低剂量地西他滨治疗中高危骨髓增生异常综合征患者38例疗效观察

Effect of low-dose decitabine on intermediate to high-risk myelodysplastic syndrome

目的探讨低剂量地西他滨治疗中高危骨髓增生异常综合征（myelodysplastic syndrome,MDS）患者的疗效及安全性。方法 38例中高危MDS患者,均在常规治疗基础上给予低剂量地西他滨25mg/d微量泵泵注,1h泵注完毕,第1～4或1～5或1～6天,每28d为1个周期。每周期治疗后评价疗效,记录不良反应发生情况,并随访观察患者生存情况。结果 38例共完成115个周期治疗,其中完成1个周期者9例,完成2个周期者12例,完成3个周期者5例,完成4个周期者5例,完成6个周期者3例,完成7个周期者3例,完成8个周期者1例;总有效率为73.68%,其中完全缓解10例,骨髓完全缓解6例,血液学改善12例;115个周期中,Ⅲ～Ⅳ度贫血发生率为37.39%（43/115）,Ⅲ～Ⅳ度中性粒细胞减少发生率为40.87%（47/115）,Ⅲ～Ⅳ度血小板减少发生率为40.00%（46/115）,Ⅲ～Ⅳ度感染发生率为13.91%（16/115）,Ⅲ～Ⅳ度出血发生率为1.74%（2/115）;骨髓抑制期内死亡3例（7.9%）,无因药物不良反应停药病例,治疗30d内无死亡患者;随访至2015年11月30日,3例失访,4例死亡,31例存活,中位生存期为14.3个月,1a累积生存率为52.1%。结论低剂量地西他滨治疗中高危MDS疗效满意,严重不良反应发生率低。

Objective To evaluate the effect and safety of low-dose decitabine in the treatment of intermediate to highrisk myelodysplastic syndrome（MDS）.Methods Thirty-eight patients with intermediate to high-risk MDS,on the basic of routine treatment,received continuous intravenous infusion of decitabine at a dose of 25mg/d for 1 hour,which was repeated by day 1 to 4,1 to 5 or 1 to 6,with 28 days as a cycle.The therapeutic effect was evaluated after treatment every cycle,the adverse reactions were recorded,and the survival was followed up.Results Thirty-eight patients completed a total of 115 cycles,in which 9patients completed 1 cycle,12 patients completed 2 cycles,5 patients completed 3 cycles,5 patients completed 4 cycles,3 patients completed 6 cycles,3 patients completed 7 cycles and 1 patient completed 8 cycles.The overall response rate was 73.68%.The responses included complete remission in 10 patients（26.32%）,marrow complete remission in 6 patients（15.79%）and hematologic improvement in 12 patients（31.57%）.In a total of 115 cycles,gradeⅢ to Ⅳanemia occurred in 43 cycles（37.39%）,gradeⅢtoⅣ neutropenia in 47 cycles（40.87%）,gradeⅢ to Ⅳthrombocytopenia in 46 cycles（40.00%）,gradeⅢ to Ⅳ infection in 16（13.91%）,and gradeⅢ to Ⅳ bleeding in 2（1.74%）.Three patients died in bone marrow suppression period（7.9%）.No drug withdrawal occurred due to adverse reaction.No patient died within 30 days.Till the last follow-up on November 11,2015,3 patients were lost,4 died,and 31 were still alive.The media overall survival time was 14.3 months.The one-year survival rate was 52.1%.Conclusion Low-dose decitabine is effective for intermediate to high-risk MDS,with low risk of severe adverse reactions.