机构地区:[1]同济大学附属第十人民医院普通外科功能肠道外科上海市肠道微生态研究中心上海人体肠道菌群功能开发工程技术研究中心同济大学医学院消化系统疾病临床研究中心,上海200027
出 处:《中华胃肠外科杂志》2025年第3期296-303,共8页Chinese Journal of Gastrointestinal Surgery
基 金:国家自然科学基金(82100698);同济大学附属第十人民医院攀登人才计划(2021SYPDRC045);上海市卫健委卫生行业临床研究专项面上项目(202240177)。
摘 要:目的 为观察肠菌移植治疗肠道菌群失调相关疾病长期疗效和并发症。方法 采用回顾性描述性研究方法。病例纳人标准为符合肠菌移植治疗适应证患者。收集2017年5月至2024年9月期间接受肠菌移植治疗并随访3个月以上患者15000例的临床资料;男性3746例,女性11254例;年龄(45.3±12.2)岁。便秘8258例,艰难梭菌感染(CDI)684例,慢性腹泻1730例,炎性肠病510例,放射性肠炎432例,肠易激综合征1940例,孤独症365例,手术后胃肠功能障碍870例以及神经退行性疾病211例。肠菌移植治疗途径包括放置鼻肠管后连续6d接受经鼻肠管(人空肠)输注肠菌溶液移植治疗(上消化道途径移植组,11125例)、连续6d口服肠菌胶囊治疗(口服胶囊移植组,3597例)以及通过结肠镜一次性将菌液注人结肠(下消化道途径移植组,278例)3种方法;治疗及随访期间停止其他治疗,非必要时不建议服用其他药物。主要观察指标为肠菌移植治疗3、12和36个月后的疗效,观察慢性便秘、CDI、慢性腹泻、炎性肠病、放射性肠炎、肠易激综合征、手术后胃肠功能紊乱及孤独症等症状改善情况。次要观察指标为短期(治疗后2周内)和长期(治疗后36个月内)的不良反应发生情况。结果 全组15000例患者治疗后3、12和36个月时,整体治疗有效率分别为71.8%(10763/15000)、64.4%(7600/11808)和58.8%(3659/6218),便秘临床改善率分别为70.3%(5805/8258)、62.6%(3970/6345)和56.5%(1894/3352),CDI临床改善率分别为85.8%(587/684)、72.3%(408/564)和67.3%(218/324),慢性腹泻临床改善率分别为81.0%(1401/1730)、78.1%(1198/1534)和72.3%(633/876),炎性肠病临床改善率分别为64.3%(328/510)、52.3%(249/476)和46.6%(97/208),放射性肠炎临床改善率分别为77.3%(334/432)、65.4%(212/324)和53.6%(82/153);肠易激综合征临床改善率分别为70.6%(1370/1940)、64.5%(939/1456)和60.4%(475/786);孤独症临床改善率分别为75.3%(275/365)、70.0%(201/287)和63.6%(Objective To examine the long-term efficacy and complications of fecal microbiota transplantation(FMT)for the treatment of diseases related to intestinal dysbiosis.Methods This was a retrospective descriptive study.Relevant data were collected from the records of 15000 patients who had undergone FMT and been followed up for more than 3 months during the period from May 2017 to September 2024.The patient cohort comprised 3746 male and 11254 female patients aged(45.3±12.2)years.The inclusion criterion was meeting the indications for FMT.Application of this criterion yielded 8258 patients with constipation,684 with Clostridium difficile infection,1730 with chronic diarrhea,510 with inflammatory bowel disease,432 with radiation enteritis,1940 with irritable bowel syndrome,365 with autism,870 with postoperative gastrointestinal dysfunction,and 211 with neurodegenerative diseases.The three routes of delivering FMT comprised infusion of an enterobacterial solution through a nasoenteric tube into the jejunum for 6 consecutive days(upper gastrointestinal FMT group,11125 patients),oral intake of enterobacterial capsules for 6 consecutive days(oral capsule FMT,3597 patients),and a single injection of a bacterial solution into the colon via colonoscopy(lower gastrointestinal FMT group,278 patients).Other treatments were discontinued during the treatment and follow-up period and administration of other medications was not recommended unless absolutely necessary.The primary outcomes were the efficacy of FMT after 3,12 and 36 months of treatment,and improvement in chronic constipation,C.difficile infection,chronic diarrhea,inflammatory bowel disease,radiation enteritis,irritable bowel syndrome,post-surgery gastrointestinal dysfunction,and autism.Other outcomes included the occurrence of short-term(within 2 weeks after treatment)and long-term(within 36 months after treatment)adverse reactions.Results At 3,12 and 36 months after treatment,the overall rates of effectiveness of treatment were 71.8%(10763/15000),64.4%(7600/11808)an
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