[Effect of fecal bacterial preservation time on the outcomes of fecal microbiota transplantation for slow transit constipation]

Objective: To investigate the effect of different fecal bacterial preservation time on the efficacy and complications of FMT. Methods: A retrospective cohort study was carried out. Clinical data of 483 patients with slow transit constipation undergoing voluntary FMT at Intestinal Microecology Diagnosis and Treatment Center from August 2017 to October 2019 were retrospectively collected. According to the storage time of fecal bacterial samples used in FMT treatment, the cases were divided into fresh bacterial solution (n=29), bacterial solution stored at -80℃ for 1 week (n=187), 1 month (n=121), 3 months (n=89), 6 months (n=38), and 12 months (n=19). The total number of complete bowel movement, Wexner constipation score, gastrointestinal quality of life index (GIQLI), FMT satisfaction score and related adverse reactions were summarized and compared among groups 1 week and 1 month after FMT treatment. Results: There were no statistically significant differences in the baseline data of patients among different bacterial solution storage time (all P>0.05). After 1 month of treatment, the overall frequency of defecation of all the patients was (3.83 ± 1.22) times/week, Wexner constipation score was (6.74 ± 3.56) points, GIQLI score was (108.76 ± 15.38) points, clinical cure rate was 57.8% (279/483). The improvement rate was 66.3% (320/483), and the treatment satisfaction was (3.85 ± 0.93) points. No severe FMT-associated complication and death were observed during treatment and follow-up period. FMT-related adverse events occurred in 115 cases (23.8%), including nausea in 25 cases (5.2%), vomiting in 13 (2.7%), diarrhea in 21 (4.3%), abdominal pain in 16 (3.3%), abdominal distension in 33 (6.8%), sore throat in 56 (11.6%) and fever in 16(3.3%), all of which relieved after symptomatic treatment. There were no statistically significant differences in the number of defecations, Wexner constipation scores, and GIQLI scores before FMT, 1 week and 1 month after FMT treatment among different bacterial solution storage groups (all P>0.05). Differences of clinical cure rate, clinical improvement rate, and treatment satisfaction of patients 1 week and 1 month after treatment were not statistically significant (all P>0.05). Among the groups, differences in the overall complications and types of complications after FMT treatment were not statistically significant (all P>0.05). Conclusions: FMT is safe and effective in the treatment of slow transit constipation. Fresh fecal bacterial samples or fecal bacterial samples frozen at -80℃ for 1 year can be safely applied to FMT for the treatment of slow transit constipation, with stable short-term efficacy and without serious adverse reactions.

目的： 探讨不同菌液保存时间对菌群移植（FMT）的疗效和并发症的影响。 方法： 采用回顾性队列研究方法，回顾性收集2017年8月至2019年10月期间，于同济大学附属第十人民医院肠道微生态治疗中心自愿接受菌群移植治疗的483例慢传输型便秘患者的临床资料。根据FMT所用菌液保存时间进行分组，分为新鲜菌液组（菌液制备完成后0~4℃冷藏6 h内，29例）、菌液保存1周组（-80℃冷冻保存1周，187例）、菌液保存1个月组（-80℃冷冻保存1周至1个月，121例）、菌液保存3个月组（-80℃冷冻保存1~3个月，89例）、菌液保存6个月组（-80℃冷冻保存3~6个月，38例）和菌液保存12个月组（-80℃冷冻保存6~12个月，19例）。比较各组间FMT治疗后1周和1月的每周完全自主排粪次数、Wexner便秘评分、胃肠生活质量（GIQLI）评分、FMT治疗满意评分及相关不良反应。 结果： 不同菌液保存时间分组的慢传输型便秘患者基线资料比较，差异均无统计学意义（均P>0.05）。治疗1个月后，全体患者总体排粪次数为（3.83±1.22）次/周，Wexner便秘评分为（6.74±3.56）分，GIQLI评分为（108.76±15.38）分，临床治愈率为57.8%（279/483），临床改善率为66.3%（320/483），治疗满意度为（3.85±0.93）分。全组病例在FMT治疗及随访期间均未出现严重的FMT相关并发症，无死亡病例。出现FMT相关不良反应事件共115例（23.8%），包括恶心25例（5.2%）、呕吐13例（2.7%）、腹泻21例（4.3%）、腹痛16例（3.3%）、腹胀33例（6.8%）、咽喉部疼痛56例（11.6%）、发热16例（3.3%），均经对症处理后症状缓解。不同菌液保存时间各分组之间，FMT治疗前以及治疗后1周和1个月患者的排粪次数、Wexner便秘评分、GIQLI评分差异均无统计学意义（均P>0.05）；各组间，治疗后1周和1个月的患者临床治愈率、临床改善率以及治疗满意度的差异均无统计学意义（均P>0.05）。各组间，FMT治疗后患者总体并发症及各类型并发症的差异亦均无统计学意义（均P>0.05）。 结论： FMT治疗慢传输型便秘安全有效。新鲜菌液样本或-80℃冷冻保存1年内的菌液样本均可安全地应用于FMT治疗慢传输型便秘，短期随访疗效稳定，且无严重不良反应。.

Keywords: Fecal bacterial preservation time; Fecal microbiota transplantation; Slow transit constipation.