摘要
目的了解小分子蛋白激酶抑制剂药品不良反应(ADR)的发生特点。方法回顾性分析医院2018年1月至2021年12月上报国家药品不良反应监测中心的有关小分子蛋白激酶抑制剂的ADR报告,对患者性别、年龄、原患疾病、药品品种、上报主体,以及ADR发生时间、累及系统/器官、临床表现、治疗及转归等进行统计与分析,根据《药品不良反应报告和监测管理办法》对ADR的关联性和严重程度分级进行评价。结果共收集到113份ADR报告,涉及患者113例,发生ADR 121例次。其中,男女性别比为1.26∶1,年龄≥61岁83例(73.45%);报告主体为医师93例(82.30%);使用9种小分子蛋白激酶抑制剂,阿帕替尼致ADR 59例(52.21%);ADR发生在用药后1个月内91例(80.53%);主要累及皮肤及其附件33例次(27.27%)和消化系统29例次(23.97%);关联性评价为可能33份(29.20%),很可能73份(64.60%),肯定7份(6.19%);停药或对症处理后痊愈或好转93例(82.30%);新的及严重ADR表现为流泪异常、皮疹各1例(0.88%),Ⅳ级血小板减少2例(1.77%)。结论临床使用小分子蛋白激酶抑制剂时,应注意患者皮肤及其附件损害、消化系统损害等的发生;同时,临床药师应加强宣教,早识别、早干预,提高患者治疗的依从性和有效性。
Objective To understand the characteristics of adverse drug reactions(ADRs)induced by small molecule protein kinase inhibitors.Methods The ADR reports related to small molecule protein kinase inhibitors reported by hospitals to the National Center for Adverse Drug Reaction Monitoring from January 2018 to December 2021 were retrospectively and statistically analyzed from the patients'gender,age,primary disease,drug variety,reporting subject,occurrence time,system/organ,clinical manifestations,treatment and outcome.According to Adverse Drug Reaction Reporting and Monitoring Management Measure,the correlation and severity of ADR were evaluated.Results A total of 113 ADR reports were collected,involving 113 patients and 121 occurrences of ADR.Among them,the ratio of male to female was 1.26∶1,83 patients(73.45%)were aged 61 years or older,and 93 cases(82.30%)were reported by physicians.Nine types of small-molecule protein kinase inhibitors were used,and 59 cases(52.21%)were induced by apatinib.A total of 91 cases(80.53%)occurred within one month after medication.A total of 33 cases(27.27%)mainly involved the skin and its accessories and 29 cases(23.97%)mainly involved the digestive system.The correlation evaluation showed that there were 33 possible cases(29.20%),73 very possible cases(64.60%),and seven positive cases(6.19%).A total of 93 cases(82.30%)recovered or improved after drug withdrawal or symptomatic treatment.The new and severe ADR manifestations were abnormal tearing in one case(0.88%),rash in one case(0.88%),and gradeⅣthrombocytopenia in two cases(1.77%).Conclusion During the course of treatment with small molecule protein kinase inhibitors in the clinic,attention should be paid to the occurrence of the damage of skin and its accessories,and digestive system.Meanwhile,clinical pharmacists should strengthen education to identify and intervene the case earlier,and improve patients'compliance and effectiveness of the treatment.
作者
戴丽
王凤玲
邢海燕
汪星辉
孟祥云
DAI Li;WANG Fengling;XING Haiyan;WANG Xinghui;MENG Xiangyun(The Second People's Hospital of Hefei,Hefei,Anhui,China 230011)
出处
《中国药业》
CAS
2023年第17期125-128,I0001,共5页
China Pharmaceuticals
基金
国家自然科学基金青年科学基金[82003849]。
关键词
小分子蛋白激酶抑制剂
药品不良反应
用药监护
small molecule protein kinase inhibitors
adverse drug reactions
medication monitoring
