Behmanesh Helen, Moghaddam Hossein Sanjari, Mohammadi Mohammad-Reza, Akhondzadeh Shahin
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Clin Neuropharmacol. 2019 Nov/Dec;42(6):189-196. doi: 10.1097/WNF.0000000000000368.
Propentofylline is a xanthine phosphodiesterase inhibitor and adenosine reuptake blocker with neuroprotective effects linked to anti-inflammatory and antiexcitatory properties. This is a double-blind, placebo-controlled trial investigating the potential beneficial effects of propentofylline, as an adjunctive treatment with risperidone, on the severity and behavioral abnormalities of autism spectrum disorder (ASD).
A total of 48 children with ASD were randomly allocated into 2 groups of risperidone (initiating at 0.5 mg/d) plus propentofylline (initiating at 300 mg/d) and risperidone plus placebo. The Aberrant Behavior Checklist-Community (ABC-C) and Childhood Autism Rating Scale (CARS) were used for the evaluation of ASD severity and behavioral disruptions at baseline, week 4, and week 10. Primary outcome measure of the study was ABC-C irritability subscale score, whereas CARS score along with other 4 subscales of ABC-C (lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech subscales) were considered as secondary outcome measures.
Results from the general linear model repeated measures analysis demonstrated significant time-treatment interaction on irritability subscale (F1.55 = 3.45; P = 0.048) and CARS (F1.41 = 4.08; P = 0.034) scores. Compared with the placebo group, children receiving propentofylline showed greater improvements in the CARS score (P = 0.037) from baseline to the study endpoint. Our results found no significant time-treatment effect on other subscales of ABC-C. Two trial groups were comparable based on the frequency of adverse effects.
Our findings demonstrated that adjunctive treatment with propentofylline is effective in alleviating disease severity and improving irritability in ASD patients. However, larger studies with longer durations are required to confirm these results.
丙戊茶碱是一种黄嘌呤磷酸二酯酶抑制剂和腺苷再摄取阻滞剂，具有与抗炎和抗兴奋特性相关的神经保护作用。这是一项双盲、安慰剂对照试验，旨在研究丙戊茶碱作为利培酮的辅助治疗，对自闭症谱系障碍（ASD）的严重程度和行为异常的潜在有益影响。
总共48名ASD儿童被随机分为两组，一组接受利培酮（起始剂量为0.5mg/d）加丙戊茶碱（起始剂量为300mg/d），另一组接受利培酮加安慰剂。在基线、第4周和第10周，使用异常行为检查表-社区版（ABC-C）和儿童自闭症评定量表（CARS）评估ASD的严重程度和行为障碍。该研究的主要结局指标是ABC-C易激惹子量表评分，而CARS评分以及ABC-C的其他4个子量表（嗜睡/社交退缩、刻板行为、多动/不依从和不当言语子量表）被视为次要结局指标。
一般线性模型重复测量分析结果显示，在易激惹子量表（F1.55 = 3.45；P = 0.048）和CARS（F1.41 = 4.08；P = 0.034）评分上存在显著的时间-治疗交互作用。与安慰剂组相比，接受丙戊茶碱治疗的儿童从基线到研究终点时CARS评分有更大改善（P = 0.037）。我们的结果发现，在ABC-C的其他子量表上没有显著的时间-治疗效应。两个试验组在不良反应发生频率方面具有可比性。
我们的研究结果表明，丙戊茶碱辅助治疗可有效减轻ASD患者的疾病严重程度并改善易激惹症状。然而，需要进行更大规模、持续时间更长的研究来证实这些结果。
