中国临床药学杂志

目的 分析2023至2024年铂类药物联合紫杉类药物在抗肿瘤治疗中的不良反应报告，促进不良反应的规范上报，明确个体化用药的药学监护重点。方法 分别提取2023年和2024年上报的铂类联合紫杉类药物引起的不良反应81例次（涉及60例病例）和72例次（涉及63例病例）。对2023年不良反应的临床表现进行归纳和分析，并进一步分析2024年不良反应的持续改进情况。结果 2023年60例病例涉及的81例次不良反应包括血液系统毒性反应65例次（占80.25%），消化系统不良反应13例次（占16.05%），其他不良反应3例次（占3.70%）。67.90%的不良反应临床表现由卡铂+紫杉醇脂质体化疗引起，其中骨髓抑制28例次（占50.91%），贫血11例次（占20.00%），肝损伤8例次（占14.55%），其他类型不良反应8例次（占14.55%）。顺铂+紫杉醇脂质体方案骨髓抑制的发生率也较高（12.35%）。含多西他赛的方案易引发白细胞和中性粒细胞减少。卡铂+紫杉醇脂质体和顺铂+紫杉醇脂质体的骨髓抑制的发生率比较差异无统计学意义（P > 0.05）。与2023年比较，2024年上报的不良反应数量有所增加。新增4种不良反应临床表现：寒战胸闷、粒细胞缺乏、眼异常和水疱。2024年临床药师加强了对化疗患者的药学监护，骨髓抑制、贫血、肝损伤、白细胞减少和中性粒细胞减少的发生率有所下降，恶心呕吐的发生率有所上升。多西他赛引起的不良反应减少，新增洛铂+紫杉醇脂质体引起的血液系统毒性2例。2个年度卡铂+紫杉醇脂质体引起骨髓移植的发生率比较差异无统计学意义（P > 0.05）。结论 药学人员应注意监护铂类联合紫杉类药物化疗后的不良反应，特别是血液系统毒性和消化系统反应，及时规范上报。在不良反应发生后，应结合患者情况积极处理，提高用药安全性。

AIM To analyze the adverse drug reaction(ADR) reports associated with platinum-paclitaxel combination chemotherapy in anti-tumor treatment from 2023 to 2024, promote standardized ADR reporting, and clarify key pharmacological monitoring priorities for individualized medication safety. METHODS A total of 81 ADRs(involving 60 patients) and 72 ADRs(involving 63 patients) associated with platinum-paclitaxel combination chemotherapy reported in 2023 and 2024 were extracted respectively. The clinical manifestations of ADRs in 2023 were summarized and analyzed, and further analysis was conducted on the continuous improvement of ADRs in 2024. RESULTS A total of 60 patients experienced adverse reactions following anti-tumor treatment with platinum-paclitaxel combination chemotherapy in 2023. There were 81 signs, which included hematological toxicity(65 cases, 80.25%), gastrointestinal adverse reactions(13 cases, 16.05%), and other adverse reactions(3 cases, 3.70%). The highest incidence of adverse reactions(67.90%) was observed in patients treated with carboplatin combined with paclitaxel liposomes, which related to bone marrow suppression(28 cases, 50.91%), anemia(11 cases, 20.00%), hepatic injury(8 cases, 14.55%), and other adverse reactions(8 cases, 14.55%). The chemotherapy regimen of cisplatin combined with paclitaxel liposomes led to a high incidence of myelosuppression(12.35%). Docetaxel treatment was associated with an increased risk of leukopenia and neutropenia. There was no significant difference between the myelosuppression caused by chemotherapy regimens of carboplatin liposome or cisplatin combined with paclitaxel liposome(P > 0.05). Compared with 2023, further analysis revealed an increase in the number of ADRs. Four new clinical manifestations of adverse reactions(chills, chest tightness, granulocytopenia, eye abnormalities and blisters) were reported. In 2024, clinical pharmacists strengthened the pharmaceutical care for chemotherapy patients. The adverse reactions of bone marrow suppression, anemia, liver injury, leukopenia and neutropenia in patients decreased, but the adverse reactions of nausea and vomiting increased. The number of adverse reactions caused by docetaxel decreased, and there were 2 new cases of ADR caused by carboplatin combined with paclitaxel liposome. There was no significant difference in the incidence of bone marrow ADR caused by carboplatin combined with paclitaxel liposomes in the 2 years(P > 0.05). CONCLUSION Pharmacists should monitor ADRs following platinum-paclitaxel chemotherapy regimens, with particular attention to haematological toxicity and gastrointestinal reactions. Such reactions must be reported promptly and in accordance with established protocols. Upon occurrence of ADRs, proactive management tailored to the patient's condition should be implemented to enhance medication safety.