Celecoxib as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial
Celecoxib as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial
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DOI：
10.1007/s00213-012-2796-8
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发表时间：
2013-01-01
影响因子：
3.4
通讯作者：
Akhondzadeh, Shahin
中科院分区：
文献类型：
--
作者：
Asadabadi, Mahtab;Mohammadi, Mohammad-Reza;Akhondzadeh, Shahin
理性自闭症与炎症反应系统的激活有关。 目的 本研究旨在评估环氧合酶 2 抑制剂塞来昔布作为辅助疗法治疗自闭症的疗效方法在一项为期 10 周的随机双盲安慰剂对照研究中，将 40 名患有《精神障碍诊断与统计手册》第四版文本修订版临床诊断自闭症的门诊儿童随机分配至塞来昔布加利培酮或安慰剂加利培酮。利培酮和塞来昔布的剂量分别滴定至 3 毫克/天和 300 毫克/天。使用异常行为检查表社区 (ABC-C) 评定量表在基线以及开始用药 2、4、6 和 10 周后对患者进行评估。主要结局指标是 ABC-C 烦躁分量表的变化。 结果 观察到烦躁（F (1.658, 63.021) = 13.580，P < 0.001）、嗜睡/社交退缩（F (1.948, 74.032) = 16.811，P < 0.001）和社交退缩方面存在显着的时间 x 治疗交互作用。刻板行为 (F(1.742, 66.198) = 12.104, P < 0.001)，但不适用于多动/不合规 (F (2.564, 97.424) = 1.469, P = 0.232) 和不当言语分量表 (F (1.607, 61.075) = 0.173，P = 0.794）。到第 10 周时，与安慰剂组相比，塞来昔布组患者在烦躁 (P < 0.001)、嗜睡/社交退缩 (P < 0.001) 和刻板行为 (P < 0.00) 方面表现出显着改善，但在多动/不依从 (P = 0.202) 和不当言语 (P = 0.802) 分量表方面没有明显改善组。安慰剂组有 4 名患者 (20%) 和塞来昔布组有 11 名患者 (55%) 获得完全缓解 (chi (2) (1) = 5.227，P = 0.022）。两组之间的副作用发生率相似。结论 利培酮和塞来昔布联合治疗在治疗自闭症儿童的烦躁、社交退缩和刻板印象方面优于单用利培酮。 （注册，www.irct.ir；IRCT138711091556N2）。
Rational Autism is associated with activation of the inflammatory response system.Objective This study aims to assess the efficacy of a cyclooxygenase-2 inhibitor, celecoxib, as adjunctive therapy in the treatment of autismMethods In a 10-week randomized double-blind placebo-controlled study, 40 outpatient children with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision clinical diagnosis of autism were randomly allocated to celecoxib plus risperidone or placebo plus risperidone. The dose of risperidone and celecoxib were titrated up to 3 and 300 mg/day, respectively. Patients were assessed at baseline and after 2, 4, 6, and 10 weeks of starting medication using the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale. Primary outcome measure was the change in irritability subscale of ABC-C.Results Significant time x treatment interaction was observed for Irritability (F (1.658, 63.021) = 13.580, P < 0.001), Lethargy/Social Withdrawal (F (1.948, 74.032) = 16.811, P < 0.001), and Stereotypic Behavior (F(1.742, 66.198) = 12.104, P < 0.001), but not for Hyperactivity/Noncompliance (F (2.564, 97.424) = 1.469, P = 0.232), and Inappropriate Speech subscales (F (1.607, 61.075) = 0.173, P = 0.794). By week 10, patients in the celecoxib group showed significantly greater improvement in the Irritability (P < 0.001), Lethargy/Social Withdrawal (P < 0.001), and Stereotypic Behavior (P < 0.00) but not in Hyperactivity/Noncompliance (P = 0.202) and Inappropriate Speech (P = 0.802) subscales than the placebo group. Complete response was achieved by four (20 %) patients in the placebo group and 11 (55 %) patients in the celecoxib group (chi (2) (1) = 5.227, P = 0.022). Frequency of side effects was similar between the two groups.Conclusions Combination of risperidone and celecoxib was superior to risperidone alone in treating irritability, social withdrawal, and stereotypy of children with autism. (Registration, www.irct.ir; IRCT138711091556N2).