Teramura Masanao, Kimura Akiro, Iwase Satsuki, Yonemura Yuji, Nakao Shinji, Urabe Akio, Omine Mitsuhiro, Mizoguchi Hideaki
Department of Hematology, Tokyo Women's Medical University, Tokyo.
Blood. 2007 Sep 15;110(6):1756-61. doi: 10.1182/blood-2006-11-050526. Epub 2007 May 25.
We report the results of a randomized study to elucidate whether addition of granulocyte colony-stimulating factor (G-CSF) to immunosuppressive therapy is valuable for the treatment of severe aplastic anemia (SAA) in adults. A total of 101 previously untreated patients (median age, 54 years; range, 19 to 75 years) were randomized to receive antithymocyte globulin (ATG) and cyclosporin A (CyA) (G-CSF- group) or ATG, CyA, and G-CSF (G-CSF+ group). In the G-CSF+ group, the hematologic response rate at 6 months was higher (77% vs 57%; P = .03) than in the G-CSF- group. No differences were observed between the groups in terms of the incidence of infections and febrile episodes. There were no differences between the G-CSF- group and the G-CSF+ group in terms of survival (88% vs 94% at 4 years), and the development of myelodysplastic syndrome (MDS)/acute leukemia (AL) (1 patient vs 2 patients). However, the relapse rate was lower in the G-CSF+ group compared with the G-CSF- group (42% vs 15% at 4 years; P = .01). Further follow-up is required to elucidate the role of G-CSF in immunosuppressive therapy for adult SAA.
我们报告了一项随机研究的结果，以阐明在免疫抑制治疗中添加粒细胞集落刺激因子（G-CSF）对治疗成人重型再生障碍性贫血（SAA）是否有价值。总共101例既往未接受治疗的患者（中位年龄54岁；范围19至75岁）被随机分为接受抗胸腺细胞球蛋白（ATG）和环孢素A（CyA）治疗（G-CSF-组）或接受ATG、CyA和G-CSF治疗（G-CSF+组）。在G-CSF+组中，6个月时的血液学缓解率高于G-CSF-组（77%对57%；P = 0.03）。两组在感染和发热发作发生率方面未观察到差异。G-CSF-组和G-CSF+组在生存率（4年时分别为88%和94%）以及骨髓增生异常综合征（MDS）/急性白血病（AL）的发生情况（分别为1例和2例）方面没有差异。然而，G-CSF+组的复发率低于G-CSF-组（4年时分别为42%和15%；P = 0.01）。需要进一步随访以阐明G-CSF在成人SAA免疫抑制治疗中的作用。
