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一项比较非格司亭、来格司亭和莫拉司亭联合化疗用于外周血祖细胞动员的随机研究。

A randomized study comparing filgrastim versus lenograstim versus molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization.

作者信息

Kopf B, De Giorgi U, Vertogen B, Monti G, Molinari A, Turci D, Dazzi C, Leoni M, Tienghi A, Cariello A, Argnani M, Frassineti L, Scarpi E, Rosti G, Marangolo M

机构信息

Department of Oncology and Hematology, Istituto Oncologico Romagnolo, Santa Maria delle Croci Hospital, Ravenna, Italy.

出版信息

Bone Marrow Transplant. 2006 Sep;38(6):407-12. doi: 10.1038/sj.bmt.1705465.

Abstract

We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or lenograstim or molgramostim at 5 microg/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1-3) was performed. The median number of CD34+ cells obtained after mobilization was 8.4 x 10(6)/kg in the filgrastim arm versus 5.8 x 10(6)/kg in the lenograstim arm versus 4.0 x 10(6)/kg in the molgramostim arm (P=0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of lenograstim (12 days) versus filgrastim (13 days) and molgramostim (14 days) (P<0.0001) and for the subgroup of chemonaive patients (12 days) versus pretreated patients (14 days) (P<0.001). In conclusion, all three growth factors were efficacious in mobilizing peripheral blood progenitor cells with no statistically significant difference between CD34+ cell yield and the different regimens, and the time to apheresis is likely confounded by the different mobilization regimens.

摘要

我们开展了一项前瞻性随机临床试验,以评估在特定疾病化疗方案后使用非格司亭、来格司亭和莫拉司亭的动员效果。动员方案包括45例(44%)患者使用高剂量环磷酰胺,22例(21%)患者使用顺铂/异环磷酰胺/依托泊苷或长春碱,随后随机分为接受5μg/kg/天的非格司亭、来格司亭或莫拉司亭治疗。103例患者被随机分组,82例(79%)进行了单采术。44例(43%)患者未接受过化疗,而59例(57%)患者接受过预处理。每位患者进行单采术的中位数为1次(范围为1 - 3次)。动员后获得的CD34+细胞中位数在非格司亭组为8.4×10⁶/kg,来格司亭组为5.8×10⁶/kg,莫拉司亭组为4.0×10⁶/kg(P = 0.1)。在生长因子给药天数中位数方面观察到统计学显著差异,来格司亭组(12天)优于非格司亭组(13天)和莫拉司亭组(14天)(P<0.0001),在未接受过化疗的患者亚组(12天)与接受过预处理的患者亚组(14天)之间也存在统计学显著差异(P<0.001)。总之,所有三种生长因子在动员外周血祖细胞方面均有效,不同方案之间CD34+细胞产量无统计学显著差异,单采术时间可能因不同的动员方案而受到混淆。

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