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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: Kangai injection combined with FLAG regimen in the treatment of recurrent and refractory acute myeloid leukemia clinical study. Methods: Forty - nine cases from 2004 to 2010 were randomly divided into treatment group (Kangai injection + FLAG chemotherapy) and control group (FLAG chemotherapy group). Results: ① The total CR rate in the two groups was 57.1% (16/28) in the treatment group, 71.4% (21/28) in the total effective rate (CR + PR) and 52.3% (11/21) in the control group The total effective rate (CR + PR) 61.9% (13/21) no significant difference. ② Hematopoietic myelosuppression, the treatment group neutrophils <0.5 × 109 / L, continuous (14 ± 6) d, while the chemotherapy group (23 ± 3) d, platelets <25 × 109 / L lasted days, treatment (17 ± 6) d, while the control group (31 ± 2) d, Ⅲ and Ⅳ degrees of infection, the treatment group 1 case (6.9%), the control group 5 cases (23.8%), P <0.05 significant difference. ③ gastrointestinal toxicity (Ⅲ, Ⅳ degrees) in the treatment group, 3 cases (10.7%), control group, 6 cases (28.5%). CONCLUSION: Kangai injection combined with FLAG regimen can improve the remission rate of refractory acute myeloid leukemia, shorten the period of myelosuppression, significantly reduce the incidence and extent of infection and play a significant attenuating and synergistic effect.