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Title: [Efficacy analysis of fecal microbiota transplantation in the treatment of 2010 patients with intestinal disorders].
Author: Li N, Tian HL, Chen QY, Yang B, Ma CL, Lin ZL, Zhang XY, Zhao D, Huang ZX, Jiang J, Qin HL.
Journal: Zhonghua Wei Chang Wai Ke Za Zhi; 2019 Sep 25; 22(9):861-868. PubMed ID: 31550826.
Abstract:
Objective: To evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for intestinal disorders. Methods: A retrospectively descriptive cohort study was carried out. Clinical data of 2010 patients who underwent FMT and received follow-up for more than 3 months from May 2014 to November 2018 were collected, including 1,206 cases from Tongji University Shanghai Tenth People's Hospital and 804 cases from Nanjing Eastern Military General Hospital. Of the 2,010 patients, 797 were male and 1,213 were female, with a mean age of (49.4±16.5) years old. Inclusion criteria were those with indications for FMT and voluntary treatment of FMT. Pregnant or lactating women, patients with end-stage disease, cases who were participating or participated in other clinical trials within 3 months, and patients with previous bowel history of pathogen infection, oral antibiotics or proton pump inhibitors (PPI) for the recent2 weeks, and those at immunosuppressive state were excluded. Informed consent was obtained from the enrolled patients and their families. There were 1,356 cases of constipation, 175 cases of inflammatory bowel disease, 148 cases of chronic diarrhea, 127 cases of radiation enteritis, 119 cases of irritable bowel syndrome, and 85 cases of autism (complicating with intestinal disorders). FMT donor requirements: (1) 18 to 30 years old non-relatives, non-pregnant healthy adults with healthy lifestyle and good eating habits as volunteers to participate in fecal donation; (2) no administration of antibiotics within 3 months; (3) no chronic diseases such as constipation, irritable bowel syndrome, inflammatory bowel disease, etc., no autoimmune disease, not in immunosuppressive state, no history of malignant disease; (4) negative pathogen examination of infectious diseases (hepatitis B virus, hepatitis C virus, syphilis, HIV, etc.); (5) negative fecal examination (C.difficile, dysentery bacillus, Shigella, Campylobacter, parasites, etc.). The donor requirements after enrollment: (1) physical examination was reviewed once every two months, and the result still met the above requirements; (2) 16S rRNA sequencing was performed for every fecal donation in order to ensure that the composition and diversity of the fecal flora was stable and reliable. The preparation of the stool suspension referred to the Amsterdam criteria and the preparation process was less than 1 hour. The preparation of the FMT capsule was processed by pre-freezing the stool suspension after the preparation of the above suspension, and the frozen sample was transferred into a freeze dryer for freezing. The dried and lyophilized powder was encapsulated in capsules, and the capsule shell was made of acid-resistant hypromellose capsule (No.0) and pediatric-specific capsule (No.3), sealed and packaged in a-20℃ refrigerator. Three ways of accepting FMT treatment pathways included 6-day transplantation after the placement of the nasointestinal tube, 6-day oral FMT capsule transplantation and one-time transplantation through colonoscopy. Intestinal preparation (nasointestinal tube feeding of polyethylene glycol until watery stool) was carried out before transplantation. Other treatments were stopped during treatment and follow-up, and any medication was not recommended when necessary. Results: Of the 2010 patients, 1,497 cases received nasointestinal tube transplantation (nasointestinal tube group), 452 cases oral capsule transplantation (oral capsule group) and 61 cases colonoscopy (colonoscopy group). At 3 time points of 3, 12, and 36 months after FMT, the clinical cure rates and the clinical improvement rates were 41.3% (560/1 356), 35.2% (320/909), 31.4% (69/220), and 29.0% (393/1 356), 27.8% (253/909), 29.1% (64/220), respectively in constipation patients; 33.1% (58/175), 29.9% (35/117), 24.5% (12/49), and 31.4% (55/175), 27.4% (32/117), 57.1% (28/49), respectively in inflammatory bowel disease patients; 87.8% (130/148), 81.8% (81/99), 78.3% (36/46), and 8.1% (12/148), 7.1% (7/99), 4.3% (2/46), respectively in chronic diarrhea patients; 61.4% (78/127), 56.5% (48/85), 47.6% (20/42), and 21.2% (27/127), 15.3% (13/85), 14.3% (6/42), respectively in radiation enteritis patients; 53.8% (64/119), 45.0% (36/80), 6/15, and 21.0% (25/119), 26.2% (21/80), 4/15, respectively in irritable bowel syndrome patients; 23.5% (20/85), 22.8% (13/57), 20.0%(5/25), and 55.3% (47/85), 49.1% (28/57), 40.0% (10/25), respectively in autism patients. Meanwhile the clinical cure rates and the clinical improvement rates at 3, 12, and 36 months were 47.7% (714/1 497), 42.8% (425/994), 39.1% (128/327), and 29.1% (436/1 497), 27.0% (268/994), 28.1% (92/327), respectively in the nasointestinal tube group; 38.7% (175/452), 30.2% (91/301), 33.3% (16/48), and 24.3% (110/452), 26.2% (79/301), 25.0% (12/48), respectively in the oral capsule group; 34.4% (21/61), 32.7% (17/52), 18.2% (4/22), and 21.3% (13/61), 13.5% (7/52), 45.5% (10/22), respectively in colonoscopy group. No serious adverse events occurred during treatment and follow-up period. The adverse event of nasointestinal tube group presented higher ratio of discomfort in respiratorytract accounting for 13.1% (196/1497); the oral capsule group had a higher proportion of nausea and vomiting when swallowing capsules accounting for 7.1% (32/452); the colonoscopy group was mainly diarrhea, accounting for 37.7% (23/61). The above symptoms disappeared after the nasointestinal tube was removed, or after treatment ended, or within 1 to 3 days after hospitalization. Conclusion: FMT is a safe and effective method for the treatment of intestinal dysfunction. 目的： 探讨菌群移植治疗肠道疾病的有效性和安全性。 方法： 采用描述性病例系列研究方法。收集2014年5月至2018年11月期间接受菌群移植治疗并随访3个月以上患者2 010例的临床资料，其中同济大学附属第十人民医院1 206例，南京东部战区总医院804例；男性797例，女性1 213例；年龄（49.4±16.5）岁。病例纳入标准为患有菌群移植治疗适应证并自愿接受菌群移植治疗者；排除孕妇或哺乳期妇女、终末期疾病患者、正在参加或3个月内参加了其他临床试验的病例、既往有肠道病原体感染史、近2周口服抗生素或质子泵抑制剂（PPI）等以及处于免疫抑制状态者。入组患者及其家属知情同意并填写知情同意书。其中便秘1 356例，炎性肠病175例，慢性腹泻148例，放射性肠炎127例，肠易激综合征119例，自闭症（合并便秘、腹泻等肠道不适）85例。供体要求标准：（1）18~30岁非亲属、非孕期健康成年人，具有健康生活方式及良好饮食习惯，自愿参加粪便捐赠工作；（2）3个月内未服用抗生素；（3）既往无慢性病如便秘、肠易激综合征、炎性肠病等，无自身免疫性疾病，未处于免疫抑制状态，无恶性病史；（4）传染病病原体检查（乙型肝炎病毒、丙型肝炎病毒、梅毒螺旋体、艾滋病病毒等）阴性；（5）粪便检查（艰难梭状芽孢杆菌、痢疾杆菌、志贺杆菌、弯曲菌属及寄生虫等）阴性。入组后的供体要求：（1）每2个月复查体检1次，仍然符合上述标准要求；（2）每次捐赠粪便均留样行16S rRNA测序，保证粪便菌群的组成及多样性稳定可靠。菌群移植菌液的制备参考国际Amsterdam菌液制备规范，制备流程不超过1 h；菌群胶囊的制备为上述菌液制备完成后制成悬液预冻，将冻结样品移入冷冻干燥机中冷冻干燥，冻干后的菌粉进行胶囊包装，胶囊壳采用耐酸羟丙甲纤维素胶囊（0号）及小儿专用型胶囊（3号），密封包装后在-20℃冰箱中保藏。菌群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（鼻肠管移植）、连续6 d口服肠菌胶囊治疗（口服胶囊移植）以及通过结肠镜一次性将菌液注入结肠（结肠镜移植）3种方法。移植治疗前进行肠道准备（鼻饲聚乙二醇，直至排水样粪便）；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。 结果： 全组2 010例患者采用鼻肠管移植（鼻肠管组）1 497例，口服胶囊移植（口服胶囊组）452例，结肠镜移植（结肠镜组）61例。便秘患者接受菌群移植治疗后3、12和36个月的临床治愈率分别为41.3%（560/1 356）、35.2%（320/909）和31.4%（69/220），临床改善率分别为29.0%（393/1 356）、27.8%（253/909）和29.1%（64/220）；炎性肠病3个时间段的临床治愈率分别为33.1%（58/175）、29.9%（35/117）和24.5%（12/49），临床改善率分别为31.4%（55/175）、27.4%（32/117）和57.1%（28/49）；慢性腹泻3个时间段的临床治愈率分别为87.8%（130/148）、81.8%（81/99）和78.3%（36/46），临床改善率分别为8.1%（12/148）、7.1%（7/99）和4.3%（2/46）；放射性肠炎3个时间段的临床治愈率分别为61.4%（78/127）、56.5%（48/85）和47.6%（20/42），临床改善率分别为21.2%（27/127）、15.3%（13/85）和14.3%（6/42）；肠易激综合征3个时间段的临床治愈率分别为53.8%（64/119）、45.0%（36/80）和6/15，临床改善率分别为21.0%（25/119）、26.2%（21/80）和4/15；自闭症3个时间段的临床治愈率分别为23.5%（20/85）、22.8%（13/57）和20.0%（5/25），临床改善率分别为55.3%（47/85）、49.1%（28/57）和40.0%（10/25）。鼻肠管组3、12和36个月的临床治愈率分别为47.7%（714/1 497）、42.8%（425/994）和39.1%（128/327），临床改善率分别为29.1%（436/1 497）、27.0%（268/994）和28.1%（92/327）；口服胶囊组3个时间段的临床治愈率分别为38.7%（175/452）、30.2%（91/301）和33.3%（16/48），临床改善率分别为24.3%（110/452）、26.2%（79/301）和25.0%（12/48）；结肠镜组3个时间段的临床治愈率分别为34.4%（21/61）、32.7%（17/52）和18.2%（4/22），临床改善率分别为21.3%（13/61）、13.5%（7/52）和45.5%（10/22）。治疗和随访期间均未发生严重不良反应，鼻肠管组患者的不良反应以呼吸道不适比例为多，占13.1%（196/1 497），口服胶囊组则以吞咽胶囊时恶心呕吐比例较高，占7.1%（32/452）；结肠镜组以腹泻为主，占37.7%（23/61）；上述症状均于鼻肠管拔除、或治疗结束、或住院观察1~3 d内消失。 结论： 菌群移植技术是一项治疗肠功能障碍疾病安全有效的方法。.

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