【摘要】 目的 对注射用白蛋白结合型紫杉醇仿制药的药物不良反应（ADR）的发生规律及相关因素进行分析，为临床安全用药提供参考。方法 回顾性收集某医院2020年1月-2021年12月使用注射用白蛋白结合型紫杉醇仿制药化疗的1 166份患者病历，统计分析贫血、骨髓抑制、周围神经毒性和肝功能异常等ADR的发生情况与相关危险因素。结果 收集到ADR 1 104例次，涉及781例患者，其中贫血和骨髓抑制ADR较为常见，其次为周围神经毒性、肝功能异常等。ADR的严重程度分级以Ⅰ、Ⅱ级为主，大部分ADR可通过对症支持治疗转归良好。Logistic多因素回归分析显示：药物剂量对贫血（P <0.01）及骨髓抑制（P=0.03）的发生具有统计学意义；患者的年龄（P <0.01）、药物剂量（P <0.01）对周围神经毒性的发生具有统计学意义。用药合理性方面，超说明书用药共152例。结论 使用注射用白蛋白结合型紫杉醇仿制药时，应充分结合患者的疾病与身体状况，选择合适的药物治疗方案与给药剂量，用药期间加强监护。更多还原

【Abstract】 AIM To analyze the characteristics and risk factors of adverse drug reaction(ADR) induced by generic albumin bound paclitaxel, and to provide reference for ensuring medication safety of patients. METHODS A total of 1 166 medical records of patients who used generic albumin-bound paclitaxel for injection for chemotherapy in a hospital from January 2020 to December 2021 were collected. The incidence of adverse drug reactions(ADRs) such as anemia, bone marrow suppression, peripheral neurotoxicity, and abnormal liver function and related risk factors were statistically analyzed.RESULTS A total of 1 104 reports of ADR were retrieved, involving 781 patients, most of them were anemia and myelosuppression, followed by peripheral neurotoxicity and liver injury. The severity of ADR was mainly graded as I and II, and most of the ADR could be treated with symptomatic support and recover well. The risk factors analysis showed that dosage was the significant factors affecting anemia and myelosuppression, age and dosage were the significant factors affecting neurotoxicity. There were 152 patients of off-label drug use. CONCLUSION The appropriate drug treatment and dosage should be selected according to the disease and physical status of patients who using the generic albumin bound paclitaxel.更多还原