Abstract：
OBJECTIVE: To understand the global incidence of the adverse events associated with fecal microbiota transplantation (FMT) in children over the past 20 years.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
目的：了解过去20年来儿童粪便微生物移植（FMT）相关不良事件的全球发生率。
方法：我们搜索了PubMed，WebofScience,Embase,和三个中文数据库(CNKI，万方,和重庆维普）为20多年来撰写的高质量文章，并根据质量标准得分做出选择。从每篇文章中提取不良事件的研究特征和发生率，使用R.3.6.3软件进行荟萃分析，采用随机效应或固定效应荟萃分析确定不良事件的发生率.进行亚组分析以确定异质性。
结果：共18篇，涉及681名儿童。儿童FMT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有效率为91.22%(95%CI:83.49-96.68%),总不良事件发生率为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%），重度不良事件发生率为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%;厌食症,1.94%；和疲劳，0.03%。唯一报告的死亡是在一项来自中国的研究中，其中患者在FMT后4周死于脓毒症和肝功能衰竭。另一个严重不良事件是患有严重便血的免疫缺陷患者。在美国的另一项研究描述了7个严重的不良事件，其中包括一个被认为与FMT无关的死亡。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发生率无差异（OR=0.61，95％CI：0.02-15.42，P=0.76）。
结论：儿童中与FMT相关的不良事件大多为轻度至中度，持续时间短，和自我限制。因此,FMT在儿童中的使用是安全的，值得广泛推广。
方法：我们搜索了PubMed，WebofScience,Embase,和三个中文数据库(CNKI，万方,和重庆维普）为20多年来撰写的高质量文章，并根据质量标准得分做出选择。从每篇文章中提取不良事件的研究特征和发生率，使用R.3.6.3软件进行荟萃分析，采用随机效应或固定效应荟萃分析确定不良事件的发生率.进行亚组分析以确定异质性。
结果：共18篇，涉及681名儿童。儿童FMT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有效率为91.22%(95%CI:83.49-96.68%),总不良事件发生率为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%），重度不良事件发生率为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%;厌食症,1.94%；和疲劳，0.03%。唯一报告的死亡是在一项来自中国的研究中，其中患者在FMT后4周死于脓毒症和肝功能衰竭。另一个严重不良事件是患有严重便血的免疫缺陷患者。在美国的另一项研究描述了7个严重的不良事件，其中包括一个被认为与FMT无关的死亡。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发生率无差异（OR=0.61，95％CI：0.02-15.42，P=0.76）。
结论：儿童中与FMT相关的不良事件大多为轻度至中度，持续时间短，和自我限制。因此,FMT在儿童中的使用是安全的，值得广泛推广。
