Abstract

Edema as an adverse drug reaction is a commonly underestimated yet potentially debilitating condition. This study analyzes the incidence of severe psychotropic drug-induced edema (e.g., edema affecting the face, legs, or multiple body parts and lasting for more than 1 week, or in any case necessitating subsequent diuretic use) among psychiatric inpatients. The cases under examination are derived from an observational pharmacovigilance program conducted in German-speaking countries (“Arzneimittelsicherheit in der Psychiatrie”, AMSP) from 1993 to 2016. Among the 462,661 inpatients monitored, severe edema was reported in 231 cases, resulting in an incidence of 0.05%. Edema occurred more frequently in women (80% of all cases) and older patients (mean age 51.8 years). Pregabalin had the highest incidence of severe edema, affecting 1.46‰ of patients treated with pregabalin, followed by mirtazapine (0.8‰). The majority of edema cases showed a positive response to appropriate countermeasures, such as dose reduction and drug discontinuation, and resolved by the end of the observation period. While most instances of drug-induced edema are reversible, they can have a significant impact on patient well-being and potentially result in decreased treatment adherence. It is, therefore, crucial to remain vigilant regarding risk-increasing circumstances during treatment with psychotropic drugs.

中文翻译：

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与精神药物治疗相关的水肿

摘要

水肿作为一种药物不良反应，是一种通常被低估但可能使人衰弱的疾病。本研究分析了精神病住院患者中严重精神药物引起的水肿（例如，水肿影响面部、腿部或身体多个部位并持续超过 1 周，或在任何情况下需要随后使用利尿剂）的发生率。接受检查的病例来源于 1993 年至 2016 年在德语国家开展的观察性药物警戒计划（“Arzneimittelsicherheit in der Psychiatrie”，AMSP）。在监测的 462,661 名住院患者中，有 231 例报告出现严重水肿，导致发病0.05%。水肿在女性（占所有病例的 80%）和老年患者（平均年龄 51.8 岁）中更常见。普瑞巴林严重水肿发生率最高，占普瑞巴林治疗患者的1.46‰，其次是米氮平（0.8‰）。大多数水肿病例对适当的对策（例如减少剂量和停药）表现出积极反应，并在观察期结束时得到缓解。虽然大多数药物引起的水肿是可逆的，但它们会对患者的健康产生重大影响，并可能导致治疗依从性下降。因此，在精神药物治疗期间对风险增加的情况保持警惕至关重要。