吉非替尼基于药动学的潜在不良药物相互作用处方分析及审方规则建立
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篇名: 吉非替尼基于药动学的潜在不良药物相互作用处方分析及审方规则建立
TITLE: Prescription investigation for potential adverse drug interactions based on pharmacokinetics of gefitinib and establishment of review rules
摘要: 目的 分析吉非替尼基于药动学的潜在不良药物相互作用(PK-pADIs),并建立相应审方规则。方法通过医院合理用药管理系统抽取我院2022年1月1日-2024年11月30日吉非替尼联合用药的门诊处方,基于Drugs.com®药物相互作用数据库鉴别处方中存在的PK-pADIs,统计具体联用药物及PK-pADIs发生例次,并根据PK-pADIs严重性分级建立审方规则。结果与结论共收集到吉非替尼联合用药处方217张,其中28张处方(12.90%)、共计28例患者存在PK-pADIs29例次,以呼吸内科处方(22张)为主;联用药物包括质子泵抑制剂(13例次)、细胞色素P4503A4(CYP3A4)强抑制剂(7例次)、H2受体拮抗剂(4例次)、CYP3A4诱导剂(3例次)、CYP2D6底物(2例次),严重性分级分别为严重、中度、严重、中度、中度。根据上述PK-pADIs严重性分级,建立审方规则4项,即吉非替尼与抑酸药物联合使用,予“人工审核”处理;吉非替尼与地塞米松、美托洛尔和CYP3A4强抑制剂联用,予“提醒”处理,并通过提醒框告知医生加强相关指标监测。临床药师需深入呼吸内科等重点临床科室加强有关吉非替尼药物相互作用知识的培训,加强针对长期使用吉非替尼患者的合理用药监测与指导,及时发现并干预PK-pADIs,提高临床用药的合理性、安全性和有效性。
ABSTRACT: OBJECTIVE To analyze the potential adverse drug interactions based on pharmacokinetics (PK-pADIs) of gefitinib, and establish its corresponding prescription review rules. METHODS Outpatient prescriptions of gefitinib combination therapy in our hospital from January 1, 2022 to November 30, 2024 were collected through rational drug software system. PK- pADIs present in the prescriptions were identified based on the Drugs.com® drug interactions database. The specific combination drugs and cases of PK-pADIs were statistically analyzed, and prescription review rules were established according to the severity classification of PK-pADIs. RESULTS & CONCLUSIONS A total of 217 prescriptions of gefitinib combination therapy were enrolled. Among them, 28 prescriptions (12.90%), involving a total of 28 patients, had 29 cases of PK-pADIs, with respiratory medicine prescriptions (22 prescriptions) being the main type. The combination drugs included proton pump inhibitors (13 cases), strong cytochrome P450 3A4 (CYP3A4) inhibitors (7 cases), H2 receptor antagonists (4 cases), CYP3A4 inducers (3 cases), and CYP2D6 substrates (2 cases). The severity classifications for these interactions were severe, moderate, severe, moderate and moderate, respectively. Based on the above severity classification of PK-pADIs, four prescription review rules had been established as follows: when gefitinib was combined with acid-suppressing drugs, it should be subject to “manual review”; when gefitinib was combined with dexamethasone, metoprolol, or strong CYP3A4 inhibitors, an “alert” should be triggered, and the physician should be informed via an alert box to strengthen the monitoring of relevant indicators. Clinical pharmacists need to conduct in-depth training on knowledge related to gefitinib drug interactions in key clinical departments such as respiratory medicine. They should strengthen the monitoring and guidance of rational drug use for patients who are on long-term gefitinib therapy, and promptly identify and intervene in PK-pADIs, thereby enhancing the rationality, safety, and effectiveness of clinical drug use.
期刊: 2025年第36卷第12期
作者: 程军;汪龙;司福国;张冠军
AUTHORS: CHENG Jun,WANG Long,SI Fuguo,ZHANG Guanjun
关键字: 吉非替尼;基于药动学的潜在不良药物相互作用;处方分析;审方规则
KEYWORDS: gefitinib; potential adverse drug interactions based on pharmacokinetics; prescription analysis; review rules
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