Department of Clinical Microbiology, Medical Research & Laboratory Diagnostic Center, Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, China.
Central Laboratory, Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, China.
PLoS One. 2020 Mar 17;15(3):e0228846. doi: 10.1371/journal.pone.0228846. eCollection 2020.
Fecal microbiota transplantation is an effective treatment for many gastrointestinal diseases, such as Clostridium difficile infection and inflammatory bowel disease, especially ulcerative colitis. Changes in colonic microflora may play an important role in the pathogenesis of ulcerative colitis, and improvements in the intestinal microflora may relieve the disease. Fecal bacterial transplants and oral probiotics are becoming important ways to relieve active ulcerative colitis.
This systematic review with meta-analysis compared the efficacy and safety of basic treatment combined with fecal microbiota transplantation or mixed probiotics therapy in relieving mild to moderate ulcerative colitis.
The PubMed, Embase, and Cochrane libraries (updated September 2019) were searched to identify randomized, placebo-controlled, or head-to-head trials assessing fecal microbiota transplantation or probiotic VSL#3 as induction therapy in active ulcerative colitis. We analyze data using the R program to obtain evidence of direct comparison and to generate intermediate variables for indirect treatment comparisons.
Seven randomized, double-blind, placebo-controlled trials were used as the sources of the induction data. All treatments were superior to placebo. In terms of clinical remission and clinical response to active ulcerative colitis, direct comparisons showed fecal microbiota transplantation (OR = 3.47, 95% CI = 1.93-6.25) (OR = 2.48, 95% CI = 1.18-5.21) and mixed probiotics VSL#3 (OR = 2.40, 95% CI = 1.49-3.88) (OR = 3.09, 95% CI = 1.53-6.25) to have better effects than the placebo. Indirect comparison showed fecal microbiota transplantation and probiotic VSL#3 did not reach statistical significance either in clinical remission (RR = 1.20, 95% CI = 0.70-2.06) or clinical response (RR = 0.95, 95% CI = 0.62-1.45). In terms of safety, fecal microbiota transplantation (OR = 1.15, 95% CI = 0.51-2.61) and VSL #3 (OR = 0.90, 95% CI = 0.33-2.49) showed no statistically significant increase in adverse events compared with the control group. In terms of serious adverse events, there was no statistical difference between the fecal microbiota transplantation group and the control group (OR = 1.29, 95% CI = 0.46-3.57). The probiotics VSL#3 seems more safer than fecal microbiota transplantation, because serious adverse events were not reported in the VSL#3 articles.
Fecal microbiota transplantation or mixed probiotics VSL#3 achieved good results in clinical remission and clinical response in active ulcerative colitis, and there was no increased risk of adverse reactions. There was no statistical difference between the therapeutic effect of fecal microbiota transplantation and that of mixed probiotics VSL#3. However, the use of fecal microbiota transplantation and probiotics still has many unresolved problems in clinical applications, and more randomized controlled trials are required to confirm its efficacy.
粪便微生物群移植是治疗许多胃肠道疾病的有效方法，例如艰难梭菌感染和炎症性肠病，尤其是溃疡性结肠炎。结肠微生物群的变化可能在溃疡性结肠炎的发病机制中起重要作用，改善肠道微生物群可能缓解疾病。粪便细菌移植和口服益生菌正在成为缓解活动期溃疡性结肠炎的重要方法。
本系统评价和荟萃分析比较了基础治疗联合粪便微生物群移植或混合益生菌治疗在缓解轻度至中度溃疡性结肠炎方面的疗效和安全性。
检索 PubMed、Embase 和 Cochrane 图书馆（更新于 2019 年 9 月），以确定评估粪便微生物群移植或益生菌 VSL#3 作为活动期溃疡性结肠炎诱导治疗的随机、安慰剂对照或头对头试验。我们使用 R 程序分析数据，以获得直接比较的证据，并为间接治疗比较生成中间变量。
七项随机、双盲、安慰剂对照试验被用作诱导数据的来源。所有治疗均优于安慰剂。在临床缓解和对活动期溃疡性结肠炎的临床反应方面，直接比较显示粪便微生物群移植（OR=3.47，95%CI=1.93-6.25）（OR=2.48，95%CI=1.18-5.21）和混合益生菌 VSL#3（OR=2.40，95%CI=1.49-3.88）（OR=3.09，95%CI=1.53-6.25）的效果优于安慰剂。间接比较显示粪便微生物群移植和益生菌 VSL#3 在临床缓解（RR=1.20，95%CI=0.70-2.06）或临床反应（RR=0.95，95%CI=0.62-1.45）方面均无统计学意义。在安全性方面，粪便微生物群移植（OR=1.15，95%CI=0.51-2.61）和 VSL#3（OR=0.90，95%CI=0.33-2.49）与对照组相比，不良反应发生率无统计学意义增加。在严重不良事件方面，粪便微生物群移植组与对照组无统计学差异（OR=1.29，95%CI=0.46-3.57）。益生菌 VSL#3 似乎比粪便微生物群移植更安全，因为 VSL#3 文章中没有报告严重不良事件。
粪便微生物群移植或混合益生菌 VSL#3 在活动期溃疡性结肠炎的临床缓解和临床反应方面取得了良好的效果，且不良反应风险无增加。粪便微生物群移植与混合益生菌 VSL#3 的治疗效果无统计学差异。然而，粪便微生物群移植和益生菌的临床应用仍存在许多悬而未决的问题，需要更多的随机对照试验来证实其疗效。
