Shi Rui, Guo Su-Qing, Chen Yuan-Yuan, Liu Shan, Li Ying-Hua
Department of Hematology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.
Department of Hematology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China,E-mail：
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Oct;27(5):1568-1573. doi: 10.19746/j.cnki.issn.1009-2137.2019.05.031.
To investigate the clinical efficacy and safety of low-dose decitabine (DAC) alone for treatment of myelodysplastic syndrome (MDS) Methods: Fifty-one patients with meddle- and high-risk MDS were selected, and were randomly divided into A, B and C groups according to the drug regimens: the therapeutic regimen in A group consisted of low dose DAC 10 mg/(m·d)×7 d; the therapeutic regimen in B group: normal dose DAC 20 mg/(m·d) ×5 d; the therapeutic regimen in C group: low dose DAC+CAG DAC 10 mg/(m·d) d 1-5，cytarabine 10 mg/(m·d) q12h d 1-7, aclaromycin 10 mg/d d 1-4，G-CSF 200 μg/(m·d), d 1-7. All patients in 3 groups were treated for 4 circles. The efficacy and response were compared among 3 groups.
The complete remission rates (CR%) in A, B and C groups were 18.75%, 22.22% and 23.53% respectively, and the overall response rate (ORR%) in A, B and C groups were 56.25%, 61.11% and 58.82% respectively, without statistical difference among 3 groups (P＞0.05)．After 1 year of follow-up, the survival rate was not significantly different among 3 groups, the blood cell accounts were higher than the basic value. After 1 course of treatment, the inhibition rate of III-IV grade myelosuppression was statistically significantly different among the 3 groups (P＜0.05), and the infection rate among 3 groups also was statistically different, The incidence of myelosuppression and infection in A group was significantly lower than that in B and C groups. The per capita blood transfusion during the four-month treatment was not statistically different among 3 groups. however, that in the A group was lesser than B and C groups.
The therapeutic efficacy of low dose decitabine alone for treatment of MDS is equal to routine dose decitabine and decitabine plus CAG, but the low dose group shows less myelosuppressive and more safe effects.
探讨小剂量地西他滨（DAC）单药治疗骨髓增生异常综合征（MDS）的临床疗效及安全性。方法：选取51例中高危MDS患者，根据用药方案随机分为A、B、C组：A组治疗方案为小剂量DAC 10mg/(m²·d)×7天；B组治疗方案为常规剂量DAC 20mg/(m²·d)×5天；C组治疗方案为小剂量DAC+CAG方案，DAC 10mg/(m²·d)第1 - 5天，阿糖胞苷10mg/(m²·d)每12小时1次第1 - 7天，阿克拉霉素10mg/d第1 - 4天，粒细胞集落刺激因子（G-CSF）200μg/(m²·d)第1 - 7天。3组所有患者均治疗4个周期，比较3组的疗效及反应情况。
A、B、C组的完全缓解率（CR%）分别为18.75%、22.22%、23.53%，总缓解率（ORR%）分别为56.25%、61.11%、58.82%，3组间差异无统计学意义（P＞0.05）。随访1年后，3组生存率差异无统计学意义，血细胞计数均高于基础值。1个疗程治疗后，3组Ⅲ - Ⅳ级骨髓抑制发生率差异有统计学意义（P＜0.05），3组感染率差异也有统计学意义，A组骨髓抑制及感染发生率明显低于B组和C组。3组治疗4个月期间人均输血量差异无统计学意义，但A组少于B组和C组。
小剂量地西他滨单药治疗MDS的疗效与常规剂量地西他滨及地西他滨联合CAG方案相当，但小剂量组骨髓抑制作用较小，安全性更高。
