Kurlan Roger, Cummings Jeffrey, Raman Rema, Thal Leon
Mt. Hope Professional Building, Rochester, NY 14620, USA.
Neurology. 2007 Apr 24;68(17):1356-63. doi: 10.1212/01.wnl.0000260060.60870.89.
To assess the efficacy and tolerability of quetiapine for agitation or psychosis in patients with dementia and parkinsonism.
Multicenter randomized, double-blind, placebo-controlled parallel groups clinical trial involving 40 patients with dementia with Lewy bodies (n = 23), Parkinson disease (PD) with dementia (n = 9), or Alzheimer disease with parkinsonian features (n = 8). The main outcome measure for efficacy was change in the Brief Psychiatric Rating Scale (BPRS) from baseline to 10 weeks of therapy. For tolerability it was change in the Unified PD Rating Scale (UPDRS) motor section over the same time period. The trial was confounded by the need for a design change and incomplete recruitment.
No significant differences in the primary or secondary outcome measures of efficacy were observed. An unexpectedly large placebo effect, inadequate dosage (mean 120 mg/day), and inadequate power may have contributed to lack of demonstrable benefit. Quetiapine was generally well-tolerated and did not worsen parkinsonism, but was associated with a trend toward a decline on a measure of daily functioning.
Quetiapine was well-tolerated and did not worsen parkinsonism. Although conclusions about efficacy may be limited, the drug in the dosages used did not show demonstrable benefit for treating agitation or psychosis in patients with dementia and parkinsonism. These findings are in keeping with prior studies reporting limited efficacy of various medications for reducing behavioral problems in demented patients.
评估喹硫平治疗痴呆和帕金森综合征患者激越或精神病的疗效及耐受性。
多中心随机、双盲、安慰剂对照平行组临床试验，纳入40例路易体痴呆患者（n = 23）、帕金森病（PD）伴痴呆患者（n = 9）或具有帕金森特征的阿尔茨海默病患者（n = 8）。疗效的主要结局指标为治疗10周时简明精神病评定量表（BPRS）相对于基线的变化。耐受性的结局指标为同一时期统一帕金森病评定量表（UPDRS）运动部分的变化。该试验因设计变更需求和招募不完全而受到干扰。
在疗效的主要或次要结局指标上未观察到显著差异。意外大的安慰剂效应、剂量不足（平均120毫克/天）以及效能不足可能导致未显示出明显益处。喹硫平总体耐受性良好，未加重帕金森综合征，但与日常功能指标呈下降趋势相关。
喹硫平耐受性良好，未加重帕金森综合征。尽管关于疗效的结论可能有限，但所用剂量的该药物在治疗痴呆和帕金森综合征患者的激越或精神病方面未显示出明显益处。这些发现与先前报道各种药物在减少痴呆患者行为问题方面疗效有限的研究一致。
