Lensker Phyllis, Cuba Lisa, Gessner Katja, Fromm Martin F, Dörje Frank, Metzler Markus
Pharmacy Department, Universitätsklinikum Erlangen and Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich- Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
PLoS One. 2024 Dec 5;19(12):e0315077. doi: 10.1371/journal.pone.0315077. eCollection 2024.
Oral antitumour therapeutics (OAT) are increasingly used due to improvements in outcomes and their convenient application. However, complex intake regimens pose several challenges. The randomised AMBORA trial (Medication Safety With Oral Antitumour Drugs) demonstrated highly positive outcomes of a clinical pharmacological/pharmaceutical care program for adults treated with numerous OAT, but comparable concepts in paediatrics are lacking so far.
We used a parallel mixed-methods approach to develop a tailored pharmacological/pharmaceutical care program for OAT in paediatrics (youngAMBORA). We combined a quantitative analysis of tumour entities and used OAT in a paediatric cancer centre with a qualitative survey for patients, caregivers, and healthcare professionals to identify particular demands and educational needs (e.g., application problems, side effects).
Leukaemia (77/315) and antimetabolites (95/151) were the most frequently observed entity and OAT, respectively. Of 22 surveyed patients, 81.8% wanted to be involved in oral medication education. Compared to caregivers, significantly more healthcare professionals graded the three most common application problems to be challenging ('Smell/taste': 32/36 vs. 23/42, p = 0.001; 'Refusal of intake': 31/36 vs. 16/42, p<0.001; 'Swallowing problems': 28/36 vs. 21/42, p = 0.011). We identified nine relevant side effects, of which two ('Skin dryness', 'Taste changes') were not included in 15 previously published core side effects of the Common Terminology Criteria of Adverse Events (CTCAE) item library.
Based on the present findings, the tailored youngAMBORA care program will include: 1) counselling sessions for classic and targeted OAT, 2) child-friendly support with drug application, and 3) systematic evaluation of 17 relevant side effects from patients' and caregivers' points of view including age-appropriate information material.
由于治疗效果的改善及其应用便捷，口服抗肿瘤疗法（OAT）的使用越来越广泛。然而，复杂的服药方案带来了诸多挑战。随机AMBORA试验（口服抗肿瘤药物的用药安全）显示，针对接受多种OAT治疗的成年人的临床药理学/药学护理计划取得了非常积极的成果，但目前儿科领域缺乏类似的方案。
我们采用平行混合方法，为儿科OAT制定了一个量身定制的药理学/药学护理计划（youngAMBORA）。我们结合了对肿瘤实体的定量分析以及在一家儿科癌症中心使用的OAT，并对患者、护理人员和医护人员进行了定性调查，以确定特殊需求和教育需求（如用药问题、副作用）。
白血病（77/315）和抗代谢药物（95/151）分别是最常观察到的肿瘤实体和OAT。在22名接受调查的患者中，81.8%希望参与口服药物教育。与护理人员相比，更多的医护人员认为三个最常见的用药问题具有挑战性（“气味/味道”：32/36对23/42，p = 0.001；“拒绝服药”：31/36对16/42，p<0.001；“吞咽问题”：28/36对21/42，p = 0.011）。我们确定了九种相关副作用，其中两种（“皮肤干燥”、“味觉改变”）未包含在先前公布的《不良事件通用术语标准》（CTCAE）项目库的15种核心副作用中。
基于目前的研究结果，量身定制的youngAMBORA护理计划将包括：1）针对经典和靶向OAT的咨询会议；2）对药物应用提供适合儿童的支持；3）从患者和护理人员的角度对17种相关副作用进行系统评估，包括提供适合年龄的信息资料。
