| 郑方英，王春莲，黄浩元.维奈克拉联合阿扎胞苷治疗急性髓系白血病的临床效果分析[J].中国医药科学,2025,(2):109-113 基金项目:广东省惠州市医疗卫生领域科技计划项目（2022CZ010149） |
| 维奈克拉联合阿扎胞苷治疗急性髓系白血病的临床效果分析 |
| Clinical efficacy analysis of venetoclax combined with azacytidine in the treatment of acute myeloid leukemia |
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| DOI： |
| 中文关键词: 急性髓系白血病；维奈克拉；阿扎胞苷；生存期；影响因素 |
| 英文关键词:Acute myeloid leukemia; Venetoclax; Azacytidine; Survival; Impacting factor |
| 作者 | 单位 | | 郑方英，王春莲，黄浩元 | 广东省惠州市第一人民医院血液内科，广东惠州 516003 |
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| 中文摘要: |
| [摘要] 目的 分析维奈克拉联合阿扎胞苷治疗急性髓系白血病（AML）的临床效果，并探讨相关影响因素。 方法 选取2022年7月1日至2023年12月31日于惠州市第一人民医院收治的52例AML患者作为研究对象，使用随机数表法将其分为观察组和对照组，每组各26例；对照组给予阿扎胞苷，观察组在此基础上联用维奈克拉，28 d为1个疗程，所有患者至少完成1个疗程。比较两组临床疗效、不良反应情况和总生存期（OS）；对患者OS影响因素进行单因素分析，并将差异指标纳入COX回归模型探讨影响AML患者临床疗效的因素。 结果 两组治疗反应分布情况比较，差异有统计学意义（P < 0.05），其中观察组总反应率（ORR）高于对照组，差异有统计学意义（P < 0.05）。两组三级以上骨髓抑制和非血液学毒性总发生率比较，差异均无统计学意义（P > 0.05）。截至随访结束，观察组OS率高于对照组，差异有统计学意义（Log-rankχ2=48.883，P < 0.001）。经OS影响单因素分析得知，欧洲白血病网络（ELN）危险分层、初始骨髓原始细胞数、肿瘤蛋白53（TP53）基因突变、综合骨髓微小残留病灶（MRD）、治疗方案和治疗疗程是影响AML患者OS的危险因素（P < 0.1）；将其纳入COX回归模型进行多因素分析得知，ELN-高危、MRD阳性和治疗方案为阿扎胞苷是导致AML患者OS率降低的重要危险因素（P < 0.05）。 结论 维奈克拉联合阿扎胞苷治疗不适合强化疗的老年AML患者安全性良好，ORR和OS升高，其生存情况受ELN危险分层、MRD状态和治疗方案影响。 |
| 英文摘要: |
| [Abstract] Objective To analyze the clinical efficacy of venetoclax combined with azacytidine in the treatment of acute myeloid leukemia (AML) and investigate the related impacting factors. Methods A total of 52 AML patients admitted to and treated in the Huizhou First Hospital from July 1, 2022 to December 31, 2023 were selected as the research object, and they were divided into the observation group (n=26) and the control group (n=26) according to the random number table method. The control group was treated with azacytidine, while the observation group was treated with venetoclax on the basis of the former. 28 days was a course of treatment, and all patients completed at least 1 course of treatment. The clinical efficacy, adverse reactions and overall survival (OS) of the two groups were compared. The impacting factors of patients’ OS were analyzed by single factor analysis, and the difference indices were included in COX regression model to explore the factors impacting the clinical efficacy of AML patients. Results There were statistically significant difference in the distribution contrast of therapeutic reaction between the two groups (P < 0.05), in which the overall response rate (ORR) of the observation group was higher than that of the control group, with statistically significant difference (P < 0.05). There were no statistically significant differences in the total incidence of gradeⅢor above bone marrow suppression and non-hematological toxicity between the two groups (P > 0.05). By the end of follow-up, the OS rate in the observation group was higher than that in the control group, with statistically significant difference (Log-rankχ2=48.883, P < 0.001). The univariate analysis of OS showed that the risk stratification of European leukemia network (ELN), the initial number of bone marrow primordial cells, the mutation of tumor protein 53 (TP53) gene, thecomprehensive minimal residual disease (MRD) of bone marrow , the therapeutic regimen and the treatment course were the risk factors that impacted the OS of AML patients (P < 0.1). Multivariate analysis showed that ELN- high-risk, MRD-positive and therapeutic regimen-azacytidine were the important risk factors for the decrease of OS rate in AML patients (P < 0.05). Conclusion Venetoclax combined with azacytidine is safe in the treatment of elderly AML patients who are not suitable for strong chemotherapy, and the ORR and OS rate increase. Their survival situation is impacted by ELN risk stratification, MRD status and therapeutic regimen. |
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