Objective

To describe the effect of prednisolone on language in children with autism spectrum disorder. This study is based upon two hypotheses: autism etiology may be closely related to neuroinflammation; and, an effective treatment should restore the individual's language skills.

Method

This is a prospective, double-blinded, randomized, placebo-controlled clinical trial, carried out in a federal university hospital. The initial patient sample consisted of 40 subjects, which were randomized into two parallel groups. Inclusion criteria were: male gender, 3–7 years of age, and meeting the Diagnostic and Statistical Manual of Mental Disorders – 4th edition (DSM-IV) diagnostic criteria. The final sample consisted of 38 patients, of whom 20 were randomized to the placebo group and 18 to the active group. The latter received prednisolone for 24 weeks, at an initial dose of 1 mg/kg/day and a tapering dose from the ninth week onward. Language was measured on four occasions over a 12-month period by applying two Brazilian tools: the Language Development Assessment (ADL) and the Child Language Test in Phonology, Vocabulary, Fluency, and Pragmatics (ABFW).

Results

The side effects were mild: two patients had hypertension, five had hyperglycemia, and two had varicella. Prednisolone increased the global ADL score in children younger than 5 years of age who had developmental regression (p = 0.0057). The ABFW's total of communicative acts also responded favorably in those participants with regression (p = 0.054). The ABFW's total of vocal acts showed the most significant results, especially in children younger than 5 years (p = 0.004, power = 0.913).

Conclusions

The benefit of prednisolone for language scores was more evident in participants who were younger than five years, with a history of developmental regression, but the trial's low dose may have limited this benefit. The observed side effects do not contraindicate corticosteroid use in autism.

中文翻译：

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泼尼松龙对自闭症谱系障碍儿童语言功能的影响：一项随机临床试验。

客观的

描述泼尼松龙对自闭症谱系障碍儿童语言的影响。这项研究基于两个假设：自闭症病因可能与神经炎症密切相关；并且，有效的治疗应该恢复个人的语言技能。

方法

这是一项前瞻性、双盲、随机、安慰剂对照的临床试验，在联邦大学医院进行。最初的患者样本由 40 名受试者组成，这些受试者被随机分为两个平行组。纳入标准为：男性，3-7 岁，符合《精神疾病诊断和统计手册》第 4 版 (DSM-IV) 诊断标准。最终样本由 38 名患者组成，其中 20 人被随机分配到安慰剂组，18 人被随机分配到活性组。后者接受泼尼松龙 24 周，初始剂量为 1 mg/kg/天，从第 9 周开始逐渐减量。在 12 个月的时间里，通过应用两种巴西工具对语言进行了四次测量：语言发展评估 (ADL) 和儿童语言测试，包括音韵、词汇、流利度、

结果

副作用轻微：2 名患者出现高血压，5 名出现高血糖，2 名出现水痘。泼尼松龙提高了 5 岁以下发育倒退儿童的总体 ADL 评分（p  = 0.0057）。ABFW 的总交际行为在回归的参与者中也有积极的反应（p  = 0.054）。ABFW 的声音行为总数显示出最显着的结果，尤其是在 5 岁以下的儿童中（p  = 0.004，功效 = 0.913）。

结论

泼尼松龙对语言成绩的益处在 5 岁以下、有发育退化史的参与者中更为明显，但试验的低剂量可能限制了这种益处。观察到的副作用并不禁止自闭症患者使用皮质类固醇。