肿瘤患者应用重组人粒细胞集落刺激因子致严重不良反应13例临床分析

摘要

目的 分析患者应用重组人粒细胞集落刺激因子(rhG-CSF)所致严重不良反应的原因及特点,为临床安全用药提供参考.方法 收集2014年1月1日~2017年5月1日湖南省肿瘤医院国家药品不良反应监测系统收到的rhG-CSF不良反应报告,筛选有效病例,并对上报病例进行提取、统计、分析.结果 共收集符合入选标准的患者13例,其中男性2例,女性11例;12例为皮下注射给药,1例为静脉滴注给药;76.92%的患者为预防性用药,且主要为使用高骨髓抑制风险药物的乳腺癌化疗患者;发生不良反应的药品均为大肠杆菌发酵来源的国产品种,主要累及的系统-器官为呼吸系统、交感副交感神经系统、胃肠系统、骨骼肌肉系统等,最常见的严重不良反应为胸闷、呼吸困难、多汗、腹痛等.有2例大肠杆菌来源的rhG-CSF(非格司亭)过敏患者再次使用糖基化的rhG-CSF(来格司亭)未发生过敏反应.结论 rhG-CSF为生物制剂,易发生不良反应,用药期间需严密监护.对于大肠杆菌发酵来源的rhG-CSF(非格司亭)过敏患者,可尝试使用糖基化的rhG-CSF(来格司亭).%Objective To learn the causes and characteristics of adverse reactions induced by recombinant human granulocyte colony stimulating factor (rhG-CSF) and to provide references for safe use in clinical practice. Methods In order to extract effective cases for this study, the author has censused and analyzed the rhG-CSF adverse effect cases reported in National Adverse Drug Effect Monitoring System from 1st January 2014 to 1st May 2017. Results There were 13 patients who met the inclusion criteria, including 2 males and 11 females. Among them, 12 patients were under treatment by hypodermic injection, 1 patient were under intravenous injection. In these cases, 76.92% of them were breast cancer patient under chemotherapy with serve myelosuppression. The medicine causing serve adverse effect were made domestically and ferment by colibacillus, which mainly brings side effect to the respiratory system, parasympathetic division, gastrointestinal system, musculoskeletal system and ect. The adverse effect mainly presented as chest suppression, dyspnea, hidrosis, abdomen pain ect. In this study, there were 2 patients who were allergic to filgrastim. After using lenograstim, no allergic effect presented. Conclusion As a biological agent which brings adverse effect, the rhG-CSF should be under serve monitoring during clinic practice. Glycosylated rhG-CSF (lenograstim) can be a replacement for patients who are allergic to rhG-CSF (filgrastim) ferment by colibacillus.