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。
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.
出处
《中国肿瘤临床》
CAS
CSCD
北大核心
2017年第14期679-684,共6页
Chinese Journal of Clinical Oncology
基金
国家重大新药创制科技重大专项(编号:2013ZX09104007)资助~~
