Pharmaceutical Science, University of Sorocaba, Sorocaba, Brazil.
Médico de Família e Comunidade, Especialista em Saúde da Família, Geriatria e Gerontologia, Secretaria Municipal de Saúde, Florianopolis, Brazil.
BMJ Open. 2023 Jun 20;13(6):e069114. doi: 10.1136/bmjopen-2022-069114.
Atypical antipsychotics have been studied to treat autism spectrum disorder (ASD). However, like little is known about whether these drugs are effective and safe when compared in controlled and non-controlled settings. This study aims to assess the efficacy and safety of second-generation antipsychotics in ASD in randomised controlled trials (RCT) and observational studies.
This systematic review will include RCT and prospective cohorts evaluating second-generation antipsychotics in people 5 years and older diagnosed with ASD. Searches will be conducted in Medline, Embase, Cochrane Library, Epistemonikos, Lilacs, CINAHL, PsycINFO, trial registries and grey literature databases without restriction on publication status, year of publication and language. The primary outcomes will be symptoms of aggressive behaviour, quality of life for the individual or their careers, and discontinuation or dropouts/withdrawals of antipsychotics due to adverse events. The secondary outcomes are other not serious adverse events and adherence to pharmacotherapy. Selection, data extraction, and quality assessment will be performed by pairs of reviewers, independently. The Risk of Bias 2 (RoB 2) and Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tools will be used to assess the risk of bias in the included studies. If appropriate, a meta-analysis and network meta-analysis will be conducted to synthesise the results. The overall quality of the evidence for each outcome will be determined by the Recommendation, Assessment, Development and Evaluation approach.
This study will systematically summarise the existing evidence evaluating the use of second-generation antipsychotics for treating ASD, in controlled and uncontrolled studies. The results of this review will be disseminated through peer-reviewed publications and conference presentations.
CRD42022353795.
已经有研究探讨了使用非典型抗精神病药治疗自闭症谱系障碍（ASD）。然而，与对照和非对照环境下比较时，这些药物的有效性和安全性知之甚少。本研究旨在评估 ASD 中第二代抗精神病药的随机对照试验（RCT）和观察性研究中的疗效和安全性。
本系统评价将包括评估 5 岁及以上被诊断为 ASD 的人群中使用第二代抗精神病药的 RCT 和前瞻性队列研究。检索将在 Medline、Embase、Cochrane 图书馆、Epistemonikos、Lilacs、CINAHL、PsycINFO、试验注册处和灰色文献数据库中进行，不限制发表状态、发表年份和语言。主要结局将是攻击性行为的症状、个体或其职业的生活质量，以及因不良事件而停用或停药/退出抗精神病药。次要结局是其他非严重不良事件和药物治疗的依从性。选择、数据提取和质量评估将由两名评审员独立进行。将使用偏倚风险 2（RoB 2）和干预措施非随机研究偏倚风险（ROBINS-I）工具评估纳入研究的偏倚风险。如果合适，将进行荟萃分析和网络荟萃分析以综合结果。每个结局的证据总体质量将通过推荐、评估、开发和评价方法确定。
本研究将系统地总结评估在对照和非对照研究中使用第二代抗精神病药治疗 ASD 的现有证据。该综述的结果将通过同行评议的出版物和会议报告进行传播。
PROSPERO 注册号：CRD42022353795。
