广西医学

目的基于美国食品药品监督管理局公共数据公开项目（OpenFDA）数据库，分析4种紫杉醇类抗肿瘤药物的不良反应发生情况。方法在OpenFDA数据库中，检索2014年1月至2022年3月传统紫杉醇制剂、紫杉醇脂质体制剂、白蛋白结合型紫杉醇及多西他赛的不良反应报告情况。使用该数据库的交互式图表板块提取相关数据，分析这4种紫杉醇类抗肿瘤药物的不良反应报告数、上报人员的职业、上报国家、患者性别、用药适应证、不良反应类型及严重程度。结果2014年1月至2022年3月，传统紫杉醇制剂、紫杉醇脂质体制剂、白蛋白结合型紫杉醇及多西他赛的不良反应报告数分别为71 926条、81 921条、56 811条、70 513条；前3种药物的不良反应多由医生上报，其次为其他医务人员，多西他赛不良反应的上报人员中医生、其他医务人员、患者或非医务人员的占比相差不大。4种药物不良反应的上报国家以日本为主，其不良反应多见于女性患者，上报的不良反应多为危及生命、死亡、住院等严重不良反应。传统紫杉醇制剂、紫杉醇脂质体制剂、白蛋白结合型紫杉醇的主要适应证为乳腺癌、卵巢癌、非小细胞肺癌，多西他赛的主要适应证为乳腺癌、转移性乳腺癌、前列腺癌。结论基于OpenFDA数据库检索的传统紫杉醇制剂、紫杉醇脂质体制剂、白蛋白结合型紫杉醇及多西他赛的适应证和不良反应与我国相关药物说明书基本一致。临床治疗时应密切关注这些药物的不良反应，必要时开展药学监护，促进临床合理用药。

ObjectiveTo analyze the occurrence of adverse reactions of 4 kinds of paclitaxel antitumor drugs based on the US Food and Drug Administration Public Data Open Project (OpenFDA) database. MethodsThe adverse reaction reports of traditional paclitaxel preparations, paclitaxel liposome preparations, albumin-bound paclitaxel, and docetaxel from January 2014 to March 2022 were retrieve from the OpenFDA database. The number of adverse reaction reports, occupation of reporting personnel, country of reporting, gender of patients, indication of medication, and type and severity of adverse reactions of these 4 kinds paclitaxel antitumor drugs were analyzed through the use of interactive charts plate to extract relevant data and charts. ResultsFrom January 2014 to March 2022, there were 71 926, 81 921, 56 811, and 70 513 adverse reaction reports of traditional paclitaxel preparations, paclitaxel liposome preparations, albumin-bound paclitaxel, and docetaxel, respectively; in addition, adverse reactions of the 3 former drugs were mainly reported by physicians, followed by other medical personnel. There was little difference in proportion between physicians, other medical personnel, patients, and non-medical personnel in the reporting personnel of docetaxel adverse reaction. The reporting country of 4 kinds of drugs was mainly Japan, and their adverse reactions were mainly found in female patients, adverse reactions reported were serious adverse reactions with respect to life-threatening, death, and hospitalization, etc. Main indications of traditional paclitaxel preparations, paclitaxel liposome preparations, albumin-bound paclitaxel were breast cancer, ovarian cancer, and non-small cell lung cancer, and main indications of docetaxel were breast cancer, metastasis of breast cancer, and prostate cancer. ConclusionIndications and adverse reactions of traditional paclitaxel preparations, paclitaxel liposome preparations, albumin-bound paclitaxel, and docetaxel retrieved based on OpenFDA database were basically consistent with relevant drug instructions in China. It is suggested to pay close attention to adverse reactions of these drugs in clinical treatment, when it is necessary, pharmaceutical surveillance should be carried out to promote clinical rational application of drugs.