超小剂量地西他滨治疗骨髓增生异常综合征的近期疗效和不良反应观察

A short-term clinical efficacy of ultra small dose of decitabine in the treatment of patients with myelodysplastic syndrome

目的：分析超小剂量地西他滨方案在治疗骨髓增生异常综合征（MDS）患者中的近期临床疗效和不良反应。方法接受地西他滨治疗的中危－1组 MDS 患者19例，其中9例接受地西他滨15 mg·m －2，每周1次，共3周为一疗程的治疗方案；10例接受地西他滨7 mg·m －2，每周1次，共3周为一疗程的治疗方案（简称15 mg 和7 mg 组）。比较两组之间的总反应率和不良反应发生率。结果19例中危－1组 MDS 患者经过地西他滨治疗后，1例获完全缓解（CR），7例获血液学改善（HI），11例病情稳定（SD），总反应率42％。其中，地西他滨15 mg 组、7 mg 组患者的总反应率分别为44％、40％，两组疗效比较差异无统计学意义（P ＞0．05）。本研究中地西他滨治疗的主要不良反应为骨髓抑制所致的感染和出血，两组患者感染发生率分别为11％和0％，Ⅲ′～Ⅳ′级血液学不良反应发生率分别为44％、10％，同时15 mg 组治疗期间分别平均输注红细胞2．2 U 和血小板1．3 U；7 mg 组治疗期间分别平均输注红细胞0．2 U 和血小板0．2 U，比较两组患者血液学不良反应、平均血小板输注量差异均有统计学意义（P ＜0．05）；两组患者在应用地西他滨治疗后三系均有所提高，其中血红蛋白改善明显（P ＜0．05）。结论超小剂量地西他滨治疗方案在中危－1组 MDS 患者中安全有效，而且其感染及血液学不良反应发生率低，耐受性好，提示可在临床进一步推广。

Objective The purpose of this study is to observe the clinical safety and efficacy of ultra small dose of decitabine in the treat-ment of patients with myelodysplastic syndrome（MDS）.Methods 19 patients with intermediate -risk -1 MDS were involved in this study,with 9 cases treated with decitabine,15 mg·m -2 ,intravenous drip 3 hours,once a week,three weeks a course and 10 cases treated with decitabine,7 mg·m -2 ,intravenous drip 3 hours,once a week,three weeks a course.The overall response rate （ORR）and the ad-verse effect rate of the two groups were recorded.Results After the treatment of decitabine,1 case achieved complete remission （CR）,7 cases achieved hematologic improvement （HI）,11 cases achieved stable disease （SD）,and ORR in all intermediate -risk -1 MDS pa-tients were 42%.The ORR in the group treated with decitabine at a dose of 15 mg·m -2 was 44% while the other group was 40%.There were no statistically significant differences between them （P 〉0.05）.Adverse events of infection and bleeding were mainly caused by decitabine in this study.Grade Ⅲ′to Ⅳ′hematological toxicities were observed in 19 cases,infection rates of two groups were 11% and 0% respectively,Grade Ⅲ′to Ⅳ′hematological toxicities were 44% and 10% respectively,and the average amount of transfused red blood cells and platelet were 2.2 U and 1.3 U respectively,while in the other group,the average amount of transfused red blood cells and plate-let were 0.2u and 0.2 U respectively.There were statistically significant differences （P 〈0.05）in terms of hematological toxicities and platelet transfusion.The hemogram indexes were all improved after the treatment of decitabine,and the hemoglobin were improved signifi-cantly （P 〈0.05）.Conclusions This study found that treating intermediate -risk -1 MDS with ultra small dose of decitabine was safe and effective,and it merits further promotion in clinic on account of the low rate of infection and hematological toxicities.