose was increased by 1-2 μg/kg per week according to the platelet count level, the maximum dose was 10 μg/kg. The blood routine was reviewed every other day. There was drug withdraw when platelet count restored to more than 75×109/L and increased more than 30×109/L from baseline. Platelet counts, bleeding and related adverse reactions were recorded before and within 21 days after treatment. Results Forty-six patients with CTIT were treated with romiplostim N01, with 38 cases complete reponse(CR), 4 cases partial response(PR), 3 cases mild response(MR) and 1 case no change(NC). The total objective response rate(ORR) was 91.3%(42/46). The response rates in the first-line treatment group and in the second-line treatment group were similar(94.1% vs. 90.0%), which had no statistically significant difference(P>0.05). The duration of platelet<50×109/L, recovery time to 75×109/L and time to 100×109/L in the first-line treatment group were shorter than those in the second-line treatment group, and the differences were statistically significant(P<0.05). Overall adverse reactions were mild, mainly manifested as mild to moderate muscle and joint pain, headache, dizziness and insomnia. Conclusion Romiplostim N01 is effective for CTIT, and only once a week. It is also effective for patients who have failed treatment with rhTPO, rhIL-11, first-generation TPO-RA. Adverse reactions is mild and no risk of thrombosis increased. Romiplostim N01 can be recommended as a first-line treatment for patients with grade 3 or higher CTIT, or as a salvage treatment for patients who have failed treatment with other drugs.
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基本信息:
中图分类号:R730.5;R558.2
引用信息:
[1]徐海源,计张奕,徐燕.罗普司亭N01在肿瘤治疗所致血小板减少症中的疗效和安全性分析[J].临床肿瘤学杂志,2025,30(05):493-497.
2025-05-28
2025-05-28