益生菌与合生元作为心力衰竭辅助治疗:一项系统综述及网络与配对荟萃分析。
完整摘要 · 中文译文
目的:本研究旨在评估益生菌和合生元作为针对微生物组的辅助疗法在心力衰竭(HF)中的应用,同时明确确定是否存在任何符合纳入标准的仅含益生元的试验。 方法:我们检索了八个中英文数据库,时间范围从建库至2026年5月1日,并于2026年7月15日在PubMed、Embase和Web of Science中进行了扩展敏感性检索。随机效应网络荟萃分析(NMA)仅用于具有连接的多节点证据;双节点证据采用直接比较分析。由于安慰剂、常规治疗和食物对照在临床上不可互换,因此使用限制性最大似然(REML)和Hartung-Knapp(HK)置信区间(CI)对直接证据进行了按对照类型分层的敏感性分析。 结果:系统评价共纳入12项随机研究(14篇报告);其中11项至少纳入了一项主要分析或敏感性定量分析,10项纳入了主要分析。修订阶段的检索审核未发现其他符合纳入标准的随机试验,也未发现符合纳入标准的仅含益生元的试验。在所有试验人群中,共随机分配1,021名受试者,其中973名被分配至符合评价条件的组别。左心室射血分数(LVEF)网络包含7项研究,分析集中有539名受试者;然而,该网络呈星形结构,无闭合环路,且依赖于一个合并的对照组节点。多菌株细菌益生菌与合并对照组的探索性NMA估计值为平均差 nce(MD)为2.13个百分点(95%置信区间[CI] -0.10至4.35)。针对常规护理的比较组分层敏感性分析显示MD为1.83个百分点(95% CI -2.33至5.98)。所有综合结果被评估为存在一些担忧或高偏倚风险。效应估计值普遍不精确,证据确定性为低或极低。不良事件的定义和分母不一致。 结论:现有证据稀少,并受到显著的非传递性、偏倚风险和不精确性的影响。网络比较和排序应被视为产生假设;因此,不能推荐任何益生菌或合生元辅助用于心力衰竭的常规管理。 系统综述注册:CRD420261413595。公开网址:https://www.crd.york.ac.uk/PROSPERO/view/CRD420261413595.
完整摘要 · 英文原文
OBJECTIVE: This study aimed to evaluate the use of probiotics and synbiotics as microbiome-directed adjunctive therapies for heart failure (HF), while explicitly determining whether any eligible prebiotic-only trials existed. METHODS: We searched eight English- and Chinese-language databases from inception to 1 May 2026 and conducted expanded sensitivity searches in PubMed, Embase, and Web of Science on 15 July 2026. Random-effects network meta-analysis (NMA) was used only for connected multi-node evidence; two-node evidence was analyzed pairwise. As placebo, usual care, and food comparators were not clinically exchangeable, comparator-stratified sensitivity analyses of direct evidence were conducted using restricted maximum likelihood (REML) and Hartung-Knapp (HK) confidence intervals (CIs). RESULTS: A total of 12 randomized studies were included in the systematic review (14 reports); 11 contributed to at least one primary or sensitivity quantitative analysis, and 10 contributed to the primary analyses. The revision-stage search audit identified no additional eligible randomized trials and no eligible prebiotic-only trials. Across all the trial populations, 1,021 participants were randomized, 973 of whom were allocated to review-eligible arms. The left ventricular ejection fraction (LVEF) network included 7 studies and 539 participants in the analysis set; however, this network was star-shaped, had no closed loops, and depended on a combined comparator node. The exploratory NMA estimate for multi-strain bacterial probiotics versus the combined comparator was a mean difference (MD) of 2.13 percentage points (95% confidence interval [CI] -0.10 to 4.35). The comparator-stratified sensitivity analysis for usual care yielded an MD of 1.83 percentage points (95% CI -2.33 to 5.98). All synthesized results were assessed as having either some concern or a high risk of bias. The effect estimates were generally imprecise, and the certainty of evidence was low or very low. Adverse event definitions and denominators were inconsistent. CONCLUSION: The available evidence is sparse and affected by significant non-transitivity, risk of bias, and imprecision. Network comparisons and rankings should be considered hypothesis-generating; therefore, no probiotic or synbiotic adjunct can be recommended for routine HF management. SYSTEMATIC REVIEW REGISTRATION: CRD420261413595. Public URL: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261413595.