[Evaluation of the efficacy and safety of multi-center fecal microbiota transplantation for treatment of functional constipation: A retrospective real-world study].

Q3 Medicine
L Li, L Wang, G G Guo, Y H Fan, J G Shi, X G Yuan, X S Dong, L Liu, N Li, Q Y Chen
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引用次数: 0

Abstract

Objective: To evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for treating functional constipation, analyze the incidence of, and factors that influence, adverse events, and provide scientific evidence for optimizing FMT treatment. Methods: This retrospective, multicenter, single-arm, pre-post real-world study included 1529 patients with functional constipation from four clinical centers. Eligibility criteria comprised meeting the diagnostic criteria for functional constipation, having undergone at least one FMT treatment, complete pre- and post-treatment data available, and age ≥18 years. Patients who had received other interventions affecting gut function within 1 month before treatment and those with severe organic diseases or immune deficiencies were excluded. Applying the above criteria yielded 1529 eligible patients with functional constipation from four medical centers (1405 from the Shanghai Tenth People's Hospital Affiliated to Tongji University, 20 from the Central Hospital of Wuhan, 67 from the Shanxi Bethune Hospital and 37 from the Longgang District People's Hospital of Shenzhen). The study cohort comprised 746 male (48.8%) and 783 female patients (51.2%) of mean age (51.4 ± 17.4) years, mean body mass index (26.4 ± 4.9) kg/m², and mean duration of disease (15.0 ± 8.3) years. The primary outcomes were the incidence, types, and severity of adverse reactions during treatment, and their impact on patients' quality of life. Secondary outcomes included: (1) the efficacy of FMT in treating constipation. This was assessed based on changes in Patient Assessment of Constipation Symptoms (PAC-SYM) scores, where higher score indicates worse symptom. (2) Subjective satisfaction, evaluated through questionnaires or rating scales, reflecting patients' acceptance of and satisfaction with the treatment, with scores ranging from 1 to 5, where higher scores indicated greater satisfaction. Paired t-tests and Wilcoxon signed-rank tests were used to evaluate changes in symptom scores and biochemical indicators before and after treatment. Logistic regression was performed to analyze factors influencing adverse events, and subgroup analyses to explored differences in efficacy between patient groups. Results: In this cohort of 1529 patients with functional constipation, adverse reactions were primarily mild to moderate (1048/1529,68.5%). They comprised fever in 54 patients (3.5%), dizziness or fatigue in 218 (14.3%), throat discomfort in 806 (52.7%), nausea and vomiting in 166 (10.9%), and abdominal distension or pain in 415 (27.1%). According to multivariate logistic regression analysis, PAC-SYM scores were associated with the rate of adverse reactions, higher scores indicating a lower risk (OR = 0.958, 95% CI: 0.923-0.993, P=0.021). Among the 1529 patients, 274 (17.9%) underwent two or more treatment courses. After one treatment course, the patients' PAC-SYM scores decreased from (37.7 ± 3.2) pre-treatment to (23.7 ± 8.6) (mean difference 14.0 ± 9.1). PAC-SYM scores decreased by (20.7 ± 7.7) after two courses of FMT, and by (19.4 ± 6.3) after three courses. After treatment, 50.7%(775/1529) of patients reported satisfaction scores of ≥4. Adverse reactions impacted satisfaction; specifically, dizziness/fatigue, throat discomfort, and abdominal distension/pain were significantly associated with satisfaction (all P < 0.05). Conclusions: FMT achieved good relief of symptoms of functional constipation and multiple treatment courses have a cumulative effect. Adverse reactions, mainly dizziness/fatigue, throat discomfort, and abdominal distension/pain, had significant negative impacts on patient satisfaction.

[评价多中心粪便微生物群移植治疗功能性便秘的有效性和安全性:一项回顾性现实世界研究]。
目的:评价粪便微生物群移植(fecal microbiota transplantation, FMT)治疗功能性便秘的疗效和安全性,分析不良事件的发生率及影响因素,为优化FMT治疗提供科学依据。方法:这项回顾性、多中心、单臂、真实世界前后研究纳入了来自四个临床中心的1529例功能性便秘患者。入选标准包括符合功能性便秘诊断标准,至少接受过一次FMT治疗,完整的治疗前后数据,年龄≥18岁。排除治疗前1个月内接受过影响肠道功能的其他干预措施的患者,以及患有严重器质性疾病或免疫缺陷的患者。应用上述标准,从4个医疗中心(同济大学附属上海第十人民医院1405例、武汉市中心医院20例、山西白求恩医院67例、深圳龙岗区人民医院37例)获得符合条件的功能性便秘患者1529例。研究队列包括746例男性(48.8%)和783例女性(51.2%),平均年龄(51.4±17.4)岁,平均体重指数(26.4±4.9)kg/m²,平均病程(15.0±8.3)年。主要结局是治疗期间不良反应的发生率、类型、严重程度及其对患者生活质量的影响。次要结局包括:(1)FMT治疗便秘的疗效。这是根据患者便秘症状评估(PAC-SYM)评分的变化来评估的,评分越高表明症状越差。(2)主观满意度,通过问卷调查或评定量表进行评估,反映患者对治疗的接受程度和满意度,得分范围为1 ~ 5分,得分越高表示满意度越高。采用配对t检验和Wilcoxon符号秩检验评价治疗前后症状评分和生化指标的变化。采用Logistic回归分析不良事件的影响因素,采用亚组分析探讨组间疗效差异。结果:在1529例功能性便秘患者中,不良反应主要为轻度至中度(1048/1529,68.5%)。其中发热54例(3.5%),头晕或疲劳218例(14.3%),咽喉不适806例(52.7%),恶心和呕吐166例(10.9%),腹胀或疼痛415例(27.1%)。多因素logistic回归分析显示,PAC-SYM评分与不良反应发生率相关,评分越高风险越低(OR = 0.958, 95% CI: 0.923-0.993, P=0.021)。在1529例患者中,274例(17.9%)接受了两个或两个以上疗程的治疗。1个疗程后,患者PAC-SYM评分由治疗前的(37.7±3.2)分降至(23.7±8.6)分(平均差值14.0±9.1)。两疗程后PAC-SYM评分下降(20.7±7.7)分,三疗程后PAC-SYM评分下降(19.4±6.3)分。治疗后,50.7%(775/1529)的患者满意度评分≥4分。不良反应影响满意度;其中,眩晕/疲劳、咽喉不适、腹胀/疼痛与满意度显著相关(均P < 0.05)。结论:FMT对功能性便秘症状有较好的缓解作用,多次治疗具有累积效应。不良反应,主要是头晕/疲劳、喉咙不适和腹胀/疼痛,对患者满意度有显著的负面影响。
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来源期刊
中华胃肠外科杂志
中华胃肠外科杂志 Medicine-Medicine (all)
CiteScore
1.00
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6776
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