Post-injection deliriumsedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II investigations of mechanism 英文参考文献.docVIP

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Post-injection deliriumsedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II investigations of mechanism 英文参考文献.doc

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Post-injection deliriumsedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II investigations of mechanism 英文参考文献

McDonnell et al. BMC Psychiatry 2010, 10:45 /1471-244X/10/45 RESEARCH ARTICLE Open Access Post-injection delirium/sedation syndrome in Research article patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism David P McDonnell*1, Holland C Detke1, Richard F Bergstrom2, Prajakti Kothare1, Jason Johnson1, Mary Stickelmeyer1, Manuel V Sanchez-Felix1, Sebastian Sorsaburu1 and Malcolm I Mitchell1 Abstract Background: Olanzapine long-acting injection (LAI) is a salt-based depot antipsychotic combining olanzapine and pamoic acid. The slow intramuscular dissolution of this practically insoluble salt produces an extended release of olanzapine lasting up to 4 weeks. However, in a small number of injections ( 0.1%), patients experienced symptoms suggestive of olanzapine overdose, a phenomenon that has been termed post-injection delirium/sedation syndrome (PDSS). The authors conducted a series of parallel investigations into the possible reasons PDSS events occur. Methods: Healthcare providers involved in the PDSS cases were queried for clinical information around the events. Plasma samples from patients experiencing PDSS were collected when possible (12/30 cases) and olanzapine concentrations compared with the known pharmacokinetic profile for olanzapine LAI. Product batches and used vials from the PDSS cases were evaluated for compliance with established manufacturing standards and/or possible user error. Because this depot formulation depends upon slow dissolution at the intramuscular injection site, in-vitro experiments were conducted to assess solubility of olanzapine pamoate in various media. Results: Injection administrators reported no unusual occurrences during the injection. No anomalies were found with the product batches or the remaining suspension in the used vials. Olanzapine concentrations during PDSS events were higher than the expected 5-73 ng/mL range, with concentrations exceeding 100 ng/mL