Grohmann R, Ströbel C, Rüther E, Dirschedl P, Helmchen H, Hippius H, Müller-Oerlinghausen B, Schmidt L G, Wolf B
Psychiatric Department of the Ludwig-Maximilian University, Munich, Germany.
Pharmacopsychiatry. 1993 May;26(3):84-93. doi: 10.1055/s-2007-1014348.
The AMUP study (AMUP = Arzneimittelüberwachung in der Psychiatrie (Drug Monitoring in Psychiatry)) was conducted from 1979 to 1989 in order to provide for a systematic and standardized assessment of all adverse reactions to psychotropic drugs under the conditions of routine clinical treatment at two psychiatric hospitals. This paper presents data from the AMUP study on the type and frequency of adverse psychic reactions to psychotropic drug groups and relevant single drugs. Psychic ADR leading to drug discontinuation were observed in 4.5% of 15,264 inpatients monitored over an eight-year period. Only neurological ADR were more frequent (4.9%). Neuroleptics and antidepressants were involved with similar frequencies in ADR that were at least "probably" drug-related (3.3 and 3.5%). Lithium salts and benzodiazepines were only rarely involved in psychic ADR. Toxic delirium (1.0%), agitation (0.9%), and sedation (0.8%) were the most frequent single events, usually rated as "probably" drug-related. Depression and psychotic states were next in frequency, but judged as only "possibly" drug-related in a considerable proportion of cases. Haloperidol, the most common high-potency neuroleptic, was imputed mainly for depression, sedation, agitation, and (malignant) neuroleptic syndrome; with medium-potency perazine, toxic delirium and sedation prevailed; among the most common antidepressants, amitriptyline was above all connected with toxic delirium, while with clomipramine agitation predominated. The paper discusses the particular difficulties encountered in the field of psychic ADR in psychiatric patients regarding causality assessment, and emphasizes the need for continuous ADR assessment studies including state hospitals.
AMUP研究（AMUP = 精神病学药物监测）于1979年至1989年开展，目的是在两家精神病医院的常规临床治疗条件下，对精神药物的所有不良反应进行系统和标准化评估。本文介绍了AMUP研究中关于精神药物组及相关单一药物的不良精神反应类型和频率的数据。在八年期间监测的15264名住院患者中，有4.5%出现了导致停药的精神性药物不良反应。只有神经方面的药物不良反应更为常见（4.9%）。抗精神病药和抗抑郁药在至少“很可能”与药物相关的不良反应中出现的频率相似（分别为3.3%和3.5%）。锂盐和苯二氮䓬类药物很少引发精神性药物不良反应。中毒性谵妄（1.0%）、激越（0.9%）和镇静（0.8%）是最常见的单一事件，通常被评定为“很可能”与药物相关。抑郁和精神病状态的频率次之，但在相当一部分病例中被判定为“可能”与药物相关。最常用的高效能抗精神病药氟哌啶醇主要引发抑郁、镇静、激越和（恶性）抗精神病药综合征；中效能的奋乃静则以中毒性谵妄和镇静为主；在最常用的抗抑郁药中，阿米替林首先与中毒性谵妄有关，而氯米帕明则以激越为主。本文讨论了在评估精神病患者精神性药物不良反应因果关系方面遇到的特殊困难，并强调需要开展包括国立医院在内的持续药物不良反应评估研究。
