Abstract: Objective　To systematically review the clinical studies of fecal microbiota transplantation（FMT）intervention in children with autism spectrum disorder（ASD），and evaluate the therapeutic effect of FMT on children with ASD. Methods　Clinical researches on the treatment of fecal microbiota transplantation for ASD children were searched on PubMed，Cochrane Library，EMBASE，China National Knowledge Infrastructure（CNKI），Wanfang Medical Database and VIP database. Papers published from the establishment date of the databases to Jun 1，2025 were extracted. Two persons independently screened the retrieved literature and extracted data. Meta-analysis was performed with RevMan 5.3 software. Results　A total of 12 articles were included，including 3 randomized controlled trials（RCTs），1 case-control study，3 retrospective observational studies，2 prospective open-label studies，and 3 case reports. All 12 studies have shown that symptoms of ASD were improved after FMT treatment.Meta-analysis of 5 studies showed that the Autism Behavior Checklist（SMD=-0.53，95%CI 0.67-0.38），Aberrant Behavior Scale（SMD=-0.79，95%CI -1.33- -0.26），Childhood Autism Rating Scale（CARS）（SMD=-0.54，95%CI -0.68- -0.41），Social Responsiveness Scale（SRS）（SMD=-1.47，95%CI -2.66- -0.28），and Gastrointestinal Symptom Rating Scale（GSRS）（SMD=-1.39，95%CI -2.03- -0.74）showed a significant decrease after FMT compared to the baseline.Meta-analysis of 3 RCTs and 1 case-control study showed that Autism Behavior Checklist（SMD=-0.67，95%CI -1.3- -0.03）and CARS（SMD=-1.08，95%CI -1.67- -0.48）showed a significant decrease after FMT compared to control group or placebo group，but heterogeneity existed among studies in the analysis of the two scales. Conclusion　In observational studies and RCTs，FMT treatment has therapeutic effects on children with ASD without serious adverse reactions. However，there is heterogeneity among RCTs， and some conclusions are inconsistent. More randomized double-blind placebo-controlled clinical studies are still needed to further support the effectiveness of FMT in the treatment of children with ASD.

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摘要： 目的　系统回顾现有粪菌移植（FMT）干预孤独症谱系障碍（ASD）儿童的临床研究，评估其治疗作用。方法　通过检索PubMed、Cochrane图书馆、EMBASE、中国知网、万方数据知识服务平台医学数据库、维普数据库关于FMT治疗ASD儿童的临床研究，检索时间段为数据库建库至2025年6月1日。2位检索人员独立筛选检索的文献并提取数据。利用RevMan 5.3软件进行Meta分析。结果　共纳入12篇文献，其中3篇随机对照研究，1篇病例对照研究，3篇回顾性观察研究，2篇前瞻性开放性研究，3篇个案报道。所有12篇研究均显示FMT治疗可改善ASD症状。对5篇组内对照研究Meta分析显示FMT干预后孤独症行为量表（SMD=-0.53，95%CI 0.67~0.38）、异常行为量表（SMD=-0.79，95%CI -1.33~-0.26）、儿童孤独症评估量表（CARS）（SMD=-0.54，95%CI -0.68~-0.41）、社交反应量表（SRS）（SMD=-1.47，95%CI -2.66~-0.28）、胃肠症状等级量表（GSRS）（SMD=-1.39，95%CI -2.03~-0.74）均较基线期显著降低。对3篇随机对照研究和1篇病例对照研究进行 Meta分析提示 FMT 治疗后干预组较对照组或安慰剂组孤独症行为量表（SMD=-0.67，95%CI -1.3~-0.03）和 CARS（SMD=-1.08，95%CI -1.67~-0.48）评分显著降低，但量表分析中各研究存在异质性。结论　在观察性研究和随机对照研究中，FMT 治疗对 ASD 儿童有治疗作用，且无严重不良反应。但随机对照研究间存在异质性，部分结论不统一，仍需要更多随机双盲安慰剂对照临床研究进一步支持 FMT 治疗 ASD 儿童的有效性。

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