目的 调查2020—2021年徐州市中心医院抗肿瘤药物严重不良反应（ADR）发生情况，并分析相关危险因素。方法 回顾性调查徐州市中心医院2020年1月—2021年12月抗肿瘤药物严重ADR患者一般情况、抗肿瘤药物种类及分布、严重ADR的发生时间和给药途径、累及系统或器官以及严重程度分布情况。采用单因素和多因素Logistic回归分析影响抗肿瘤药物严重不良反应发生的相关因素。结果 119例患者共接受538例次抗肿瘤药物治疗，共90例患者在化疗过程发生195例次严重ADR，其中男性39例发生75例次严重ADR，女性51例发生120例次严重ADR。严重ADR以累及血液系统和消化系统最多，分别为107例次（54.87%）和49例次（25.13%）；Ⅲ级和Ⅳ级ADR分别为136例次（69.74%）和59例次（30.26%）。单因素分析结果显示，ADR和非ADR组患者平均年龄、性别、合并肝功能损害、合并肾功能损害、合并慢性病、单次给药、给药途径等存在显著差异（P＜0.05）。Logistic回归分析发现，年龄、性别、肝功能损害、肾功能损害、合并慢性病、单次给药、给药途径是造成肿瘤患者发生抗肿瘤药物严重ADR的危险因素（P＜0.05）。结论 对于合并风险因素的肿瘤患者需在给予抗肿瘤药物治疗前进行严重ADR综合评估和药师咨询，制定合理用药方案，并在治疗过程中应监测血药浓度和严重ADR情况，以达到减少严重ADR发生和减轻其程度的目的。

Objective To investigate the serious ADR of antineoplastic drugs in Xuzhou Central Hospital from 2020 to 2021, and to analyze the relevant risk factors. Methods The general situation, types and distribution of antineoplastic drugs, occurrence time and route of severe ADRs, involved systems or organs, and distribution of severe ADRs were retrospectively investigated in Xuzhou Central Hospital from January 2020 to December 2021. Univariate and multivariate Logistic regression were used to analyze the factors influencing the occurrence of serious adverse reactions of antineoplastic drugs. Results 119 patients received 538 cases of chemotherapy and anti-tumor drugs. A total of 90 patients had 195 cases of serious ADR during chemotherapy. 39 male patients had 75 cases of serious ADR, and 51 female patients had 120 cases of serious ADR. The most serious ADR involved the blood system and digestive system, 107 (54.87%) and 49 (25.13%) respectively. Class III and class IV ADR were 136 (69.74%) and 59 (30.26%) respectively. Univariate analysis showed that there were significant differences between ADR and non-ADR groups in average age, gender, combined liver function impairment, combined renal function impairment, combined chronic disease, single dose and route of administration (P < 0.05). Logistic regression analysis showed that age, gender, liver function damage, renal function damage, combined with chronic diseases, single administration, and route of administration were the risk factors for serious ADR of antineoplastic drugs in tumor patients (P < 0.05). Conclusion For cancer patients with risk factors, a comprehensive assessment of serious ADR and pharmacist consultation should be conducted before antineoplastic drug treatment, rational drug use plan should be formulated, and blood drug concentration and serious ADR should be monitored during treatment, so as to reduce the occurrence and degree of serious ADR.

R979.1