国产去甲氧柔红霉素和进口柔红霉素治疗急性白血病的疗效及安全性比较

摘要

目的 对比国产去甲氧柔红霉素( IDA)和进口柔红霉素(DNR)在急性白血病治疗中的的疗效和安全性.方法 68例急性白血病患者按随机数字表法分为IDA组35例和DNR组33例.IDA组35例患者中,急性髓细胞白血病用IA(国产IDA、阿糖胞苷)方案治疗,急性淋巴细胞白血病用VICLP(长春新碱、国产IDA、环磷酰胺、左旋门冬酰胺酶和泼尼松)方案治疗；同期DNR组33例患者中,急性髓细胞白血病用DA(进口DNR、阿糖胞苷)方案治疗,急性淋巴细胞白血病用VDCLP(长春新碱、进口DNR、环磷酰胺、左旋门冬酰胺酶和泼尼松)方案治疗.结果 IDA组完全缓解21例,部分缓解5例,总缓解率74.2％(26/35),DNR组完全缓解16例,部分缓解4例,总缓解率62.3 ％(20/33),两组总缓解率差异无统计学意义( x2=0.89,P=0.50)；IDA组缓解时间超过一年者占完全缓解患者的80％(17/21),而DNR组为37.5％(6/16),两组差异有统计学意义(x2=5.56,P=0.02).结论 国产IDA治疗急性白血病缓解率及长期缓解率均优于进口DNR,是疗效确切、安全可靠的抗白血病药物.%Objective To compare the effect and toxicity of domestic idarubicin (IDA) and imported daunorubicin (DNR) in the treatment of acute leukemia (AL).Methods According to the random number table method,68 patients were randomly divided in IDA group with 35 patients and DNR group with 33 patients.In IDA group,the patients with acute myelocytic leukemia were treated following IA scheme (domestic idataubicin plus cytosine arabinoside) and the patients with acute lymphoblastic leukemia were treated following VICLP scheme (vincristine,domestic idataubicin,cyclophosphamide,lasparaginase and prednisone).In DNR group,the patients with acute myelocytic leukemia were treated following DA scheme (imported daunorubicin plus cytosine arabinoside) and the patients with acute lymphoblastic leukemia were treated following VDCLP scheme (vincristine,imported daunorubicin,cyclophosphamide,lasparaginase and prednisone).Results In IDA group,21 patients achieved a complete remission(CR),5 patients achieved a partial remission(PR),with a 74.2 ％ (26/35) remission rate (RR).In DNR group,the remission rate was 62.3 ％ (20/33).No differences of the remission rate was found between the two groups (t =0.89,P =0.50).17 patients were found remission over one year in IDA group,and 6 patients were in DNR group.The difference was statistically significant between the two groups (x2 =5.56,P =0.02).Conclusion IDA is more effective than DNR in AL treatment.The higher RR and longer remission time are found in IDA group than DNR group.IDA is effective and safe in the treatment of AL.