不同去甲氧柔红霉素诱导治疗急性髓系白血病的临床观察

目的 比较国产和进口去甲氧柔红霉素（IDA）诱导治疗急性髓系白血病（AML）的疗效和患者不良反应.方法 47例初治AML（AML-M3除外）患者分为国产IDA组（17例）和进口IDA组（30例）.两组诱导治疗方案均为IDA每天10 mg/m2第1天至第3天,联合阿糖胞苷（Ara-C）每天150 mg/m2第1天至第7天,即标准IDA-A方案.观察诱导化疗1个疗程后的临床情况.结果 国产IDA和进口IDA两组完全缓解率分别为70.6％（12/17）和70.0％（21/30）,总有效率分别为88.2％（15/17）、80.0％（24/30）,差异无统计学意义（P=0.453）.两组在治疗过程中均发生严重骨髓抑制（Ⅳ级）,其中国产IDA组中性粒细胞缺乏及血小板计数＜20×109/L的持续时间分别为（11.64±5.47）d和（11.61±4.20）d,进口IDA组分别为（12.66±3.82）d和（12.97±5.29）d,两组差异无统计学意义（P＞0.05）.国产IDA组和进口IDA组感染发生率分别为64.7％（11/17）及76.7％（23/30）,总感染发生率及各类型感染的发生率差异均无统计学意义（均P＞ 0.05）.两组死亡各1例,原因分别是败血症（国产IDA组）和颅内出血（进口IDA组）.两组胃肠道不良反应发生率分别为17.6％（3/17）（国产IDA组）和13.3％（4/30）（进口IDA组）.进口IDA组有2例轻度肝损害,未出现心、肾损害表现.结论 国产IDA和进口IDA诱导治疗AML的疗效及不良反应相当.

Clinical comparison of two different idarubicin in inductive treatment for acute myeloid leukemia

Objective To compare the efficacy and toxicity of domestic and imported idarubicin （IDA） in the treatment of acute myeloid leukemia （AML）.Methods 47 initial AML cases （except AML-M3） were treated with the classic inductive treatment,which was IDA （10 mg·m-2·d-1,d1-d3） combined with cytarabine （Ara-C,150 mg·m-2·d-1,d1-d7）.The patients were divided into domestic IDA group （17 cases） and imported IDA group （30 cases）.The differences of clinical efficacy and toxicity between two groups were observed after inductive treatment for 1 course.Results The complete remission （CR） rates in domestic and imported IDA groups were 70.6 % （12/17） and 70.0 % （21/30）,respectively,and the total effective rates were 88.2 % （15/17） and 80.0 % （24/30）,respectively,there was no significant difference between two groups （P =0.453）.The severe bone marrow suppression during the inductive treatment was found in both groups,including agranulocytosis lasted （11.64±5.47） days and （12.66±3.82） days,respectively,and platelet 〈 20× 109/L lasted （11.61±4.20） days and （12.97±5.29） days,respectively.Infection rates in two groups were 64.7 % （11/17） and 76.7 % （23/30）,there is no statistical significance between two groups （P 〉 0.05）.There was one case dead of sepsis and intracranial hemorrhage in each groups,respectively.The rates of the gastrointestinal toxicity were 17.6 % （3/17） and 13.3 % （4/30）,respectively.2 liver dysfunction cases was observed in imported idarubicin group.There were no damages of heart and kidney for the chemotherapy drugs in both groups.Conclusion The efficacy and toxicity of domestic IDA is consistent with that of imported IDA in treatment of AML.