Chue Pierre, Chue James
Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.
Clinical Trials and Research Program, Edmonton, AB, Canada.
Ther Clin Risk Manag. 2016 Jan 27;12:109-16. doi: 10.2147/TCRM.S81581. eCollection 2016.
Schizoaffective disorder (SCA) is a chronic and disabling mental illness that presents with mixed symptoms of schizophrenia and affective disorders. SCA is recognized as a discrete disorder, but with greater heterogeneity and symptom overlap, leading to difficulty and delay in diagnosis. Although the overall prognosis is intermediate between schizophrenia and mood disorders, SCA is associated with higher rates of suicide and hospitalization than schizophrenia. No treatment guidelines exist for SCA, and treatment is frequently complex, involving off-label use and polypharmacy (typically combinations of antipsychotics, mood stabilizers, and antidepressants). Oral paliperidone extended-release was the first agent to be approved for the treatment of SCA. As in schizophrenia and bipolar disorder, adherence to oral medications is poor, further contributing to suboptimal outcomes. The use of an antipsychotic in a long-acting injection (LAI) addresses adherence issues, thus potentially reducing relapse. Paliperidone palmitate represents the LAI formulation of paliperidone. In a long-term, double-blind, randomized, controlled trial of adult patients (n=334; intent-to-treat [ITT]) with SCA, paliperidone long-acting injection (PLAI) significantly delayed risk of relapse compared to placebo (hazard ratio 2.49, 95% confidence interval, 1.55-3.99; P<0.001). This study demonstrated the efficacy and safety of PLAI when used as either monotherapy or adjunctive therapy for the maintenance treatment of SCA. The results are consistent with a similarly designed study conducted in patients with schizophrenia, which suggests a benefit in the long-term control of not only psychotic but also affective symptoms. No new safety signals were observed. When used in monotherapy, PLAI simplifies treatment by reducing complex pharmacotherapy and obviating the necessity for daily oral medications. PLAI is the second agent, and the first LAI, to be approved for the treatment of SCA; as an LAI formulation, there is the advantage of improved adherence and simplified treatment in the long-term management of SCA.
分裂情感性障碍（SCA）是一种慢性致残性精神疾病，具有精神分裂症和情感障碍的混合症状。SCA被认为是一种独立的疾病，但具有更大的异质性和症状重叠，导致诊断困难和延迟。尽管总体预后介于精神分裂症和心境障碍之间，但SCA的自杀率和住院率高于精神分裂症。目前尚无SCA的治疗指南，治疗通常很复杂，包括超说明书用药和联合用药（通常是抗精神病药、心境稳定剂和抗抑郁药的联合使用）。口服帕利哌酮缓释片是首个被批准用于治疗SCA的药物。与精神分裂症和双相情感障碍一样，口服药物的依从性较差，这进一步导致治疗效果欠佳。使用长效注射用抗精神病药物可解决依从性问题，从而有可能减少复发。棕榈酸帕利哌酮是帕利哌酮的长效注射剂剂型。在一项针对成年SCA患者（n = 334；意向性治疗[ITT]）的长期、双盲、随机对照试验中，与安慰剂相比，长效注射用帕利哌酮（PLAI）显著延迟了复发风险（风险比2.49，95%置信区间，1.55 - 3.99；P < 0.001）。这项研究证明了PLAI作为单药治疗或辅助治疗用于SCA维持治疗时的有效性和安全性。结果与在精神分裂症患者中进行的一项设计类似的研究一致，这表明PLAI不仅对长期控制精神病性症状有益，对情感症状也有益。未观察到新的安全信号。当用于单药治疗时，PLAI通过减少复杂的药物治疗并避免每日口服药物的必要性，简化了治疗。PLAI是第二个被批准用于治疗SCA的药物，也是首个长效注射剂；作为长效注射剂剂型，在SCA的长期管理中具有提高依从性和简化治疗的优势。
