Wang Ji-Gan, Liang Qing, Dou Hui-Hong, Ou Yuan
Department of Pediatrics, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Guangxi Clinical Research Center for Pediatric Diseases, Nanning, China.
Department of Pediatrics, Ethnic Hospital of Guangxi Zhuang Autonomous Region, Affiliated Ethnic Hospital of Guangxi Medical University, Nanning, China.
J Gastroenterol Hepatol. 2022 Nov;37(11):2031-2038. doi: 10.1111/jgh.15996. Epub 2022 Sep 23.
To understand the global incidence of the adverse events associated with fecal microbiota transplantation (FMT) in children over the past 20 years.
We searched PubMed, Web of Science, Embase, and three Chinese databases (CNKI, Wanfang, and Chongqing Weipu) for high-quality articles written over the past 20 years and made selections based on the quality standard score. The study characteristics and incidences of adverse events were extracted from each article, meta-analysis was performed using the R.3.6.3 software, and randomized-effect or fixed-effect meta-analyses were used to determine the incidence of adverse events. Subgroup analysis was performed to determine heterogeneity.
A total of 18 articles involving 681 children were included in the analysis. The total effective rate of FMT in children was 85.75% (95% CI: 76.23-93.15%), of which the overall efficacy of FMT for the treatment of Clostridium difficile infection was 91.22% (95% CI: 83.49-96.68%) and the overall adverse event rate was 28.86% (95% CI: 19.56-39.15%), with a mild to moderate adverse event rate of 27.72% (95% CI: 17.86-38.83%) and a severe adverse event rate of 0.90% (95% CI: 0.33-1.76%). The most common mild to moderate adverse events were as follows: bellyache, 14.02% (95% CI: 5.43-25.77%); diarrhea, 7.75% (95% CI: 2.69-15.11%); and bloating, 7.36% (95% CI: 1.79-16.28%). Other adverse events included fever, 2.34%; vomiting, 3.12%; nausea, 1.50%; hematochezia, 2.30%; anorexia, 1.94%; and fatigue, 0.03%. The only death reported was in a study from China, in which the patient died of sepsis and liver failure 4 weeks after FMT. The other serious adverse event was an immunodeficiency patient with severe hematochezia. Another study in the United States described seven serious adverse events including one death that was not considered to be related to FMT; however, they did not describe the events in detail. There was no difference in the incidence of adverse events between the upper and lower gastrointestinal tracts (OR = 0.61, 95% CI: 0.02-15.42, P = 0.76).
Adverse events related to FMT in children are mostly mild to moderate, of short duration, and self-limiting. Therefore, the use of FMT in children is safe and worthy of widespread promotion.
了解过去20年全球儿童粪便微生物群移植（FMT）相关不良事件的发生率。
我们检索了PubMed、Web of Science、Embase和三个中文数据库（中国知网、万方和重庆维普），查找过去20年撰写的高质量文章，并根据质量标准评分进行筛选。从每篇文章中提取研究特征和不良事件发生率，使用R.3.6.3软件进行荟萃分析，并采用随机效应或固定效应荟萃分析来确定不良事件的发生率。进行亚组分析以确定异质性。
共纳入18篇涉及681名儿童的文章进行分析。儿童FMT的总有效率为85.75%（95%CI：76.23 - 93.15%），其中FMT治疗艰难梭菌感染的总体有效率为91.22%（95%CI：83.49 - 96.68%），总体不良事件发生率为28.86%（95%CI：19.56 - 39.15%），轻度至中度不良事件发生率为27.72%（95%CI：17.86 - 38.83%），严重不良事件发生率为0.90%（95%CI：0.33 - 1.76%）。最常见的轻度至中度不良事件如下：腹痛，14.02%（95%CI：5.43 - 25.77%）；腹泻，7.75%（95%CI：2.69 - 15.11%）；腹胀，7.36%（95%CI：1.79 - 16.28%）。其他不良事件包括发热，2.34%；呕吐，3.12%；恶心，1.50%；便血，2.30%；厌食，1.94%；疲劳，0.03%。唯一报告的死亡病例来自中国的一项研究，该患者在FMT后4周死于败血症和肝衰竭。另一例严重不良事件是一名免疫缺陷患者出现严重便血。美国的另一项研究描述了7例严重不良事件，包括1例死亡，该死亡病例被认为与FMT无关；然而，他们没有详细描述这些事件。上消化道和下消化道不良事件的发生率没有差异（OR = 0.61，95%CI：0.02 - 15.42，P = 0.76）。
儿童FMT相关不良事件大多为轻度至中度，持续时间短且具有自限性。因此，儿童使用FMT是安全的，值得广泛推广。
