[Systematic review and Meta-analysis of efficacy and safety of Kunxian Capsules in treatment of glomerular diseases].

This study systematically evaluated the efficacy and safety of Kunxian Capsules(KXC), used alone or in combination with western medicine, for the treatment of glomerular diseases. A comprehensive computerized search was conducted in PubMed, Web of Science, EMbase, Cochrane Library, ClinicalTrials.gov, CNKI, Wanfang, VIP, and SinoMed databases to collect randomized controlled clinical trials(RCTs) on KXC for glomerular diseases from database inception to May 2025. The risk of bias for the included studies was assessed using the Cochrane handbook of systematic reviews of interventions(5.1.0). Meta-analysis was performed using RevMan 5.4 and STATA 18.0. The analysis included four types of glomerular diseases, namely chronic glomerulonephritis(CGN), nephrotic syndrome(NS), lupus nephritis(LN), and diabetic kidney disease(DKD). A total of 17 RCTs comprising 1 368 patients(687 cases in the experimental group and 681 cases in the control group) were included. Meta-analysis showed that KXC, either alone or combined with western medicine, yielded significant overall therapeutic benefits in the treatment of glomerular diseases. These benefits included a higher complete clinical complete remission rate(OR=2.33, 95%CI[1.71, 3.19], P<0.000 01), a greater proportion of patients achieving ≥50% decrease in proteinuria from baseline(OR=3.51, 95%CI[2.38, 5.17], P<0.000 01), and a significantly higher total clinical effective rate(OR=3.33, 95%CI[2.31, 4.80], P<0.000 01). Furthermore, regardless of the baseline 24hUTP level, KXC demonstrated a better effect in proteinuria reduction compared to the control group(SMD_(baseline 24hUTP<3.5 g)=-2.09, 95%CI[-3.41,-0.77], P=0.002; SMD_(baseline 24hUTP≥3.5 g)=-1.45, 95%CI[-2.21,-0.68], P=0.000 2). Subgroup analysis showed that the proteinuria-lowering effect of KXC was most pronounced in DKD(SMD=-1.61, P=0.000 2). The therapeutic effect was also evident in CGN(OR=4.46,P=0.03) and NS(OR=2.83, P<0.000 01), but the improvement in 24hUTP for LN did not reach statistical significance(SMD=-0.90, P=0.30). Although its effect in reducing urinary protein was significant, the serum albumin(ALB) levels did not increase synchronously(SMD=0.60, P=0.08). Safety analysis showed a lower overall incidence of adverse reactions in the experimental group compared to the control group(OR=0.57, 95%CI[0.39, 0.82], P=0.003), with significant advantages observed in terms of liver function impairment(4.0% vs 4.9%), infection risk(2.4% vs 5.9%), and leukopenia(1.9% vs 3.8%). However, a prominent risk of reproductive toxicity was noted, with a significantly higher incidence of menstrual disorders in the experimental group(5.9% vs 1.8%) compared to the control group. In conclusion, KXC, administered alone or in combination with western medicine, may be an effective intervention for delaying the progression of glomerular disease and may also mitigate certain toxicities to some extent. However, despite the formulation strategies aimed at reducing toxicity, gonadal inhibition remains an inherent drawback of Tripterygium species drugs. The design concept of attenuated toxicity compatibility does not completely antagonize its reproductive toxicity.