患者的药物动力学和药效学plerixafor非霍奇金淋巴瘤和多发性骨髓瘤。
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斯图尔特·史密斯C, MacFarland R, Calandra G
患者的药物动力学和药效学plerixafor非霍奇金淋巴瘤和多发性骨髓瘤。
杂志的血液骨髓移植。2009年1月,15 (1):39-46。doi: 10.1016 / j.bbmt.2008.10.018。
- PubMed ID
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19135941 (在PubMed]
- 文摘
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期药代动力学(PK)和药效学(PD)在健康志愿者的研究表明plerixafor (AMD3100)趋化因子受体CXCR4拮抗剂,管理独自或者与粒细胞集落刺激因子(g - csf),导致剂量依赖性动员外周血CD34(+)细胞。本研究的目的是评估的安全性和PK和PD患者与g - csf plerixafor非霍奇金淋巴瘤(NHL)和多发性骨髓瘤(MM)。这是第二阶段,非盲、单臂2中心的研究在加拿大。患者年龄在18岁到70岁NHL或毫米资格获得自体移植是合格的。共有22名患者与NHL和14毫米(8)参加这项研究。病人有g - csf (10 microg /公斤/天皮下注射(南))4天早上plerixafor 240 microg /公斤南卡罗来纳州apheresis每天晚上。Apheresis发起10到11个小时后每天晚上剂量的plerixafor后,g - csf的早晨剂量。这个方案是重复5天或直到> = 5 x 10 (6) CD34(+)细胞收集/公斤。目标是确定的安全性和有效性plerixafor NHL患者和MM, PK和PD的单240 - microg /公斤剂量plerixafor管理经过4天的g - csf动员这些病人。中值绝对外周血CD34(+)细胞计数增加从24.0细胞/ microL plerixafor之前政府75.0 / microL之前第一个apheresis(10到11个小时治疗后plerixafor)。 The median number of CD34(+) cells collected in a median of 1 day was 5.7 x 10(6) cells/kg in the patients with NHL and 12.0 x 10(6) cells/kg in those with MM. All patients underwent transplantation with prompt and durable engraftment. The PK profile of plerixafor was characterized in 13 patients (5 with NHL and 8 with MM). Overall, the PK parameters were comparable in the patients with NHL and those with MM. Plerixafor was rapidly absorbed after s.c. administration with no observable lag time, with peak plasma concentrations occurring 0.5 hour after administration in most patients. Plerixafor was rapidly cleared, with a median terminal half-life of 4.6 hours. The median maximum increase in the number of circulating cells from baseline was 4.2-fold (range, 3.0- to 5.5-fold), with the maximum fold increase occurring approximately 10 hours after plerixafor injection for all patients. The plerixafor PK and PD profiles in the study patients were consistent with those in healthy volunteers and support the current dosing regimen and timing of apheresis. Plerixafor was safe and effective in mobilizing CD34(+) cells for transplantation.
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- 药物