Lee S M, Radford J A, Dobson L, Huq T, Ryder W D, Pettengell R, Morgenstern G R, Scarffe J H, Crowther D
CRC Department of Medical Oncology, Christie Hospital NHS Trust, Manchester, UK.
Br J Cancer. 1998 Apr;77(8):1294-9. doi: 10.1038/bjc.1998.216.
In order to evaluate the potential clinical and economic benefits of granulocyte colony-stimulating factor (G-CSF, filgrastim) following peripheral blood progenitor cells (PBPC) rescue after high-dose chemotherapy (HDCT), 23 consecutive patients aged less than 60 years with poor-prognosis, high-grade non-Hodgkin's lymphoma (NHL) were entered into a prospective randomized trial between May 1993 and September 1995. Patients were randomized to receive either PBPC alone (n = 12) or PBPC+G-CSF (n = 11) after HDCT with busulphan and cyclophosphamide. G-CSF (300 microg day[-1]) was given from day +5 until recovery of granulocyte count to greater than 1.0 x 10(9) l(-1) for 2 consecutive days. The mean time to achieve a granulocyte count > 0.5 x 10(9) l(-1) was significantly shorter in the G-CSF arm (9.7 vs 13.2 days; P<0.0001) as was the median duration of hospital stay (12 vs 15 days; P = 0.001). In addition the recovery periods (range 9-12 vs 11-17 days to achieve a count of 1.0 x 10(9) l[-1]) and hospital stays (range 11-14 vs 13-22 days) were significantly less variable in patients receiving G-CSF in whom the values clustered around the median. There were no statistically significant differences between the study arms in terms of days of fever, documented episodes of bacteraemia, antimicrobial drug usage and platelet/red cell transfusion requirements. Taking into account the costs of total occupied-bed days, drugs, growth factor usage and haematological support, the mean expenditure per inpatient stay was pound sterling 6500 (range pound sterling 5465-pound sterling 8101) in the G-CSF group compared with pound sterling 8316 (range pound sterling 5953-pound sterling 15,801) in the group not receiving G-CSF, with an observed mean saving of 1816 per patient (or 22% of the total cost) in the G-CSF group. This study suggests that after HDCT and PBPC rescue, the use of G-CSF leads to more rapid haematological recovery periods and is associated with a more predictable and shorter hospital stay. Furthermore, and despite the additional costs for G-CSF, these clinical benefits are not translated into increased health care expenditure.
为了评估大剂量化疗(HDCT)后外周血祖细胞(PBPC)解救后使用粒细胞集落刺激因子(G-CSF,非格司亭)的潜在临床和经济效益,1993年5月至1995年9月,23例年龄小于60岁、预后不良的高级别非霍奇金淋巴瘤(NHL)患者连续纳入一项前瞻性随机试验。患者在接受白消安和环磷酰胺的HDCT后,随机分为单独接受PBPC组(n = 12)或PBPC + G-CSF组(n = 11)。从第5天开始给予G-CSF(300μg/天),直至粒细胞计数连续2天恢复至大于1.0×10⁹/L⁻¹。G-CSF组达到粒细胞计数>0.5×10⁹/L⁻¹的平均时间显著缩短(9.7天对13.2天;P<0.0001),住院中位时间也显著缩短(12天对15天;P = 0.001)。此外,接受G-CSF的患者恢复期(达到计数1.0×10⁹/L⁻¹的时间范围为9 - 12天对11 - 17天)和住院时间(范围为11 - 14天对13 - 22天)的变异性显著更小,其数值集中在中位数附近。在发热天数、记录的菌血症发作次数、抗菌药物使用以及血小板/红细胞输注需求方面,研究组之间没有统计学显著差异。考虑到总占用床日、药物、生长因子使用和血液学支持的成本后,G-CSF组每位住院患者的平均支出为6500英镑(范围为5465英镑 - 8101英镑),而未接受G-CSF组为8316英镑(范围为5953英镑 - 15801英镑),G-CSF组观察到每位患者平均节省1816英镑(占总成本约22%)。本研究表明,HDCT和PBPC解救后,使用G-CSF可使血液学恢复期更快,且住院时间更可预测和缩短。此外,尽管G-CSF有额外成本,但这些临床益处并未转化为医疗保健支出的增加。