聚乙二醇化重组人粒细胞刺激因子预防化疗后中性粒细胞减少症的多中心上市后临床研究

发布时间：2018-06-12 20:30

本文选题：聚乙二醇化重组人粒细胞刺激因子 + 中性粒细胞减少症　；参考：《中国肿瘤临床》2017年14期

【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。
[Abstract]:Aim: to investigate the efficacy and safety of pegylated recombinant human granulocyte-colony stimulating factor PEG-rhG-CSF in preventing neutropenia in multiple chemotherapy cycles. Methods: this study was a multicenter prospective open single-arm clinical trial. PEG-rhG-CSF was given to patients with malignant solid tumors such as lung ovarian cancer colorectal cancer and so on for 2 to 4 consecutive cycles. Results the incidence of neutropenia in grade 4 was decreased from 4.76 / 273 in the first chemotherapy cycle to 1.83% of 1.83% in 2 ~ 4 cycles, respectively, and the incidence of neutropenia in grade 2.08% / 963 grade neutropenia decreased from 11.36% to 31% / 273 in the first cycle of chemotherapy, respectively. Don't drop to 6.23 in 2 to 4 cycles, 17 / 273 / 2.87, 5 / 174) and 3.13 / 3 / 96. The incidence of febrile neutropenia (FN) in the first follow-up was 0.73 / 273FN; in 1 case, the duration of FN was 2 days, in 1 case was 5 days; in the second follow-up, the incidence rate of FN was 0; the incidence rate of grade 4 neutropenia after secondary prevention was 0; the occurrence rate of grade 4 neutropenia after secondary prevention was 0. The incidence of neutropenia decreased from 25 / 28 in the screening period to 3.57 / 28 in the following 1-3 cycles, respectively. The incidence of neutropenia decreased from 71.43 / 20 / 28 to 10.71 / 32 / 14.29 / 428 and 0 / 0 / 15 / 10 / 28, respectively. The antibiotic use rate in the study was 10.48 / 420. Conclusion: PEG-rhG-CSF can effectively prevent the occurrence of neutropenia after chemotherapy in patients with malignant solid tumor.
【作者单位】：国家癌症中心/中国医学科学院肿瘤医院内科;常州市第一人民医院肿瘤内科;石家庄市第一医院肿瘤科;唐山市人民医院放化疗科;武警广东总队医院肿瘤内科;邯郸市中心医院放疗科;东南大学医学院附属江阴医院肿瘤科;浙江省肿瘤医院胸部肿瘤内科;锦州市中心医院肿瘤科;北京军区总医院肿瘤内科;湖南省肿瘤医院胸内二科;河北省人民医院肿瘤科;河北医科大学第一医院肿瘤内科;河北医科大学第三医院放疗科;安徽医科大学第二附属医院肿瘤内科;承德医学院附属医院放化疗科;北京胸科医院综合科;河北胸科医院肿瘤科;中国人民解放军总医院肿瘤内科;
【基金】：国家重大新药创制科技重大专项(编号:2013ZX09104007)资助~~
【分类号】：R730.53

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