三氧化二砷与HAG方案治疗骨髓增生异常综合征的对比研究

Comparision of between arsenic trioxide and HAG regimen in the treatment of myelodysplastic syndrome

目的 HAG方案是目前治疗骨髓增生异常综合征难治性贫血伴原始细胞增多(MDS-RAEB)的重要化疗方案之一,但不良反应仍较大。本研究的目的是比较三氧化二砷与HAG治疗MDS-RAEB的近期疗效和不良反应。方法将40例骨髓增生异常综合征患者随机分成A组(预激方案20例)和B组(三氧化二砷20例),化疗2～3个周期,评价疗效。结果 A组有效率70.0%,B组有效率80.0%,两组比较,差异无统计学意义(P>0.05);A组≥Ⅱ级感染的发生率为43.8%,≥Ⅱ级出血(需予局部压迫、药物止血或血小板输注等相应处理)的发生率为37.5%;B组≥Ⅱ级感染发生率为9.09%及≥Ⅱ级出血率为12.1%,两组比较,差异有统计学意义(P<0.05)。结论三氧化二砷与HAG方案治疗MDS-RAEB疗效相近,三氧化二砷治疗的不良反应轻,值得推荐。

Objective HAG regimen（Homoharringtonine and Low-dose Cytosine Arabinoside Combined with G-CSF or GM-CSF）is an important regimen for refractory anemia with excess blasts of myelodysplastic syndrome（MDS-RAEB）,but the side effect is severe.This study aims to compare the short-term efficiency,toxicity and side effect between arsenic trioxide and HAG regimen in the treatment of MDS-RAEB.Methods All patients were randomly divided into two groups： A group and B group.20 cases in A group：were treated with HAG regimen for remission induction and consolidation therapy.20 cases in B group were Arsenic trioxide was administered 10 mg/d,intravenous infusion,14 times per month,2~3 weeks interval for a course of treatment.Results Response rates were 70.0%（group A）and 80.0%（group B）.The response rate between two groups were not statistical difference（P0.05）.The incidences of infection which exceed grade Ⅱ were 43.8%（group A） and 9.09 %（group B）,and the incidences of hemorrhage which exceed grade Ⅱwere 37.5%（group A）,and 12.1%（group B）,with statistical difference between the two groups（P0.05）.Conclusion The therapeutic efficiency of arsenic trioxide was similarly to that of HAG regimen and side-effect of arsenic trioxide were milder than that of HAG regimen.