Salvi Virginio, Cerveri Giancarlo, Aguglia Andrea, Calò Salvatore, Corbo Mariangela, Martinotti Giovanni, Serafini Gianluca, Signorelli Maria Salvina, Aguglia Eugenio, Amore Mario, Biggio Giovanni, DI Sciascio Guido, Mencacci Claudio
J Psychiatr Pract. 2019 Jul;25(4):318-327. doi: 10.1097/PRA.0000000000000405.
Bipolar disorder (BD) is characterized by recurrent depressive and manic episodes. Lithium, valproate, lamotrigine, and some second-generation antipsychotics (SGAs) are the most typical pharmacological treatments for BD, the main goal being mood stabilization. However, despite these treatments, most patients continue to experience recurrent mood episodes and residual symptoms. Findings from several studies suggest that some SGAs may be beneficial beyond approved indications. The goal of the survey presented in this article was to examine Italian psychiatrists' attitudes concerning the off-label use of SGAs in depressive and maintenance phases of BD. A questionnaire about the off-label prescription of SGAs was e-mailed to 300 psychiatrists from Northern, Central, and Southern Italy affiliated with the Italian Society of Psychopharmacology (SINPF) to investigate the frequency of and motivation for off-label use of SGAs and evaluate the psychiatrists' attitude toward use of specific SGAs in BD; 202 questionnaires were completed. The respondents were equally distributed in terms of sex, and the mean age of respondents was 44.1 years. The majority of the sample reported use of SGAs for off-label indications either very often (16.7%), often (33.7%), or occasionally (34.7%). The main motivation for off-label use of the SGAs was the presence of published evidence (51.5%), followed by patients' nonresponse to previous treatment (37.1%). With regard to the use of specific SGAs in BD, off-label aripiprazole was considered appropriate for depressive episodes by 46% of the psychiatrists, followed by olanzapine which was considered appropriate by 33.7%. For maintenance treatment of BD, off-label asenapine was considered appropriate by 45% of the psychiatrists, followed by long-acting aripiprazole and olanzapine pamoate, which were considered appropriate by 37.1% and 23.8%, respectively. In summary, ~50% of Italian psychiatrists frequently (very often or often) prescribe SGAs for off-label indications. Given the relatively limited number of indicated effective treatments for BD, the use of some SGAs off-label may be considered appropriate when dealing with patients whose BD is resistant to medications with labeled indications for BD.
双相情感障碍（BD）的特征是反复出现抑郁和躁狂发作。锂盐、丙戊酸盐、拉莫三嗪以及一些第二代抗精神病药物（SGA）是治疗BD最典型的药物，主要目标是稳定情绪。然而，尽管有这些治疗方法，大多数患者仍会反复出现情绪发作和残留症状。多项研究结果表明，一些SGA可能在获批适应症之外还有益处。本文所呈现的调查目的是探究意大利精神科医生对于在BD的抑郁期和维持期超说明书使用SGA的态度。一份关于SGA超说明书处方的问卷通过电子邮件发送给了300名隶属于意大利精神药理学会（SINPF）的来自意大利北部、中部和南部的精神科医生，以调查SGA超说明书使用的频率和动机，并评估精神科医生对于在BD中使用特定SGA的态度；共完成了202份问卷。受访者在性别上分布均匀，受访者的平均年龄为44.1岁。大多数样本报告非常频繁（16.7%）、经常（33.7%）或偶尔（34.7%）将SGA用于超说明书适应症。SGA超说明书使用的主要动机是有已发表的证据（51.5%），其次是患者对先前治疗无反应（37.1%）。关于在BD中使用特定SGA，46%的精神科医生认为超说明书使用阿立哌唑适用于抑郁发作，其次是奥氮平，33.7%的精神科医生认为其适用。对于BD的维持治疗，45%的精神科医生认为超说明书使用阿塞那平适用，其次是长效阿立哌唑和奥氮平棕榈酸酯，分别有37.1%和23.8%的精神科医生认为其适用。总之，约50%的意大利精神科医生经常（非常频繁或经常）为超说明书适应症开具SGA。鉴于BD的有效适应症治疗方法数量相对有限，在处理对BD有标注适应症的药物耐药的BD患者时，超说明书使用一些SGA可能被认为是合适的。
