Teri L, Logsdon R G, Peskind E, Raskind M, Weiner M F, Tractenberg R E, Foster N L, Schneider L S, Sano M, Whitehouse P, Tariot P, Mellow A M, Auchus A P, Grundman M, Thomas R G, Schafer K, Thal L J
University of Washington, Department of Psychosocial and Community Health, Seattle 98195-7263, USA.
Neurology. 2000 Nov 14;55(9):1271-8. doi: 10.1212/wnl.55.9.1271.
Treatment of agitation is a crucial problem in the care of patients with AD. Although antipsychotic and antidepressant medications and behavior management techniques (BMT) have each been used to treat agitation, clinical trials of these treatments have been characterized by small sample sizes and uncontrolled treatment designs.
To compare haloperidol, trazodone, and BMT with placebo in the treatment of agitation in AD outpatients.
A total of 149 patients with AD and their caregivers participated in a randomized, placebo-controlled, multicenter trial. Blind assessment was conducted at baseline and after 16 weeks of treatment. The three active treatments were haloperidol, trazodone, and BMT. The Alzheimer's Disease Cooperative Study Clinical Global Impression of Change was the primary outcome measure. Secondary outcomes included patient agitation, cognition, and function, and caregiver burden.
Thirty-four percent of subjects improved relative to baseline. No significant differences on outcome were obtained between haloperidol (mean dose, 1.8 mg/d), trazodone (mean dose, 200 mg/d), BMT, or placebo. Significantly fewer adverse events of bradykinesia and parkinsonian gait were evident in the BMT arm. No other significant difference in adverse events was seen. Symptoms did not respond differentially to the different treatments.
Comparable modest reductions in agitation occurred in patients receiving haloperidol, trazodone, BMT, and placebo. More effective pharmacologic, nonpharmacologic, and combination treatments are needed.
激越的治疗是阿尔茨海默病（AD）患者护理中的一个关键问题。尽管抗精神病药物、抗抑郁药物和行为管理技术（BMT）都曾用于治疗激越，但这些治疗方法的临床试验样本量较小且治疗设计缺乏对照。
比较氟哌啶醇、曲唑酮和行为管理技术与安慰剂治疗AD门诊患者激越的效果。
共有149例AD患者及其照料者参与了一项随机、安慰剂对照、多中心试验。在基线和治疗16周后进行盲法评估。三种积极治疗方法分别为氟哌啶醇、曲唑酮和行为管理技术。阿尔茨海默病协作研究临床总体印象变化是主要结局指标。次要结局包括患者激越、认知和功能以及照料者负担。
34%的受试者相对于基线有所改善。氟哌啶醇（平均剂量1.8mg/d）、曲唑酮（平均剂量200mg/d）、行为管理技术或安慰剂在结局上无显著差异。行为管理技术组中运动迟缓及帕金森步态等不良事件明显较少。不良事件未见其他显著差异。不同治疗方法所对应的症状改善无差异。
接受氟哌啶醇、曲唑酮、行为管理技术和安慰剂治疗的患者激越程度均有适度降低且效果相当。需要更有效的药物、非药物及联合治疗方法。
