GCP药师在抗肿瘤药物临床试验配置管理中的作用  

The Role of GCP Pharmacists in the Management of Clinical Trial Configuration of Anti-tumor Drugs

作　　者：马雁 汪丰 MA Yan;WANG Feng(Department of Pharmacy,Fudan University Shanghai Cancer Center,Department of Oncology,Shanghai Medical College,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属肿瘤医院药剂科,复旦大学上海医学院肿瘤学系,上海200032

出　　处：《生物医学工程学进展》2024年第3期234-237,共4页Progress in Biomedical Engineering

基　　金：吴阶平医学基金会(课题编号:320.6750.2023-10-6)。

摘　　要：目的临床试验中抗肿瘤药物的配置与普通药物不同。近年来,抗肿瘤新药临床试验越来越多,在试验过程中,抗肿瘤药物的配置管理工作也越来越重要。该文主要探讨GCP药师在Ⅱ期、Ⅲ期抗肿瘤药物临床试验配置管理中的作用,以期为同行提供经验参考。方法回顾2023年1—11月我院Ⅱ期、Ⅲ期抗肿瘤药物临床试验中的冲配工作,总结GCP药师参与Ⅱ期、Ⅲ期临床试验产生的积极作用。结果2023年1—11月的所有在研临床试验配置工作显示:①冲配临床试验药物4464袋,没有发生因冲配错误导致用药延迟的事件;②GCP药师拦截次数共19次,主要涉及药物剂量错误、冲配表单不规范等;③共发生不良反应事件314次,其中III度、IV度不良事件83次,发生次数最多的不良反应主要有眼科毒性、中性粒细胞数降低、血小板数降低及白细胞数降低等,涉及的药物主要有抗体偶联药物、紫杉醇、顺铂等;④GCP药师不断优化工作流程,制定相关SOP及标准化配置表单。结论GCP药师参与抗肿瘤药物临床试验配置管理,在方案审核、药物配置规范执行、人员防护、不良反应监测等各环节都能发挥积极的作用。同时他们可以极大地提高配置效率,有效保证输液质量,保障抗肿瘤药物临床试验用药安全。Objective The configuration of anti-tumor drugs in clinical trials is different from that of ordinary drugs.In recent years,there have been more and more clinical trials of new anti-tumor drugs,and the management of the configuration of anti-tumor drugs during the trial process has become increasingly important.This article mainly explores the role of GCP pharmacists in drug configuration management in phase II and III anti-tumor clinical trials,in order to provide experience reference for peers.Methods Review the preparation of anti-tumor drugs in phase II and III clinical trials of our hospital from January 2023 to November 2023,and summarize the positive effects of GCP pharmacists participating in phase II and III clinical trials.Results All ongoing clinical trial configuration work in the first 11 months of 2023 showed that:①4464 bags of clinical trial drugs were dispensed without any incidents of medication delay caused by dispensing errors;②GCP Pharmacists intercepted a total of 19 times,mainly involving errors in drug dosage and non-standard preparation forms;③A total of 314 adverse reactions occurred with anti-tumor drugs,including 83 grade III and IV adverse events.The most frequent adverse reactions were mainly ophthalmic toxicity,decreased neutrophil count,decreased platelet count,and decreased white blood cell count.The drugs involved mainly included antibody conjugated drugs,paclitaxel,cisplatin,etc.;④GCP pharmacists continuously optimize workflow,develop relevant SOPs,and standardize configuration forms.Conclusion GCP pharmacists participate in the management of infusion configuration in clinical trials of anti-tumor drugs,playing a positive role in various aspects such as scheme review,standardized drug configuration,personnel protection,and adverse reaction monitoring.At the same time,they greatly improve the efficiency of configuration,effectively ensure infusion quality,and ensure the safety of clinical trials of anti-tumor drugs.

关 键 词：GCP药师 Ⅱ期、Ⅲ期临床试验 抗肿瘤药物配置 

分 类 号：R9[医药卫生—药学]