To observe the efficacy of Qingbu Jiushen Formula combined with Western medicine in treating chronic kidney disease (CKD) with Qi-Yin deficiency and damp-heat internal retention, and its effects on peripheral blood levels of Cystatin C and pro-gastrin-releasing peptide (proGRP).

A total of 100 CKD patients with Qi-Yin deficiency and damp-heat internal retention admitted to the Department of Nephrology, Luoyang Hospital, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, from January 2022 to October 2024, were randomly divided into a Western medicine group and a combination group using the envelope method, with 50 cases in each group. The Western medicine group received routine Western medical treatment, while the combination group received Qingbu Jiushen Formula in addition to the same Western treatment, for 12 consecutive weeks. The following parameters were measured before and after treatment: 24-hour urinary protein (24 h Upro), estimated glomerular filtration rate (eGFR), urinary albumin excretion rate (UAER), serum creatinine (Scr), blood urea nitrogen (BUN), Cystatin C, proGRP, and factors related to the nuclear factor erythroid 2-related factor 2-antioxidant response element (Nrf2-ARE) signaling pathway. Traditional Chinese medicine (TCM) symptom scores were assessed before and after treatment, and the overall response rate and incidence of adverse reactions were recorded.

Before treatment, there were no significant differences between the two groups in 24 h Upro, eGFR, UAER, Scr, Cystatin C, or proGRP (P>0.05). After 12 weeks of treatment, 24 h Upro, UAER, Scr, Cystatin C, and proGRP decreased significantly in both groups compared with baseline (P<0.05), and the combination group showed significantly lower levels than the Western medicine group (P<0.05). eGFR increased significantly in both groups after treatment (P<0.05), with the combination group showing a higher eGFR than the Western medicine group (P<0.05). Regarding Nrf2-ARE pathway-related factors, no significant differences were found between the two groups at baseline (P>0.05). After 12 weeks, catalase (CAT), superoxide dismutase (SOD), heme oxygenase-1 (HO-1), and glutathione peroxidase (GSH-Px) all increased significantly in both groups (P<0.05), and the combination group had significantly higher levels than the Western medicine group (P<0.05). TCM symptom scores were comparable between groups before treatment (P>0.05), but after 12 weeks both groups showed significant reductions (P<0.05), with the combination group scoring lower than the Western medicine group (P<0.05). The overall response rate in the combination group was 92.00% (46/50), which was higher than that in the Western medicine group (76.00%, 38/50). The incidence of adverse reactions was 12.00% (6/50) in the combination group versus 8.00% (4/50) in the Western medicine group, with no statistically significant difference (P>0.05).

Qingbu Jiushen Formula combined with Western medicine can improve renal function, regulate the Nrf2-ARE signaling pathway, and enhance therapeutic efficacy in CKD patients with Qi-Yin deficiency and damp-heat internal retention.