异基因造血干细胞移植后复发AML患者应用含地西他滨化疗方案维持治疗的疗效观察

doi:10.3969/j.issn.1006-6233.2023.10.019

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摘要 目的:探究地西他滨联合FLAG化疗方案在急性髓系白血病(AML)异基因造血干细胞移植(allo-HSCT)后复发患者中的治疗效果。方法:回顾性分析2014年1月至2020年6月95例allo-HSCT治疗后复发的AML患者临床资料,根据治疗方案不同,95例患者分为联合组51例与FLAG组44例,联合组予以地西他滨(5~7mg/m²/d皮下注射,d1~d5)联合FLAG方案治疗,FLAG组行FLAG方案治疗,两组均有相同对症支持治疗,治疗4周后复查疗效,并记录两组化疗毒副反应、对症支持治疗情况,以2022年6月31日为随访截止时间,采用Kaplan-meier行生存分析,记录两组总生存期及2年生存率。结果:治疗后,联合组完全缓解率(CR)、总有效率(ORR)分别为50.98%、80.39%,较FLAG组的34.09%、56.82%高,其中ORR比较差异有统计学意义(P<0.05)。化疗期间,两组不良反应中骨髓抑制(Z=0.18,P=0.855)、胃肠道反应(Z=0.63,P=0.531)、肝损伤(Z=1.06,P=0.288)、出血(Z=0.61,P=0.540)、肺部感染(Z=0.33,P=0.739)分度比较差异均无统计学意义(P>0.05);两组去白红细胞悬液、血小板、抗生素应用率比较差异无统计学意义(P>0.05)。截至2022年6月31日,联合组中位总生存时间为14.5(1.2~34.8)个月,2年总生存率为41.18%,较FLAG组的11.4(0.9~26.9)个月、22.73%高,但Log-rank检验显示,两组生存率比较差异无统计学意义(Log-rank χ²=3.758,P=0.053)。结论:在FLAG方案治疗基础上,联合地西他滨治疗allo-HSCT术后复发AML患者可取得更好近期疗效,且未增加化疗不良反应。

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	吴燕
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关键词 ：急性髓系白血病, 异基因造血干细胞移植, 复发, 地西他滨

Abstract：Objective: To explore the therapeutic effects of decitabine combined with FLAG chemotherapy regimen on patients with recurrent acute myeloid leukemia (AML) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Methods: The clinical data of 95 patients with recurrent AML after allo-HSCT treatment between January 2014 and June 2020 were retrospectively analyzed. According to different treatment regimens, 95 patients were divided into combined group (51 cases) and FLAG group (44 cases). Combined group was given decitabine (5~7mg/m2/d, subcutaneous injection, d1~d5) combined with FLAG regimen, and FLAG group was treated with FLAG regimen, and the two groups had the same symptomatic and supportive treatment. The efficacy was reviewed after 4 weeks of treatment, and the toxic and side effects of chemotherapy and status of symptomatic and supportive treatment were recorded in the two groups. June 31, 2022 was the deadline for follow-up, and Kaplan-meier survival analysis was used to record the overall survival time and 2-year survival rate in the two groups. Results: After treatment, the complete remission rate (CR) and overall response rate (ORR) with 50.98% and 80.39% in combined group were higher than those in FLAG group with 34.09% and 56.82%. There was a statistically significant difference in the ORR (P<0.05). During chemotherapy, there were no statistically differences between the two groups in terms of adverse reactions such as bone marrow suppression (Z=0.18, P=0.855), gastrointestinal reactions (Z=0.63, P=0.531), liver injury (Z=1.06, P=0.288), bleeding (Z=0.61, P=0.540), and pulmonary infection (Z=0.33, P=0.739) (P>0.05). There was no statistically significant difference in the comparison of the rates of deleterious erythrocyte suspension, platelets, and antibiotic application between the 2 groups (P>0.05). As of June 31, 2022, the median overall survival time and 2-year overall survival rate with 14.5 (1.2-34.8) months and 41.18% in combined group were higher than those in FLAG group with 11.4 (0.9~26.9) months and 22.73%. However, Log-rank test showed that there was no significant difference in survival rate between the two groups (Log-rank χ²=3.758, P=0.053). Conclusion: On the basis of FLAG regimen, combined with decitabine in the treatment of patients with recurrent AML after allo-HSCT can achieve better short-term efficacy without increasing the adverse reactions of chemotherapy.

Key words： Acute myeloid leukemia Allogeneic hematopoietic stem cell transplantation Recurrence Decitabine

基金资助:四川省科技计划项目,(编号:2020YJ0021)

通讯作者: 陈羽

引用本文:

吴燕, 刘艳, 陈羽. 异基因造血干细胞移植后复发AML患者应用含地西他滨化疗方案维持治疗的疗效观察[J]. 河北医学, 2023, 29(10): 1683-1688.
WU Yan, LIU Yan, et al. Efficacy of Maintenance Therapy with Decitabine-Containing Chemotherapy in Patients with Relapsed AML after Allogeneic Hematopoietic Stem Cell Transplantation. HeBei Med, 2023, 29(10): 1683-1688.

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http://www.hbyxzzs.cn/CN/10.3969/j.issn.1006-6233.2023.10.019 或 http://www.hbyxzzs.cn/CN/Y2023/V29/I10/1683