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益生菌、益生元和合生元制剂在辅助治疗成人轻中度溃疡性结肠炎中的疗效和耐受性比较:一项网络荟萃分析。

Comparative efficacy and tolerability of probiotic, prebiotic, and synbiotic formulations for adult patients with mild-moderate ulcerative colitis in an adjunctive therapy: A network meta-analysis.

机构信息

College of Marine Science and Biological Engineering, Qingdao University of Science and Technology, Qingdao 266000, China.

Emergency Department, Qingdao Municipal Hospital, University of Health and Rehabilitation Sciences, Qingdao 266000, China.

出版信息

Clin Nutr. 2024 Jan;43(1):20-30. doi: 10.1016/j.clnu.2023.11.010. Epub 2023 Nov 15.

DOI:10.1016/j.clnu.2023.11.010
PMID:37995508
Abstract

BACKGROUND & AIMS: Probiotics, prebiotics, and synbiotics (PPS) have been widely used as adjuvant treatments in patients with ulcerative colitis (UC) in recent years. However, the most effective formulations of PPS have yet to be identified. We thus aimed to compare the efficacy and tolerability of different PPS formulations for mild-moderate UC.

METHODS

We searched PubMed, Embase, Web of Science, and Cochrane CENTRAL from inception to June 24, 2023 for double-blind randomized controlled trials. We used a frequentist approach in random-effects models for network meta-analysis and the Grading of Recommendations Assessment, Development, and Evaluation approach to evaluate the certainty of evidence.

RESULTS

We analysed data from 20 trials involving 1153 patients. The combinations of specific strains of Lactobacillus and Bifidobacterium (CLB) (odds ratio (OR), 3.85; 95 % confidence interval (CI), 1.40-10.60; low certainty) and combinations of specific strains of Lactobacillus, Bifidobacterium, and Streptococcus (CLBS) (OR, 2.20; 95 % CI, 1.47-3.28; low certainty) significantly increased the clinical remission rate in intention-to-treat analysis (ITT) when compared to placebo. Similarly, compared with placebo, the two combinations significantly reduced clinical activity scores (standardized mean difference (SMD), -1.17 (95 % CI, -1.68 to -0.65), low certainty; and SMD, -1.33 (95 % CI, -1.81 to -0.86), low certainty, respectively). Hierarchical cluster analyses showed the two combinations formed clusters with high efficacy (clinical remission in ITT and clinical activity score) and tolerability (withdrawal due to worsening symptoms) within 12 weeks.

CONCLUSION

In this systematic review, we found CLB and CLBS demonstrated a clinical benefit in adjuvant treatments, with a comparable tolerability and safety profile to placebo. Further trials are needed.

TRIAL REGISTRATION NUMBER

CRD42022344905.

摘要

背景与目的

近年来,益生菌、益生元和合生元(PPS)已被广泛用作溃疡性结肠炎(UC)患者的辅助治疗。然而,最有效的 PPS 配方仍有待确定。因此,我们旨在比较不同 PPS 配方治疗轻中度 UC 的疗效和耐受性。

方法

我们从建库至 2023 年 6 月 24 日在 PubMed、Embase、Web of Science 和 Cochrane CENTRAL 中检索了双盲随机对照试验。我们使用随机效应模型进行网络荟萃分析,并采用推荐评估、制定与评价分级方法评估证据的确定性。

结果

我们分析了来自 20 项试验的 1153 名患者的数据。特定菌株的乳酸杆菌和双歧杆菌(CLB)组合(比值比(OR),3.85;95%置信区间(CI),1.40-10.60;低确定性)和特定菌株的乳酸杆菌、双歧杆菌和链球菌(CLBS)组合(OR,2.20;95%CI,1.47-3.28;低确定性)在意向治疗分析(ITT)中显著增加了临床缓解率。同样,与安慰剂相比,这两种组合显著降低了临床活动评分(标准化均数差(SMD),-1.17(95%CI,-1.68 至-0.65),低确定性;和 SMD,-1.33(95%CI,-1.81 至-0.86),低确定性)。层次聚类分析显示,这两种组合在 12 周内形成了具有高疗效(ITT 临床缓解和临床活动评分)和耐受性(因症状恶化而停药)的聚类。

结论

在这项系统评价中,我们发现 CLB 和 CLBS 在辅助治疗中表现出临床获益,且与安慰剂的耐受性和安全性相当。需要进一步的试验。

临床试验注册号

CRD42022344905。

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