乳腺癌术后放疗预防性使用聚乙二醇化重组人粒细胞刺激因子的临床观察

doi:10.3760/cma.j.issn.1673-422X.2020.03.003

国际肿瘤学杂志 ›› 2020, Vol. 47 ›› Issue (3): 141-145.doi: 10.3760/cma.j.issn.1673-422X.2020.03.003

乳腺癌术后放疗预防性使用聚乙二醇化重组人粒细胞刺激因子的临床观察

杜艳芳^1,², 范艳玲², 胡兵^1,³, 孙雷², 刘元建², 李宝生³, 黄伟³()

¹ 济南大学山东省医学科学院医学与生命科学学院,济南 250200;
² 山东省金乡县人民医院肿瘤科 272000;
³ 山东省肿瘤防治研究院(山东省肿瘤医院)放疗科,山东第一医科大学(山东省医学科学院),济南 250117

收稿日期:2020-01-02 修回日期:2020-01-30 出版日期:2020-03-08 发布日期:2020-05-27
通讯作者: 黄伟 E-mail:alvinbird@163.com
基金资助:
国家自然科学基金(81773232);泰山学者青年专家计划(tsqn201909187);北京市希思科临床肿瘤学研究基金(Y-sy2018-086)

Clinical observation of prophylactic use of pegylated recombinant human granulocyte stimulating factor in breast cancer patients with postoperative radiotherapy

Du Yanfang^1,², Fan Yanling², Hu Bing^1,³, Sun Lei², Liu Yuanjian², Li Baosheng³, Huang Wei³()

¹ School of Medicine and Life Sciences, University of Jinan-Shandong Academy of Medical Sciences, Jinan 250200, China;
² Department of Oncology, Jinxiang People's Hospital of Shandong Province, Jinxiang 272000, China;
³ Department of Radiation Oncology, Shandong Cancer Hospital and Institute (Shandong Cancer Hospital), Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250117, China

Received:2020-01-02 Revised:2020-01-30 Online:2020-03-08 Published:2020-05-27
Contact: Huang Wei E-mail:alvinbird@163.com
Supported by:
National Natural Science Foundation of China(81773232);Project of Young Taishan Scholars(tsqn201909187);Beijing Xisike Clinical Oncology Research Foundation(Y-sy2018-086)

摘要/Abstract

摘要：

目的探讨聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)用于乳腺癌术后化疗后序贯行辅助放疗患者预防中性粒细胞减少的疗效及不良反应。方法收集2017年1月至2019年1月山东省肿瘤防治研究院收治的43例女性乳腺癌患者进行回顾性研究。观察组患者21例,于放疗前1~3 d皮下注射PEG-rhG-CSF 6 mg;对照组患者22例,放疗前不予PEG-rhG-CSF处理。对两组患者放疗过程中中性粒细胞绝对计数(ANC)最低值、中性粒细胞减少致放疗中断天数、重组人粒细胞刺激因子(rhG-CSF)使用支数及药物所致骨骼肌疼痛发生情况进行统计学分析。结果两组患者放疗期间均未出现中性粒细胞减少性发热,观察组未出现Ⅲ度中性粒细胞减少,对照组出现3例Ⅲ度中性粒细胞减少患者。观察组中位ANC最低值为1.56×10 ⁹/L,高于对照组的1.37×10 ⁹/L,差异有统计学意义(Z=-2.261,P=0.023)。观察组和对照组中位rhG-CSF使用支数分别为1、2支,差异有统计学意义(Z=-2.498,P=0.012)。观察组和对照组中位放疗中断天数分别为0、3 d,差异有统计学意义(Z=-3.117,P=0.001)。观察组和对照组出现药物所致骨骼肌疼痛患者分别为1例(4.8%)和5例(22.7%),差异无统计学意义(χ ²=1.586,P=0.208)。结论 PEG-rhG-CSF可以有效预防乳腺癌术后辅助化疗后放疗所致的中性粒细胞减少,减少由此带来的放疗中断及放疗期间rhG-CSF的使用,有利于放疗的顺利进行。

关键词: 乳腺肿瘤, 放射疗法, 中性粒细胞减少, 粒细胞集落刺激因子, 聚乙二醇化

Abstract:

Objective To investigate the efficacy and adverse effects of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing neutropenia in patients undergoing sequential adjuvant radiotherapy after postoperative chemotherapy for breast cancer. Methods A total of 43 female patients with breast cancer from January 2017 to January 2019 in Shandong Cancer Hospital and Institute were analyzed prospectively. Twenty-one patients in the experimental group were given 6 mg of PEG-rhG-CSF subcutaneously 1-3 days before radiotherapy. In the control group, 22 patients were enrolled without PEG-rhG-CSF utilization. The lowest absolute neutrophil count (ANC), the number of days of radiotherapy interruption due to neutropenia, the number of recombinant human granulocyte colony-stimulating factor (rhG-CSF) used during radiotherapy and the occurrence of drug-induced skeletal muscle pain in the two groups were statistically analyzed. Results No neutropenia fever was observed in the two groups during radiotherapy. In the experimental group, there was no case of grade Ⅲ neutropenia; while in the control group, there were 3 cases of grade Ⅲ neutropenia. The median value of the lowest ANC in the experimental group was 1.56×10 ⁹/L, higher than that in the control group (1.37×10 ⁹/L), with a statistically significant difference (Z=-2.261, P=0.023). The median number of rhG-CSF used in the experimental group was 1, which was smaller than 2 in the control group, and the difference was statistically significant (Z=-2.498, P=0.012). The median numbers of days of radiotherapy interruption due to neutropenia were 0 and 3 in the experimental group and the control group, with a statistically significant difference (Z=-3.117, P=0.001). One case (4.8%) of drug-induced skeletal muscle pain was found in the experimental group and 5 cases (22.7%) in the control group, with no statistically significant difference (χ ²=1.586, P=0.208). Conclusion PEG-rhG-CSF can effectively prevent neutropenia caused by radiotherapy after postoperative chemotherapy for patients with breast cancer, and can reduce the interruption of radiotherapy and the use of rhG-CSF during radiotherapy, which is helpful to the smooth process of radiotherapy.

Key words: Breast neoplasms, Radiotherapy, Neutropenia, Granulocyte colony-stimulating factor, Pegylation

杜艳芳, 范艳玲, 胡兵, 孙雷, 刘元建, 李宝生, 黄伟. 乳腺癌术后放疗预防性使用聚乙二醇化重组人粒细胞刺激因子的临床观察[J]. 国际肿瘤学杂志, 2020, 47(3): 141-145.

Du Yanfang, Fan Yanling, Hu Bing, Sun Lei, Liu Yuanjian, Li Baosheng, Huang Wei. Clinical observation of prophylactic use of pegylated recombinant human granulocyte stimulating factor in breast cancer patients with postoperative radiotherapy[J]. Journal of International Oncology, 2020, 47(3): 141-145.

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参考文献 22

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临床特征	观察组 (n=21)	对照组 (n=22)	χ²值	P值
年龄(岁)
<50	11	11	0.024	0.876
≥50	10	11
KPS评分
80~90	12	11	0.220	0.639
>90	9	11
术后分期
Ⅱ期	7	6	0.187	0.665
Ⅲ期	14	16
初始ANC
<3×10⁹/L	12	12	0.029	0.864
≥3×10⁹/L	9	10

指标	观察组 (n=21)	对照组 (n=22)	Z值	P值
ANC最低值(×10⁹/L)	1.56(1.19~4.03)	1.37(0.82~3.06)	-2.261	0.023
rhG-CSF使用支数(支)	1(0~3)	2(0~14)	-2.498	0.012
放疗中断天数(d)	0(0~2)	3(0~4)	-3.117	0.001

乳腺癌术后放疗预防性使用聚乙二醇化重组人粒细胞刺激因子的临床观察

Clinical observation of prophylactic use of pegylated recombinant human granulocyte stimulating factor in breast cancer patients with postoperative radiotherapy

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