Efficacy of decitabine combined with recombinant human interferon α-2b in children with acute myeloid leukemia

doi:10.3760/cma.j.issn.1007-1245.2024.22.001

Abstract

Abstract:

Objective　To explore the efficacy of decitabine combined with recombinant human interferon α-2b in the treatment of acute myeloid leukemia (AML) in children and its effects on routine blood parameters, immune function, minimal residual disease (MRD) expression, and incidence of adverse reactions. Methods　This study was a randomized controlled trial. A total of 100 children with AML treated at the Department of Oncology and Hematology, Xi'an Children's Hospital from May 2020 to January 2024 were divided into an observation group and a control group with 50 cases in each group according to the random number table method. The control group consisted of 29 boys and 21 girls, aged (9.79±2.60) years. The observation group consisted of 27 boys and 23 girls, aged (9.96±2.35) years. The control group was treated with decitabine at a dose of 15 mg/m² intravenously once a day for 5 days. The observation group was combined with recombinant human interferon α-2b treatment on the basis of the control group: at the same time of decitabine treatment, recombinant human interferon α-2b was given subcutaneous or intramuscular injection at a dose of 3 mIU/m², 3 times a week for 6 weeks. The clinical efficacy, blood routine parameters, immune function, MRD expression, and incidence of adverse reactions were compared between the two groups. χ² test, Fisher exact probability method, and independent sample t test were used. Results　The total effective rate of the observation group was higher than that of the control group [76.00% (38/50) vs. 52.00% (26/50)], with a statistically significant difference (χ²=6.250, P=0.012). Six weeks later, the platelet count, red blood cell count, CD3⁺, and CD4⁺ levels in the observation group were higher than those in the control group [(116.24±12.52) ×10⁹/L vs. (99.20±10.93) ×10⁹/L, (197.12±17.27) ×10⁹/L vs. (169.67±14.64) ×10⁹/L, (58.74±5.40)% vs. (54.94±5.97)%, (34.09±4.26)% vs. (30.37±3.80)%], and the proportion of bone marrow blasts was lower than that in the control group [(9.46±3.13)% vs. (12.90±3.54)%], with statistically significant differences (all P<0.05). There was no statistically significant difference in the rate of MRD positive expression or the incidence of adverse reactions between the two groups (both P>0.05). Conclusion　Decitabine combined with recombinant human interferon α-2b in the treatment of children with AML can effectively improve the clinical efficacy, blood routine parameters, and immune function, with good safety.

Key words:

Decitabine, Recombinant human interferon α-2b, Acute myeloid leukemia, Children, Clinical efficacy, Minimal residual disease, , Adverse reactions

摘要：

目的　探讨地西他滨联合重组人干扰素ɑ-2b治疗儿童急性髓系白血病（AML）的疗效及对血常规指标、免疫功能、微小残留病变（MRD）表达情况、不良反应发生率的影响。方法　本研究为随机对照试验，将西安市儿童医院血液肿瘤科2020年5月至2024年1月收治的100例AML患儿按随机数字表法分为观察组和对照组各50例。对照组男29例，女21例，年龄（9.79±2.60）岁；观察组男27例，女23例，年龄（9.96±2.35）岁。对照组接受地西他滨治疗，以15 mg/m²的剂量静脉滴注，每天一次，连续5 d。观察组在对照组基础上联合重组人干扰素ɑ-2b治疗：从地西他滨治疗的第1天开始，给予重组人干扰素ɑ-2b皮下或肌肉注射，剂量为3 mIU/m²，每周3次，连续治疗6周。比较两组患儿的临床疗效、血常规指标、免疫功能、MRD表达情况及不良反应发生率。采用χ²检验、Fisher确切概率法、独立样本t检验。结果　观察组总有效率高于对照组［76.00%（38/50）比52.00%（26/50）］，差异有统计学意义（χ²=6.250，P=0.012）。6周后，观察组血小板计数和血红细胞计数、CD3⁺和CD4⁺水平高于对照组［（116.24±12.52）×10⁹/L比（99.20±10.93）×10⁹/L、（197.12±17.27）×10⁹/L比（169.67±14.64）×10⁹/L、（58.74±5.40）%比（54.94±5.97）%、（34.09±4.26）%比（30.37±3.80）%］，骨髓原始细胞比例低于对照组［（9.46±3.13）%比（12.90±3.54）%］，差异均有统计学意义（均P<0.05）。两组MRD阳性表达率和不良反应发生率差异均无统计学意义（均P>0.05）。结论　地西他滨联合重组人干扰素ɑ-2b治疗儿童AML能有效提高临床疗效，改善血常规指标和免疫功能，且安全性良好。

关键词:

地西他滨, 重组人干扰素ɑ-2b, 急性髓系白血病, 儿童, 临床疗效, 微小残留病变, 不良反应

Huan Fangna, Fan Keliao, Wang Hua.

Efficacy of decitabine combined with recombinant human interferon α-2b in children with acute myeloid leukemia [J]. International Medicine and Health Guidance News, 2024, 30(22): 3697-3702.

宦芳娜范可辽王华.

地西他滨联合重组人干扰素ɑ-2b对儿童急性髓系白血病的疗效 [J]. 国际医药卫生导报, 2024, 30(22): 3697-3702.

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