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Title: [A single-center, randomized controlled trial of PEG-rhG-CSF and common rhG-CSF to promote neutrophil recovery after induction chemotherapy in newly diagnosed acute myeloid leukemia].
Author: Liu KQ, Wang Y, Zhao Z, Lin D, Zhou CL, Liu BC, Gong XY, Zhao XL, Wei SN, Zhang GJ, Gong BF, Li Y, Liu YT, Mi YC, Wang JX, Wei H.
Journal: Zhonghua Xue Ye Xue Za Zhi; 2019 Jun 14; 40(6):497-501. PubMed ID: 31340623.
Abstract:
Objective: To compare the time of the recovery of neutrophils or leukocytes by pegylated recombinant human granulocyte stimulating factor (PEG-rhG-CSF) or common recombinant human granulocyte stimulating factor (rhG-CSF) in the myelosuppressive phase after induction chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients. At the same time, the incidences of infection and hospitalization were compared. Methods: A prospective randomized controlled trial was conducted in patients with newly diagnosed AML who met the enrollment criteria from August 2014 to December 2017. The patients were randomly divided into two groups according to a 1:1 ratio: PEG-rhG-CSF group and rhG-CSF group. The time of neutrophil or leukocyte recovery, infection rate and hospitalization interval were compared between the two groups. Results: 60 patients with newly diagnosed AML were enrolled: 30 patients in the PEG-rhG-CSF group and 30 patients in the rhG-CSF group. There were no significant differences in age, chemotherapy regimen, pre-chemotherapy ANC, WBC, and induction efficacy between the two groups (P>0.05) . The median time (range) of ANC or WBC recovery in patients with PEG-rhG-CSF and rhG-CSF were 19 (14-35) d and 19 (15-26) d, respectively, with no statistical difference (P=0.566) . The incidences of infection in the PEG-rhG-CSF group and the rhG-CSF group were 90.0%and 93.3%, respectively, and there was no statistical difference (P=1.000) . The median days of hospitalization (range) was 20.5 (17-49) days and 21 (19-43) days, respectively, with no statistical difference (P=0.530) . Conclusions: In AML patients after induction therapy, there was no significant difference between the application of PEG-rhG-CSF and daily rhG-CSF in ANC or WBC recovery time, infection incidence and hospitalization time. 目的： 比较初诊急性髓系白血病（AML）患者诱导化疗后骨髓抑制期应用聚乙二醇化重组人G-CSF（PEG-rhG-CSF）与普通重组人G-CSF（rhG-CSF）促进中性粒细胞或白细胞恢复的时间。同时比较两种药物对患者感染发生率、住院时间的影响。 方法： 采用前瞻性随机对照研究方法，将2014年8月至2017年12月间符合入组条件的初诊AML患者诱导治疗后按1∶1比例随机分成两组：PEG-rhG-CSF组和rhG-CSF组。对比分析两组患者中性粒细胞计数（ANC）或WBC恢复时间、感染发生率和住院时间。 结果： 共入组初诊AML患者60例，PEG-rhG-CSF组30例，rhG-CSF组30例。两组患者除性别构成外，在年龄、化疗方案、化疗前ANC、WBC、诱导化疗疗效方面差异均无统计学意义（P值均>0.05）。PEG-rhG-CSF组患者与rhG-CSF组患者的ANC、WBC恢复中位时间分别为19（14~35）d、19（15~26）d，差异无统计学意义（t=0.580，P=0.566）。PEG-rhG-CSF组、rhG-CSF组患者骨髓抑制期感染的发生率分别为90.0%、93.3%，差异无统计学意义（P=1.000）。两组患者的中位住院时间分别为20.5（17~49）d、21（19~43）d，差异无统计学意义（P=0.530）。 结论： AML患者诱导治疗后应用PEG-rhG-CSF与rhG-CSF无论在ANC或WBC恢复时间，还是在感染的发生率及住院时间均相当。.

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