Adverse Effects Associated with Second-Generation Antipsychotic Long-Acting Injection Treatment: A Comprehensive Systematic Review

Adverse Effects Associated with Second-Generation Antipsychotic Long-Acting Injection Treatment: A Comprehensive Systematic Review
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DOI:
10.1002/phar.1313
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发表时间:
2013-10-01
期刊:
影响因子:
4.1
通讯作者:
Gentile, Salvatore
Gentile, Salvatore
中科院分区:
医学2区
文献类型:
--
作者:
Gentile, Salvatore

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随着第二代抗精神病药长效注射剂(SGA-LAI)迅速取代第一代长效抗精神病药作为治疗精神分裂症谱系障碍的一线药物,对其不良反应进行系统评估是及时的。通过检索MEDLINE、EMBASE、PsycINFO和DARE数据库以及科克伦图书馆(2001年1月至2013年4月),以电子方式识别报告SGA-LAI安全性和耐受性原始数据的英文同行评审文章。除第二代(非典型)抗精神病药和长效注射(长效)抗精神病药外,还对每种可用药物进行了单独检索:阿立哌唑LAI、双羟萘酸奥氮平、棕榈酸帕利哌酮和利培酮LAI。如果文章是综述文章、事后分析、既往试验入组患者子集分析、单个病例报告、病例系列研究、小型自然主义研究(涉及不到50例患者)、未提供安全性数据的研究和持续时间不到8周的研究,则将其排除。在检索到的181篇文章中,排除了140篇;因此,41篇文章符合纳入标准。可以预见的是,审查的信息显示,SGA-LAI的安全性特征与其口服母体制剂一致。然而,它们似乎也显示出不可预见和令人担忧的安全信号。事实上,奥氮平-LAI在临床实践中的常规使用不仅受到众所周知的注射后综合征风险的限制,其临床管理仍然是一个值得关注的问题,而且还受到精神病恶化风险的限制。审查的信息似乎表明,精神病症状和抑郁的恶化也可能与利培酮-LAI和棕榈酸帕利哌酮相关。利培酮-LAI研究中入组患者的主要死亡原因是自杀。鉴于SGA-LAI的临床使用呈指数增长,必须紧急进行进一步研究,以确认或排除与此类药物相关的潜在安全性信号。
As second-generation antipsychotic long-acting injections (SGA-LAIs) are rapidly replacing depot first-generation antipsychotics as first-line agents in treating schizophrenia spectrum disorders, a systematic assessment of their adverse effects is timely. English-language, peer-reviewed articles reporting original data on the safety and tolerability of SGA-LAIs were identified electronically by searching the MEDLINE, EMBASE, PsycINFO, and DARE databases and the Cochrane Library (January 2001-April 2013). In addition to second-generation (atypical) antipsychotics and long-acting injection (depot) antipsychotics, a separate search was performed for each available drug: aripiprazole LAI, olanzapine pamoate, paliperidone palmitate, and risperidone LAI. Articles were excluded if they were review articles, post hoc analyses, analyses of subsets of patients enrolled in previous trials, single case reports, case series studies, small naturalistic studies (involving less than 50 patients), studies providing no safety data, and studies lasting less than 8weeks. Of 181 articles identified from the search, 140 were excluded; thus, 41 articles met the inclusion criteria. Predictably, the reviewed information revealed that SGA-LAIs have safety profiles consistent with their oral parent formulations. However, they seem to also show unforeseen and worrisome safety signals. Indeed, the routine use of olanzapine-LAI in clinical practice could be limited not only by the well-known risk of postinjection syndrome, whose clinical management remains a matter of concern, but also by the risk of worsening of psychosis. The reviewed information seems to suggest that worsening of psychotic symptoms and depression could also be associated with both risperidone-LAI and paliperidone palmitate. The leading cause of death among patients enrolled in risperidone-LAI studies was suicide. Given the exponential growth in the clinical use of SGA-LAIs, further studies must be urgently performed in order to confirm or exclude the potential safety signals associated with such drugs.