Czekalla Jörg, Wagner Thomas, Schacht Alexander, Kluge Michael, Kinon Bruce
Department of Psychiatry and Psychotherapy, RWTH Aachen University, Germany;
Patient Prefer Adherence. 2007 Dec 20;1:19-27. doi: 10.2147/ppa.s2300.
This study compared effectiveness and acceptance of orally disintegrating olanzapine tablets (ODT) with standard-coated tablets (SOT) in acutely ill psychiatric patients admitted to psychiatric hospitals for emergency treatment.
Large, prospective, observational study at hospital emergency units across Germany in patients with a diagnosis or tentative diagnosis of acute schizophrenia treated with ODT or SOT. Clinical (CGI-S and CGI-I) outcomes, attitudes towards medication (Nursing Assessment of Medication Acceptance, NAMA) scale, suicidal ideation, and adverse events were assessed at start of treatment and after 2 weeks.
Both olanzapine formulations, ODT (N = 247) and SOT (N = 207), showed similar effectiveness after 2 weeks. CGI-I improved in 92.1% of patients (ODT: 91.8%, SOT: 92.3%). In patients receiving both formulations suicidal ideations were reduced (ODT from 53.9% to 20.6%, SOT from 51.2% to 22.7%). ODT was preferably given to severely ill (SOT: 49.8%, ODT: 64.4%) and aggressive patients. Adverse events were reported for 6.5% of ODT- and 2.9% of SOT-patients. This difference was possibly caused by the characteristics of patients receiving ODT.
This non-randomized, observational study shows comparable outcomes and tolerability in patients treated with both olanzapine formulations. In an acute treatment setting, orally disintegrating tablets were preferably used for more severely ill and aggressive patients with low medication acceptance.
本研究比较了口腔崩解型奥氮平片（ODT）与标准包衣片（SOT）在因紧急治疗而入住精神病医院的急性病精神病患者中的有效性和可接受性。
在德国各地医院急诊科对诊断或初步诊断为急性精神分裂症且接受ODT或SOT治疗的患者进行大型前瞻性观察性研究。在治疗开始时和2周后评估临床（CGI-S和CGI-I）结果、对药物的态度（药物接受度护理评估，NAMA）量表、自杀意念和不良事件。
两种奥氮平制剂，ODT（N = 247）和SOT（N = 207），在2周后显示出相似的有效性。92.1%的患者CGI-I有所改善（ODT：91.8%，SOT：92.3%）。接受两种制剂的患者自杀意念均有所降低（ODT从53.9%降至20.6%，SOT从51.2%降至22.7%）。ODT更常用于重症患者（SOT：49.8%，ODT：64.4%）和有攻击性的患者。报告ODT患者中有6.5%发生不良事件，SOT患者中有2.9%发生不良事件。这种差异可能是由接受ODT治疗的患者特征所致。
这项非随机观察性研究表明，两种奥氮平制剂治疗的患者结果和耐受性相当。在急性治疗环境中，口腔崩解片更适合用于病情更严重、有攻击性且药物接受度低的患者。
