康艾注射液联合FLAG方案治疗复发性、难治性急性髓性白血病的临床研究

Clinical study of Kangai injection plus FLAG regimen for refractory/relapsed acute leukemia

目的:康艾注射液联合FLAG方案治疗复发性、难治性急性髓性白血病的临床研究。方法:选取2004年至2010年病例49例,随机分组,分治疗组(康艾注射液+FLAG方案化疗)28例,对照组21例(FLAG化疗组)。结果:①2组总CR率%,治疗组57.1%(16/28),总有效率%(CR+PR)71.4%(21/28),对照组总CR率%52.3%(11/21),总有效率(CR+PR)61.9%(13/21)无显著差别。②血液系统骨髓抑制,治疗组中性粒细胞<0.5×109个/L,持续(14±6)d,而化疗组(23±3)d,血小板<25×109个/L持续天数,治疗组(17±6)d,而对照组(31±2)d,Ⅲ,Ⅳ度感染,治疗组1例(6.9%),对照组5例(23.8%),P<0.05有显著差别。③消化道毒性(Ⅲ,Ⅳ度)治疗组3例(10.7%),对照组6例(28.5%)。结论:康艾注射液配合FLAG方案能提高复发性、难治性急性髓性白血病的缓解率,缩短骨髓抑制期,明显降低感染的发生率及程度,起到明显的减毒增效作用。

Objective： To assess the efficacy and toxicity of the kangai injection combination of fludarabine（Flud）,cytosine arabinoside（Ara-C）,and granulocyte colony-stimulating factor（G-CSF）（FLAG） in refractory/relapsed acute leukemia（AL） patients.Method： From 2004 to 2010 in our hospital,the 49 cases of refractory/relapsed acute luekemia were randomly divided into treatment group（28 cases） and control group（21 cases）.The control group were treated by kangai injection plus FLAG regimen,and the control group were treated by FLAG regimen.Result： The remission rate of treatment and total effective rate treatment group were 57.1%（16/28）and 71.4%（21/28）,the control group were 52.3%（11/21）and 61.9%（13/21）,there were no significant differences in the two groups.Duration of neutrophils less than 0.5×10^9/L in treatment group was（14±6） day,control group was（23±3） day,Duration of platelet less than 25×10^9/L in treatment group was（17±6） day,control group was（31±2） day,treatment group of Ⅲ-Ⅳ degree of infection was 6.9%（1/28） and control group was 23.8%（5/21） between the two groups were significantly different（P〈0.05）.treatment group of Ⅲ-Ⅳ degree of gastrointestinal toxicity was 10.7%（3/28） and control group was 28.5%（6/21）.Conclusion： Kangai injection plus FLAG regimen could increase the remission rate,shorten the period of bone marrow suppression,significantly reduced the incidence and degree of infection,play a important role in attenuated efficiency.