標題: Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial
作者: Huang, Charles Lung-Cheng
Hwang, Tzung-Jeng
Chen, Yi-Hsing
Huang, Guan-Hua
Hsieh, Ming H.
Chen, Hsiu-Hsi
Hwu, Hai-Gwo
統計學研究所
Institute of Statistics
關鍵字: agitation;haloperidol;injection;lorazepam;olanzapine;schizophrenia
公開日期: 1-May-2015
摘要: Background/Purpose: To compare the efficacy and safety profile between intramuscular (IM) olanzapine and IM haloperidol plus IM lorazepam in acute schizophrenic patients with moderate to severe agitation. Methods: This was a prospective, randomized, open-label study. Acutely agitated patients with schizophrenia or schizoaffective disorder (n = 67) were randomized to receive 10 mg IM olanzapine (n = 37) or 5 mg IM haloperidol plus 2 mg IM lorazepam (n = 30). Agitation was measured with Positive and Negative Syndrome Scale Excited Component (PANSS-EC) and AgitationeCalmness Evaluation Scale (ACES) during the first 2 hours and at 24 hours after the first injection. Safety was assessed using the SimpsoneAngus Scale and Barnes Akathisia Rating Scale and by recording adverse events at 24 hours following the first injection. The Clinical Global Impression-Severity scale was also rated. Results: The PANSS-EC scores decreased significantly at 2 hours after the first injection in both groups (olanzapine: -10.2, p < 0.001; haloperidol + lorazepam: -9.9, p < 0.001). Haloperidol plus lorazepam was not inferior to olanzapine in reducing agitation at 2 hours. There were no significant differences in PANSS-EC or ACES scores between the two groups within 2 hours following the first injection. The frequencies of adverse events and changes in Clinical Global Impression-Severity, SimpsoneAngus Scale, and Barnes Akathisia Rating Scale scores from baseline to 24 hours showed no significant differences between the groups. Conclusion: The findings suggest that IM haloperidol (5 mg) plus lorazepam (2 mg) is not inferior to IM olanzapine (10 mg) in the treatment of acute schizophrenic patients with moderate to severe agitation. Copyright (C) 2015, Elsevier Taiwan LLC & Formosan Medical Association. All rights reserved.
URI: http://dx.doi.org/10.1016/j.jfma.2015.01.018
http://hdl.handle.net/11536/124826
ISSN: 0929-6646
DOI: 10.1016/j.jfma.2015.01.018
期刊: JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION
Volume: 114
起始頁: 438
結束頁: 445
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