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目的:研究小剂量阿糖胞苷(Ara-c)联合亚砷酸序贯沙利度胺治疗高危骨髓增生异常综合征(MDS)的临床疗效及安全性。方法:应用小剂量阿糖胞苷联合亚砷酸诱导治疗39例国际预后积分系统(IPSS)评分为高危(中危Ⅱ组及高危组MDS)患者,经过中位3(2～5)个疗程后评估疗效,有效者序贯以沙利度胺维持治疗中位13.5(8.0～18.0)个月。结果:完全缓解(CR)者16例,部分缓解(PR)者9例,血液学改善(HI)者8例,未缓解(NR)者6例;总有效率为87.12%,CR率为43.93%。疗效维持中位时间为12.5(6.0～16.0)个月,其中有11例患者转为急性髓系白血病,中位转白时间为12.5(8.0～18.0)个月,12例患者复发,复发率为37.7%,共有30例死亡,1年总生存率为42.2%,2年总生存率为26.6%。主要不良反应为骨髓抑制;中危Ⅱ组与高危组有效率、疗效维持时间、2年总体生存率差异无统计学意义(P>0.05),中危Ⅱ组CR率,中位转白时间优于高危组(P<0.01)。结论:结论小剂量阿糖胞苷联合亚砷酸,并序贯沙利度胺治疗高危MDS安全有效,中危Ⅱ组患者有较好的疗效,有更好的生存获益。
Objective: To study the clinical efficacy and safety of low-dose cytarabine (Ara-c) and sequential alysis of thalidomide in the treatment of high-risk myelodysplastic syndrome (MDS). Methods: Thirty-nine patients with IPSS score at high risk (intermediate risk group Ⅱ and high risk group) underwent induction therapy with low dose of cytarabine and arsenious acid. After a median of 3 (2 ~ 5) courses Post-evaluation of the curative effect, the effective person was followed by thalidomide maintenance treatment median 13.5 (8.0 ~ 18.0) months. Results: There were 16 patients with complete remission (CR), 9 patients with partial remission (PR), 8 patients with hematological improvement (HI) and 6 patients without remission (NR). The total effective rate was 87.12% and the CR rate was 43.93 %. The median duration of treatment was 12.5 (6.0 ~ 16.0) months, of which 11 patients were converted to acute myeloid leukemia with a median transit time of 12.5 (8.0 ~ 18.0) months. The recurrence rate was 37.7%, a total of 30 deaths, one-year overall survival was 42.2%, 2-year overall survival rate was 26.6%. The main adverse reactions were myelosuppression. There was no significant difference in the effective rate, the duration of curative effect and the 2-year overall survival rate between the moderate-risk group and the high-risk group (P> 0.05). The CR rate and median transit time At high risk group (P <0.01). Conclusions: Conclusions Small dose of cytarabine combined with arsenious acid and sequential thalidomide is safe and effective in the treatment of high-risk MDS. Patients in intermediate risk group Ⅱ have better curative effect and better survival benefit.