Schmidt L G, Grohmann R, Helmchen H, Langscheid-Schmidt K, Müller-Oerlinghausen B, Poser W, Rüther E, Scherer J, Strauss A, Wolf B
Acta Psychiatr Scand. 1984 Jul;70(1):77-89. doi: 10.1111/j.1600-0447.1984.tb01185.x.
A drug monitoring system has been established at psychiatric university hospitals in Berlin, Goettingen, and Munich since 1979 in order to investigate adverse reactions to psychotropic drugs. This report describes the system and presents results obtained over 3 years. 504 randomly selected patients were observed by Intensive Drug Monitoring; 75% of them had an adverse drug reaction (ADR) during hospitalization that was assessed as possible, probable, or definite including all grades (I-III) of severity. 5,096 other patients were monitored by Organized Spontaneous Reporting during treatment with psychotropic drugs: ADRs were responsible for drug withdrawal (severity grade III) in about 10% of them. Parkinsonism, psychomotor disturbance, akathisia, delirium, oversedation and increased transaminases were the most frequent ADRs of this kind. The relative frequency of ADRs was calculated, and ADR-profiles established for drugs most frequently withdrawn. The impact of ADRs on ongoing therapy of patients was assessed. Reliable data obtained by drug monitoring systems can be expected to aid in therapeutic decisions in patients with special risks of side effects to psychotropic drugs.
自1979年起，柏林、哥廷根和慕尼黑的大学精神病医院建立了一个药物监测系统，以调查精神药物的不良反应。本报告介绍了该系统并展示了3年期间获得的结果。通过强化药物监测观察了504名随机选择的患者；其中75%在住院期间出现了药物不良反应（ADR），这些反应被评估为可能、很可能或肯定，包括所有严重程度等级（I - III级）。另外5096名患者在接受精神药物治疗期间通过有组织的自发报告进行监测：ADR导致约10%的患者停药（严重程度III级）。帕金森症、精神运动障碍、静坐不能、谵妄、过度镇静和转氨酶升高是这类最常见的ADR。计算了ADR的相对频率，并为最常导致停药的药物建立了ADR特征。评估了ADR对患者正在进行的治疗的影响。药物监测系统获得的可靠数据有望有助于对有精神药物副作用特殊风险的患者做出治疗决策。
