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临床试验中迟发性运动障碍和锥体外系反应的评估。临床试验评估协作工作组。

Assessment of EPS and tardive dyskinesia in clinical trials. Collaborative Working Group on Clinical Trial Evaluations.

出版信息

J Clin Psychiatry. 1998;59 Suppl 12:23-7.

PMID:9766616
Abstract

The incidence of acute extrapyramidal symptoms (EPS)--akathisia, dystonia, and parkinsonism--associated with traditional antipsychotics varies, but most researchers agree that neuroleptic-induced EPS occur in 50% to 75% of patients who take conventional antipsychotics. Atypical antipsychotics were developed to widen the therapeutic index and to reduce EPS. Although the mechanisms are unclear, the risk of EPS is less with the novel antipsychotics than with conventional drugs, and agents that produce low levels of acute EPS are likely to produce less tardive dyskinesia. Nevertheless, clinicians should exercise caution when comparing data from investigations of the novel antipsychotics and, until long-term data become available, should administer the new drugs at doses below the EPS-producing level.

摘要

与传统抗精神病药物相关的急性锥体外系症状(EPS)——静坐不能、肌张力障碍和帕金森症——的发生率各不相同,但大多数研究人员一致认为,服用传统抗精神病药物的患者中,有50%至75%会出现抗精神病药物诱发的EPS。非典型抗精神病药物的研发旨在扩大治疗指数并减少EPS。尽管其机制尚不清楚,但新型抗精神病药物引发EPS的风险低于传统药物,而且产生低水平急性EPS的药物引发迟发性运动障碍的可能性也较小。然而,临床医生在比较新型抗精神病药物的研究数据时应谨慎,在长期数据可得之前,应以低于产生EPS水平的剂量使用这些新药。

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