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首页> 外文期刊>BMC Psychiatry >Olanzapine long-acting injection: a review of first experiences of post-injection delirium/sedation syndrome in routine clinical practice
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Olanzapine long-acting injection: a review of first experiences of post-injection delirium/sedation syndrome in routine clinical practice

机译：奥氮平长效注射剂：常规临床实践中注射后ir妄/镇静综合征的首次使用经验回顾

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摘要

Olanzapine long-acting injection (LAI) for the treatment of schizophrenia was associated with a cluster of symptoms termed post-injection delirium/sedation syndrome (PDSS) in a small percentage (~2%) of patients during clinical trials. The objective of this analysis was to evaluate the rate and clinical characteristics of PDSS since olanzapine LAI entered commercial use. Cases of PDSS were identified from all reported adverse events during worldwide commercial use of olanzapine LAI through to 1 March 2014. Data sources included two ongoing post-marketing safety studies as well as spontaneously reported adverse events from routine clinical practice over a 5-year period (1 March 2009 to 1 March 2014). A total of 338 PDSS events were identified. Of these, 91% occurred within 1 hour of injection, and 52% of these occurred within 15 minutes. None of the PDSS events in this analysis were fatal, and most resolved within 72 hours. The most common symptoms (occurring in >30% of cases) were sedation (61%), confusion (56%), dysarthria (54%), somnolence (46%), dizziness (45%) and disorientation (35%). Overall, PDSS occurred with approximately 0.07% of injections and in 0.46–1.03% of patients (reporting and incidence rates from spontaneous reports and post-marketing safety studies, respectively). The PDSS events reported during routine clinical use of olanzapine LAI are generally similar in incidence and presentation to those reported in clinical trials. Caution should be applied when interpreting spontaneously reported rates of adverse events, however, due to potential under-reporting. Implemented risk-minimisation activities may contribute substantially to the identification and appropriate management of patients with PDSS in clinical practice.
机译：奥氮平长效注射剂（LAI）用于治疗精神分裂症，在临床试验中，只有一小部分（〜2％）患者与一系列称为注射后del妄/镇静综合症（PDSS）的症状相关。该分析的目的是评估奥氮平LAI进入商业用途以来PDSS的发生率和临床特征。截止到2014年3月1日，奥氮平LAI在全球范围内的商业使用期间，从所有报告的不良事件中识别出PDSS病例。数据来源包括两项正在进行的上市后安全性研究以及在5年期间常规临床实践中自发报告的不良事件（2009年3月1日至2014年3月1日）。总共确定了338个PDSS事件。其中91％发生在注射后1小时内，其中52％发生在15分钟内。该分析中没有PDSS事件是致命的，大多数事件在72小时内得到解决。最常见的症状（发生在30％以上的病例中）是镇静（61％），精神错乱（56％），构音障碍（54％），嗜睡（46％），头晕（45％）和神志不清（35％）。总体而言，PDSS发生在大约0.07％的注射剂中，在0.46-1.03％的患者中发生（分别来自自发性报告和上市后安全性研究的报告和发生率）。奥氮平LAI常规临床使用期间报告的PDSS事件的发生率和表现与临床试验中报告的事件和表现通常相似。在解释自发报告的不良事件发生率时应谨慎，但是由于潜在的报告不足。实施的风险最小化活动可能在临床实践中极大地有助于识别和适当治疗PDSS患者。

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