【摘要】 目的评价国产去甲氧基柔红霉素(IDA)治疗急性白血病的安全性和有效性。方法采用随机、对照、单盲、多中心的研究方法,入组患者155例,其中试验组77例,对照组78例。急性髓系(M3型除外)白血病(AML)采用IA方案,急性淋巴白血病(ALL)采用IVCP方案,试验组采用国产IDA,对照组采用善唯达。化疗前、后进行血常规、肝、肾功能、心肌酶等检查。结果有129例可评价疗效,155例可评价不良反应。试验组和对照组总有效率分别为78.1%(50/64)和76.9%(50/65),完全缓解率(CR)分别为68.8%(44/64)和67.7%(44/65);AML的有效率为82.4%(28/34)和71.8%(28/39),CR率为76.5%(26/34)和64.1%(25/39);对ALL的有效率为80.0%(20/25)和81.8%(18/22),CR率分别为68.0%(17/25)和68.2%(15/22),两组差异无统计学意义。两组患者的血液学和非血液学毒性反应差异无统计学意义。结论国产IDA治疗急性白血病的疗效和毒副作用与善唯达相当,是一种能够用于临床的、比较安全有效的药物。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of IDA (Haizheng Parmacy, China) in the treatment of acute leukemia. Methods A multi-institutional single-blind randomized controlled clinical trial was carried out. A total of 155 newly diagnosed patients with AML and ALL were enrolled. The patients were randomly divided into two groups, one was given IDA (n=77) and the other given zevodas (Pharnacia & Upjohn, n=78) for comparison. Results All the patients enrolled in this trial were eligible for assessment of side effects, and 129 patients for evaluation of overall response rate. In patients treated with IDA vs zevodas, the overall response rate (OR) was 78.1% vs 76.9%, CR was 68.8% vs 67.7%; in AML patients, OR was 82.4% vs 71.8%, and CR was 76.5% vs 64.1%; in ALL patients, OR was 80.0% vs 81.8%, and CR was 68.0% vs 68.2%. There was no sitatistically significant difference in hematologic and non-hematologic toxicities between the two groups. Conclusion The efficacy of IDA in the treatment of acute leukemia is comparable to that of zevodas. Both have similar toxic side effects.更多还原