维奈克拉联合地西他滨治疗老年初治急性髓系白血病的疗效及安全性分析

Analysis of the Efficacy and Safety of Venetoclax Combined with Decitabine in the Treatment of Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia

摘要: 目的：分析维奈克拉(Venetoclax, VEN)联合地西他滨(Decitabine, DAC)治疗老年初治急性髓系白血病(Acute Myeloid Leukemia, AML)患者的疗效及安全性，为白血病的临床治疗提供指导依据。方法：回顾性分析了2021年1月至2025年1月就诊于邯郸市中心医院的39例老年初治急性髓系白血病患者的临床资料，所有患者均应用VEN + DAC方案治疗，主要观察终点为1个诱导周期后的完全缓解(CR)、复合完全缓解(CRc)、完全缓解伴不完全血液学恢复(CRi)，次要观察终点为总体缓解率(ORR)、中位总生存期(OS)、不良反应。结果：39例患者经过1个周期的诱导治疗后，CR率为71.8%，CRc率为84.6%，ORR率为89.7%；截至到2025年1月，所有患者的中位OS为12个月(2~36.9个月)；安全性方面，所有患者均发生了3~4级血液学不良反应，诱导治疗后的中性粒细胞 > 0.5 × 10⁹/L的时间为21天、血小板 > 20 × 10⁹/L的时间为15天，非血液学不良反应以肺部感染和消化道症状为主。结论：VEN + DAC方案治疗老年初治AML患者疗效显著且安全性较好，与传统强化疗方案相比，在缓解率、骨髓抑制方面均具有明显优势。

Abstract: Objective: To analyze the efficacy and safety of venetoclax (VEN) combined with decitabine (DAC) in the treatment of elderly patients with newly diagnosed acute myeloid leukemia (AML), and to provide guidance for the clinical treatment of leukemia. Methods: The clinical data of 39 elderly patients with newly diagnosed AML who were treated in Handan Central Hospital from January 2021 to January 2025 were retrospectively analyzed. All patients were treated with the VEN + DAC regimen. The primary endpoints were complete remission (CR), composite complete remission (CRc), and complete remission with incomplete hematological recovery (CRi) after one induction cycle. The secondary endpoints were overall response rate (ORR), median overall survival (OS), and adverse reactions. Results: After one induction cycle of treatment, the CR rate was 71.8%, the CRc rate was 84.6%, and the ORR rate was 89.7% in 39 patients. As of January 2025, the median OS for all patients was 12 months (2~36.9 months). In terms of safety, all patients experienced grade 3~4 hematological adverse reactions. The time for neutrophils to exceed 0.5 × 10⁹/L after induction therapy was 21 days, and the time for platelets to exceed 20 × 10⁹/L was 15 days. Non-hematological adverse reactions were mainly pulmonary infection and gastrointestinal symptoms. Conclusion: The VEN + DAC regimen is significantly effective and safe in the treatment of elderly patients with newly diagnosed AML. Compared with traditional intensive chemotherapy regimens, it has obvious advantages in terms of remission rate and bone marrow suppression.