A Randomized, Placebo-Controlled Trial of the Discontinuation of Long-Term Antipsychotics in Dementia

A Randomized, Placebo-Controlled Trial of the Discontinuation of Long-Term Antipsychotics in Dementia
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一项关于痴呆症患者停用长期抗精神病药物的随机、安慰剂对照试验

DOI:
10.1017/s1041610202008396
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发表时间:
2002
影响因子:
7
通讯作者:
L. Ostrander
L. Ostrander
中科院分区:
医学1区
文献类型:
--
作者:
R. van Reekum;D. Clarke;D. Conn;N. Herrmann;G. Eryavec;T. Cohen;L. Ostrander

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这项随机临床试验的目的是调查长期护理机构中患有痴呆症的居民停用长期抗精神病药物的影响,并确定安全停药的临床预测因素。受试者包括 34 名患有痴呆症的居民,他们服用抗精神病药物超过 6 个月,目前行为稳定。受试者被随机分配继续接受常规剂量的抗精神病药物或接受安慰剂 6 个月。各组之间提前退出研究没有统计学差异(相对风险 [RR] = 1.57,95% 置信区间 [CI] 0.76–3.26),虽然没有显着差异,但安慰剂组的受试者更有可能因行为恶化而退出研究(RR = 1.25,95% CI 0.33–4.76)。安慰剂组中的三名受试者因锥体外系症状恶化而退出研究。与安慰剂组相比,积极治疗组有更多的行为问题(例如,对他人的身体攻击,p < .05)。安慰剂组变得更加冷漠,但平衡这一结果是认知功能的相对改善。基线抗精神病药物剂量可预测长期抗精神病药物停用后行为恶化。该研究的主要限制是样本量较小。总之,应考虑在该人群中尝试停用抗精神病药物。
The objectives of this randomized clinical trial were to investigate the impact of the discontinuation of long-term antipsychotics in residents with dementia in chronic care institutions and to identify clinical predictors of safe discontinuation. Subjects included 34 residents with dementia who were on antipsychotics for more than 6 months and whose behavior was currently stable. Subjects were randomized to either continue receiving their regular dosage of antipsychotics or to receive placebo for 6 months. Early withdrawal from the study was not statistically different between the groups (relative risk [RR] = 1.57, 95% confidence interval [CI] 0.76–3.26), and though not significantly different, subjects in the placebo group were more likely to be withdrawn from the study because of worsening behavior (RR = 1.25, 95% CI 0.33–4.76). Three subjects in the placebo group were withdrawn from the study due to worsening of extrapyramidal symptoms. The active treatment group had more behavioral problems (e.g., physical aggression towards others, p < .05) compared to the placebo group. The placebo group developed more apathy, but balancing this outcome was a relative improvement in congitive functioning. Baseline antipsychotic dose was predictive of behavioral worsening upon discontinuation of long-term antipsychotic drugs. The primary limitation of the study was the small sample size. In conclusion, a trial of discontinuation of antipsychotics should be considered in this population.
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期刊: The American journal of psychiatry
影响因子: --
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