Baker Robert W, Kinon Bruce J, Maguire Gerald A, Liu Hong, Hill Angela L
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285.
J Clin Psychopharmacol. 2003 Aug;23(4):342-8. doi: 10.1097/01.jcp.0000085406.08426.a8.
Patients experiencing an acute decompensation of schizophrenia or bipolar disorder often present in an agitated state. Agitation presents a barrier to therapy, interrupting the typical physician-patient alliance and creating a disruptive, even hazardous, environment. Rapid assessment and effective treatment are necessary to manage agitation and, potentially, to shorten the time to recovery.
One hundred forty-eight acutely agitated patients received either: rapid initial dose escalation (RIDE) in which up to 40 mg of oral olanzapine was allowed on days 1 and 2, up to 30 mg on days 3 and 4, and 5 to 20 mg thereafter; or usual clinical practice (UCP) in which patients received 10 mg/d olanzapine plus up to 4 mg lorazepam on days 1 and 2, up to 2 mg on days 3 and 4, and olanzapine 5 to 20 mg/d thereafter. The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC: poor impulse control, tension, hostility, uncooperativeness, and excitement) measured at 24 hours was the primary measure. Secondary assessments of agitation and safety were also performed.
Agitation improved significantly from baseline for both treatment groups; however, improvement with the RIDE strategy was superior to UCP. The RIDE group improvement was superior on the primary efficacy measure (PANSS-Excited) at 24 hours; it was superior on all agitation measures at the end of double-blind treatment. Both treatments were well tolerated, with no clinically significant differences in safety measures. Treatment was not limited by oversedation and attention improved from baseline in both groups.
This study demonstrates the value of olanzapine in the treatment of acutely agitated patients. A new approach to olanzapine dosing that expands the initial dose range up to 40 mg/d may offer superior efficacy in rapidly and effectively controlling the symptoms of agitation.
患有精神分裂症或双相情感障碍急性失代偿的患者常表现为激动状态。激动是治疗的障碍，会中断典型的医患关系，并营造出一种具有破坏性甚至危险的环境。快速评估和有效治疗对于控制激动情绪以及可能缩短康复时间是必要的。
148名急性激动的患者接受以下两种治疗之一：快速初始剂量递增（RIDE），即第1天和第2天允许口服奥氮平最高达40mg，第3天和第4天最高达30mg，之后为5至20mg；或常规临床实践（UCP），即患者第1天和第2天接受10mg/d奥氮平加最高达4mg劳拉西泮，第3天和第4天最高达2mg，之后奥氮平为5至20mg/d。以24小时时测量的阳性和阴性症状量表 - 激动分量表（PANSS - EC：冲动控制差、紧张、敌意、不合作和兴奋）作为主要测量指标。还进行了激动和安全性的次要评估。
两个治疗组的激动情绪均较基线有显著改善；然而，RIDE策略的改善效果优于UCP。RIDE组在24小时时主要疗效指标（PANSS - 激动）上的改善更优；在双盲治疗结束时，在所有激动测量指标上也更优。两种治疗耐受性均良好，安全指标无临床显著差异。治疗未受过度镇静限制，两组注意力均较基线有所改善。
本研究证明了奥氮平在治疗急性激动患者中的价值。一种新的奥氮平给药方法，将初始剂量范围扩大至最高40mg/d，可能在快速有效控制激动症状方面具有更优疗效。
