Objective: To explore the efficacy and safety of polyethylene glycal recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patiens with breast cancer. Methods: There were two parts in the present phase Ⅳ clinical study. One was a randomized, controlled clinical study. Patients in this study received PEG-rhG-CSF or rhG-CSF in the first cycle and followed with both PEG-rhG-CSF in the rest of 3 cycles. The other one was a single arm study. Patients who developed Ⅲ/Ⅳ grade neutropenia in the screening cycle received PEG-rhG-CSF in the rest of 3 cycles chemotherapy. Results: In the first cycle of randomized, controlled study, the incidence of Ⅳ grade neutropenia are 31.48% and 35.58% respectively in PEG-rhG-CSF and rhG-CSF group, with no statistically significant differences (P=0.527 6). The duration of Ⅳ grade neutropenia respectively are 2.22±1.58 and 3.00±1.59 days, with a statistically significant difference (P=0.016 6). In the single arm study, the incidence of Ⅳ grade neutropenia was 57.76% in screening cycle. And the incidence decreased to 16.35%, 10%, and 8.57% in the followed 3 cycle after the use of PEG-rhG-CSF. The incidence of adverse effects was 5.06%, and the major adverse effect was bone pain which with an incidence of 2.8%. Conclusion: The fixed 6mg dose of PEG-rhG-CSF can effectively prevent neutropenia in patients with breast cancer in multicycle chemotherapy and it has a low incidence of adverse events and mild adverse reaction.
目的： 评价聚乙二醇化重组人粒细胞刺激因子(PEG－rhG－CSF)预防乳腺癌患者化疗后发生中性粒细胞减少症的有效性和安全性。 方法： 本研究为多中心、开放、前瞻性的Ⅳ期临床研究，包括两部分内容。第一部分为随机对照研究，第1个周期试验组预防性使用受试药物PEG－rhG－CSF，对照组预防性使用对照药物重组人粒细胞刺激因子(rhG－CSF)，之后3个周期两组均使用PEG－rhG－CSF。第二部分为单臂研究，第1个化疗周期出现Ⅲ/Ⅳ度中性粒细胞减少的患者，在后续的每个化疗周期均使用PEG－rhG－CSF。 结果： 随机对照研究中试验组和对照组第1周期中Ⅳ度中性粒细胞(ANC)减少症的发生率分别为31.48%和35.58%，PEG－rhG－CSF与rhG－CSF疗效相当(P＝0.527 6)。试验组和对照组第1个化疗周期Ⅳ度ANC减少症的持续时间为(2.22±1.58)d和(3.00±1.59)d，两组差异有统计学意义(P＝0.016 6)，PEG－rhG－CSF优于rhG－CSF。单臂研究中，患者在筛选期Ⅳ度ANC的发生率为57.76%，使用PEG－rhG－CSF后第1～3化疗周期Ⅳ度ANC的发生率分别为16.35%、10.00%、8.57%。筛选周期FN发生率为7.45%，使用PEG－rhG－CSF后第1～3化疗周期FN的发生率分别为1.27%、0.24%、0.29%。本研究共有30例PEG－rhG－CSF药物受试者发生不良反应，发生率为5.06%。最常见的不良反应为骨痛，发生率为2.8%。 结论： 固定剂量PEG－rhG－CSF可以有效的预防乳腺癌患者在多周期化疗中中性粒细胞减少症的发生，且不良反应良好。.
Keywords: Breast neoplasms; Chemotherapy; Neutropenia; Pegylated recombinant human granulocyte colony-stimulating factor.