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棕榈酸帕利哌酮长效注射制剂在精神分裂症谱系障碍中的应用:首发精神病干预计划(CRUPEP)的回顾性队列研究。

Oral and Palmitate Paliperidone Long-Acting Injectable Formulations' Use in Schizophrenia Spectrum Disorders: A Retrospective Cohort Study from the First Episode Psychosis Intervention Program (CRUPEP).

机构信息

Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bilbao, Spain.

Department of Psychiatry, Cruces University Hospital, Bilbao, Spain.

出版信息

Int J Neuropsychopharmacol. 2021 Sep 21;24(9):694-702. doi: 10.1093/ijnp/pyab021.

Abstract

BACKGROUND

Long-acting injectable antipsychotics (LAIs) may be a suitable therapeutic option for those patients in earlier stages of psychosis to avoid relapses and disease progression. Despite that, there is a lack of evidence in the literature regarding the use of LAIs in this profile of patients.

METHODS

This is a retrospective cohort analysis to assess the efficacy, tolerability, and pattern of use of palmitate paliperidone long-acting injectable (PPLAI) formulations (1- and 3-month doses) compared to oral paliperidone/risperidone in patients with a nonaffective first episode of psychosis (FEP) over 12 months of follow-up. Relevant sociodemographic and clinical information were assessed, as well as main clinical scales: Positive and Negative Syndrome Scale, Personal and Social Performance Scale, and Clinical Global Impression Scale Improvement and Severity measures.

RESULTS

The study included 48 patients, 16 per arm, who were aged 20-50 years and had an FEP. Significant improvements were registered for all treatment groups. Despite that, patients receiving PPLAI 1- and 3-month formulations obtained greater improvements than those in the oral group in the main domains assessed (P < .001). We found no statistically significant differences in hospitalizations between groups. Side effects were presented in 24% of patients. A trend towards reducing antipsychotic doses was observed in 43.8% of patients to achieve the minimum effective dose and avoid the occurrence of side effects.

CONCLUSIONS

To our knowledge, this is the first study assessing the use of palmitate paliperidone long-acting formulations versus oral risperidone or paliperidone in FEP. Treatment with PPLAI formulations seems to be an effective therapeutic choice at earlier stages of the disease.

摘要

背景

长效注射抗精神病药(LAIs)可能是早期精神病患者避免复发和疾病进展的合适治疗选择。尽管如此,文献中缺乏关于在这种患者群体中使用 LAIs 的证据。

方法

这是一项回顾性队列分析,旨在评估棕榈酸帕利哌酮长效注射剂(PPLAI)制剂(1 个月和 3 个月剂量)与口服帕利哌酮/利培酮在非情感首发精神病(FEP)患者中的疗效、耐受性和使用模式,随访时间为 12 个月。评估了相关的社会人口学和临床信息,以及主要的临床量表:阳性和阴性综合征量表、个人和社会表现量表以及临床总体印象量表改善和严重程度测量。

结果

该研究纳入了 48 名患者,每组 16 名,年龄在 20-50 岁之间,患有 FEP。所有治疗组均有显著改善。尽管如此,接受 PPLAI 1 个月和 3 个月制剂的患者在主要评估领域获得的改善均大于口服组(P <.001)。我们没有发现组间住院治疗存在统计学上的显著差异。24%的患者出现了副作用。在 43.8%的患者中,出现了减少抗精神病药物剂量的趋势,以达到最小有效剂量并避免副作用的发生。

结论

据我们所知,这是第一项评估棕榈酸帕利哌酮长效制剂与口服利培酮或帕利哌酮在 FEP 中的使用的研究。在疾病的早期阶段,PPLAI 制剂的治疗似乎是一种有效的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6031/8453287/ac825feaecb3/pyab021f0001.jpg

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