Gentile Salvatore
Department of Mental Health ASL Salerno, Piazza Galdi, 1 Cava de' Tirreni 84013, Salerno, Italy.
University of Naples, Medical School "Federico II", Department of Neurosciences, Psychiatry and Drug-resistance Unit, Perinatal Psychiatry, Via S. Pansini, 5 Naples 80131, Italy, Phone: +39 089 4455439, Fax: +39 089 4455440.
Horm Mol Biol Clin Investig. 2017 Jun 23;36(2):/j/hmbci.2018.36.issue-2/hmbci-2017-0004/hmbci-2017-0004.xml. doi: 10.1515/hmbci-2017-0004.
Background It has been recently suggested that second-generation antipsychotic long-acting injection (SGA-LAIs) are underutilized in clinical practice, despite that their costs significantly impact on national health system budgets. Hence, an updated analysis of safety data shown by SGA-LAIs may contribute to clarify their role in clinical practice. Materials and methods English-language, peer-reviewed articles reporting updated, primary findings on the SGA-LAI safety were identified (updated through an electronic search of five databases - PubMed, EMBASE, PsycInfo, DARE and the Cochrane Library). Results The articles reviewed suggest that the most frequent treatment emergent adverse events (TEAEs) associated with aripiprazole long-acting injection (ARI-LAI) are psychotic symptoms, extrapyramidal symptoms (EPS) and weight gain. Data on olanzapine long-acting injection (OLA-LAI)-associated TEAEs highlight the risk of psychosis, metabolic disturbances and hyperprolactinemia. Four-hundred and forty cases of post-injection delirium/sedation syndrome (PDSS) have also been recorded. Although not reported in reviewed studies, the risk of impulse-control problem and drug reaction with eosinophilia and systemic symptoms (DRESS) ARI- and OLA-associated, respectively, must not be underestimated. With regards paliperidone palmitate 1-month formulation (PP1), the high incidence of clinically relevant weight gain and hyperprolactinemia are both findings of concern. Reviewed data also confirm that the leading cause of death in risperidone long-acting injection (RIS-LAI) clinical trials is suicide. The new 3-month paliperidone palmitate formulation, risperidone sustained release 1-month formulation (RIS-SR1), aripiprazole lauroxil (ARI-LXL) are still lacking exhaustive safety data. Conclusion The risk of specific TEAEs associated with all SGA-LAIs confirms SGA-LAIs do not offer advantages in safety compared with FGA-LAIs or oral antipsychotics and, especially, in early-phase schizophrenia patients. Implementing non pharmacological intervention and strategies can be effective for people with schizophrenia and bipolar disorder who adhere poorly to medication regimens.
背景 最近有人指出，尽管第二代抗精神病长效注射剂（SGA-LAIs）的成本对国家卫生系统预算有重大影响，但在临床实践中其使用不足。因此，对SGA-LAIs显示的安全性数据进行更新分析可能有助于阐明其在临床实践中的作用。
材料与方法 检索英文、经同行评审的文章，这些文章报告了SGA-LAI安全性的最新主要研究结果（通过对五个数据库——PubMed、EMBASE、PsycInfo、DARE和Cochrane图书馆进行电子检索进行更新）。
结果 所审查的文章表明，与阿立哌唑长效注射剂（ARI-LAI）相关的最常见治疗中出现的不良事件（TEAE）是精神病症状、锥体外系症状（EPS）和体重增加。与奥氮平长效注射剂（OLA-LAI）相关的TEAE数据突出了精神病、代谢紊乱和高催乳素血症的风险。还记录了440例注射后谵妄/镇静综合征（PDSS）病例。尽管在审查的研究中未报告，但与ARI和OLA相关的冲动控制问题风险以及伴有嗜酸性粒细胞增多和全身症状的药物反应（DRESS）绝不能被低估。关于棕榈酸帕利哌酮1个月剂型（PP1），临床上相关的体重增加和高催乳素血症的高发生率都是令人担忧的发现。审查的数据还证实，利培酮长效注射剂（RIS-LAI）临床试验中的主要死亡原因是自杀。新的3个月棕榈酸帕利哌酮剂型、利培酮缓释1个月剂型（RIS-SR1）、阿立哌唑月桂醇（ARI-LXL）仍然缺乏详尽的安全性数据。
结论 与所有SGA-LAIs相关的特定TEAE风险证实，与第一代抗精神病长效注射剂（FGA-LAIs）或口服抗精神病药物相比，SGA-LAIs在安全性方面没有优势，尤其是在早期精神分裂症患者中。实施非药物干预和策略对依从性差的精神分裂症和双相情感障碍患者可能有效。
