【摘要】 目的:探究聚乙二醇化重组人粒细胞刺激因子(pegylated recombinant human granulocyte-colony stimulating factor,PEG-rhG-CSF)在多个化疗周期中预防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、前瞻性、开放性单臂临床试验,对需接受多周期化疗的肺癌、卵巢癌、结直肠癌等恶性实体瘤患者连续2~4个周期预防性给予PEG-rhG-CSF。结果:PEG-rhG-CSF初级预防给药后,4级中性粒细胞减少症的发生率从第1个化疗周期的4.76%(13/273)分别降至2~4个周期的1.83%(5/273)、1.15%(2/174)和2.08%(2/96),3级中性粒细胞减少症的发生率从第1个化疗周期的11.36%(31/273)分别降至2~4个周期的6.23%(17/273)、2.87%(5/174)和3.13%(3/96)。第1次随访发热性中性粒细胞减少症(febrile neutropenia,FN)的发生率为0.73%(2/273);FN持续时间中1例为2 d,1例为5 d;第2~4次随访的FN发生率均为0;次级预防给药后,4级中性粒细胞减少症的发生率从筛选期的25%(7/28),分别降至后续1~3个周期的3.57%(1/28)、0(0/28)和6.67%(1/15),3级中性粒细胞减少症的发生率则从71.43%(20/28)分别降至10.71%(3/28)、14.29%(4/28)和0(0/15)。研究中抗生素的使用率为10.48%(44/420)。结论:每个化疗周期应用1次PEG-rhG-CSF可有效预防恶性实体瘤患者化疗后中性粒细胞减少症的发生,多个周期应用可以显示同样的疗效,且安全性良好。更多还原

【Abstract】 Objective:To investigate the efficacy and safety of using pegylated recombinant human granulocyte-colonystimulating factor(PEG-rhG-CSF) in preventing neutropenia in multiple chemotherapy cycles.Methods:A multicenter,prospective,open-label,singlearm study was designed.Patients with malignant tumors,such as lung,ovarian,and colorectal cancers,who received multiple cycles of chemotherapy with the prophylactic use of PEG-rhG-CSF for 2-4 consecutive cycles participated in the study.Results:After the prophylactic use of PEG-rhG-CSF,the incidence of grade IV neutropenia decreased from 4.76%(13/273) in the first cycle to 1.83%(5/273),1.15%(2/174),and 2.08%(2/96) in subsequent cycles.Meanwhile,the incidence of grade III neutropenia decreased from 11.36%(31/273) in the first cycle to 6.23%(17/273),2.87%(5/174),and 3.13%(3/96) in subsequent cycles.The incidence of febrile neutropenia(FN) during the first cycle was 0.73%(2/273).The duration of FN was 2 days in one case and 5 days in another case.FN was not observed during the second,third,or fourth cycle.After the secondary prophylactic use of PEG-rhG-CSF,the incidence of grade IV neutropenia decreased from 25%(7/28) to 3.57%(1/28),0%(0/28),and 6.67%(1/15) in subsequent cycles.Meanwhile,the incidence of grade III neutropenia decreased from 71.43%(20/28) to 10.71%(3/28),14.29%(4/28),and 0%(0/15) in subsequent cycles.The proportion of patients who received antibiotic therapy during the entire chemotherapy period was 10.48%(44/420).Conclusion:The application of PEG-rhG-CSF once per chemotherapy cycle can effectively reduce the occurrence of neutropenia in patients under multiple cycles of chemotherapy treatment with good safety.更多还原