摘要
目的评价聚乙二醇化重组人粒细胞刺激因子（PEG—rhG-CSF）预防淋巴瘤患者化疗后发生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、开放、单臂、Ⅳ期临床试验。纳入410例淋巴瘤患者接受多周期化疗并预防性使用PEG-rhG-CSF。主要观察患者各化疗周期Ⅲ／Ⅳ度中性粒细胞减少症和发热性中性粒细胞减少（FN）的发生率，同时观察患者整个化疗期间抗生素的使用率。结果①410例患者中，违背人选标准8例（1．95％），失访35例（8．54％），发生不良事件19例（4．63％），出现符合终止研究标准者12例（2．93％），疾病进展或复发15例（3．66％），故最终321例（78．29％）进入符合方案集。②在第1～4个治疗周期，初级预防给予PEG-rhG—CSF后，Ⅳ度中性粒细胞减少症的发生率分别为19．14％（49／256）、12．50％（32／256）、12．18％（24／197）、13．61％（20／147），FN的发生率分别为3．52％（9／256）、0．39％（1／256）、2．54％（5／197）、2．04％（3／147）；次级预防给药后，Ⅳ度中性粒细胞减少症的发生率从61．54％（40／65）降至16．92％（11／65）、18．46％（12／65）、20．75％（11／53），FN的发生率从16．92％（11／65）降至1．54％（1／65）、4．62％（3／65）、3．77％（2／53）。③整个化疗期间接受抗生素治疗的受试者比例为34．39％（141／410）。④与PEG-rhG-CSF相关的不良事件发生率为4．63％（19／410），最常见的不良反应为骨痛[3．90％（16／410）]、乏力（0．49％）和发热（0．24％）。结论在淋巴瘤患者化疗过程中，预防性使用PEG-rhG-CSF能够有效降低化疗过程中Ⅲ／Ⅳ度中性粒细胞减少症和FN的发生率，确保淋巴瘤患者接受标准剂量化疗，提高治愈率。
Objective To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor （PEG-rhG-CSF） in prophylaxis neutropenia after chemotherapy in patients with lymphoma. Methods This was a multicenter, single arm, open, phase IV clinical trial. Included 410 patients with lymphoma received multiple cycles of chemotherapy and PEG-rhG-CSF was administrated as prophylactic. The primary endpoint was the incidence of III/IV grade neutropenia and febrile neutropenia （FN） after each chemotherapy cycle during the whole period of chemotherapy was observed. Meanwhile the rate of antibiotics application Results ①Among the 410 patients, 8 cases （1.95%） were contrary to the selected criteria, 35 cases （8.54%） lost, 19 cases （4.63%） experienced adverse events, 12 cases （2.93%） were eligible for the termination criteria, 15 cases （3.66%） develpoed disease progression or recurrence, thus the rest 321 cases （78.29%） were into the Per Protocol Set. ② During the first to fourth treatment cycles, the incidences of grade IV neutropenia after prophylactic use of PEG-rhG-CSF were 19.14% （49/256）, 12.5% （32/256）, 12.18% （24/197）, 13.61% （20/147）, respectively. The incidences of FN were 3.52% （9/256）, 0.39% （1/256）, 2.54% （5/197）, 2.04% （3/147）, respectively. After secondary prophylactic use of PEG-rhG-CSF, the incidences of IV grade neutropenia decreased from 61.54% （ 40/65 ） in the screening cycle to 16.92% （ 11/65 ）, 18.46% （ 12/65 ） and 20.75% （ 11/53 ） in 1-3 cycles, respectively. The incidences of FN decreased from 16.92% （11/65） in the screening cycle to 1.54% （1/65）, 4.62% （3/65）, 3.77% （2/53） in 1-3 cycles, respectively. ③The proportion of patients who received antibiotic therapy during the whole period of chemotherapy was 34.39% （141/410）. ④The incidence of adverse events associated with PEG-rhG-CSF was 4.63% （19/410）. The most common adverse events were bone pain t3.90% （16/410） 1, fatigue （0.49%） and fever（0.24%）. Conclusion During the chemotherapy in patients with lymphoma, the prophylactic use of PEG-rhG-CSF could effectively reduce the incidences of grade III/IV neutropenia and FN, which ensures that patients with lymphoma receive standard-dose chemotherapy to improve its cure rate.
出处
《中华血液学杂志》
CAS
CSCD
北大核心
2017年第10期825-830,共6页
Chinese Journal of Hematology
基金
国家科技重大专项课题（2013ZX09104007）
