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培非格司亭第 4 天与第 2 天给药预防化疗引起的白细胞减少症的随机比较。

Randomized comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia.

机构信息

Department of Oncology, Saarland University Medical School, Homburg, Germany.

出版信息

Ann Oncol. 2011 Aug;22(8):1872-7. doi: 10.1093/annonc/mdq674. Epub 2011 Feb 3.

DOI:10.1093/annonc/mdq674
PMID:21292644
Abstract

BACKGROUND

To study the effects of deferring pegfilgrastim until day 4 on the reduction of chemotherapy-induced leukocytopenia.

PATIENTS AND METHODS

Patients of age 61-80 years with aggressive lymphoma were randomly assigned to receive 6 mg pegfilgrastim on day 2 or 4 of a 2-week chemotherapy regimen (R-CHOP-14).

RESULTS

Two hundred and ninety-two and 313 chemotherapy cycles were evaluable in 103 patients. Post-nadir pegfilgrastim serum levels were higher after day 4 than after day 2 application. This was associated with an attenuated leukocyte nadir after day 4 pegfilgrastim and there were fewer days with leukocytes <2 × 10(3)/mm(3) compared with day 2 pegfilgrastim. Grade 3 and 4 leukocytopenias (70% versus 43.3%; P < 0.001) and grade 4-only leukocytopenias (47% versus 20.5%; P < 0.001) were more frequent after day 2 pegfilgrastim. There were more chemotherapy cycles with grade 3 and 4 infections after day 2 than day 4 pegfilgrastim (9.4% versus 6.0%; P = 0.118). Interventional antibiotics were given more often after day 2 than after day 4 pegfilgrastim (30.7% versus 21.9% of cycles; P = 0.008). There were five deaths during leukocytopenia after day 2 and none after day 4 pegfilgrastim (P = 0.027).

CONCLUSIONS

Administration of pegfilgrastim on day 4 was more effective in reducing severe leukocytopenias and resulted in fewer deaths during leukocytopenia. Pegfilgrastim should be given on day 4 to better exploit its myeloprotective potential.

摘要

背景

研究延迟培非格司亭至第 4 天对减少化疗引起的白细胞减少症的影响。

患者和方法

年龄在 61-80 岁之间的侵袭性淋巴瘤患者被随机分配接受 6mg 培非格司亭在两周化疗方案(R-CHOP-14)的第 2 天或第 4 天。

结果

103 例患者中有 292 和 313 个化疗周期可评估。第 4 天培非格司亭后血清水平较第 2 天更高。这与第 4 天培非格司亭后白细胞减少的峰值较低有关,并且与第 2 天培非格司亭相比,白细胞<2×10(3)/mm(3)的天数更少。第 2 天培非格司亭组(70%比 43.3%;P<0.001)和第 4 天培非格司亭组(47%比 20.5%;P<0.001)更常见 3 级和 4 级白细胞减少症,仅 4 级白细胞减少症更常见。第 2 天培非格司亭组比第 4 天培非格司亭组更频繁地发生 3 级和 4 级感染的化疗周期(9.4%比 6.0%;P=0.118)。第 2 天培非格司亭组比第 4 天培非格司亭组更常使用介入性抗生素(30.7%比 21.9%的周期;P=0.008)。第 2 天培非格司亭后白细胞减少症期间有 5 例死亡,第 4 天培非格司亭后无死亡(P=0.027)。

结论

第 4 天给予培非格司亭更有效降低严重白细胞减少症,并且在白细胞减少症期间导致更少的死亡。培非格司亭应在第 4 天给予,以更好地利用其骨髓保护潜力。

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