Wright Padraig, Lindborg Stacy R, Birkett Martin, Meehan Karena, Jones Barry, Alaka Karla, Ferchland-Howe Iris, Pickard Anne, Taylor Cindy C, Roth John, Battaglia John, Bitter István, Chouinard Guy, Morris Philip L P, Breier Alan
Clinical Neuroscience, Lilly Research Centre, Eli Lilly and Company, Surrey, UK.
Can J Psychiatry. 2003 Dec;48(11):716-21. doi: 10.1177/070674370304801102.
To determine the antipsychotic efficacy and extrapyramidal safety of intramuscular (i.m.) olanzapine and i.m. haloperidol during the first 24 hours of treatment of acute schizophrenia.
Patients (n = 311) with acute schizophrenia were randomly allocated (2:2:1) to receive i.m. olanzapine (10.0 mg, n = 131), i.m. haloperidol (7.5 mg, n = 126), or i.m. placebo (n = 54).
After the first injection, i.m. olanzapine was comparable to i.m. haloperidol and superior to i.m. placebo for reducing mean change scores from baseline on the Brief Psychiatric Rating Scale (BRPS) Positive at 2 hours (-2.9 olanzapine, -2.7 haloperidol, and -1.5 placebo) and 24 hours (-2.8 olanzapine, -3.2 haloperidol, and -1.3 placebo); the BPRS Total at 2 hours (-14.2 olanzapine,-13.1 haloperidol, and -7.1 placebo) and 24 hours (-12.8 olanzapine, -12.9 haloperidol, and -6.2 placebo); and the Clinical Global Impressions (CGI) scale at 24 hours (-0.5 olanzapine, -0.5 haloperidol, and -0.1 placebo). Patients treated with i.m. olanzapine had significantly fewer incidences of treatment-emergent parkinsonism (4.3% olanzapine vs 13.3% haloperidol, P = 0.036), but not akathisia (1.1% olanzapine vs 6.5% haloperidol, P = 0.065), than did patients treated with i.m. haloperidol; they also required significantly less anticholinergic treatment (4.6% olanzapine vs 20.6% haloperidol, P < 0.001). Mean extrapyramidal symptoms (EPS) safety scores improved significantly from baseline during i.m. olanzapine treatment, compared with a general worsening during i.m. haloperidol treatment (Simpson-Angus Scale total score mean change: -0.61 olanzapine vs 0.70 haloperidol; P < 0.001; Barnes Akathisia Scale global score mean change: -0.27 olanzapine vs 0.01 haloperidol; P < 0.05).
I.m. olanzapine was comparable to i.m. haloperidol for reducing the symptoms of acute schizophrenia during the first 24 hours of treatment, the efficacy of both being evident within 2 hours after the first injection. In general, more EPS were observed during treatment with i.m. haloperidol than with i.m. olanzapine.
确定在急性精神分裂症治疗的最初24小时内，肌内注射奥氮平和肌内注射氟哌啶醇的抗精神病疗效及锥体外系安全性。
将311例急性精神分裂症患者随机分配（2∶2∶1），分别接受肌内注射奥氮平（10.0 mg，n = 131）、肌内注射氟哌啶醇（7.5 mg，n = 126）或肌内注射安慰剂（n = 54）。
首次注射后，在2小时（奥氮平-2.9、氟哌啶醇-2.7、安慰剂-1.5）和24小时（奥氮平-2.8、氟哌啶醇-3.2、安慰剂-1.3）时，肌内注射奥氮平在降低简明精神病评定量表（BRPS）阳性项目基线平均变化得分方面与肌内注射氟哌啶醇相当，且优于肌内注射安慰剂；在2小时（奥氮平-14.2、氟哌啶醇-13.1、安慰剂-7.1）和24小时（奥氮平-12.8、氟哌啶醇-12.9、安慰剂-6.2）时，BPRS总分；以及在24小时时临床总体印象（CGI）量表（奥氮平-0.5、氟哌啶醇-0.5、安慰剂-0.1）。与肌内注射氟哌啶醇的患者相比，肌内注射奥氮平治疗的患者治疗中出现帕金森症的发生率显著更低（奥氮平4.3% 对比氟哌啶醇13.3%，P = 0.036），但静坐不能发生率并非如此（奥氮平1.1% 对比氟哌啶醇6.5%，P = 0.065）；他们也显著更少需要抗胆碱能治疗（奥氮平4.6% 对比氟哌啶醇20.6%，P < 0.001）。与肌内注射氟哌啶醇治疗期间总体恶化相比，在肌内注射奥氮平治疗期间，锥体外系症状（EPS）平均安全评分从基线显著改善（辛普森-安格斯量表总分平均变化：奥氮平-0.61对比氟哌啶醇0.70；P < 0.001；巴恩斯静坐不能量表总体评分平均变化：奥氮平-0.27对比氟哌啶醇0.01；P < 0.05）。
在治疗的最初24小时内，肌内注射奥氮平在减轻急性精神分裂症症状方面与肌内注射氟哌啶醇相当，两者的疗效在首次注射后2小时内即明显显现。总体而言，肌内注射氟哌啶醇治疗期间比肌内注射奥氮平观察到更多的EPS。
