摘要目的: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。病例纳入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15 000例的临床资料；男性3 746例，女性11 254例；年龄（45.3±12.2）岁。便秘8 258例，艰难梭菌感染（CDI）684例，慢性腹泻1 730例，炎性肠病510例，放射性肠炎432例，肠易激综合征1 940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6 d接受经鼻肠管（入空肠）输注肠菌溶液移植治疗（上消化道途径移植组，11 125例）、连续6 d口服肠菌胶囊治疗（口服胶囊移植组，3 597例）以及通过结肠镜一次性将菌液注入结肠（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15 000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%（10 763/15 000）、64.4%（7 600/11 808）和58.8%（3 659/6 218），便秘临床改善率分别为70.3%（5 805/8 258）、62.6%（3 970/6 345）和56.5%（1 894/3 352），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%（1 401/1 730）、78.1%（1 198/1 534）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%（1 370/1 940）、64.5%（939/1 456）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%（112/176）；手术后胃肠功能障碍临床改善率分别为65.3%（568/870）、54.3%（355/654）和46.5%（114/245）；神经退行性疾病临床改善率分别为45.0%（95/211）、40.5%（68/168）和34.7%（34/98）。治疗后3、12和36个月时，上消化道途径组的临床改善率分别为77.1%（8 580/11 125）、67.1%（6 437/9 595）和62.1%（3 196/5 145）；口服胶囊组的临床改善率分别为57.3%（2 062/3 597）、53.6%（1 115/2 081）和45.0%（453/1 006）；下消化道途径组的临床改善率分别为43.5%（121/278）、36.4%（48/132）和14.9%（10/67）。治疗和随访期间均未发生严重不良反应，上消化道途径组、口服胶囊组和下消化道途径组最常见的不良反应分别为呼吸道不适（20.4%，2 269/11 125）、吞咽胶囊时恶心呕吐（7.6%，273/3 597）和腹泻（47.5%，132/278）；上述症状均于治疗结束后消失。随访36个月，有19例患者描述原有疾病症状加重，16例非肠菌移植直接相关死亡，未发现肠菌移植后全身各个系统疾病发病异常。结论:肠菌移植治疗肠道菌群紊乱相关的肠功能障碍疾病及相关肠外疾病长期疗效确切，无严重不良事件发生。

abstractsObjective: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 15 000 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 11 254 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, 11 125 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% (10 763/15 000), 64.4% (7600/11 808) and 58.8% (3659/6218), respectively. Specifically, the rates of clinical improvement were 70.3% (5805/8258), 62.6% (3970/6345), and 56.5% (1894/3352), respectively, for constipation; 85.8% (587/684), 72.3% (408/564), and 67.3% (218/324), respectively, for C.difficile infection; 81.0% (1401/1730), 78.1% (1198/1534), and 72.3% (633/876), respectively, for chronic diarrhea; 64.3% (328/510), 52.3% (249/476), and 46.6 % (97/208), respectively, for inflammatory bowel disease; 77.3% (334/432), 65.4% (212/324), and 53.6% (82/153), respectively, for radiculitis; 70.6% (1370/1940), 64.5% (939/1456), and 60.4% (475/786), respectively, for irritable bowel syndrome; 75.3% (275/365), 70.0% (201/287), and 63.6% (112/176), respectively, for autism; 65.3% (568/870), 54.3% (355/654), and 46.5% (114/245), respectively, for post-surgical gastrointestinal dysfunction; and 45.0% (95/211), 40.5% (68/168), and 34.7% (34/98), respectively, for neurodegenerative diseases. At 3, 12, and 36 months post-treatment, clinical improvement rates were 77.1% (8580/11 125), 67.1% (6437/9595), and 62.1% (3196/5145), respectively, in the upper gastrointestinal route group; and 57.3% (2062/3597), 53.6% (1115/2081), and 45.0% (453/1006), respectively, in the oral capsule group; and 43.5% (121/278) , 36.4% (48/132) and 14.9% (10/67), respectively, in the lower gastrointestinal route group. No serious adverse reactions occurred during treatment or follow-up. The most common adverse reactions in the upper gastrointestinal route group, oral capsule group, and lower gastrointestinal route group were respiratory discomfort (20.4%, 2269/11 125), nausea and vomiting on swallowing the capsule (7.6%, 273/3597), and diarrhea (47.5%, 132/278), respectively; these symptoms resolved at the end of treatment. At 36 months of follow-up, 19 patients reported exacerbation of symptoms of pre-existing diseases and there had been 16 deaths that were not directly related to FMT. Additionally, no systemic diseases had developed after FMT.Conclusion:FMT for the treatment of intestinal dysfunction associated with disorders of the intestinal flora and related extraintestinal diseases is effective and not associated with serious adverse events.