A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia
A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia
复制标题
DOI：
10.1212/wnl.53.5.946
复制
发表时间：
1999-09-22
期刊：
影响因子：
9.9
通讯作者：
Lawlor, BA
中科院分区：
文献类型：
--
作者：
De Deyn, PP;Rabheru, K;Lawlor, BA
目的：比较利培酮与安慰剂（疗效和耐受性）和氟哌啶醇（耐受性）治疗伴有攻击等行为症状的痴呆患者的疗效。方法：一项为期13周的双盲研究，涉及344名痴呆患者，随机分配接受安慰剂或灵活剂量（0.5至4mg /d）利培酮或氟哌啶醇。行为症状采用阿尔茨海默病行为病理学评定量表（Behavior - ad）、Cohen-Mansfield躁动量表（CMAI）和临床总体印象量表（CGI）进行评估。耐受性评估包括锥体外系症状评定量表、镇静水平、功能评估分期、小型精神状态检查和不良事件发生率。结果：利培酮的平均剂量为1.1 mg/d，氟哌啶醇为1.2 mg/d。虽然不显著，但在终点和第12周，接受利培酮治疗的患者比接受安慰剂治疗的患者表现出更高的临床改善（从基线到终点的BEHAVE-AD总分大于或等于30%）。在第12周，利培酮组的BEHAVE-AD总分的降低明显大于安慰剂组。在进一步的攻击分析中，这些患者最主要的症状，behavior - ad和CMAI攻击集群得分在终点和第12周与安慰剂相比显着降低。在终点和第12周时，CGI评分也显著降低。利培酮组锥体外系症状的严重程度与安慰剂组无显著差异，且低于氟哌啶醇组。事后分析显示，在第12周，利培酮比氟哌啶醇显著降低了behavior - ad攻击性评分。结论：低剂量利培酮（平均1.1 mg/d）耐受性良好，与老年痴呆患者行为症状的严重程度和频率降低有关，特别是攻击行为。
Objective: To compare effects of risperidone with placebo (efficacy and tolerability) and haloperidol (tolerability) for treating demented patients with aggression and other behavioral symptoms. Methods: A 13-week double-blind study involving 344 patients with dementia randomly assigned to receive placebo or flexible doses (0.5 to 4 mg/d) of risperidone or haloperidol. Behavioral symptoms were assessed by the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD), the Cohen-Mansfield Agitation Inventory (CMAI), and the Clinical Global Impression (CGI) scale. Tolerability assessments included the Extrapyramidal Symptom Rating Scale, sedation levels, Functional Assessment Staging, Mini-Mental State Examination, and incidence of adverse events. Results: The mean dose at endpoint was 1.1 mg/d of risperidone and 1.2 mg/d of haloperidol. Although not significant, a higher percentage of patients receiving risperidone than those receiving placebo showed clinical improvement (greater than or equal to 30% reduction from baseline to endpoint in BEHAVE-AD total score) at endpoint and week 12. Reductions in the BEHAVE-AD total score were significantly greater with risperidone than with placebo at week 12. In a further analysis of aggression, the most dominant symptom in these patients, BEHAVE-AD and CMAI aggression cluster scores were significantly reduced compared with placebo at endpoint and week 12. CGI scores were also significantly reduced at endpoint and week 12. Severity of extrapyramidal symptoms with risperidone did not differ significantly from that of placebo and was less than that of haloperidol. A post hoc analysis showed significantly greater reductions in the BEHAVE-AD aggressiveness score with risperidone than haloperidol at week 12. Conclusion: Low-dose risperidone (mean 1.1 mg/d) was well tolerated and associated with reductions in the severity and frequency of behavioral symptoms, particularly aggression, in elderly patients with dementia.