Chen Q Y, Tian H L, Yang B, Lin Z L, Zhao D, Ye C, Zhang X Y, Qin H L, Li N
Department of Colorectal Disease Specialty, Intestinal Microecology Diagnosis and Treatment Center, theTenth People's Hospital, Tongji University, Shanghai 200072, China.
Department of Colorectal Disease Specialty, Intestinal Microecology Diagnosis and Treatment Center, theTenth People's Hospital, Tongji University, Shanghai 200072, China; Institute of Intestinal Diseases, Tongji University, Shanghai 200072, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2020 Jul 10;23(Z1):48-55. doi: 10.3760/cma.j.cn.441530-20200418-00225.
To investigate the effect of intestinal preparation on the efficacy and complications of fecal microbiota transplantation (FMT). A retrospective cohort study was performed. Clinical and follow-up data of 1501 patients who received FMT in the department of Colorectal Disease Specialty, Intestinal Microecology Diagnosis and Treatment Center, the Tenth People's Hospital, Tongji University from February 2018 to June 2019 were collected retrospectively. According to the intestinal preparation before FMT treatment, patients were divided into non-intestinal preparation group (=216), antibiotic pretreatment group (=383), intestinal cleansing group (=267), and antibiotic combined with intestinal cleansing group (=635). The adverse reactions after FMT treatment and the effective rates at 4-week and 8-week after treatment among the groups were compared. Patients, who repeated FMT treatment in the 3rd month and the 6th month due to reduced efficacy or ineffectiveness were divided into two subgroups: without intestinal preparation group and with intestinal preparation group. The effective rates of the two subgroups were compared. Of the 1501 cases, 588 were male and 913 were female with mean age of (43.3±13.7) years and body mass index of (20.2±2.1) kg/m(2). Transplantation course was (3.3±1.7) weeks. The underlying diseases mainly included constipation (=564), Crohn's disease (=157), ulcerative colitis (=142), irritable bowel syndrome (=158), recurrent C. difficile infection (CDI) (=106), autism (=84), radiation intestinal injury (=133), radiation enteritis (=133), and non-CDI chronic diarrhea (=60); the remaining cases (=155). Baseline data among the 4 groups were not significantly different (all >0.05). The overall morbidity of complication was 31.1% (467/1501), including 41 cases of vomiting (2.7%), 91 of nausea (6.1%), 49 of diarrhea (3.3%), 41 of abdominal pain (2.7%), 79 of bloating (5.3%), 72 of throat pain (4.8%), 38 of dizziness (2.5%), 51 of fever (3.4%), 3 of pulmonary infection (0.2%) and 2 of intestinal infection (0.1%). The above symptoms disappeared after symptomatic treatment. There was no statistically significant difference in the incidence of adverse reactions among the 4 groups (>0.05). After 4-week of FMT treatment, the overall effective rate was 63.5% (902/1420); the effective rate of non-intestinal preparation group, antibiotic pretreatment group, intestinal cleaning group, and antibiotic combined with intestinal cleansing groupwas 57.6% (114/198), 64.2% (231/360), 60.2% (154/265) and 66.5% (403/606), respectively, with no statistically significant difference (χ(2)=6.659, =0.084). After 8-week of FMT treatment, the overall effective rate was 61.3% (729/1293); the effective rate of non-intestinal preparation group, antibiotic pretreatment group, intestinal cleaning group, and antibiotic combined with intestinal cleansing group was 54.0% (88/163), 62.2% (202/325), 57.4% (132/230) and 64.4% (370/575), respectively, with no statistically significant difference (χ(2)=13.620, =0.003). The effective rates of antibiotic combined with intestinal cleansing group and antibiotic pretreatment group were obviously higher than that of non-intestinal preparation group (χ(2)=5.789, =0.016; χ(2)=10.117, =0.001). Subgroup analysis showed that in the third month, the effective rate at 4-week after treatment was 60.1% (184/306) in the without intestinal preparation group and 61.5% (115/187) in the with intestinal preparation group, whose difference was not significant (χ(2)=0.091, =0.763); however, in the sixth month, the effective rate at 4-week after treatment was 51.4% (89/173) in the without intestinal preparation group and 61.2% (161/263) in the with intestinal preparationgroup, whose difference was significant (χ(2)=4.229, =0.040). FMT treatment is safe and effective. The combination of antibiotics and intestinal cleaning can improve overall efficacy of FMT. For patients who need repeated FMT treatment, the combination of antibiotics and intestinal cleaning program within 3 months has no significant effect on the effective rate, but in the sixth month, combinedpreparation is necessary.
探讨肠道准备对粪便微生物群移植(FMT)疗效及并发症的影响。进行了一项回顾性队列研究。回顾性收集了2018年2月至2019年6月在同济大学附属第十人民医院肠道微生态诊疗中心大肠疾病专科接受FMT的1501例患者的临床及随访资料。根据FMT治疗前的肠道准备情况,将患者分为未进行肠道准备组(=216)、抗生素预处理组(=383)、肠道清洁组(=267)和抗生素联合肠道清洁组(=635)。比较各组FMT治疗后的不良反应及治疗后4周和8周的有效率。因疗效降低或无效在第3个月和第6个月重复进行FMT治疗的患者分为两个亚组:未进行肠道准备组和进行肠道准备组。比较两个亚组的有效率。1501例患者中,男性588例,女性913例,平均年龄(43.3±13.7)岁,体重指数(20.2±2.1)kg/m²。移植疗程为(3.3±1.7)周。基础疾病主要包括便秘(=564)、克罗恩病(=157)、溃疡性结肠炎(=142)、肠易激综合征(=158)、艰难梭菌反复感染(CDI)(=106)、自闭症(=84)、放射性肠损伤(=133)、放射性肠炎(=133)和非CDI慢性腹泻(=60);其余病例(=155)。4组间基线资料差异无统计学意义(均>0.05)。并发症总发生率为31.1%(467/1501),包括呕吐41例(2.7%)、恶心91例(6.1%)、腹泻49例(3.3%)、腹痛41例(2.7%).,腹胀79例(5.3%)、咽痛72例(4.8%)、头晕38例(2.5%)、发热51例(3.4%)、肺部感染3例(0.2%)和肠道感染2例(0.1%)。经对症治疗后上述症状消失。4组间不良反应发生率差异无统计学意义(>0.05)。FMT治疗4周后,总有效率为63.5%(902/1420);未进行肠道准备组、抗生素预处理组、肠道清洁组和抗生素联合肠道清洁组的有效率分别为57.6%(114/198)、64.2%(231/360)、60.2%(154/265)和66.5%(403/606),差异无统计学意义(χ²=6.659,P=0.084)。FMT治疗8周后,总有效率为61.3%(729/1293);未进行肠道准备组、抗生素预处理组、肠道清洁组和抗生素联合肠道清洁组的有效率分别为54.0%(88/163)、62.2%(202/325)、57.4%(132/230)和64.4%(370/575),差异无统计学意义(χ²=13.620,P=0.003)。抗生素联合肠道清洁组和抗生素预处理组的有效率明显高于未进行肠道准备组(χ²=5.789,P=0.016;χ²= l0.117,P=0.001)。亚组分析显示,在第3个月,未进行肠道准备组治疗后4周有效率为60.1%(184/306),进行肠道准备组为61.5%(115/187),差异无统计学意义(χ²=0.091,P=0.763);然而,在第6个月,未进行肠道准备组治疗后4周有效率为51.4%(89/173),进行肠道准备组为61.2%(161/263),差异有统计学意义(χ²=4.229,P=0.040)。FMT治疗安全有效。抗生素与肠道清洁联合应用可提高FMT的总体疗效。对于需要重复进行FMT治疗的患者,3个月内抗生素与肠道清洁联合方案对有效率无显著影响,但在第6个月,联合准备是必要的。