Carlson Christopher D, Cavazzoni Patrizia A, Berg Paul H, Wei Hank, Beasley Charles M, Kane John M
Eli Lilly and Company, Indianapolis, Ind., USA.
J Clin Psychiatry. 2003 Aug;64(8):898-906. doi: 10.4088/jcp.v64n0807.
The frequency and severity of extrapyramidal syndrome (EPS) were evaluated in patients with DSM-III or DSM-IV schizophrenia in the acute phase (- 8 weeks) of randomized, double-blind, controlled trials from the integrated olanzapine clinical trial database.
This retrospective analysis included 23 clinical trials and 4611 patients from November 11, 1991, through July 31, 2001. Incidences of dystonic, parkinsonian, and akathisia events were compared using treatment-emergent adverse-event data. Categorical analyses of Simpson-Angus Scale and Barnes Akathisia Scale (BAS) scores, use of anticholinergic medications, and baseline-to-endpoint changes in Simpson-Angus Scale and BAS scores were compared.
A significantly smaller percentage of olanzapine-treated patients experienced dystonic events than did haloperidol- (p <.001) or risperidone-treated patients (p =.047). A significantly greater percentage of haloperidol-treated patients experienced parkinsonian (p <.001) and akathisia (p <.001) events than did olanzapine-treated patients. Categorical analysis of Simpson-Angus Scale scores showed significantly more haloperidol- (p <.001) or risperidone-treated patients (p =.004) developed parkinsonism than did olanzapine-treated patients. Olanzapine-treated patients experienced significantly greater reductions in Simpson-Angus Scale scores than did haloperidol- (p <.001), risperidone- (p <.001), or clozapine-treated (p =.032) patients. Categorical analysis of BAS scores showed significantly more haloperidol-treated patients experienced treatment-emergent akathisia versus olanzapine-treated patients (p <.001). Significantly greater reductions in BAS scores were experienced during olanzapine treatment versus placebo (p =.007), haloperidol (p <.001), and risperidone (p =.004) treatments. A significantly smaller percentage of olanzapine-treated patients received anticholinergic medications compared with that of haloperidol- (p <.001) or risperidone-treated patients (p =.018). Compared with that in olanzapine-treated patients, the duration of anticholinergic cotreatment was significantly longer among haloperidol- (p <.001) or risperidone-treated patients (p =.040) and significantly shorter among clozapine-treated patients (p =.021).
This analysis of available data from olanzapine clinical trials lends additional support to olanzapine's favorable EPS profile.
从奥氮平综合临床试验数据库中选取随机、双盲、对照试验急性期（-8周）的DSM-III或DSM-IV精神分裂症患者，评估锥体外系综合征（EPS）的发生频率和严重程度。
这项回顾性分析纳入了1991年11月11日至2001年7月31日期间的23项临床试验和4611例患者。使用治疗中出现的不良事件数据比较肌张力障碍、帕金森症和静坐不能事件的发生率。比较辛普森-安格斯量表和巴恩斯静坐不能量表（BAS）评分的分类分析、抗胆碱能药物的使用情况，以及辛普森-安格斯量表和BAS评分从基线到终点的变化。
与接受氟哌啶醇治疗的患者（p<.001）或利培酮治疗的患者（p =.047）相比，接受奥氮平治疗的患者发生肌张力障碍事件的比例显著更低。与接受奥氮平治疗的患者相比，接受氟哌啶醇治疗的患者发生帕金森症（p<.001）和静坐不能（p<.001）事件的比例显著更高。辛普森-安格斯量表评分的分类分析显示，与接受奥氮平治疗的患者相比，接受氟哌啶醇治疗的患者（p<.001）或利培酮治疗的患者（p =.004）发生帕金森症的比例显著更高。与接受氟哌啶醇治疗的患者（p<.001）、利培酮治疗的患者（p<.001）或氯氮平治疗的患者（p =.032）相比，接受奥氮平治疗的患者辛普森-安格斯量表评分的降低幅度显著更大。BAS评分的分类分析显示，与接受奥氮平治疗的患者相比，接受氟哌啶醇治疗的患者出现治疗中出现的静坐不能的比例显著更高（p<.001）。与安慰剂（p =.007）、氟哌啶醇（p<.001）和利培酮（p =.004）治疗相比，奥氮平治疗期间BAS评分的降低幅度显著更大。与接受氟哌啶醇治疗的患者（p<.001）或利培酮治疗的患者（p =.018）相比，接受奥氮平治疗的患者接受抗胆碱能药物治疗的比例显著更低。与接受奥氮平治疗的患者相比，氟哌啶醇治疗的患者（p<.001）或利培酮治疗的患者（p =.040）抗胆碱能联合治疗的持续时间显著更长，而氯氮平治疗的患者抗胆碱能联合治疗的持续时间显著更短（p =.021）。
对奥氮平临床试验现有数据的分析为奥氮平良好的EPS特征提供了更多支持。
