Volume 3,Issue 4
Fall 2025
低剂量 PEG-rhG-CSF 预防乳腺癌AT方案新辅助化疗粒细胞缺乏的临床研究
目的：AT方案作为乳腺癌新辅助化疗最常用治疗方案之一，不可避免的会出现粒细胞降低。本研究探讨了低剂量PEG-rhG-CSF（聚乙二醇化重组人粒细胞集落刺激因子）预防乳腺癌AT方案新辅助化疗粒细胞缺乏的疗效与安全性。方法：将60例乳腺癌患者随机（1∶1）纳入研究。30例随机分配到实验组的患者化疗后接受低剂量（3mg）PEG-rhG-CSF预防粒细胞缺乏，30例随机分配到对照组的患者不接受PEG-rhG-CSF预防粒细胞缺乏。主要终点是3-4级中性粒细胞减少(ANC<1.0x10 9/L)的发生率及恢复时间。次要研究终点包括发生发热性中性粒细胞减少（febrile neutropenia，FN）患者的发生率(体温≥38.2 ℃，且ANC < 0.5 x 10 9 /L)及恢复时间。结果：与对照组患者相比，实验组患者3-4级中性粒细胞减少和FN发生率均明显降低（3-4级，P＜0.001；FN，P＜0.05），且中性粒细胞减少症恢复时间（平均±标准差）明显缩短（P＜0.05），且实验组患者3-4级中性粒细胞减少及FN恢复时间随化疗周期逐渐缩短。亚组分析实验组患者无论年龄是否≥60岁在3-4级中性粒细胞减少恢复时间上均较对照组明显缩短，且差异有统计学意义（P＜0.05）。两组患者分别：实验组：17例，56.7%，对照组：15例，50%，报告了任何级别的不良事件（AEs）。未见≥3级AEs的报告。结论：乳腺癌AT方案新辅助化疗后应用低剂量PEG-rhG-CSF，能够显著降低3-4级中性粒细胞减少和FN的发生率及恢复时间，应用更方便，且不增加患者不良反应，值得临床推广。
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