Luedecke Daniel, Schöttle Daniel, Karow Anne, Lambert Martin, Naber Dieter
Department of Psychiatry and Psychotherapy, Centre of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany,
CNS Drugs. 2015 Jan;29(1):41-6. doi: 10.1007/s40263-014-0216-9.
Second-generation antipsychotics (SGAs) are a mainstay in the treatment of patients with schizophrenia. However, continuity in intake of the prescribed medication has been one of the greatest challenges in these patients. One option to improve medication adherence is to prescribe depot or long-acting injectable formulations (LAIs) of antipsychotics. Following risperidone, several other SGAs have been introduced as LAIs. Olanzapine pamoate, paliperidone palmitate, and aripiprazole are the new-generation LAIs, which are available for 2- to 4-week intervals of application in many countries. The literature shows a clear advantage of these drugs over placebo regarding symptom reduction and relapse prevention. LAIs show a similar safety profile to oral formulations of the relevant drug, with the exception of olanzapine pamoate, which can lead to rare cases of post-injection delirium/sedation syndrome (PDSS). PDSS is characterized by heavy sedation (possibly including coma) and/or delirium after injection. During PDSS events, patients show higher plasma concentrations of olanzapine, leading to the assumption that unintended partial intravascular injection or blood vessel injury during the injection is causative of PDSS. Therefore, a risk-management plan proposing an observation period of 3 h was introduced. In August 2013, a new proposal by the European Medicines Agency terminated the requirement to accompany these patients to their next destination, although this requirement remains in place according to US FDA recommendations.
第二代抗精神病药物（SGAs）是治疗精神分裂症患者的主要药物。然而，这些患者坚持服用规定药物一直是最大的挑战之一。提高药物依从性的一种选择是开具长效注射用抗精神病药物制剂。继利培酮之后，其他几种SGAs也已作为长效注射剂推出。奥氮平棕榈酸酯、帕利哌酮棕榈酸酯和阿立哌唑是新一代长效注射剂，在许多国家可每2至4周使用一次。文献表明，这些药物在减轻症状和预防复发方面比安慰剂具有明显优势。长效注射剂与相关药物的口服制剂具有相似的安全性，奥氮平棕榈酸酯除外，它可能导致罕见的注射后谵妄/镇静综合征（PDSS）。PDSS的特征是注射后出现深度镇静（可能包括昏迷）和/或谵妄。在PDSS事件中，患者的奥氮平血浆浓度较高，这导致人们认为注射过程中意外的部分血管内注射或血管损伤是PDSS的病因。因此，引入了一项风险管理计划，建议观察期为3小时。2013年8月，欧洲药品管理局的一项新提议取消了陪同这些患者前往下一个目的地的要求，不过根据美国食品药品监督管理局的建议，这一要求仍然有效。
