Research Division, Federal Institute for Drugs and Medical Devices, Bonn, North Rhine-Westphalia, Germany.
German Center for Neurodegenerative Diseases (DZNE), Bonn, North Rhine-Westphalia, Germany.
PLoS One. 2024 Oct 10;19(10):e0311267. doi: 10.1371/journal.pone.0311267. eCollection 2024.
Pharmacogenetic testing in routine care could provide benefits for patients, doctors and statutory health insurances. Therefore, the aim of the retrospective, observational study Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der Routineversorgung (EMPAR) was to analyze the relationship between pharmacogenetic profiles, the risk of adverse drug reactions, and patients' perceptions of drug therapy in 10748 adult (≥18 years) participants in Germany.
A questionnaire was used to assess views and beliefs about medicines and participants individual perception of sensitivity to drug therapies. The questionnaire consisted of the Beliefs about Medicines Questionnaire (BMQ)-General scales (Overuse, Harm, Benefit), the Perceived Sensitivity to Medicines (PSM), Natural Remedy, and Gene Testing scales. The influence of gender, age, study collective, genotype and phenotype of relevant pharmacogenes on participant's perception were evaluated.
Overuse, PSM and Benefit scores were significantly higher among patients of the collective International Classification of Diseases and Health Related Disorders (ICD)-10 Y57.9! diagnosis, which indicates complications related to drugs, compared to the anticoagulant/antiplatelet and cholesterol-lowering drug collective. Age and gender also played a significant role in patients' perceptions, with younger patients and female participants more likely to believe in medication overuse according to the Overuse scale score compared to older and male participants. Female participants compared to male participants and the old age group compared to the young and/or middle-age subgroup, scored higher in PSM and/or Harm scales, respectively. Only a tendency of increased Harm, Overuse and PSM scores was observed in the participant group with five or more relevant actionable variants compared to subgroups with 0 up to 4 variants.
In conclusion, patients' beliefs about medicines and their drug sensitivity perceptions are influenced by various factors including age, gender, previous complications with medicines, and with some tendency also pharmacogenetic profiles. The higher association with more negative views related to treatment indicates that there is a need to target the underlying issues in affected patient groups in order to improve compliance to treatment and outcomes in routine care. Trial registration: EMPAR was registered in the German Clinical Trials Register (DRKS) on 06 July 2018 (DRKS00013909).
在常规护理中进行药物遗传学检测可能会使患者、医生和法定健康保险公司受益。因此，回顾性观察研究“代谢谱对常规治疗中药物治疗安全性的影响（EMPAR）”的目的是分析药物遗传学谱与药物不良反应风险以及 10748 名成年（≥18 岁）参与者对药物治疗的看法之间的关系。
使用问卷评估对药物的看法和信念以及参与者对药物治疗敏感性的个体感知。问卷包括药物信念问卷（BMQ）-一般量表（过度使用、伤害、益处）、药物敏感性感知量表（PSM）、天然药物和基因检测量表。评估了性别、年龄、研究群体、相关药物基因的基因型和表型对参与者感知的影响。
与抗凝/抗血小板和降胆固醇药物组相比，国际疾病分类和健康相关障碍（ICD）-10 Y57.9！诊断相关药物并发症的患者群体中，过度使用、PSM 和益处评分明显更高。年龄和性别也对患者的感知有重要影响，与年龄较大和男性参与者相比，年轻患者和女性参与者根据过度使用量表评分更有可能相信药物过度使用。与男性参与者和老年组相比，女性参与者在 PSM 和/或伤害量表中得分更高，而年轻和/或中年亚组则得分更高。与亚组 0 到 4 个相关可操作变体相比，参与者组中具有 5 个或更多相关可操作变体的组中，仅观察到伤害、过度使用和 PSM 评分增加的趋势。
总之，患者对药物的信念和他们对药物敏感性的感知受到多种因素的影响，包括年龄、性别、以前与药物相关的并发症，以及药物遗传学特征也有一定的影响。与更负面的治疗相关观点的更高关联表明，需要针对受影响的患者群体中的潜在问题，以提高常规护理中的治疗依从性和结果。
EMPAR 于 2018 年 7 月 6 日在德国临床试验注册处（DRKS）注册（DRKS00013909）。
