真实世界临床实践中的非适应证长效注射用抗精神病药：STAR 网络 DEPOT 研究处方模式的横断面分析。

Off-label long acting injectable antipsychotics in real-world clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study.

机构信息

Department of Health Sciences, Università degli Studi di Milano, Milan, Italy.

Department of Mental Health, San Paolo Hospital, ASST Santi Paolo e Carlo, Milan, Italy.

出版信息

BMC Psychiatry. 2022 Jun 30;22(1):442. doi: 10.1186/s12888-022-04071-2.

DOI:10.1186/s12888-022-04071-2

PMID:35773631

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9245273/

Abstract

INTRODUCTION

Information on the off-label use of Long-Acting Injectable (LAI) antipsychotics in the real world is lacking. In this study, we aimed to identify the sociodemographic and clinical features of patients treated with on- vs off-label LAIs and predictors of off-label First- or Second-Generation Antipsychotic (FGA vs. SGA) LAI choice in everyday clinical practice.

METHOD

In a naturalistic national cohort of 449 patients who initiated LAI treatment in the STAR Network Depot Study, two groups were identified based on off- or on-label prescriptions. A multivariate logistic regression analysis was used to test several clinically relevant variables and identify those associated with the choice of FGA vs SGA prescription in the off-label group.

RESULTS

SGA LAIs were more commonly prescribed in everyday practice, without significant differences in their on- and off-label use. Approximately 1 in 4 patients received an off-label prescription. In the off-label group, the most frequent diagnoses were bipolar disorder (67.5%) or any personality disorder (23.7%). FGA vs SGA LAI choice was significantly associated with BPRS thought disorder (OR = 1.22, CI95% 1.04 to 1.43, p = 0.015) and hostility/suspiciousness (OR = 0.83, CI95% 0.71 to 0.97, p = 0.017) dimensions. The likelihood of receiving an SGA LAI grew steadily with the increase of the BPRS thought disturbance score. Conversely, a preference towards prescribing an FGA was observed with higher scores at the BPRS hostility/suspiciousness subscale.

CONCLUSION

Our study is the first to identify predictors of FGA vs SGA choice in patients treated with off-label LAI antipsychotics. Demographic characteristics, i.e. age, sex, and substance/alcohol use co-morbidities did not appear to influence the choice towards FGAs or SGAs. Despite a lack of evidence, clinicians tend to favour FGA over SGA LAIs in bipolar or personality disorder patients with relevant hostility. Further research is needed to evaluate treatment adherence and clinical effectiveness of these prescriptive patterns.

摘要

简介

关于长效注射型（LAI）抗精神病药在真实世界中的非适应证使用信息尚缺乏。本研究旨在确定在日常临床实践中，接受适应证内和适应证外 LAI 治疗的患者的社会人口统计学和临床特征，以及预测第一代或第二代抗精神病药（FGA 与 SGA）LAI 选择的非适应证处方的因素。

方法

在 STAR Network Depot 研究中，449 名开始 LAI 治疗的患者组成了一个自然主义的全国队列，根据处方是适应证内还是适应证外，将他们分为两组。使用多变量逻辑回归分析来检验几种临床相关变量，并确定与非适应证组中选择 FGA 与 SGA 处方相关的因素。

结果

SGA LAI 在日常实践中更常被开出处方，而其适应证内和适应证外使用没有显著差异。大约 1/4 的患者接受了非适应证处方。在非适应证组中，最常见的诊断是双相障碍（67.5%）或任何人格障碍（23.7%）。FGA 与 SGA LAI 选择显著与 BPRS 思维障碍（OR=1.22，95%CI 1.04 至 1.43，p=0.015）和敌意/多疑（OR=0.83，95%CI 0.71 至 0.97，p=0.017）维度相关。随着 BPRS 思维障碍评分的增加，接受 SGA LAI 的可能性稳步增加。相反，随着 BPRS 敌意/多疑亚量表评分的升高，更倾向于开处方 FGA。

结论

本研究首次确定了接受非适应证 LAI 抗精神病药治疗的患者中 FGA 与 SGA 选择的预测因素。人口统计学特征，如年龄、性别和物质/酒精使用合并症，似乎并不影响 FGA 或 SGA 的选择。尽管缺乏证据，但临床医生倾向于在有相关敌意的双相障碍或人格障碍患者中，更倾向于使用 FGA 而非 SGA LAI。需要进一步研究来评估这些处方模式的治疗依从性和临床效果。