Kinon Bruce J, Stauffer Virginia L, Kollack-Walker Sara, Chen Lei, Sniadecki Jennifer
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46258, USA.
J Clin Psychopharmacol. 2008 Dec;28(6):601-7. doi: 10.1097/JCP.0b013e31818aaf6c.
Rapid control of agitation is of critical importance in the treatment of acutely ill patients with schizophrenia. Both olanzapine and aripiprazole have been shown to be safe and effective in this setting, with each having somewhat different receptor binding affinity profiles. This 5-day, randomized, double-blind trial evaluated relative improvements in agitation in hospitalized patients who received orally dosed olanzapine (n = 306, 20 mg/d) or aripiprazole (n = 298, 15 mg/d, increasing to 30 mg/d as needed). Lorazepam was also given as needed (total dose, < or =4 mg/d) but not in place of a study drug dose increase. The primary efficacy measure was daily mean change from baseline in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score. Secondary measures of positive symptoms and safety were also assessed. Significant improvements from baseline in PANSS-EC and secondary efficacy measures were seen for both olanzapine and aripiprazole (P < 0.001),with no between-group differences. A greater proportion of aripiprazole-treated patients received lorazepam at each visit compared with olanzapine-treated patients, but this difference was significant only at visit 5 (41.2% vs 31.0%, P = 0.033). Fasting glucose and triglycerides increased more significantly in olanzapine-treated patients (P = 0.030 and P < 0.001, respectively). Prolactin increased in the olanzapine group and decreased in the aripiprazole group with a significant between-group difference (P < 0.001). During the first 5 days of randomized treatment, olanzapine and aripiprazole displayed similar efficacy profiles for treating agitation associated with schizophrenia. Aripiprazole-treated patients had smaller increases in glucose and lipids, but no difference was observed between treatments in the proportion of patients experiencing categorical shifts in these measures.
快速控制激越在精神分裂症急性病患者的治疗中至关重要。奥氮平和阿立哌唑在这种情况下均已被证明是安全有效的,且它们各自具有略有不同的受体结合亲和力特征。这项为期5天的随机双盲试验评估了口服奥氮平(n = 306,20 mg/天)或阿立哌唑(n = 298,15 mg/天,必要时增至30 mg/天)的住院患者激越情况的相对改善。必要时也给予劳拉西泮(总剂量≤4 mg/天),但不作为研究药物剂量增加的替代。主要疗效指标是阳性和阴性症状量表-激越分量表(PANSS-EC)评分自基线的每日平均变化。还评估了阳性症状和安全性的次要指标。奥氮平和阿立哌唑的PANSS-EC及次要疗效指标均较基线有显著改善(P < 0.001),组间无差异。与奥氮平治疗的患者相比,每次就诊时接受劳拉西泮治疗的阿立哌唑治疗患者比例更高,但这种差异仅在第5次就诊时显著(41.2%对31.0%,P = 0.033)。奥氮平治疗的患者空腹血糖和甘油三酯升高更为显著(分别为P = 0.030和P < 0.001)。奥氮平组催乳素升高,阿立哌唑组降低,组间差异显著(P < 0.001)。在随机治疗的前5天,奥氮平和阿立哌唑在治疗与精神分裂症相关的激越方面显示出相似的疗效。阿立哌唑治疗的患者血糖和血脂升高幅度较小,但在这些指标出现分类变化的患者比例方面,两种治疗之间未观察到差异。