Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
Gastroenterology. 2021 May;160(6):1961-1969.e3. doi: 10.1053/j.gastro.2021.01.010. Epub 2021 Jan 11.
Fecal microbiota transplantation (FMT) is highly effective for treating recurrent Clostridioides difficile infection (CDI), with emerging data on intermediate and long-term safety.
A prospective survey-based study was conducted (September 2012-June 2018) in patients undergoing FMT for recurrent CDI. Data on demographics and comorbidities were abstracted from medical records. Patients were contacted at 1 week, 1 month, 6 months, 1 year (short-term), and ≥2 years post-FMT (long-term). Symptoms and new medical diagnoses were recorded at each time point. Data were weighted to account for survey nonresponse bias. Multivariate logistic regression models for adverse events were built using age (per 10-year increment), sex, time of survey, and comorbidities. P < .05 was considered statistically significant.
Overall, 609 patients underwent FMT; median age was 56 years (range, 18-94), 64.8% were women, 22.8% had inflammatory bowel disease (IBD). At short-term follow-up (n = 609), >60% of patients had diarrhea and 19%-33% had constipation. At 1 year, 9.5% reported additional CDI episodes. On multivariable analysis, patients with IBD, dialysis-dependent kidney disease, and multiple FMTs had higher risk of diarrhea; risk of constipation was higher in women and lower in IBD (all P < .05). For long-term follow-up (n = 447), median time of follow-up was 3.7 years (range, 2.0-6.8). Overall, 73 new diagnoses were reported: 13% gastrointestinal, 10% weight gain, 11.8% new infections (all deemed unrelated to FMT). Median time to infections was 29 months (range, 0-73) post-FMT.
FMT appears safe with low risk of transmission of infections. Several new diagnoses were reported, which should be explored in future studies.
粪便微生物群移植（FMT）治疗复发性艰难梭菌感染（CDI）非常有效，并且有越来越多的关于中期和长期安全性的数据。
对 2012 年 9 月至 2018 年 6 月期间接受 FMT 治疗复发性 CDI 的患者进行了一项前瞻性基于调查的研究。从病历中提取人口统计学和合并症的数据。在 FMT 后 1 周、1 个月、6 个月、1 年（短期）和≥2 年（长期）时联系患者。在每个时间点记录症状和新的医疗诊断。数据经过加权处理，以考虑调查无应答偏倚。使用年龄（每 10 岁增加 1 岁）、性别、调查时间和合并症构建不良事件的多变量逻辑回归模型。P<.05 被认为具有统计学意义。
总体而言，609 名患者接受了 FMT；中位年龄为 56 岁（范围，18-94），64.8%为女性，22.8%患有炎症性肠病（IBD）。在短期随访（n=609）中，超过 60%的患者有腹泻，19%-33%的患者有便秘。在 1 年时，9.5%的患者报告了额外的 CDI 发作。多变量分析显示，患有 IBD、依赖透析的肾脏疾病和多次 FMT 的患者腹泻风险更高；女性便秘风险较高，而 IBD 患者便秘风险较低（均 P<.05）。在长期随访（n=447）中，中位随访时间为 3.7 年（范围，2.0-6.8）。总体而言，报告了 73 例新诊断：13%为胃肠道疾病，10%为体重增加，11.8%为新感染（均认为与 FMT 无关）。感染的中位时间为 FMT 后 29 个月（范围，0-73）。
FMT 似乎是安全的，感染传播的风险较低。报告了一些新的诊断，这应该在未来的研究中进一步探讨。
