II类改良型新药对双相情感障碍疗效研究进展——基于随机对照试验与真实世界研究

Advances in the Efficacy of Category II Improved New Drugs for Bipolar Disorder—Evidence from Randomized Controlled Trials and Real-World Studies

摘要: 双相情感障碍是高复发、高致残的重性精神障碍，患者长期治疗依从性差、代谢不良反应突出、急性激越控制困难、复发住院率较高是制约疗效的主要瓶颈。II类改良型新药通过在已知活性成份基础上优化剂型、给药途径或组方，在改善药代动力学、提升依从性和减轻不良反应方面展现出独特价值。本文按药物剂型与给药途径分类，系统综述随机对照试验与真实世界研究证据，阐述口服新剂型与新复方制剂、长效注射剂及经黏膜与吸入给药制剂在成人BD治疗中的作用机制与疗效进展。

Abstract: Bipolar disorder (BD) is a severe mental disorder characterized by high rates of relapse and disability. Poor long-term treatment adherence, prominent metabolic adverse effects, difficult-to-control acute agitation, and a high rate of relapse-related hospitalization are the main bottlenecks limiting therapeutic effectiveness. Category II improved new drugs, which are developed by optimizing the dosage form, route of administration, or formulation on the basis of known active ingredients, have demonstrated unique value in improving pharmacokinetics, enhancing adherence, and reducing adverse effects. This review systematically synthesizes evidence from randomized controlled trials and real-world studies, classified by dosage form and route of administration, and elaborates on the mechanisms of action and therapeutic advances of novel oral dosage forms and new combination products, long-acting injectables, and transmucosal and inhaled formulations in the treatment of adults with BD.