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贝林妥欧单抗联合达沙替尼治疗儿童费城染色体阳性急性淋巴细胞白血病的安全性分析
郑方圆, 丁明明, 陆爱东, 贾月萍, 曾慧敏, 张乐萍
中国当代儿科杂志 ›› 2026, Vol. 28 ›› Issue (4) : 417-422.
PDF(653 KB)
PDF(653 KB)
贝林妥欧单抗联合达沙替尼治疗儿童费城染色体阳性急性淋巴细胞白血病的安全性分析
Safety of blinatumomab combined with dasatinib in the treatment of pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia
目的 探讨贝林妥欧单抗联合达沙替尼在儿童费城染色体阳性急性淋巴细胞白血病(Philadelphia chromosome positive acute lymphoblastic leukemia, Ph+ ALL)中的安全性。 方法 回顾性分析2023年8月—2025年6月期间北京大学人民医院儿科使用贝林妥欧单抗联合达沙替尼治疗的Ph+ ALL患儿临床资料,观察治疗过程中药物不良反应,评估联合治疗的安全性。 结果 共纳入10例患儿(男7例,女3例),共13例次联合用药,治疗后BCR∶∶ABL1基因水平较治疗前有所下降或者持续保持阴性。中位随访13个月,10例患儿全部存活且无疾病复发。治疗期间,达沙替尼血药谷浓度及峰浓度均未受影响(P>0.05)。主要不良反应包括:血液学不良反应(Ⅰ~Ⅱ级发生率77%,Ⅲ~Ⅳ级发生率23%,所有级别开始出现中位时间4 d,持续中位时间7 d)、细胞因子释放综合征(均为Ⅰ级,发生率61%,开始中位时间3 d,持续中位时间2 d)、神经毒性(Ⅰ~Ⅱ级发生率30%,Ⅲ~Ⅳ级发生率7%,所有级别开始出现中位时间3 d,持续中位时间1 d)及低丙种球蛋白血症(发生率90%,中位出现时间13 d,6例需长期静脉注射免疫球蛋白治疗)。所有不良反应经对症处理后缓解,无治疗相关死亡。 结论 贝林妥欧单抗联合达沙替尼用于儿童Ph+ ALL具有良好的安全性,不良反应可控。
Objective To evaluate the safety of blinatumomab combined with dasatinib in children with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Methods A retrospective review was conducted of clinical data for children with Ph+ ALL treated with blinatumomab plus dasatinib in the Department of Pediatrics, Peking University People's Hospital, from August 2023 to June 2025. Adverse events during therapy were recorded to assess safety. Results Ten children were included (7 boys, 3 girls), with a total of 13 instances of combination therapy. After treatment, BCR∶∶ABL1 transcript levels decreased from baseline or remained persistently negative. At a median follow-up of 13 months, all patients were alive without disease relapse. During treatment, dasatinib trough and peak plasma concentrations were not significantly affected (P>0.05). Major adverse events were as follows: hematologic toxicity (grade I-II: 77%; grade III-IV: 23%; median time to onset: 4 days; median duration: 7 days), cytokine release syndrome (all grade I; incidence: 61%; median time to onset: 3 days; duration: 2 days), neurotoxicity (grade I-II: 30%; grade III-IV: 7%; median time to onset: 3 days; duration: 1 day), and hypogammaglobulinemia (incidence: 90%; median time to onset: 13 days), with six patients requiring long-term intravenous immunoglobulin therapy. All adverse events resolved with supportive care, and no treatment-related deaths occurred. Conclusions Blinatumomab combined with dasatinib is well tolerated in pediatric Ph+ ALL, and the adverse events are manageable.
贝林妥欧单抗 / 达沙替尼 / 急性淋巴细胞白血病 / 费城染色体阳性 / 儿童
Blinatumomab / Dasatinib / Acute lymphoblastic leukemia / Philadelphia chromosome-positive / Child
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所有作者均声明无利益冲突。