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银杏叶提取物联合利培酮治疗孤独症谱系障碍的双盲安慰剂对照试验。

A double-blind placebo controlled trial of Ginkgo biloba added to risperidone in patients with autistic disorders.

机构信息

Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, 13337 Tehran, Iran.

出版信息

Child Psychiatry Hum Dev. 2012 Oct;43(5):674-82. doi: 10.1007/s10578-012-0292-3.

DOI:10.1007/s10578-012-0292-3
PMID:22392415
Abstract

Ginkgo biloba has been reported to affect the neurotransmitter system and to have antioxidant properties that could impact the pathogenesis of Autism Spectrum Disorder. Based on these studies, we decided to assess the effectiveness of Ginkgo biloba extract (Ginko T.D., Tolidaru, Iran) as an adjunctive agent to risperidone in the treatment of autism. Forty-seven outpatients with a DSM-IV-TR diagnosis of autism ages between 4 and 12 years were assigned to this double blinded clinical trial and were randomly divided into two groups. One group received risperidone plus Ginko T.D and the other received risperidone plus placebo. The dose of risperidone was 1-3 mg/day and the dose of Ginko T.D. was 80 mg/day for patients under 30 kg and 120 mg/day for patients above 30 kg. Patients were assessed using Aberrant Behavior Checklist-Community (ABC-C) rating scale and the side effect check list every 2 weeks until the endpoint. None of the 5 subscales of ABC-C rating scale showed significant differences between the two groups. Incidents of side effects were not significantly different between the two groups. Adding Ginkgo biloba to risperidone did not affect the treatment outcome of ADs. Nevertheless, further observations are needed to confirm this result.

摘要

银杏已被报道能影响神经递质系统,具有抗氧化特性,可能影响自闭症谱系障碍的发病机制。基于这些研究,我们决定评估银杏叶提取物(Ginko T.D.,Tolidaru,伊朗)作为利培酮辅助治疗自闭症的疗效。47 名符合 DSM-IV-TR 自闭症诊断标准的门诊患者年龄在 4 至 12 岁之间,被纳入这项双盲临床试验,并随机分为两组。一组接受利培酮加 Ginko T.D.,另一组接受利培酮加安慰剂。利培酮的剂量为 1-3mg/天,体重低于 30kg 的患者给予银杏叶提取物 80mg/天,体重超过 30kg 的患者给予 120mg/天。每两周评估一次患者,使用异常行为检查表-社区(ABC-C)评分量表和副作用检查表,直到终点。ABC-C 评分量表的 5 个分量表在两组之间均无显著差异。两组的不良反应发生率无显著差异。将银杏叶提取物加入利培酮治疗不会影响 ADs 的治疗效果。然而,需要进一步观察以确认这一结果。

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