Effect of Lenograstim (Glycosylated Recombinant Human Granulocyte-colony Stimulating Factor) on Peripheral Blood Stem Cell Mobilization in Healthy Volunteers

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  • レノグラスチム（顆粒球コロニー刺激因子）の健常人を対象とした末梢血幹細胞動員効果の検討

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The efficacy and safety of high-dose lenograstim on CD34 positive (CD34+) cell mobilization into peripheral blood were investigated in 18 healthy male volunteers. The volunteers were divided into 3 lenograstim dose groups of 6 subjects each. Lenograstim was administered at a dose of 2, 5, or 10 μg/kg/day, b.i.d. by subcutaneous injection for a total of 5 days. The median peak number of CD34+ cells/μl of blood was 16.3, 53.9, and 96.6 in the 2, 5, and 10 μg/kg/day groups, respectively. A positive correlation was observed between the peak CD34+ level and dose of lenograstim (P=0.002). The percentage of volunteers achieving more than 50 CD34+ cells/μl of blood was significantly higher in the 10 μg/kg/day group (83.3%, P=0.010) than in the 2 μg/kg/day group (0%). On the subject of safety, at least 1 adverse drug reaction (ADR) was observed in each of the volunteers, and a total of 12, 33, and 45 ADRs were observed in the 2, 5, and 10 μg/kg/day groups, respectively. A dose-dependent increase in the number of ADRs was also observed, including an elevation of LDH (P<0.001), bone pain (P<0.001), and fatigue (P=0.008). However, no volunteers required symptomatic treatment or discontinuation of lenograstim. We concluded that administration of lenograstim at a dose of 10 μg/kg/day for 5 days is highly effective for CD34+ cell mobilization into peripheral blood and tolerable in healthy volunteers.

Journal

  • Rinsho Ketsueki

    Rinsho Ketsueki 41 (3), 198-205, 2000

    The Japanese Society of Hematology

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