Medical Center for Digestive Diseases, the Second Affiliated Hospital of Nanjing Medical University, China.
Medical Center for Digestive Diseases, the Second Affiliated Hospital of Nanjing Medical University, China; Key Lab of Holistic Integrative Enterology, Nanjing Medical University, China.
Radiother Oncol. 2020 Feb;143:12-18. doi: 10.1016/j.radonc.2020.01.011. Epub 2020 Feb 7.
Increasing evidence has indicated that gut microbiota is closely associated with radiation-induced bowel injury. We aimed to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) in patients with chronic radiation enteritis (CRE).
A pilot study of FMT for CRE was performed. The primary outcomes were safety and response to FMT which was defined as a ≥1-grade reduction in Radiation Therapy Oncology Group (RTOG/EORTC) late toxicity grade from baseline, by 8 weeks post-FMT. The secondary outcomes included a decrease in the severity of four common symptoms (diarrhea, rectal hemorrhage, abdominal/rectal pain and fecal incontinence) in CRE and changes in Karnofsky Performance Status (KPS) score. Microbial analyses were performed by 16S rRNA sequencing.
Five female patients underwent FMT from January to November 2018 with a median age of 58 (range 45-81) years. The median baseline RTOG/EORTC grade was 2 (range 2-4). Three patients responded to FMT and experienced improvement in diarrhea, rectal hemorrhage, abdominal/rectal pain and fecal incontinence as well as a decrease in KPS score. No FMT-related death and infectious complications occurred. One mild FMT-related AE was observed during a follow-up ranged from 8 to 18 months. 16S rRNA sequencing indicated that FMT altered the composition of gut microbiota of patients.
The present case series first demonstrated that FMT might be safe and effective to improve intestinal symptoms and mucosal injury in patients with CRE for a period of time. Trial registration ID: NCT03516461.
越来越多的证据表明,肠道微生物群与放射性肠炎密切相关。我们旨在评估粪便微生物群移植(FMT)在慢性放射性肠炎(CRE)患者中的安全性和疗效。
进行了一项关于 CRE 的 FMT 的初步研究。主要结局是 FMT 的安全性和反应,定义为自 FMT 后 8 周,根据放射治疗肿瘤学组(RTOG/EORTC)晚期毒性分级标准,至少降低 1 级。次要结局包括 CRE 中四种常见症状(腹泻、直肠出血、腹痛/直肠痛和粪便失禁)的严重程度下降和卡氏功能状态(KPS)评分的变化。通过 16S rRNA 测序进行微生物分析。
5 名女性患者于 2018 年 1 月至 11 月接受 FMT,中位年龄为 58 岁(范围 45-81 岁)。中位基线 RTOG/EORTC 分级为 2 级(范围 2-4 级)。3 名患者对 FMT 有反应,腹泻、直肠出血、腹痛/直肠痛和粪便失禁症状改善,KPS 评分降低。无 FMT 相关死亡和感染性并发症发生。1 例轻度 FMT 相关不良事件在随访 8-18 个月期间发生。16S rRNA 测序表明,FMT 改变了患者肠道微生物群的组成。
本病例系列首次表明,FMT 可能安全且有效,可在一段时间内改善 CRE 患者的肠道症状和黏膜损伤。试验注册号:NCT03516461。