基于GTT的哌拉西林他唑巴坦钠ADR主动监测模型构建OA
Construction of active monitoring model for ADR of piperacillin tazobactam sodium based on GTT
基于全面触发工具(GTT)对哌拉西林钠他唑巴坦钠的药品不良反应(ADR)构建主动监测模型,旨在为医疗机构对患者使用哌拉西林钠他唑巴坦钠 ADR 主动监测和防治提供参考.参考全面触发工具白皮书中推荐的触发器条目,采用德尔菲专家咨询法(Delpji method)建立哌拉西林钠他唑巴坦钠主动监测触发器.借助 GTT 和中国医院药物警戒系统(CHPS)回顾性分析该院2024 年3 月30 日后入院至 2024 年9 月30 日前出院并使用过哌拉西林钠他唑巴坦钠的住院病历,评价 GTT 的性能并统计分析相关ADR 情况.共156 例住院患者,经人工审查,哌拉西林钠他唑巴坦钠导致不良事件的例次共计为66 次,ADRs 发生率为 42.31%(66/156).其中以临床症状的例次为 6 次,占比3.85%.不良反应以功能障碍最常见,触发器包括肝功能异常、肾功能异常指标等共74 例,占比 72.55%.同期 ADRs 自愿上报率为 6.41%(10/156),与本次主动监测模型及人工审查检出的 ADR 相比,GTT 检出率是自愿上报率的 660.00%,差异具有统计学意义(P<0.05).本研究建立的哌拉西林钠他唑巴坦钠不良反应触发器及主动监测的风险分析模型的可行性较好,可为哌拉西林钠他唑巴坦钠不良反应的主动监测以及其他药品不良反应主动监测的开展提供依据.
This paper aimed to construct an active monitoring model for adverse drug reactions(ADRs)of piperacillin sodium and tazobactam sodium based on the comprehensive trigger tool(GTT),and to provide reference for medical institutions to carry out active monitoring,prevention and treatment of ADRs of this drug.Referring to the trigger items recommended in the white paper of the comprehensive trigger tool,established the ADR active monitoring trigger of piperacillin sodium and tazobactam sodium by Delphi method.With the help of GTT and Chinese Hospital Pharmacovigilance System(CHPS),retrospectively analyzed the inpatient medical records of patients who used piperacillin sodium and tazobactam sodium in a hospital from March 30,2024 to September 30,2024,evaluated the performance of GTT,and statistically analyzed the occurrence of related ADRs.A total of 156 hospitalized patients were included.After manual review,there were 66 cases of adverse events caused by piperacillin sodium and tazobactam sodium,with an ADR incidence rate of 42.31%(66/156).Among them,6 cases were clinical symptom-related ADRs,accounting for 3.85%.Organ dysfunction-related ADRs were the most common,and triggers including abnormal liver function and renal function indicators were triggered 74 times,accounting for 72.55%.The voluntary reporting rate of ADRs in the same period was 6.41%(10/156).Compared with the ADRs detected by manual review,the detection rate of GTT was 660.00%of the voluntary reporting rate,with a statistically significant difference(P<0.05).The ADR trigger and active monitoring model of piperacillin sodium and tazobactam sodium established in this paper has good feasibility,which can provide reference for the active monitoring of ADRs of this drug and other drugs.
王昌盛;李冰;洪燕萍;黎锦健;赖莎
广东药科大学附属第一医院 临床药学重点专科,广州 510080广东药科大学 药学院,广州 510006广东药科大学附属第一医院 临床药学重点专科,广州 510080广东药科大学附属第一医院 临床药学重点专科,广州 510080广东药科大学附属第一医院 临床药学重点专科,广州 510080
医药卫生
药品不良反应全面触发工具哌拉西林钠他唑巴坦钠主动监测德尔菲法药物警戒
adverse drug reactionscomprehensive trigger toolpiperacillin sodium and tazobactam sodiumactive monitoringdelphi methodpharmacovigilance
《哈尔滨商业大学学报(自然科学版)》 2026 (3)
271-278,8
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