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Abstract：
BACKGROUND: The efficacy of washed microbiota transplantation (WMT) in terms of refractory functional constipation (FC)-related therapeutic targets and influencing factors have not been elucidated. This study aimed to assess the efficacy and influencing factors of WMT in treating refractory FC-related therapeutic targets.
METHODS: The clinical data of patients diagnosed with refractory FC and received with WMT were retrospectively collected. The therapeutic targets included straining, hard stools, incomplete evacuation, a sense of anorectal obstruction, manual maneuvers, and decreased stool frequency. Each target was recorded as 1 (yes) or 0 (no). All patients were followed up for approximately 24 weeks from the end of the first course of WMT. The primary outcomes were the improvement rates for the individual therapeutic targets and the overall response in respect of the therapeutic targets decreased by 2 at weeks 4, 8, and 24. The secondary outcomes were the clinical remission rate (i.e., the proportion of patients with an average of 3 or more spontaneous complete bowel movements per week), clinical improvement rate (i.e., the proportion of patients with an average increase of 1 or more SCBMs/week or patients with remission), stool frequency, Wexner constipation score, Bristol Stool Form Scale (BSFS) score, and adverse events. The factors influencing the efficacy were also analyzed.
RESULTS: Overall, 63 patients with 112 WMT courses were enrolled. The improvement rates at weeks 8 and 24 were 45.6% and 35.0%, 42.9% and 38.6%, 45.0% and 35.7%, 55.6% and 44.4%, and 60.9% and 50.0%, respectively, for straining, hard stools, incomplete evacuation, a sense of anorectal obstruction, and decreased stool frequency. The overall response rates were 49.2%, 50.8%, and 42.9%, respectively, at weeks 4, 8, and 24. The rates of clinical remission and clinical improvement were 54.0% and 68.3%, respectively, at weeks 4. The stool frequency, BSFS score, and Wexner constipation score tended to improve post-WMT. Only 22 mild adverse events were observed during the 112 WMT courses and the follow-up. The number of WMT courses was identified to be the independent factor influencing the efficacy.
CONCLUSIONS: WMT is efficacious in improving refractory FC-related therapeutic targets. The effectiveness of WMT in the management of FC is enhanced with the administration of multiple courses.
METHODS: The clinical data of patients diagnosed with refractory FC and received with WMT were retrospectively collected. The therapeutic targets included straining, hard stools, incomplete evacuation, a sense of anorectal obstruction, manual maneuvers, and decreased stool frequency. Each target was recorded as 1 (yes) or 0 (no). All patients were followed up for approximately 24 weeks from the end of the first course of WMT. The primary outcomes were the improvement rates for the individual therapeutic targets and the overall response in respect of the therapeutic targets decreased by 2 at weeks 4, 8, and 24. The secondary outcomes were the clinical remission rate (i.e., the proportion of patients with an average of 3 or more spontaneous complete bowel movements per week), clinical improvement rate (i.e., the proportion of patients with an average increase of 1 or more SCBMs/week or patients with remission), stool frequency, Wexner constipation score, Bristol Stool Form Scale (BSFS) score, and adverse events. The factors influencing the efficacy were also analyzed.
RESULTS: Overall, 63 patients with 112 WMT courses were enrolled. The improvement rates at weeks 8 and 24 were 45.6% and 35.0%, 42.9% and 38.6%, 45.0% and 35.7%, 55.6% and 44.4%, and 60.9% and 50.0%, respectively, for straining, hard stools, incomplete evacuation, a sense of anorectal obstruction, and decreased stool frequency. The overall response rates were 49.2%, 50.8%, and 42.9%, respectively, at weeks 4, 8, and 24. The rates of clinical remission and clinical improvement were 54.0% and 68.3%, respectively, at weeks 4. The stool frequency, BSFS score, and Wexner constipation score tended to improve post-WMT. Only 22 mild adverse events were observed during the 112 WMT courses and the follow-up. The number of WMT courses was identified to be the independent factor influencing the efficacy.
CONCLUSIONS: WMT is efficacious in improving refractory FC-related therapeutic targets. The effectiveness of WMT in the management of FC is enhanced with the administration of multiple courses.
摘要：
背景：洗涤微生物移植（WMT）在难治性功能性便秘（FC）相关治疗靶点和影响因素方面的功效尚未阐明。本研究旨在评估WMT治疗难治性FC相关治疗靶点的疗效及影响因素。
方法：回顾性收集确诊为难治性FC并接受WMT治疗的患者的临床资料。治疗目标包括紧张，硬凳子,不完全疏散,肛门直肠梗阻的感觉，手动机动,大便频率降低。每个目标记录为1(是)或0(否)。所有患者从WMT的第一个疗程结束后随访约24周。主要结果是单个治疗靶标的改善率和治疗靶标的总体反应在第4、8和24周时降低2。次要结果是临床缓解率(即，每周平均有3次或更多自发性完全排便的患者比例），临床改善率(即，每周平均增加1个或更多SCBMs的患者或缓解的患者的比例），大便频率,Wexner便秘评分,布里斯托尔凳子表格量表（BSFS）得分，和不良事件。分析影响疗效的因素。
结果：总体而言，纳入63例患者，112个WMT疗程。第8周和第24周的改善率分别为45.6％和35.0％，42.9%和38.6%,45.0%和35.7%，55.6%和44.4%,60.9%和50.0%，分别,因为紧张，硬凳子,不完全疏散,肛门直肠梗阻的感觉，大便频率降低。总有效率为49.2%,50.8%,和42.9%，分别,在第4、8和24周。临床缓解率和临床改善率分别为54.0%和68.3%,分别,在第4周。大便频率，BSFS评分,WMT后，Wexner便秘评分趋于改善。在112个WMT疗程和随访期间，仅观察到22个轻度不良事件。WMT课程的数量被确定为影响疗效的独立因素。
结论：WMT可有效改善难治性FC相关治疗靶点。通过管理多个课程，WMT在FC管理中的有效性得到了提高。
方法：回顾性收集确诊为难治性FC并接受WMT治疗的患者的临床资料。治疗目标包括紧张，硬凳子,不完全疏散,肛门直肠梗阻的感觉，手动机动,大便频率降低。每个目标记录为1(是)或0(否)。所有患者从WMT的第一个疗程结束后随访约24周。主要结果是单个治疗靶标的改善率和治疗靶标的总体反应在第4、8和24周时降低2。次要结果是临床缓解率(即，每周平均有3次或更多自发性完全排便的患者比例），临床改善率(即，每周平均增加1个或更多SCBMs的患者或缓解的患者的比例），大便频率,Wexner便秘评分,布里斯托尔凳子表格量表（BSFS）得分，和不良事件。分析影响疗效的因素。
结果：总体而言，纳入63例患者，112个WMT疗程。第8周和第24周的改善率分别为45.6％和35.0％，42.9%和38.6%,45.0%和35.7%，55.6%和44.4%,60.9%和50.0%，分别,因为紧张，硬凳子,不完全疏散,肛门直肠梗阻的感觉，大便频率降低。总有效率为49.2%,50.8%,和42.9%，分别,在第4、8和24周。临床缓解率和临床改善率分别为54.0%和68.3%,分别,在第4周。大便频率，BSFS评分,WMT后，Wexner便秘评分趋于改善。在112个WMT疗程和随访期间，仅观察到22个轻度不良事件。WMT课程的数量被确定为影响疗效的独立因素。
结论：WMT可有效改善难治性FC相关治疗靶点。通过管理多个课程，WMT在FC管理中的有效性得到了提高。
