进一步提高中国肠道菌群移植标准化建设和发展水平

Further improve the standardization construction and development level of fecal microbiota transplantation(FMT)in China

近十年来, 肠道菌群移植(FMT)治疗肠道内外相关性疾病的临床应用备受关注。我国开展FMT的医院已超过300余家, 但目前FMT的发展仍在早期阶段, 包括供体和受体管理、菌液胶囊制备、疗效评价以及肠道微生物组学从失衡到重塑与疾病表征的关系方面的研究亟待加强。本文根据国内外相关文献及本中心近万余例、95 300余次的FMT治疗经验, 结合1 000 m2标准化肠道菌群制备GMP车间的建设, 就国内FMT标准化和规范管理等临床问题做一阐述, 以期推动临床FMT标准化体系的建立经验, 促进其健康发展。

In the past ten years,the clinical application of fecal microbiota transplantation(FMT)in the treatment of intestinal and extraintestinal diseases has attracted much attention.In China,there are more than 300 hospitals that have developed FMT,but the development of FMT is still in its early stage.The clinical practice of FMT needs to form a standardized system,including management of donors and acceptors,preparation of capsules containing certain gut bacteria,evaluation of effectiveness,and study of fecal microbiota and disease.In order to promote the establishment of the standard system of FMT and the healthy development of FMT,this paper expounds the establishment of the standardization of domestic flora transplantation according to the relevant literature,as well as the experience of 10000 cases and 95300 times of FMT in our center.