抗肿瘤药物不良反应信息评价与分析

Evaluation and analysis of adverse reactions of antineoplastic agents

目的:评价药物不良反应(ADR)报告质量,分析抗肿瘤药物使用中发生ADR患者临床资料,为指导临床合理用药提供参考。方法:收集某院2015年1月1日-12月31日上报的住院患者ADR报告,收集2014年、2015年住院患者使用抗肿瘤药发生ADR肿瘤患者病历资料。符合纳入标准的ADR报告,按患者性别、药品种类、给药途径、ADR类型进行回顾性分析。对2014年、2015年住院患者使用抗肿瘤药发生ADR病历资料进行危险因素分析。结果:2015年合格ADR报告共1 053份,男487例(46.25%)、女566例(53.75%);药品种类涉及20类,排名前5位的分别是心血管系统药、抗微生物药、电解质酸碱平衡及营养药、抗肿瘤用药、诊断用药;静脉滴注给药引发ADR例数最多,共529例(50.24%);新的ADR有30例(2.80%),严重ADR有90例(8.39%)。2014年和2015年抗肿瘤药合格ADR报告186例,严重ADR有25例(13.44%)。ADR主要临床表现为恶心呕吐、骨髓抑制等。抗肿瘤药致ADR发生的单因素分析影响因素共有3个指标,分别是:中性粒细胞数、血小板数、谷草转氨酶量;抗肿瘤药致ADR发生的多因素分析危险因素共有2个指标,分别是:中性粒细胞数的降低和血小板数的减少。结论:医疗机构需重视ADR监测、加强上报ADR报告质量管理;临床观察用药过程中患者的临床表现、临床指标、抗肿瘤药检测危险因素,以便及时得到预警信息,为合理指导用药,保障用药安全服务。

OBJECTIVE To evaluate adverse drug reaction（ADR）and analyze the risk factors of antineoplastic agents for rational drug use.METHODS ADR qualified reports were selected for evaluation by clinical retrospective review assay according to sex,dosing,pharmacological categories,ADR severity information in inpatients from January 1 to December 31,2015.ADR qualified reports were selected for risk factors and analyzed by logistic regression using antineoplastic agents in inpatients in 2014 and 2015.RESULTS In total,the 1 053 patients qualified ADR reports in 2015 were identified in 20 pharmacological categories,in which the top five categories were cardiovascular,anti-microorganism,electrolyte acid-base balance and nutritional,antineoplastic agents,and diagnosis medicine.In the 1 053 reports,there were 487（46.25%）in male patients and 566（53.75%）in female patients.The maximum occurrence of ADR happened in 529 cases（50.24%）by intravenous drop infusion.There were 30（2.80%）new ADRs,including 90（8.39%）severe ADR cases.Antineoplastic agents qualified ADR reports in 2014 and 2015 year were 186 cases,in which severe ADR reports were 25（13.44%）.The main clinical features of the ADRs were nausea,vomiting and myelosuppression.In addition,the risk factors of ADRs of antineoplastic agents were the reduction of neutrophil and platelet,and the increase of glutamic oxalacetic transaminase.CONCLUSION It is critical to evaluate ADRs in clinical practice.The medical staff should pay attentions to the quality of ADR reports.Observations should focus on the clinical manifestations,especially clinical indications of antineoplastic agents and detection of risk factors during treatment in order to timely access to early warning,rational drug guidance and ADR occurrence reduction.