某院419例药品不良反应报告分析

周伟 马天宇 娜荣华 代亚军

[摘要]目的探讨锡林郭勒盟中心医院（我院）419例药品不良反应（ADR）的发生特点，促进临床合理用药。方法回顾性分析我院2020年度上报至国家 ADR 监测中心的419例 ADR 报告，对患者的性别、年龄、给药途径、药物类别、ADR 涉及的器官/系统及临床表现进行统计分析。结果419例 ADR 中，女性患者数量（224例）高于男性（195例）;60～69岁年龄段的患者 ADR 发生率最高（111例，占26.49%）;口服给药途径 ADR 发生比例最高（199例，占47.49%）;ADR 涉及药物品种主要为抗感染药物（116例，占27.69%），其次为抗肿瘤药物（80例，占19.33%）;ADR 累及的器官/系统以消化系统最常见（136例，占29.82%），主要表现为恶心、呕吐等胃肠道反应。结论抗感染药物及抗肿瘤药物是 ADR 监测重点药物类别，老年人是 ADR 重点监测人群，口服给药是 ADR 重点监测给药途径，恶心、呕吐等消化道反应是提示 ADR 发生的重要信号。

[关键词]药品不良反应;监测;用药安全;风险评估

[中图分类号] R95  [文献标识码] A   [文章编号]2095-0616（2021）24-0151-05

Analysis of ADR reports of 419 cases in a hospital

ZHOU  Wei    MA  Tianyu    NA  Ronghua    DAI  Yajun

Department of Pharmacy， Central Hospital of Xilingol League， Inner Mongolia， Xilinhot 026000， China

[Abstract] Objective To explore the characteristics of adverse drug reactions （ADR） in 419 cases in Xilingol League Central Hospital （our hospital）， and to promote clinical rational drug use. Methods Reports of 419 cases of ADR in our hospital in 2020 reported to the National ADR Monitoring Center were analyzed retrospectively， and the gender， age， route of administration， drug category， organs/systems involved in ADR and clinical manifestations of patients were analyzed statistically. Results Among 419 cases with ADR， the number of female patients （224 cases） was more than that of male patients （195 cases）. Patients aged 60-69 years old had the highest incidence of ADR （111 cases， accounting for 26.49%）. The proportion of ADR related to oral administration was the highest （199 cases， accounting for 47.49%）. The main drug varieties involved in ADR were anti-infective drugs （116 cases， accounting for 27.69%）， followed by anti-tumor drugs （80 cases， accounting for 19.33%）. The digestive system （136 cases， accounting for 29.82%） was the most common organ/system involved in ADR， and the main manifestations were gastrointestinal reactions such as nausea and vomiting. Conclusion Anti-infective drugs and anti-tumor drugs are the key drug categories in ADR monitoring， the elderly are the key population in ADR monitoring， oral administration is the key administration route in ADR monitoring， and digestive tract reactions such as nausea and vomiting are important signals of the occurrence of ADR.

[Key words] Adverse drug reactions; Monitoring; Medication safety; Risk assessment

藥品在疾病诊断、治疗和预防等领域为人类健康带来益处[1]。但在临床疾病治疗过程中，常因药品不良反应（adverse drug reaction， ADR）而影响治疗效果，甚至可能对患者造成生命威胁[2]。为了解锡林郭勒盟中心医院（我院）ADR 情况，笔者回顾性分析我院2020年度上报至国家 ADR 监测中心的419例 ADR 情况，包括患者的一般情况、ADR 相关的给药途径及药品种类、ADR 累及器官/系统和临床表现等，以探讨 ADR 发生的相关因素，了解 ADR 发生的特点及规律，为临床合理、安全用药提供参考。

1资料与方法

1.1资料来源

我院2020年度上报至国家 ADR 监测系统，并经上级 ADR 监测中心审核通过的 ADR 报告。……