Post-injection deliriumsedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I analysis of cases 英文参考文献.docVIP

Detke et al. BMC Psychiatry 2010, 10:43 /1471-244X/10/43 RESEARCH ARTICLE Open Access Post-injection delirium/sedation syndrome in Research article patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases Holland C Detke*, David P McDonnell, Elizabeth Brunner, Fangyi Zhao, Sebastian Sorsaburu, Victoria J Stefaniak and Sara A Corya Abstract Background: An advance in the treatment of schizophrenia is the development of long-acting intramuscular formulations of antipsychotics, such as olanzapine long-acting injection (LAI). During clinical trials, a post-injection syndrome characterized by signs of delirium and/or excessive sedation was identified in a small percentage of patients following injection with olanzapine LAI. Methods: Safety data from all completed and ongoing trials of olanzapine LAI were reviewed for possible cases of this post-injection syndrome. Descriptive analyses were conducted to characterize incidence, clinical presentation, and outcome. Regression analyses were conducted to assess possible risk factors. Results: Based on approximately 45,000 olanzapine LAI injections given to 2054 patients in clinical trials through 14 October 2008, post-injection delirium/sedation syndrome occurred in approximately 0.07% of injections or 1.4% of patients (30 cases in 29 patients). Symptomatology was consistent with olanzapine overdose (e.g., sedation, confusion, slurred speech, altered gait, or unconsciousness). However, no clinically significant decreases in vital signs were observed. Symptom onset ranged from immediate to 3 to 5 hours post injection, with a median onset time of 25 minutes post injection. All patients recovered within 1.5 to 72 hours, and the majority continued to receive further olanzapine LAI injections following the event. No clear risk factors were identified. Conclusions: Post-injection delirium/sedation syndrome can be readily identified based on symptom presentation, progression,