a Dipartimento di Medicina Clinica e Sperimentale, Section of Psychiatry , University of Pisa , Pisa , Italy.
Expert Opin Pharmacother. 2019 Aug;20(11):1321-1330. doi: 10.1080/14656566.2019.1617849. Epub 2019 May 27.
: Bipolar I disorder (BDI) is amongst the most debilitating psychiatric conditions with a great impact on both patients and their families. A class of drugs commonly used in this condition is second-generation antipsychotics (SGAs) including asenapine, one of the latest to be introduced into the clinical practice worldwide to treat manic episodes in BDI. : The aim of this paper is to critically review the literature on the pharmacological characteristics, tolerability, and safety data of asenapine, as well as on its short- and long-term clinical trials in manic episodes as both a monotherapy and as an add-on treatment. : The available data indicate that asenapine is an effective antimanic agent in both adult and pediatric patients and that it might also improve depressive symptoms and recurrences in BDI patients. Its tolerability profile is good, and its most common side effects are somnolence, light extrapyramidal symptoms, dizziness, weight gain, and oral (but reversible) hypoesthesia. Taken together, the published studies indicate that asenapine might be an effective therapeutic agent in BDI with a broad spectrum of clinical activities. Further double-blind, short- and long-term studies are, however, necessary to clarify its precise role in the treatment of BD.
双相 I 障碍 (BDI) 是最具致残性的精神疾病之一，对患者及其家属都有很大的影响。在这种情况下，一类常用的药物是第二代抗精神病药 (SGAs)，包括阿塞那平，这是世界范围内最新引入临床实践的药物之一，用于治疗 BDI 的躁狂发作。
本文旨在对阿塞那平的药理学特征、耐受性和安全性数据，以及其在躁狂发作中的短期和长期临床试验（单药治疗和附加治疗）的文献进行批判性评价。
现有数据表明，阿塞那平是一种有效的成人和儿科抗躁狂药物，它也可能改善 BDI 患者的抑郁症状和复发。其耐受性良好，最常见的副作用是嗜睡、轻度锥体外系症状、头晕、体重增加和口腔（但可逆转）感觉迟钝。总之，已发表的研究表明，阿塞那平可能是 BDI 的一种有效治疗药物，具有广泛的临床活性。然而，还需要进一步的双盲、短期和长期研究来阐明其在 BD 治疗中的确切作用。
