Efficacy and safety of Bailing Capsule for the treatment of adult primary nephrotic syndrome: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND

Bailing Capsule, a standardized fungal medicinal preparation recorded in the Chinese Pharmacopoeia (2020 Edition), is widely applied in the clinical management of various kidney diseases including adult primary nephrotic syndrome (PNS). However, the conclusions of existing clinical studies on its therapeutic effects for adult PNS remain inconsistent, lacking a comprehensive and quantitative evidence synthesis.

METHODS

A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate the efficacy and safety of Bailing Capsule for adult PNS. Eight major databases were systematically searched from their inception to December 20, 2025, for relevant RCTs. Meta-analytical data processing was performed using Review Manager (RevMan) version 5.4, with no language restrictions applied to the literature search.

RESULTS

A total of 11 eligible RCTs involving 920 adult patients with PNS were included in this study. Compared with conventional therapy alone, Bailing Capsule (used as monotherapy or adjunctive therapy) significantly reduced levels of 24-hour urinary protein excretion (24hUpro), serum creatinine (Scr), blood urea nitrogen (BUN) and total cholesterol (TC), and markedly increased serum albumin (ALB), CD3+ T lymphocytes, CD4+ T lymphocytes and the CD4+/CD8+ ratio. Additionally, Bailing Capsule exhibited significant renoprotective effects, improved the overall clinical response rate, and presented a favorable safety profile with a low incidence of adverse events.

CONCLUSION

Bailing Capsule may serve as a safe and effective adjunctive therapeutic option for adult patients with PNS, with positive effects on improving renal function indicators, regulating immune function and enhancing clinical efficacy. However, further high-quality, large-scale and multicenter RCTs are still required to validate the long-term efficacy and safety of Bailing Capsule for adult PNS.