Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection

Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection
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精神分裂症复发及每月一次阿立哌唑长效注射液的临床疗效

DOI:
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发表时间:
2014
影响因子:
3.2
通讯作者:
C. Pae
C. Pae
中科院分区:
医学4区
文献类型:
--
作者:
Sheng;Changsu Han;Soo;A. Patkar;P. Masand;C. Pae

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改善药物依从性对改善精神分裂症患者的结局至关重要。长效注射(贮库)抗精神病药是提高精神分裂症患者治疗依从性和降低再住院率的最有效方法之一。直到最近,只有三种第二代抗精神病药可用于长效注射制剂(利培酮、帕利哌酮和奥氮平)。在这方面,2013年美国食品和药物管理局批准用于治疗精神分裂症的长效阿立哌唑注射液(ALAI)的出现是及时的。ALAI是阿立哌唑的冻干粉末,并且阿立哌唑分子是未修饰的。ALAI的初始和目标剂量为400 mg,每月一次,但如果400 mg发生不良反应,则可以将其减少到300 mg。首次给予ALAI时,建议继续口服阿立哌唑(10-20 mg/天)或另一种口服抗精神病药物治疗2周,以维持抗精神病药物的治疗浓度。ALAI的主要清除途径是肝脏,即细胞色素P450(CYP)2D 6和CYP 3A 4,因此在CYP 2D 6代谢不良者中需要调整剂量。三项研究证实了ALAI的疗效。一项随机对照试验为ALAI治疗精神分裂症的批准奠定了基础,该试验显示,与安慰剂相比,ALAI显著延迟了至即将复发的时间(P<0.0001,对数秩检验)。一项开放标签、镜像研究表明,从口服抗精神病药转换为ALAI后,总精神病住院率显著降低。另一项以海报形式呈现的随机对照试验表明,ALAI 400 mg在预防复发方面与口服阿立哌唑10-30 mg相当。在短期和长期研究中,ALAI通常耐受良好。其耐受性特征,包括锥体外系症状和临床相关代谢参数,与安慰剂相似。然而,失眠、头痛、焦虑、静坐不能、体重增加、注射部位疼痛和震颤需要临床关注。这些研究表明,ALAI是精神分裂症患者的一种可行的治疗选择,但需要将ALAI与其他长效注射抗精神病药进行直接的头对头比较,以阐明其风险-获益特征。
Improving medication adherence is critical to improving outcomes in patients with schizophrenia. A long-acting injectable (depot) antipsychotic is one of the most effective methods for improving treatment adherence and decreasing rehospitalization rates in patients with schizophrenia. Until recently, only three second-generation antipsychotics were available in a long-acting injectable formulation (risperidone, paliperidone, and olanzapine). In this respect, the emergence of long-acting aripiprazole injection (ALAI), approved by the US Food and Drug Administration for the treatment of schizophrenia in 2013, is timely. ALAI is a lyophilized powder of aripiprazole, and the aripiprazole molecule is unmodified. The initial and target dosage of ALAI is 400 mg once monthly, but it could be reduced to 300 mg if adverse reactions occur with 400 mg. When first administering ALAI, it is recommended to continue treatment with oral aripiprazole (10–20 mg/day) or another oral antipsychotic for 2 weeks in order to maintain therapeutic antipsychotic concentrations. The primary clearance route for ALAI is hepatic, ie, cytochrome P450 (CYP)2D6 and CYP3A4, so dose adjustment is required in poor CYP2D6 metabolizers. The efficacy of ALAI was demonstrated in three studies. A randomized controlled trial that formed the basis for approval of ALAI in the treatment of schizophrenia showed that ALAI significantly delayed time to impending relapse when compared with placebo (P<0.0001, log-rank test). An open-label, mirror study demonstrated that total psychiatric hospitalization rates were significantly lower after switching from oral antipsychotics to ALAI. Another randomized controlled trial presented in poster form suggested that ALAI 400 mg was comparable with oral aripiprazole 10–30 mg in preventing relapse. ALAI was generally well tolerated during both short-term and long-term studies. Its tolerability profile, including extrapyramidal symptoms and clinically relevant metabolic parameters, was similar to placebo. However, insomnia, headache, anxiety, akathisia, weight gain, injection site pain, and tremor need clinical attention. These studies suggest that ALAI is a viable treatment option for patients with schizophrenia, but direct head-to-head comparisons between ALAI and other long-acting injectable antipsychotics are needed to elucidate its risk–benefit profile.
住院患者出院后的用药依从性从口服抗精神病药方案转为长效抗精神病药方案。
DOI: 10.1176/ps.46.10.1049
发表时间: 1995
期刊: Psychiatric services (Washington, D.C.)
影响因子: --
作者:
Weiden,P;Rapkin,B;Zygmunt,A;Mott,T;Goldman,D;Frances,A
通讯作者: Frances,A