COMPARATIVE STUDIES OF GRANULOCYTE COLONY-STIMULATING FACTOR AND DEXAMETHASONE, A

粒细胞集落刺激因子与地塞米松的比较研究

基本信息

  • 批准号:
    6289448
  • 负责人:
  • 金额:
    --
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
  • 资助国家:
    美国
  • 起止时间:
  • 项目状态:
    未结题

项目摘要

The efficacy of therapeutic granulocyte transfusions is limited by the rela-tively small number of cells obtained using standard apheresis techniques. To define a mobilization schedule that maximizes cell yields while minimizing donor discomfort, we studied three donor mobilization schedules. Donors received either dexamethasone (dexa) 8 mg orally 12 hours prior to donation, granulocyte colony-stimulating factor (G-CSF) 5 mg/kg SQ 16-24 hrs prior to apheresis, or dexa plus G- CSF (D+G) in the same doses. Seven liters of whole blood were processed on the CS-3000 Plus device using Hetastarch as the sedimenting agent. Administration of G-CSF alone or the combination of dexa plus G-CSF resulted in 2.3- and 3.5-fold increases in granulocyte content in the product compared to dexa alone (from 2.09 + 0.68 with dexa alone to 4.87 + 1.02 and 7.31 + 1.56 x10 to the 10th power cells total with G- CSF and D+G, respectively) (p<0.01 for dexa vs. G-CSF alone or D+G). Addition of dexa to G-CSF resulted in a 49 percent increase in product granulocyte content compared to G-CSF alone. 72 percent of donors getting D+G had had bone pain, headache, insomnia, or fatigue. Ten percent of donors requested discontinuation of participation in the study due to the inconvenience and discomfort of the mobilization regimen. Thirty Clinical Center patients have received G-CSF mobilized granulocytes. Twenty were profoundly neutropenic, including eight patients with severe aplastic anemia, six stem cell transplant recipients, five patients with lymphoma, and one with breast cancer. The remaining ten patients had chronic granulomatous disease (CGD). In the neutropenic patients, 12 had systemic filamentous fungal infections, one had candidemia, six had bac-terial infections, and one had RSV. The mean increment in granulocyte count one hour posttransfusion was 2600/mL, and counts above 500/mL were sustained for 12 to 24 hours. Of the patients with tissue molds, seven of 12 stabilized or improved during granulocyte transfusion therapy, but only one of 12 survived hospitalization. In contrast, 3 of 6 with bacterial processes were discharged from hospital. Of ten patients with CGD, nine had complete resolution of their fungal (n=5) or bacterial (n=5) infections; the one patient who expired had extensive tissue mold. These pilot studies of G-CSF mobilized granulocytes suggest that they may confer survival benefit in carefully selected neutropenic patients with life-threatening infections. A randomized prospective study of the efficacy of G-CSF mobilized granulocyte transfusions in patients with severe aplastic anemia hospitalized at the Clinical Center is being designed to answer this question.
治疗性粒细胞输注的疗效受到使用标准单采技术获得的细胞数量相对较少的限制。为了定义一个动员时间表,最大限度地提高细胞产量,同时尽量减少供体的不适,我们研究了三个供体动员时间表。供体在捐献前12小时口服地塞米松(dexa)8 mg,在单采前16-24小时接受粒细胞集落刺激因子(G-CSF)5 mg/kg SQ,或以相同剂量接受dexa加G-CSF(D+G)。使用羟乙基淀粉作为沉淀剂,在CS-3000 Plus装置上处理7升全血。与单独使用dexa相比,单独使用G-CSF或dexa + G-CSF的联合给药导致产品中粒细胞含量增加2.3倍和3.5倍(从单独使用dexa的2.09 ± 0.68到使用G-CSF和D+G的4.87 ± 1.02和7.31 ± 1.56 × 10 ~(10)次幂细胞总数,(对于dexa相对于单独的G-CSF或D+G,p<0.01)。与单独使用G-CSF相比,向G-CSF中添加dexa导致产物粒细胞含量增加49%。72%的D+G捐赠者有骨痛,头痛,失眠或疲劳。10%的供体由于动员方案的不便和不适而要求停止参与研究。30例临床中心患者接受了G-CSF动员的粒细胞。其中20例患者严重贫血,包括8例重度再生障碍性贫血患者、6例干细胞移植患者、5例淋巴瘤患者和1例乳腺癌患者。其余10例患者患有慢性肉芽肿病(CGD)。在中性粒细胞减少症患者中,12例患有全身性丝状真菌感染,1例患有念珠菌血症,6例患有细菌感染,1例患有RSV。输血后1小时粒细胞计数平均增加2600/mL,计数高于500/mL持续12至24小时。在患有组织霉菌的患者中,12例中有7例在粒细胞输注治疗期间稳定或改善,但12例中只有1例存活住院。相比之下,6例细菌性过程中有3例出院。在10例CGD患者中,9例真菌(n=5)或细菌(n=5)感染完全消退; 1例死亡患者有广泛的组织霉菌。这些G-CSF动员的粒细胞的初步研究表明,他们可能会赋予精心挑选的危及生命的感染的血小板减少症患者的生存益处。正在设计一项关于G-CSF动员的粒细胞输注在临床中心住院的重度再生障碍性贫血患者中的疗效的随机前瞻性研究来回答这个问题。

项目成果

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SUSAN F LEITMAN-KLINMAN其他文献

SUSAN F LEITMAN-KLINMAN的其他文献

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{{ truncateString('SUSAN F LEITMAN-KLINMAN', 18)}}的其他基金

Acquisition of Hematopoietic Stem Cells for Second Transplants by Apheresis of Fi
通过 Fi 血浆分离术获取用于第二次移植的造血干细胞
  • 批准号:
    6103656
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
PROPHYLACTIC CALCIUM ADMINISTRATION IN PLATELETPHERESIS
血小板去除术中的预防性补钙
  • 批准号:
    6414317
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Ther of Von Willebrand Disease w/Single-donor Cryoprecipitate Collected by Apher
Apher 收集的冯·维勒布兰德病与单一供体冷沉淀物
  • 批准号:
    6431830
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Faciliation of Peripheral Blood Stem Cell Transplants by Nat
Nat 促进外周血干细胞移植
  • 批准号:
    6431823
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Kinetic Studies Of Indium-labeled Leukocytes
铟标记白细胞的动力学研究
  • 批准号:
    6546520
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Therapeutic Efficacy Of Granulocyte Colony-stimulating F
粒细胞集落刺激F的治疗效果
  • 批准号:
    6683842
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Citrate Effects and Bone Density Changes in Serial Long-
连续长期的柠檬酸盐效应和骨密度变化
  • 批准号:
    7332515
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Peripheral Blood Stem Cell Collections From NMDP Donors
来自 NMDP 捐赠者的外周血干细胞采集
  • 批准号:
    7331982
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Iron Replacement in Blood Donors
献血者的铁替代
  • 批准号:
    7593051
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
KINETIC STUDIES OF INDIUM-LABELED LEUKOCYTES
铟标记白细胞的动力学研究
  • 批准号:
    6289435
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:

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