Department of Psychiatry, University of Western Ontario, Chatham, Ontario, Canada.
Int J Clin Pract. 2009 Aug;63(8):1249-58. doi: 10.1111/j.1742-1241.2009.02116.x. Epub 2009 Jun 24.
This study compared the safety, tolerability and switch to oral medication in patients with bipolar disorder or schizophrenia who received intramuscular (IM) olanzapine or other IM antipsychotics for the treatment of acute agitation.
Patients (N = 2011) from 15 countries participated in this prospective, observational, non-interventional study. Inpatients requiring treatment with at least one IM injection of a short-acting antipsychotic were assessed at baseline and within 7 days after the first IM injection. Treatment groups comprised: (i) patients prescribed IM olanzapine at baseline; and (ii) patients prescribed any other IM antipsychotic medication at baseline. Outcome measures included: treatment-emergent adverse events, concomitant psychotropic medication and the time taken to switch to oral medication.
Fewer patients in the IM olanzapine group experienced an adverse event than patients in the other IM antipsychotic group (34.4% vs. 46.2%, p < 0.001). The most frequently reported adverse events in both groups were: sedation, Parkinsonism, disturbance in attention, akathisia, dystonia and orthostatic hypotension. Fewer patients in the IM olanzapine group used anticholinergics (13.9% vs. 42.5%, p < 0.001) or anxiolytics/hypnotics (47.6% vs. 51.6%, p = 0.023). Patients in the IM olanzapine group switched to oral medication earlier than patients in the other IM antipsychotic group (median time = 46.5 vs. 48.0 h, p = 0.009).
These findings suggest that IM olanzapine may have a favourable impact on individual patients. However, the high rate of oral concomitant medication used throughout the study limits these findings from being associated with IM olanzapine alone.
本研究比较了接受肌肉注射(IM)奥氮平或其他 IM 抗精神病药治疗急性激越的双相情感障碍或精神分裂症患者的安全性、耐受性和转为口服药物治疗的情况。
来自 15 个国家的 2011 名患者参与了这项前瞻性、观察性、非干预性研究。需要至少接受一次 IM 短效抗精神病药注射治疗的住院患者在基线时和首次 IM 注射后 7 天内进行评估。治疗组包括:(i)基线时处方 IM 奥氮平的患者;和(ii)基线时处方任何其他 IM 抗精神病药物的患者。主要观察终点为:治疗期间出现的不良事件、合并使用的精神科药物和转为口服药物的时间。
IM 奥氮平组患者发生不良事件的比例低于其他 IM 抗精神病药物组(34.4% vs. 46.2%,p < 0.001)。两组中最常报告的不良事件为:镇静、帕金森病、注意力障碍、静坐不能、肌张力障碍和体位性低血压。IM 奥氮平组患者使用抗胆碱能药物(13.9% vs. 42.5%,p < 0.001)或抗焦虑/催眠药物(47.6% vs. 51.6%,p = 0.023)的比例较低。IM 奥氮平组患者转为口服药物治疗的时间早于其他 IM 抗精神病药物组(中位数时间=46.5 与 48.0 h,p = 0.009)。
这些发现表明 IM 奥氮平可能对个别患者有积极影响。然而,研究期间使用的高比例口服合并药物限制了这些发现与 IM 奥氮平本身的关联。