原创力文档post-injection deliriumsedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, i analysis of casespost-injection deliriumsedation综合症与奥氮平治疗的精神分裂症患者长效针剂,我分析的病例.pdfVIP
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post-injection deliriumsedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, i analysis of casespost-injection deliriumsedation综合症与奥氮平治疗的精神分裂症患者长效针剂,我分析的病例
Detke et al. BMC Psychiatry 2010, 10:43
/1471-244X/10/43
R E S E A R C H A R T I C L E Open Access
Research article
Post-injection delirium/sedation syndrome in
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
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