Department of Medicine.
Division of Gastroenterology and Hepatology, University of Toledo Medical Center.
J Clin Gastroenterol. 2023 Mar 1;57(3):239-245. doi: 10.1097/MCG.0000000000001777.
Clostridium difficile Infection is a significant source of morbidity and mortality, which is on the rise. Fecal Microbiota Transplantation (FMT) is an alternative therapy to antibiotics with a high success rate and low relapse rate. Current data regarding the efficacy of the types of FMT used, namely fresh, frozen, and lyophilized is conflicting. Our review attempts to consolidate this data and highlight the most efficacious treatment currently available.
MEDLINE, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, SciELO, the Korean Citation Index, and Global Index Medicus were systematically searched from inception through May 3, 2022. Studies in which patients are undergoing any form of FMT who had failed antibiotic treatment previously were included. Both pairwise (direct) and network (direct + indirect) meta-analysis were performed using a random effects model and DerSimonian-Laird approach. A frequentist approach was used for network meta-analysis. Risk differences with (RD) with 95% confidence interval (CI) were calculated.
A total of 8 studies, including 4 RCTs and 4 cohort studies, were included with a total of 616 patients. Fresh FMT was determined to be most successful with 93% efficacy 95% CI (0.913 to 0.999) followed by frozen with 88% efficacy 95% CI (0.857 to 0.947) and lyophilized with 83% efficacy 95% CI (0.745 to 0.910). The direct meta-analysis showed no statistically significant difference between fresh and frozen group. (RD -0.051 95% CI -0.116 to 0.014 P =0.178). No significant differences were noted in frozen versus lyophilized groups with an overall trend towards Fresh FM (RD -0.061 95% CI -0.038 to 0.160 P =0.617). On network meta-analysis, when compared with fresh group, a lower recovery rate was noted with both frozen group (RD -0.06 95% CI -0.11 to 0.00 P =0.05) and lyophilized group (RD -0.16 95% CI -0.27 to -0.05 P =0.01).
We conclude the efficacy of Frozen and Lyophilized preparations is high with no difference in direct comparison, and the relative efficacy reduction based on network analysis is outweighed by the safety, accessibility, and practicality of Frozen or Lyophilized preparations.
艰难梭菌感染是发病率和死亡率的重要来源，且呈上升趋势。粪便微生物群移植（FMT）是一种替代抗生素的治疗方法，具有很高的成功率和很低的复发率。目前关于使用的 FMT 类型（新鲜、冷冻和冻干）的疗效的数据存在冲突。我们的综述试图整合这些数据，并强调目前最有效的治疗方法。
系统检索了 MEDLINE、Embase、Web of Science 核心合集、Cochrane 对照试验中心注册库、SciELO、韩国引文索引和全球医学索引，检索时间从建库至 2022 年 5 月 3 日。纳入了正在接受任何形式的 FMT 治疗且先前抗生素治疗失败的患者的研究。使用随机效应模型和 DerSimonian-Laird 方法进行了直接（成对）和网络（直接+间接）荟萃分析。网络荟萃分析采用了似然比检验。计算风险差异（RD）和 95%置信区间（CI）。
共纳入 8 项研究，包括 4 项 RCT 和 4 项队列研究，共纳入 616 例患者。新鲜 FMT 的成功率最高，为 93%，95%CI（0.913 至 0.999），其次是冷冻 FMT，成功率为 88%，95%CI（0.857 至 0.947），冻干 FMT 成功率为 83%，95%CI（0.745 至 0.910）。直接荟萃分析显示，新鲜组与冷冻组之间无统计学差异。（RD-0.051，95%CI-0.116 至 0.014，P=0.178）。冷冻组与冻干组之间无显著差异，总体趋势为新鲜 FMT 效果更好。（RD-0.061，95%CI-0.038 至 0.160，P=0.617）。网络荟萃分析显示，与新鲜组相比，冷冻组和冻干组的恢复率均较低。（RD-0.06，95%CI-0.11 至 0.00，P=0.05）和冻干组（RD-0.16，95%CI-0.27 至-0.05，P=0.01）。
我们的结论是，冷冻和冻干制剂的疗效很高，直接比较无差异，基于网络分析的相对疗效降低被冷冻或冻干制剂的安全性、可及性和实用性所抵消。
