硫培非格司亭预防性治疗恶性肿瘤患者化疗后重度中性粒细胞减少症的临床研究

Clinical Study of Mecapegfilgrastim in the Prevention of Chemotherapy-Induced Severe Neutropenia in Patients with Malignant Tumor

目的 研究分析硫培非格司亭预防性治疗恶性肿瘤患者化疗后重度中性粒细胞减少症的临床疗效。方法 选取2020年11月至2022年9月苏州大学附属第一医院肿瘤内科收治的接受化疗并出现重度中性粒细胞减少症的恶性肿瘤患者160例,按预防性治疗中性粒细胞减少症方案的不同分为2组,采用重组人粒细胞集落刺激因子(rhG-CSF)预防的为对照组(n=80),采用硫培非格司亭(mecapegfilgrastim)预防的为实验组(n=80)。干预后分析化疗患者中性粒细胞计数(ANC)变化,并观察患者中性粒细胞减少症分级情况、中性粒细胞减少性发热(febrile neutropenia, FN)发生率、不良反应发生率及按期足剂量化疗率。结果 2组患者预防性治疗后1周的ANC显著高于化疗前(P<0.01),且实验组ANC升高更显著(P<0.01),在预防性治疗2周后恢复至正常范围。实验组重度中性粒细胞减少症的发生率显著降低(P<0.01),FN发生率显著降低(P<0.01),按期足剂量化疗率显著提高(P<0.01)。实验组患者在低风险骨髓抑制组、中风险骨髓抑制组和高风险骨髓抑制组3个亚组中预防性治疗后1周的ANC显著高于对照组,差异有统计学意义(P<0.05);实验组患者在高风险骨髓抑制组预防性治疗后2周的ANC显著高于对照组,差异有统计学意义(P<0.05)。2组患者研究期间的不良反应主要有骨痛、肌痛和乏力,差异无统计学意义(P>0.05)。结论 硫培非格司亭预防性治疗既往出现过重度中性粒细胞减少症的恶性肿瘤患者过程中,重度中性粒细胞减少症再发生率明显降低,并且显著提高按期足剂量化疗率,临床使用效果好。

OBJECTIVE To study the clinical effect of mecapegfilgrastim in the prevention of chemotherapy induced severe neutropenia in patients with malignant tumor.METHODS A total of 160 patients with chemotherapy induced severe neutropenia were admitted to the oncology department of the first affiliated hospital of soochow university from november 2020 to september 2022.These patients were divided into two groups according to different preventive treatment of neutropenia.The control group was treated with recombinant human granulocyte-colony stimulating factor(rhG-CSF)(n=80),and the experimental group was treated with mecapegfilgrastim(n=80).After intervention,the changes of absolute neutrophil count(ANC)of chemotherapy patients,the grade of neutropenia,the incidence of adverse reactions and the rate of scheduled full-dose chemotherapy were observed.RESULTS The ANC of the two groups after 1 week of preventive treatment was significantly higher than that before chemotherapy(P<0.01),and the ANC of the experimental group increased more significantly(P<0.01),then returned to the normal range after 2 weeks of preventive treatment.In the experimental group,the incidence of severe neutropenia was significantly decreased(P<0.01),the incidence of FN was significantly decreased(P<0.01),and the rate of scheduled full-dose chemotherapy was significantly increased(P<0.01).ANC in the experimental group was significantly higher than that in the control group 1 week after preventive treatment in the low-risk,medium-risk and high-risk myelosuppression groups(P<0.05).ANC in the experimental group was significantly higher than that in the control group 2 weeks after preventive treatment in the high-risk myelosuppression group,and the difference was statistically significant(P<0.05).The main adverse reactions in 2 groups during the study period were bone pain,myalgia and fatigue,and there is no statistical significance(P>0.05).CONCLUSION In the course of preventive treatment of mecapegfilgrastim for malignant tumor patients with severe neutropenia before,the recurrence rate of severe neutropenia is significantly reduced,and the rate of scheduled full-dose chemotherapy is significantly increased,which shows good clinical effect.