不同剂量地西他滨治疗骨髓增生异常综合征临床疗效观察

The clinical efficacy of different doses of decitabine to treat myelodysplastic syndrome

目的:探讨不同剂量地西他滨治疗骨髓增生异常综合征(MDS)的临床疗效。方法:地西他滨治疗中高危MDS患者29例,根据患者应用地西他滨剂量的不同,分为8 d方案组(12 mg·m^(-2)·d^(-1)×8 d,11例)和5d方案组(20 mg·m^(-2)·d^(-1)×5 d,18例),比较2组地西他滨的疗效及不良反应。结果:29例患者中完全缓解(CR)率为37.9%,总有效率(ORR)为62.1%。8 d方案组及5 d方案组CR率分别为45.5%和33.3%,ORR分别为72.7%和55.6%,2组比较均差异无统计学意义。地西他滨应用后,2组各疗程发生各级粒细胞及Ⅲ~Ⅳ级血红蛋白减少均差异无统计学意义,但8 d方案组各疗程发生各级血红蛋白及血小板减少均较5 d方案组轻(P<0.05),2组骨髓抑制期三系血细胞最低值差异无统计学意义。感染仍为骨髓抑制期主要并发症,其中40.0%的用药疗程中出现感染,肺部细菌感染占首位。结论:8 d方案和5 d方案均有较好的疗效,但8 d方案骨髓抑制程度轻,安全性更高。

Objective： To observe the clinical efficacy and safety of the patients with myelodysplastic syndrome（ MDS） treated with different doses of decitabine. Method： Twenty-nine patients with medium and high-risk MDS were evaluated,and were divided into 8-day program（ 12 mg·m^-2·d^-1× 8 d,n = 11） and 5-day program（ 20 mg·m^-2·d^-1× 5 d,n = 18） according to the doses of decitabine. We observed the efficacy and adverse events of the two groups.Result： Of all the patients,complete remission（ CR） rate was 37. 9%,and overall response rate（ ORR） was 62. 1%. The CR rate and ORR in the two groups were 45. 5% vs. 33. 3%,72. 7% vs. 55. 6% respectively,with no significant differences. All grades of granulocytopenia and III or IV grade of anemia in two groups showed no significant differences after decitabine treatment,while all grades of anemia and thrombocytopenia in 8-day program were less severe than those in 5-day program（ P〈0. 05）. There was no significant difference in the nadir of pancytopenia during bone marrow suppression. Infection was the main adverse event caused by decitabine and occurred in 40. 0% of treatment courses,with lung was the primary bacterial infection site. Conclusion： 8-day program and 5-day program are equally effective,but 8-day program is less myelosuppressive and more safe.