一项针对100名痴呆症患者的为期3个月的随机、安慰剂对照、抗精神病药物停药研究：神经精神科量表中位数临界值是临床结果的预测指标。

A 3-month, randomized, placebo-controlled, neuroleptic discontinuation study in 100 people with dementia: the neuropsychiatric inventory median cutoff is a predictor of clinical outcome.

作者信息

Ballard Clive G, Thomas Alan, Fossey Jane, Lee Lesley, Jacoby Robin, Lana Marisa M, Bannister Carol, McShane Rupert, Swann Alan, Juszczak Ed, O'Brien John T

机构信息

Wolfson Research Centre, Newcastle General Hospital, Newcastle, UK.

出版信息

J Clin Psychiatry. 2004 Jan;65(1):114-9. doi: 10.4088/jcp.v65n0120.

DOI:10.4088/jcp.v65n0120

PMID:14744180

Abstract

BACKGROUND

Although few placebo-controlled neuroleptic discontinuation studies have been conducted in people with dementia, such studies are essential to inform key clinical decisions.

METHOD

A 3-month, double-blind, placebo-controlled, neuroleptic discontinuation study (June 2000 to June 2002) was completed in 100 care-facility residents with probable or possible Alzheimer's disease (according to National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association criteria) who had no severe behavioral disturbances and had been taking neuroleptics for longer than 3 months. The Neuropsychiatric Inventory (NPI) was used to measure changes in behavioral and psychiatric symptoms. Quality of life was evaluated using Dementia Care Mapping.

RESULTS

Eighty-two patients completed the 1-month assessment (36 placebo, 46 active). The number of participants withdrawing overall (N = 14 [30%] placebo, N = 14 [26%] active treatment) and because of exacerbation of behavioral symptoms (N = 6 [13%] placebo, N = 5 [9%] active treatment) was similar in the neuroleptic- and placebo-treated patients. As hypothesized, patients with baseline NPI scores at or below the median (< or = 14) had a particularly good outcome, with a significantly greater reduction of agitation in the patients receiving placebo (Mann-Whitney U test, z = 2.4, p =.018), while patients with higher baseline NPI scores were significantly more likely to develop marked behavioral problems if discontinued from neuroleptics (chi(2) = 6.8, p =.009). There was no overall difference in the change of quality of life parameters between groups.

DISCUSSION

A standardized evaluation with an instrument such as the NPI may be a clinical indicator of which people with dementia are likely to benefit from discontinuation of neuroleptic treatment.

摘要

背景

尽管针对痴呆患者开展的安慰剂对照抗精神病药物停药研究很少，但此类研究对于指导关键临床决策至关重要。

方法

一项为期3个月的双盲、安慰剂对照抗精神病药物停药研究（2000年6月至2002年6月）纳入了100名居住在护理机构的可能或疑似阿尔茨海默病患者（根据美国国立神经疾病和中风研究所/阿尔茨海默病及相关疾病协会标准），这些患者无严重行为障碍且服用抗精神病药物超过3个月。使用神经精神科问卷（NPI）来衡量行为和精神症状的变化。采用痴呆症护理图谱评估生活质量。

结果

82名患者完成了1个月的评估（36名服用安慰剂，46名接受活性药物治疗）。抗精神病药物治疗组和安慰剂治疗组中，总体退出研究的患者数量（安慰剂组14例[30%]，活性药物治疗组14例[26%]）以及因行为症状加重而退出的患者数量（安慰剂组6例[13%]，活性药物治疗组5例[9%]）相似。正如所假设的，基线NPI评分处于或低于中位数（≤14）的患者预后特别好，接受安慰剂治疗的患者躁动显著减少（曼-惠特尼U检验，z = 2.4，p = 0.018），而基线NPI评分较高的患者停用抗精神病药物后出现明显行为问题的可能性显著更高（χ² = 6.8，p = 0.009）。两组之间生活质量参数的变化没有总体差异。