清肾颗粒治疗慢性肾脏病湿热证患者的疗效Meta分析及GRADE 证据评价

Efficacy of Qingshen Granules in the Treatment of Patients with Chronic Kidney Disease with Damp-Heat Syndrome： A Meta-Analysis and GRADE Evidence Evaluation

摘要:

目的：系统评价清肾颗粒治疗慢性肾脏病（CKD） 湿热证患者的有效性，并为临床实践提供循证医学证据。方法：计算机检索中国知网、万方、维普、SinoMed、PubMed、Web of Science、Cochrane Library、Embase等数据库中关于清肾颗粒治疗CKD湿热证的随机对照试验（RCT），检索时间从各数据库自建库至2025年11月28日。由2名研究者独立筛选文献、提取资料并评价偏倚风险。采用RevMan 5.3软件进行Meta分析，对二分类变量使用优势比（OR），连续变量使用均数差（MD） 作为效应量，并计算95%置信区间（CI）。采用GRADEpro GDT工具对主要结局指标进行证据质量分级。结果：共纳入16项RCT，合计1 286例患者。Meta分析结果显示，与单纯基础治疗相比，联合清肾颗粒可提高临床总有效率［OR=2.73，95%CI（2.06，3.61）］ 和中医证候疗效［OR=3.57，95%CI （2.46，5.17）］，并改善肾功能指标，包括降低血肌酐（SCr）［MD=-42.74，95%CI （-53.66，-31.82）］、尿素氮（BUN）［MD=-2.67，95%CI （-3.57，-1.76）］ 及提高估算肾小球滤过率（eGFR）［MD=7.55，95%CI （4.21，10.89）］，差异均有统计学意义（P＜0.05）。GRADE 证据分级显示，临床疗效、中医证候疗效和SCr为中级证据，BUN和eGFR为低级证据。亚组分析提示，不同疗程（8周和12周）对BUN与eGFR结局的异质性解释有限，2组疗效趋势一致。结论：清肾颗粒联合基础治疗可有效改善CKD湿热证患者的临床症状及肾功能指标。受纳入研究方法学质量及异质性限制，未来仍需更多高质量研究进一步验证其疗效。

Abstract:

Abstract： Objective： To systematically evaluate the efficacy of Qingshen Granules in the treatment of patients with chronic kidney disease （CKD） with damp-heat syndrome， and to provide evidence-based medical support for clinical practice. Methods： Randomized controlled trials （RCTs） on Qingshen Granules for CKD with damp-heat syndrome were retrieved from databases including China National Knowledge Infrastructure（CNKI）， Wanfang Data Knowledge Service Platform （Wanfang），China Science and Technology Journal Database （VIP），China Biomedical Literature Database （SinoMed）， PubMed， Web of Science， Cochrane Library， and The Excerpta Medica Database （Embase）. The search period covered from the inception of each database to November 28， 2025. Two researchers independently screened the literature， extracted data， and assessed the risk of bias. Meta-analysis was performed using RevMan 5.3 software. The odds ratio （OR） was used as the effect measure for dichotomous variables， and the mean difference （MD） for continuous variables， with their 95% confidence intervals （CIs）. The GRADEpro GDT tool was used to grade the quality of evidence for the primary outcome measures. Results： A total of 16 RCTs involving 1 286 patients were included. Meta-analysis results showed that compared with basic treatment alone， the combination of Qingshen Granules significantly improved the total clinical effective rate [OR=2.73， 95% CI （2.06， 3.61）] and traditional Chinese medicine syndrome efficacy [OR=3.57， 95% CI （2.46， 5.17）]. It also improved renal function parameters， including reducing serum creatinine （SCr） [MD= -42.74， 95% CI （ -53.66， -31.82）]， reducing blood urea nitrogen （BUN） [MD=-2.67， 95% CI （-3.57， -1.76）]， and increasing estimated glomerular filtration rate （eGFR） [MD=7.55， 95% CI （4.21， 10.89）]， with all differences being statistically significant （P＜ 0.05）. GRADE evidence grading indicated that clinical efficacy，traditional Chinese medicine syndrome efficacy，and SCr were moderate-quality evidence， while BUN and eGFR were low-quality evidence. Subgroup analysis suggested that different treatment durations （8 weeks vs. 12 weeks） had limited explanatory power for the heterogeneity in BUN and eGFR outcomes， with consistent efficacy trends between the two groups. Conclusion： Qingshen Granules combined with basic treatment can effectively improve clinical symptoms and renal function parameters in the treatment of CKD with damp-heat syndrome. Due to limitations in the methodological quality and heterogeneity of the included studies，more high-quality research is needed to further validate its efficacy.