目的 探讨聚乙二醇化重组人粒细胞刺激因子（PEG-rhG-CSF）在宫颈癌同步放化疗中预防中性粒细胞减少的疗效及安全性。方法 按单中心单臂历史对照研究，选取2019年6月—2021年1月32例符合入排条件，拟行同步放化疗的宫颈癌患者组成试验组，同时搜集2017年1月—2019年6月行同步放化疗且符合对照组治疗方案的宫颈癌患者病历资料，按1∶1倾向性评分匹配法组成对照组。试验组为前瞻性入组，患者第1次化疗给药结束24 h后sc聚乙二醇化重组人粒细胞刺激因子注射液，每次6 mg，每化疗周期1次，共给药2次。若使用PEG-rhG-CSF预防后，中性粒细胞计数（ANC）仍＜1.0×109·L^-1，可给予短效重组人粒细胞刺激因子注射液5 μg·kg^-1，sc给药，直至ANC≥2.0×109·L^-1。对照组患者采用倾向性评分匹配既往同步放化疗的宫颈癌患者，初始不给予PEG-rhG-CSF，当患者出现ANC＜1.0×109·L^-1后sc给予重组人粒细胞刺激因子注射液，5 μg·kg^-1，持续使用，每日1次，直至ANC≥2.0×109·L^-1。记录两组患者3、4度中性粒细胞减少症发生率及持续时间；粒细胞减少性发热（FN）发生率；中性粒细胞减少导致化疗延迟和放疗中断发生率；评价两组不良反应情况，包括乏力、骨关节痛、发热、皮肤黏膜反应、恶心及呕吐等。结果 试验组与对照组各32例，两组基线均衡。试验组中性粒细胞减少症发生率59.4%，对照组为84.3%，试验组显著低于对照组（P＜0.05）；3、4度中性粒细胞减少症发生率试验组为31.3%（10/32），对照组为56.3%（18/32），试验组显著低于对照组（P＜0.05）。3度中性粒细胞减少持续时间，试验组中位时间为0 d（0～29 d），显著低于对照组2 d（0～38 d）；4度中性粒细胞减少持续时间，试验组中位时间为0 d（0～22 d），显著低于对照组1 d（0～38 d）。两组FN发生率比较无明显差异，但试验组有降低趋势。试验组放疗中断1例，对照组2例，两组比较无显著统计学差异（P＞0.05）；试验组延迟化疗出现4例（12.5%），对照组出现12例（37.5%），两组比较差异显著（P＜0.05）。两组不良反应主要包括乏力、骨关节痛、发热、皮肤黏膜反应、恶心及呕吐等，组间比较，差异不显著（P＞0.05）。结论 宫颈癌同步放化疗过程中预防性应用PEG-rhG-CSF具有安全性、有效性，可以降低中性粒细胞减少症发生率，减少FN和不良反应，避免治疗延迟。

Objective To explore effectiveness, safety and adverse reaction of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in preventing radiochemotherapy-induced neutropenia of cervical cancer. Methods From June 2019 to January 2021, 32 cervical cancer patients who met the inclusion criteria and planned to receive concurrent chemoradiotherapy were selected as the experimental group. At the same time, medical records of cervical cancer patients who received concurrent chemoradiotherapy and met the treatment plan of the control group from January 2017 to June 2019 were collected, and the control group was constituted according to 1∶1 propensity score matching method. The experimental group was prospectively enrolled, and 24 h after the end of the first chemotherapy administration, the patients were injected with Polyethylene Glycol Recombinant Human Granulocyte Stimulating Factor Injection at a dose of 6 mg each time, once per chemotherapy cycle, and administered twice in total. If PEG-rhG-CSF is used for prevention, the neutrophil count (ANC) remains less than 1.0×109·L^-1, can be administered with short acting Recombinant Human Granulocyte Stimulating Factor Injection 5 μg·kg^-1, sc administered until ANC ≥ 2.0×109·L^-1. Patients in the control group were matched with cervical cancer patients who had previously undergone concurrent radiotherapy and chemotherapy using a propensity score, and initially did not receive PEG-rhG-CSF. When the patient showed ANC < 1.0×109·L^-1, administered with Recombinant Human Granulocyte Stimulating Factor Injection, 5 μg·kg^-1, continue to use once a day until ANC ≥ 2.0×109·L^-1. The incidence and duration of degree three and four neutropenia in two groups of patients, the incidence of granulocytopenic fever (FN), the incidence of delayed chemotherapy and interrupted radiotherapy due to neutropenia were recorded. The adverse reactions in both groups were evaluated, including fatigue, joint pain, fever, skin mucosal reactions, nausea, and vomiting. Results There were 32 cases in the experimental group and 32 cases in the control group, and the baseline of the two groups was balanced. The incidence of neutropenia was 59.4% in the experimental group and 84.3% in the control group, which was significantly lower than that in the control group (P < 0.05). The incidence of grade three neutropenia was 31.3% in the experimental group and 56.3% in the control group, which was significantly lower than that in the control group (P < 0.05). The median duration of grade three neutropenia in the experimental group was 0 d (0—29 d), which was significantly lower than 2 d (0—38 d) in the control group. The duration of grade four neutropenia in the experimental group was a median of 0 d (0— 22 d), which was significantly lower than 1 d (0—38 d) in the control group. There was no significant difference in the incidence of granulocytopenia fever (FN) between the two groups, but there was a trend to decrease in the experimental group. There was no significant difference between the two groups (P > 0.05). Delayed chemotherapy occurred in four cases (12.5%) in the experimental group and 12 cases (37.5%) in the control group, and there was a significant difference between the two groups (P < 0.05). The adverse reactions mainly included fatigue, arthralgia, fever, skin and mucosa reaction, nausea and vomiting, and there was no significant difference between the two groups (P > 0.05). Conclusion The prophylactic application of PEG-rhG-CSF in concurrent radiochemotherapy for cervical cancer was safe and effective, which can reduce the incidence of neutropenia, FN, adverse reactions and delayed chemotherapy cycles.

R969.4

中国临床肿瘤学会-CSCO基金（Y-QL2019-0137）；内蒙古自治区科技计划项目（2019GG039/086、2021GG0167）；内蒙古自然科学基金（2021MS08152/8154）；希思科-石药肿瘤研究基金项目（Y-SY201901-0008）；希思科-2019年度齐鲁肿瘤研究基金项目（Y-QL2019-0137）；三生TCP中青年科研基金（008）；北京医学奖励基金项目（YXJL-2020-0785-0315）；内蒙古自治区卫生健康科技计划项目（202202017）；三生TCP中青年科研基金（011）