Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial
Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial
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DOI：
10.1016/s0140-6736(08)60072-0
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发表时间：
2008-01-05
期刊：
影响因子：
168.9
通讯作者：
Crawford, Mike
中科院分区：
文献类型：
--
作者：
Tyrer, Peter;Oliver-Africano, Patricia C.;Crawford, Mike
背景 智力障碍的成年人经常报告攻击性挑战行为，并且通常用抗精神病药物治疗。然而，这种做法没有足够的证据基础。我们比较了灵活剂量的氟哌啶醇（一种典型的第一代抗精神病药）、利培酮（一种非典型的第二代抗精神病药）和安慰剂对这种行为的治疗。方法来自英格兰和威尔士的 10 个中心以及澳大利亚昆士兰州的 1 个中心的 86 名表现出攻击性挑战行为的非精神病患者被随机分配到氟哌啶醇（n=28）、利培酮（n=29）或安慰剂组。安慰剂（n=29）。在第 4、12 和 26 周时记录了攻击性、异常行为、生活质量、药物不良反应、护理者提升（对残疾人护理的积极感受）和负担以及总费用的临床评估。主要结果是治疗 4 周后攻击性的变化，用改良的明显攻击性量表 (MOAS) 记录。 Analysis was by intention to treat.该研究注册号为 ISRCTN 11736448。研究结果显示 80 名患者对处方药物的依从性达到 80% 或以上。到 4 周时，所有三种治疗方法的攻击性均大幅下降，其中安慰剂组变化最大（安慰剂组 4 周后 MOAS 评分中位数下降 = 9 [95% CI 5-14]，较基线下降 79%；利培酮为 7 [4-14]，较基线下降 58%；氟哌啶醇为 6.5 [5-14]，较基线下降 65%；p=0.06）。此外，虽然治疗之间没有记录到重要差异，包括不良反应，但给予安慰剂的患者在任何时间点都没有显示出比接受任何一种抗精神病药物的患者反应更差的证据。 解释 抗精神病药物不应再被视为智力障碍患者攻击性挑战性行为的可接受的常规治疗。
Background Aggressive challenging behaviour is frequently reported in adults with intellectual disability and it is often treated with antipsychotic drugs. However, no adequate evidence base for this practice exists. We compared flexible doses of haloperidol (a typical, first-generation antipsychotic drug), risperidone (an atypical, second-generation antipsychotic), and placebo, in the treatment of this behaviour.Methods 86 non-psychotic patients presenting with aggressive challenging behaviour from ten centres in England and Wales, and one in Queensland, Australia, were randomly assigned to haloperidol (n=28), risperidone (n=29), or placebo (n=29). Clinical assessments of aggression, aberrant behaviour, quality of life, adverse drug effects, and carer uplift (positive feelings about the care of the disabled person) and burden, together with total costs, were recorded at 4, 12, and 26 weeks. The primary outcome was change in aggression after 4 weeks' treatment, which was recorded with the modified overt aggression scale (MOAS). Analysis was by intention to treat. This study is registered as ISRCTN 11736448.Findings 80 patients had adherence of 80% or more to prescribed drug. Aggression decreased substantially with all three treatments by 4 weeks, with the placebo group showing the greatest change (median decrease in MOAS score after 4 weeks=9 [95% CI 5-14] for placebo, 79% from baseline; 7 [4-14] for risperidone, 58% from baseline; 6.5 [5-14] for haloperidol, 65% from baseline; p=0.06). Furthermore, although no important differences between the treatments were recorded, including adverse effects, patients given placebo showed no evidence at any time points of worse response than did patients assigned to either of the antipsychotic drugs.Interpretation Antipsychotic drugs should no longer be regarded as an acceptable routine treatment for aggressive challenging behaviour in people with intellectual disability.