微生态制剂治疗慢性肾脏病的伞状评价

Umbrella Review of Microecological Preparations for Chronic Kidney Disease

摘要: 目的：本研究通过伞状meta分析方法整合证据，系统评估微生态制剂对慢性肾脏病(CKD)的疗效并明确证据可靠性等级。方法：系统检索PubMed、Embase、Cochrane Library、Web of Science、CNKI、Sinomed及万方数据库(建库至2025年2月)，双人独立筛选文献并提取数据。采用AMSTAR-2量表评价meta分析方法学质量，GRADE系统评定证据体质量，通过随机效应模型计算加权均数差(WMD)及标准化均数差(SMD)效应量，并行亚组分析及敏感性分析追溯异质性来源。结果：共纳入15项meta分析(涉及4625例CKD患者)。meta分析表明：氧化应激指标：MDA显著降低(WMD = −0.83, 95% CI: −0.99~−0.68)，TAC (SMD = 0.55, 95% CI: 0.22~0.88)及GSH (WMD = 0.44，95% CI: 0.30~0.59)显著升高；炎症标志物：CRP水平下降(SMD = −0.62, 95% CI: −0.89~−0.35)，IL-6无统计学差异(P = 0.23)；肾功能指标：BUN降低(SMD = −0.89, 95% CI: −1.23~−0.56)，Scr无显著变化(P = 0.15)，eGFR出现降低趋势(SMD = −0.34, 95% CI: −0.61~−0.07)。结论：微生态制剂可改善CKD患者部分氧化应激及炎症指标，但对肾功能的影响存在矛盾性证据。当前研究受限于异质性高、证据等级偏低等问题，尚无法形成明确临床推荐。建议未来开展多中心、大样本随机对照试验，重点探索菌株特异性效应及干预时间窗，为精准治疗策略提供循证依据。

Abstract: Objective: This study utilizes an umbrella meta-analytic approach to synthesize evidence, systematically evaluate the efficacy of microecological preparations in chronic kidney disease (CKD), and establish the hierarchy of evidence reliability. Methods: Systematic searches were conducted in PubMed, Embase, Cochrane Library, Web of Science, CNKI, Sinomed, and Wanfang databases (from inception to February 2025). Two reviewers independently screened the literature and extracted data. Methodological quality of the included meta-analyses was assessed using the AMSTAR-2 tool, and the quality of the evidence body was rated using the GRADE system. Weighted mean difference (WMD) and standardized mean difference (SMD) effect sizes were calculated using random-effects models. Subgroup analyses and sensitivity analyses were performed to explore sources of heterogeneity. Results: A total of 15 meta-analyses (involving 4625 CKD patients) were included. The meta-analysis demonstrated that: Oxidative stress markers: Malondialdehyde (MDA) significantly decreased (WMD = −0.83, 95% CI: −0.99 to −0.68), while total antioxidant capacity (TAC) (SMD = 0.55, 95% CI: 0.22 to 0.88) and glutathione (GSH) (WMD = 0.44, 95% CI: 0.30 to 0.59) significantly increased; Inflammatory markers: C-reactive protein (CRP) levels decreased (SMD = −0.62, 95% CI: −0.89 to −0.35), but interleukin-6 (IL-6) showed no statistically significant difference (P = 0.23); Renal function markers: Blood urea nitrogen (BUN) decreased (SMD = −0.89, 95% CI: −1.23 to −0.56), serum creatinine (Scr) showed no significant change (P = 0.15), and estimated glomerular filtration rate (eGFR) exhibited a decreasing trend (SMD = −0.34, 95% CI: −0.61 to −0.07). Conclusion: Microecological preparations can improve certain oxidative stress and inflammatory markers in CKD patients, but evidence regarding their impact on renal function is contradictory. The current evidence is limited by high heterogeneity and low evidence quality, precluding definitive clinical recommendations. Future research should focus on conducting multicenter, large-sample randomized controlled trials to specifically investigate strain-specific effects and optimal intervention time windows, thereby providing an evidence base for precision treatment strategies.