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奥氮平长效注射剂:用于治疗精神分裂症的综述。

Olanzapine long-acting injection: a review of its use in the treatment of schizophrenia.

机构信息

Adis, a Wolters Kluwer Business, Auckland, New Zealand.

出版信息

Drugs. 2010 Dec 3;70(17):2289-313. doi: 10.2165/11204930-000000000-00000.

Abstract

Olanzapine pamoate (olanzapine long-acting injection [OLAI]; Zypadhera®; Zyprexa® Relprevv™) is the intramuscular depot formulation of the atypical antipsychotic olanzapine. In two pivotal, double-blind clinical trials of 8 or 24 weeks' duration, the efficacy of recommended dosages of OLAI injected every 2 or 4 weeks (without oral supplementation) was greater than that of placebo in improving symptoms in acutely ill patients with schizophrenia, and generally similar to that of continuing oral olanzapine in preventing psychotic exacerbations in patients with schizophrenia whose symptoms had previously been stabilized on oral olanzapine. The effectiveness of OLAI in the maintenance treatment of schizophrenia was also demonstrated in an (ongoing) open-label extension study in which the all-cause discontinuation rate was 34.3% after 18 months. OLAI is generally well tolerated. It has an adverse event profile similar to that of oral olanzapine, with the exception of adverse events related to the intramuscular route of administration; these include a manageable post-injection syndrome, which occurred in <0.1% of injections in clinical trials. The possibility of a post-injection syndrome event requires a risk management plan (RMP) to be adopted that includes observation by appropriately qualified personnel in a healthcare facility for at least 3 hours post-injection. With its potential to improve adherence to medication, and thereby treatment outcomes, OLAI is a useful addition to the pharmacological options available for the maintenance therapy of schizophrenia. Given its benefit/risk profile, OLAI appears most suited for patients who, despite responding well to oral olanzapine, have difficulties remaining adherent to this form of medication, provided they can comply with the conditions of the RMP.

摘要

奥氮平癸酸酯(奥氮平长效注射剂[OLAI];Zypadhera®;Zyprexa® Relprevv™)是一种非典型抗精神病药奥氮平的肌肉注射剂。在两项为期 8 或 24 周的关键性、双盲临床试验中,推荐剂量的 OLAI 每 2 或 4 周注射一次(无需口服补充)的疗效优于安慰剂,能改善急性精神病患者的症状,且与继续口服奥氮平预防先前口服奥氮平稳定的精神分裂症患者精神恶化的疗效大致相当。在一项正在进行的开放标签扩展研究中,奥氮平癸酸酯在精神分裂症的维持治疗中也显示了有效性,18 个月后全因停药率为 34.3%。OLAI 通常具有良好的耐受性。其不良事件谱与口服奥氮平相似,除了与肌肉注射途径相关的不良事件外;这些包括管理方便的注射后综合征,在临床试验中,不到 0.1%的注射中发生。注射后综合征事件的可能性需要采用风险管理计划(RMP),包括在注射后至少 3 小时由合格的医疗保健人员进行观察。由于其可能提高对药物的依从性,从而改善治疗效果,OLAI 是治疗精神分裂症维持治疗的另一种有用药物。鉴于其获益/风险特征,OLAI 似乎最适合那些尽管对口服奥氮平反应良好,但难以坚持这种药物形式治疗的患者,只要他们能遵守 RMP 的条件。

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