2023 年第 12 期 第 18 卷

两种多西他赛联合环磷酰胺治疗乳腺癌的不良反应及影响因素研究

Study on adverse reactions and influencing factors of two kinds of docetaxel combined with cyclophosphamide for the treatment of breast cancer

作者：邢雪婷丁维洁张若梅雷莹张晓庆

英文作者：Xing Xueting Ding Weijie Zhang Ruomei Lei Ying Zhang Xiaoqing

单位：上海交通大学医学院附属国际和平妇幼保健院药剂科上海市胚胎源性疾病重点实验室上海市临床重点专科建设项目——“强主体”妇产科，上海200030

英文单位：Department of Pharmacy the International Peace Maternity and Child Health Hospital School of Medicine Shanghai Jiao Tong University Shanghai Key Laboratory of Embryo Original Diseases Shanghai Municipal Key Clinical Speciality "Strong Subject" Obstetrics and Gynecology Shanghai 200030 China

关键词：多西他赛；乳腺癌；不良反应；影响因素

英文关键词：Docetaxel;Breastcancer;Adversereactions;Influencingfactors

• 摘要：

• 目的  研究国产和进口多西他赛联合环磷酰胺化疗后导致乳腺癌患者发生的药物不良反应（ADR）及影响因素。方法  选取2020年1月至2022年12月于上海交通大学医学院附属国际和平妇幼保健院化疗的200例女性乳腺癌患者进行回顾性研究，根据使用国产或进口多西他赛，将患者分为多帕菲组（100例）和泰索帝组（100例）。多帕菲组给予多帕菲（国产多西他赛）联合环磷酰胺化疗；泰索帝组给予泰索帝（进口多西他赛）联合环磷酰胺化疗，连续化疗4或6个疗程。分析患者使用多西他赛发生ADR的情况及影响因素。结果  2组各项ADR发生率比较差异均无统计学意义（均P＞0.05）。治疗后，泰索帝组血红蛋白、白细胞计数和中性粒细胞计数均低于多帕菲组，血小板计数、血肌酐、丙氨酸转氨酶和天冬氨酸转氨酶水平均高于多帕菲组，但组间比较差异均无统计学意义（均P＞0.05）。多因素分析结果显示，体重指数（比值比=0.416，95%置信区间：0.193～0.900，P=0.026）是使用多西他赛发生ADR的独立影响因素。结论  国产与进口多西他赛均会导致骨髓抑制和肝肾功能损害等ADR，但二者在安全性方面的差异不明显。对于体重指数较低的乳腺癌患者，化疗期间应加强用药监护以避免或减少使用多西他赛引发的ADR。

• Objective To investigate the occurrence of adverse drug reaction (ADR) in breast cancer patients receiving cyclophosphamide in combination with domestic and imported docetaxel and to analyze the influencing factors. Methods Totally 200 patients with breast cancer treated with chemotherapy from January 2020 to December 2022 were selected retrospectively in the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University. Patients were divided into Dopafei group (100 cases) and Taxotere group (100 cases) according to the use of domestic or imported docetaxel. Dopafei group was given Dopafei (domestic docetaxel) combined with cyclophosphamide chemotherapy, and Taxotere group was given Taxotere (imported docetaxel) combined with cyclophosphamide chemotherapy, all for 4 or 6 courses. ADR in patients and the influencing factors were analyzed. Results  There were no significant differences in the rate of ADR between the two groups (all P>0.05). After treatment, haemoglobin, white blood cell count, and neutrophil count in Taxotere group were lower than those in Dopafei group, and platelet count, serum creatinine, alanine aminotransferase, and aspartate aminotransferase levels in Taxotere group were higher than those in Dopafei group, while the differences between the two groups were not significantly statistical (all P>0.05). Multivariate analysis showed that body mass index (odds ratio=0.416, 95% confidence interval: 0.193-0.900, P=0.026) was an independent influencing factor for the occurrence of ADR from docetaxel. Conclusions  Both domestic and imported docetaxel can cause ADR such as bone marrow suppression and liver and kidney function damage. There is no significant difference in safety between the two drugs. In addition, for breast cancer patients with low body mass index during chemotherapy, drug monitoring should be strengthened to avoid or reduce ADR caused by docetaxel.