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不同肠道准备方式对菌群移植疗效及安全性的影响

Effect of intestinal preparation on the efficacy and safety of fecal microbiota transplantation treatment

摘要:

目的:探讨不同肠道准备方式对菌群移植(FMT)的疗效和不良反应情况的影响。方法:采用回顾性队列研究方法,收集2018年2月至2019年6月期间,于同济大学附属第十人民医院肠道微生态诊疗中心自愿接受FMT治疗的1 501例患者的治疗及随访资料。根据FMT治疗前肠道准备情况,分为无肠道准备组(216例)、抗生素预处理组(383例)、肠道清洁组(267例)和抗生素联合肠道清洁组(635例)。比较各组间FMT治疗后的不良反应情况以及治疗后4周和8周的有效率。在第3个月和第6个月由于疗效下降或无效重复行FMT治疗的患者;根据是否再次行抗生素联合清洁肠道的肠道准备方案,分为无肠道准备和肠道准备组,比较两亚组有效率。结果:全组男性588例,女性913例,年龄(43.3±13.7)岁,体质指数(20.2±2.1)kg/m 2,移植疗程共(3.3±1.7)周。包括便秘564例,克罗恩病157例,溃疡性结肠炎142例,肠易激综合征158例,复发性艰难梭菌感染(CDI)106例,自闭症84例,放射性肠损伤133例,放射性肠炎133例,非CDI慢性腹泻60例,其他155例。4组间基线资料的比较,差异均无统计学意义(均 P>0.05)。全组总体不良反应发生率为31.1%(467/1 501),其中呕吐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%)、咽喉部疼痛72例(4.8%)、头晕38例(2.5%)、发热51例(3.4%)、肺部感染3例(0.2%)以及肠源性感染2例(0.1%);经对症处理后症状均消失。4组间不良反应发生率的差异均无统计学意义(均 P>0.05)。FMT治疗4周后,总有效率为63.5%(902/1 420);无肠道准备组FMT有效率为57.6%(114/198)、抗生素预处理组为64.2%(231/360)、肠道清洁组为60.2%(154/256),抗生素预处理联合肠道清洁组66.5%(403/606),4组间有效率差异无统计学意义(χ 2=6.659, P=0.084)。FMT治疗8周后,总有效率为61.3%(729/1 293);无肠道准备组有效率为54.0%(88/163),抗生素预处理组为62.2%(202/325),肠道清洁组为57.4%(132/230),抗生素联合肠道清洁组为64.4%(370/575),4组间有效率的比较,差异有统计学意义(χ 2=13.620, P=0.003);其中抗生素联合肠道清洁组及抗生素预处理组有效率均明显高于无肠道准备组(分别为χ 2=5.789, P=0.016;χ 2=10.117, P=0.001)。亚组分析中,第3个月重复FMT治疗结束4周随访发现,无肠道准备组与肠道准备组有效率差异无统计学意义[60.1%(184/306)比61.5%(115/187),χ 2=0.091, P=0.763]。在第6个月重复FMT治疗结束4周随访发现,无肠道准备组有效率明显低于肠道准备组,差异有统计学意义[51.4%(89/173)比61.2%(161/263),χ 2=4.229, P=0.040]。 结论:FMT治疗安全有效,抗生素联合肠道清洁的肠道准备方案可提高FMT总体疗效。对疗效下降需FMT重复治疗的患者,3个月内再次行抗生素联合肠道清洁方案对FMT有效率无明显影响,但在第6个月,再次的肠道准备是必要的。

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abstracts:

Objective:To investigate the effect of intestinal preparation on the efficacy and complications of fecal microbiota transplantation (FMT).Methods: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 ( n=216), antibiotic pretreatment group ( n=383), intestinal cleansing group ( n=267), and antibiotic combined with intestinal cleansing group ( n=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. Results: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 ( n=564), Crohn's disease ( n=157), ulcerative colitis ( n=142), irritable bowel syndrome ( n=158), recurrent C. difficile infection (CDI) ( n=106), autism ( n=84), radiation intestinal injury ( n=133), radiation enteritis ( n=133), and non-CDI chronic diarrhea ( n=60); the remaining cases ( n=155). Baseline data among the 4 groups were not significantly different (all P>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 ( P>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, P=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, P=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, P=0.016; χ 2=10.117, P=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, P=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, P=0.040). Conclusions: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.

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