Department of Psychiatry, Vanderbilt University School of Medicine, 1500 21st Ave., South, Suite 2200, Village at Vanderbilt, Nashville, TN 37212, USA.
Expert Rev Neurother. 2010 Nov;10(11):1637-58. doi: 10.1586/ern.10.143.
Poor adherence to pharmacotherapy during maintenance-phase treatment of bipolar disorder is a common occurrence, exposing patients to a high risk of illness relapses, rehospitalization and other negative outcomes. In view of this, there has been a reawakening of interest in the potential of long-acting injectable antipsychotic medications to improve treatment outcome during bipolar maintenance therapy. Indeed, long-acting injectable medications have practical advantages of assuring delivery of medication at a prescribed dose, and perhaps also making it easier to monitor adherence, at least to the long-acting drug. However, there are important limitations to the long-term use of depot typical neuroleptics in patients with bipolar disorder, including risk of extrapyramidal side effects and tardive dyskinesia, which may exceed that of patients with schizophrenia, and the potential for treatment-emergent exacerbation of depressive symptoms. Long-acting injectable risperidone (RLAI) has recently been approved for maintenance treatment in patients with bipolar I disorder. Evidence supporting the use of RLAI for this indication consists of several nonrandomized, open-label studies; one randomized, open-label trial; and two adequately powered randomized, double-blind trials. In general, these studies have shown RLAI to be effective for the prevention of relapse or hospitalization during bipolar maintenance treatment. In the double-blind studies, RLAI was associated with reduced relapse rates, increased time to relapse and greater control of clinical symptoms during maintenance treatment following initial stabilization, compared with oral medication treatment or placebo injection. RLAI appeared to be more effective for preventing manic/mixed episodes than depressive episodes. RLAI showed good tolerability across studies; however, dose-related extrapyramidal effects, sedation, weight gain and prolactin elevation may occur during long-term treatment. Responder-enriched designs and exclusion of important clinical subgroups in the double-blind trials may limit translation of these results to routine care settings.
在双相情感障碍的维持期治疗中，药物治疗依从性差是很常见的，这会使患者面临疾病复发、再次住院和其他不良后果的高风险。鉴于此，人们重新关注长效注射抗精神病药物在改善双相情感障碍维持治疗中的治疗效果的潜力。事实上，长效注射药物具有确保以规定剂量给药的实际优势，也许还更容易监测依从性，至少对长效药物而言是这样。然而，在双相情感障碍患者中长期使用长效典型神经阻滞剂存在重要限制，包括出现锥体外系副作用和迟发性运动障碍的风险，其风险可能超过精神分裂症患者，并且可能会导致治疗中出现抑郁症状恶化。长效注射利培酮（RLAI）最近已获准用于双相 I 型障碍患者的维持治疗。支持将 RLAI 用于该适应证的证据包括几项非随机、开放标签研究；一项随机、开放标签试验；以及两项充分有力的随机、双盲试验。一般来说，这些研究表明 RLAI 可有效预防双相情感障碍维持治疗中的复发或住院。在双盲研究中，与口服药物治疗或安慰剂注射相比，RLAI 与降低复发率、延长复发时间和更好地控制维持治疗期间的临床症状有关。RLAI 似乎对预防躁狂/混合发作比预防抑郁发作更有效。RLAI 在各项研究中具有良好的耐受性；然而，在长期治疗中可能会出现与剂量相关的锥体外系效应、镇静、体重增加和催乳素升高。双盲试验中的应答者富集设计和排除重要的临床亚组可能会限制这些结果在常规治疗环境中的转化。
