目的 探究低剂量聚乙二醇化重组人粒细胞刺激因子（PEG-rhG-CSF）治疗食管癌化疗后中性粒细胞减少症的临床疗效。方法 前瞻性选取哈励逊国际和平医院胸外科2019年5月-2021年10月收治的食管癌术后化疗患者200例为研究对象，采用随机数字表法，将所有患者均分为对照组和试验组，每组100例。两组患者均采用氟尿嘧啶联合顺铂3周疗法进行化疗，3周为1个周期。对照组患者化疗1个周期结束后24～48 h开始，给予5 μg·kg^-1·d^-1的人粒细胞刺激因子注射液进行sc用药，每天1次，直至外周血中性粒细胞绝对值（ANC）降至最低值后连续两次≥5.0×10⁹·L^-1或1次≥10.0×10⁹·L^-1，或连续用药14 d。试验组患者给药开始时间同对照组，给予3 mg的聚乙二醇化重组人粒细胞刺激因子注射液进行sc用药，1个化疗周期用药1次。两组患者均进行1个化疗周期的治疗。对两组患者中性粒细胞变化情况、Ⅲ/Ⅳ度中性粒细胞减少症发生率及持续时间、中性粒细胞缺乏伴发热（FN）发生率及再次返院情况、不良反应及并发症发生率、患者给药前后生活质量评分进行比较。结果 试验组患者化疗结束后第6、9、12、15、18天时的外周血ANC显著高于对照组（P＜0.05），第1、3、21天时的ANC与对照组相比，均无统计学差异（P＞0.05）。与对照组相比，试验组患者中性粒细胞减少症发生率及其持续时间显著降低（P＜0.05），FN发生率及再次返院率显著减少（P＜0.05），不良反应及并发症发生率显著减少（P＜0.05）。给药前，两组癌症治疗功能评价量表（FACT-G）中身体状况、社会/家庭状况、功能状况、情绪状况4个方面内容评分比较无统计学差异（P＞0.05），给药后，两组FACT-G量表各项内容评分均较给药前升高，试验组给药后FACT-G评分显著高于对照组（P＜0.05）。结论 低剂量PEG-rhG-CSF用于食管癌化疗后中性粒细胞减少症治疗，能显著预防中性粒细胞减少症及FN的发生，同时还能有效缩短中性粒细胞减少症持续时间，降低因FN再住院率，减少患者不良反应及并发症，有效改善患者生活质量。

Objective To investigate the clinical efficacy of low-dose polyethylene glycol-recombinant human granulocyte stimulating factor (PEG-rhG-CSF) in treatment of neutropenia after chemotherapy in esophageal cancer. Methods A total of 200 patients with esophageal cancer undergoing postoperative chemotherapy in the Department of Thoracic Surgery of Harrison International Peace Hospital from May 2019 to October 2021 were prospectively selected as the research objects. The patients were equally grouped into two groups by random number table method, 100 cases in each group. Both groups of patients were treated with fluorouracil combined with cisplatin for three weeks, with three weeks as a cycle. Patients in the control group were given 5 μg·kg^-1·d^-1 human granulocyte stimulating factor injection was administered with sc once a day from 24 to 48 h after one cycle of chemotherapy until the absolute value of neutrophils (ANC) in peripheral blood dropped to the lowest value for two consecutive times ≥ 5.0×10⁹·L^-1 or once ≥ 10.0×10⁹·L^-1, or continuous administration for 14 days. The patients in the experimental group were given 3 mg of Polyethylene Glycol-Recombinant Human Granulocyte Stimulating Factor Injection for sc at the same time as those in the control group, once in every chemotherapy cycle. Both groups were treated with one chemotherapy cycle. The changes of neutrophils, the incidence and duration of grade III/IV neutropenia, the incidence of neutropenia with fever (FN), rehospitalization, adverse reactions, complications, and the quality of life before and after treatment were compared between two groups. Results The ANC in peripheral blood in the experimental group at 6th, 9th, 12th, 15th, and 18th day after chemotherapy was obviously higher than that in the control group (P< 0.05), and there was no significant difference in ANC on the 3rd, and 21st day (P> 0.05). Compared with the control group, the incidence and duration of neutropenia in the experimental group were obviously reduced (P< 0.05), the incidence of FN and the rate of hospital rehospitalization were obviously reduced (P< 0.05), the incidences of adverse reactions and complications were obviously reduced (P< 0.05. Before treatment, there was no significant difference in the scores of physical status, social/family status, functional status, and emotional status in Functional Assessment of Cancer Therapy (FACT-G) between two groups (P> 0.05), after treatment, the scores of FACT-G scale in both groups were higher than those before treatment, and the FACT-G scores in the experimental group after treatment were obviously higher than those in the control group after treatment (P< 0.05). Conclusion Low-dose PEG-rhG-CSF for the treatment of neutropenia after esophageal cancer chemotherapy can obviously prevent the occurrences of neutropenia and FN, and can effectively shorten the duration of neutropenia, reduce the rate of rehospitalization due to FN, reduce the adverse reactions and complications of patients, and effectively ameliorate the quality of life of patients.

R973

衡水市重点研发计划项目（2021014030Z）