McQuaker I G, Hunter A E, Pacey S, Haynes A P, Iqbal A, Russell N H
Department of Haematology, University of Nottingham, United Kingdom.
J Clin Oncol. 1997 Feb;15(2):451-7. doi: 10.1200/JCO.1997.15.2.451.
To assess the clinical and economic benefit of low-dose (50 microg/m2) filgrastim after peripheral blood stem-cell transplantation (PBSCT) in a randomized, placebo-controlled double-blinded study.
Thirty-eight patients with lymphoproliferative disorders were randomized to receive low-dose filgrastim (19 patients) or placebo (19 patients) beginning on the first day after stem-cell reinfusion and continuing until absolute neutrophil count (ANC) was greater than 0.5 x 10(9)/L. All patients received greater than 2.5 x 10(6) CD34+ cells/kg, which was mobilized with chemotherapy and filgrastim 300 microg from the fifth day. An economic analysis was performed based on the outcome in the two groups.
Neutrophil engraftment was significantly more rapid in patients who received filgrastim with a median number of days until ANC was greater that 0.5 x 10(9)/L of 10 (9 to 13) versus 14 (9 to 19; P < .0001). The time to reach an ANC greater than 1 x 109/L was 12 (9 to 14) versus 16 days (10 to 25; P < .0001). The total number of patients who required intravenous antibiotic therapy was lower in the filgrastim-treated group (68%) compared with the placebo group (89%); also, the median number of days with fever and the duration of antibiotic therapy were shorter, although these differences did not reach statistical significance. However, although only three of 19 (16%) patients who received filgrastim required amphotericin, 11 of 19 (58%) who received placebo did require it, and amphotericin usage was significantly less in the filgrastim group (P = .029). Finally, in-patient stay was significantly shortened in those who received filgrastim from 16 (13 to 23) to 13 days (11 to 18; P = .0003).
Low-dose filgrastim significantly reduces neutrophil engraftment time post-PBSCT and also reduces in-patient stay and costs, which makes it economically viable for patients who are undergoing high-dose chemotherapy.
在一项随机、安慰剂对照双盲研究中，评估外周血干细胞移植（PBSCT）后低剂量（50微克/平方米）非格司亭的临床和经济效益。
38例淋巴增生性疾病患者被随机分为两组，分别在干细胞回输后的第一天开始接受低剂量非格司亭治疗（19例患者）或安慰剂治疗（19例患者），持续至绝对中性粒细胞计数（ANC）大于0.5×10⁹/L。所有患者接受的CD34⁺细胞均大于2.5×10⁶/kg，这些细胞通过化疗和从第五天开始使用的300微克非格司亭进行动员。基于两组的结果进行了经济分析。
接受非格司亭治疗的患者中性粒细胞植入明显更快，ANC大于0.5×10⁹/L的中位天数为10天（9至13天），而接受安慰剂治疗的患者为14天（9至19天；P <.0001）。达到ANC大于1×10⁹/L的时间分别为12天（9至14天）和16天（10至25天；P <.0001）。接受非格司亭治疗的组中需要静脉使用抗生素治疗的患者总数低于安慰剂组（68%对比于89%）；此外，发热的中位天数和抗生素治疗的持续时间在非格司亭治疗组较短，尽管这些差异未达到统计学意义。然而，虽然接受非格司亭治疗的19例患者中只有3例（16%）需要使用两性霉素，但接受安慰剂治疗的19例患者中有11例（58%）需要使用，非格司亭组两性霉素的使用明显较少（P =.029）。最后，接受非格司亭治疗的患者住院时间从16天（13至23天）显著缩短至13天（11至18天；P =.0003）。
低剂量非格司亭显著缩短了PBSCT后中性粒细胞植入时间，还缩短了住院时间并降低了成本，这使其对于接受高剂量化疗的患者在经济上可行。
