广西医学

目的探讨艾贝格司亭α与聚乙二醇化重组人粒细胞刺激因子（PEG⁃rhG⁃CSF）预防局部晚期鼻咽癌（LA⁃NPC）患者诱导化疗（IC）序贯同步放化疗（CCRT）后中性粒细胞减少症（CIN）的疗效及安全性。方法回顾性分析204例Ⅲ~ⅣA期LA⁃NPC患者的临床资料，按用药方案分为艾贝格司亭α组（n=78）与PEG⁃rhG⁃CSF组（n=126）。艾贝格司亭α组在标准化治疗方案基础上皮下注射艾贝格司亭α注射液，PEG⁃rhG⁃CSF组在标准化治疗方案基础上皮下注射PEG⁃rhG⁃CSF注射液。采用倾向性得分匹配法（PSM）以1∶1比例匹配混杂因素，比较匹配后两组患者3~4级CIN持续时间及发生率、4级CIN发生率、发热性中性粒细胞减少症（FN）发生率，3个IC周期及3个序贯CCRT周期中3~4级CIN持续时间，骨痛发生情况、不良反应发生情况及化疗完成情况。结果 PSM后，最终成功匹配63对患者。在3个IC周期及3个序贯CCRT周期中，两组患者的3~4级CIN发生率、4级CIN发生率、FN发生率的差异无统计学意义（P>0.05），艾贝格司亭α组的3~4级CIN持续时间短于PEG⁃rhG⁃CSF组，骨痛发生率低于PEG⁃rhG⁃CSF组，骨痛程度轻于PEG⁃rhG⁃CSF组（P<0.05）。两组患者在3个IC周期及3个序贯CCRT周期中的化疗完成率均为100%，两组患者不良反应发生率、化疗延迟率及延迟天数的差异无统计学意义（P>0.05）。结论艾贝格司亭α在预防LA⁃NPC患者IC序贯CCRT后CIN的效果与PEG⁃rhG⁃CSF基本相当，但能更有效地缩短骨髓抑制时间、减轻骨痛程度、降低骨痛风险，且安全性良好。

Objective To investigate the efficacy and safety of efbemalenograstim alfa versus polyethylene glycol recombinant human granulocyte colony⁃stimulating factor (PEG‑rhG‑CSF) in preventing neutropenia (CIN) after induction chemotherapy (IC) and sequential concurrent chemoradiotherapy (CCRT) for patients with locally advanced nasopharyngeal carcinoma (LA‑NPC). Methods Clinical data of 204 LA‑NPC patients in stage Ⅲ-ⅣA were retrospectively analyzed. Patients were divided into efbemalenograstim alfa group (n=78) or PEG‑rhG‑CSF group (n=126) according to the medication regimen. The efbemalenograstim alfa group received subcutaneous injection of Efbemalenograstim Alfa Injection on the basis of standard therapeutic regimen, while the PEG‑rhG‑CSF group received subcutaneous injection of PEG‑rhG‑CSF Injection on the basis of standard therapeutic regimen. Propensity score matching (PSM) was used to match confounding factors at a 1:1 ratio. After matching, The duration and incidence rate of grade 3-4 CIN, incidence rate of grade 4 CIN, incidence rate of febrile neutropenia (FN), duration of grade 3-4 CIN during the 3 cycles of IC and 3 cycles of sequential CCRT, occurrence of bone pain, adverse reactions, and chemotherapy completion status were compared between patients of the two groups. Results After PSM, 63 pairs of patients were successfully matched. During the three IC cycles and three sequential CCRT cycles, there was no statistically significant difference in the incidence rates of grade 3-4 CIN, grade 4 CIN, or FN between the two groups (P>0.05). The duration of grade 3-4 CIN in the efbemalenograstim alfa group was shorter, the incidence rate of bone pain was lower, and the severity of bone pain was milder than that in the PEG‑rhG‑CSF group (P<0.05). The chemotherapy completion rate was 100% in both groups during the three IC cycles and three sequential CCRT cycles. There was no statistically significant difference in the incidence rate of adverse reactions, chemotherapy delay rate, or number of days of chemotherapy delay between the two groups (P>0.05). Conclusion Efbemalenograstim alfa is non⁃inferior to PEG‑rhG‑CSF in preventing CIN after IC and sequential CCRT in LA‑NPC patients. However, it can more effectively shorten the duration of myelosuppression, reduce the severity of bone pain, and decrease the risk of bone pain, with a favorable safety profile.

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