Objective:To investigate the effects of Jianpi Yishen Xiezhuo Decoction on residual renal function and immune function in patients with end-stage renal disease undergoing peritoneal dialysis.Methods:Randomized controlled trial study was performed. A total of 102 end-stage renal patients with peritoneal dialysis in the Shehong Traditional Chinese Medicine Hospital from March 2021 to March 2023 were selected as the observation objects, and were divided into 2 groups by random number table method, with 51 cases in each group. The control group was given conventional Western medicine therapy on the basis of peritoneal dialysis, and the observation group was given Jianpi Yishen Xiezhuo Decoction on the basis of peritoneal dialysis. Both groups were treated continuously for 3 months. TCM syndrome score was performed before and after treatment, and serum SCr and BUN levels were detected by automatic biochemical analyzer. The levels of CD3 +, CD4 + and CD8 + were detected by flow cytometry; the ratio of CD4 +/CD8 + was calculated; the levels of IL-2, CXC chemokine ligand 9 (CXCL9) and hypersensitive C-reactive protein (hs-CRP) were detected by ELISA. 24 h urine was collected and 24 h urine protein quantification (24 hUP) was performed by automatic urine routine analyzer. The adverse reactions during treatment were recorded and the clinical efficacy was evaluated. Results:The total effective rate was 92.16% (47/51) in the observation group and 76.47% (39/51) in the control group, with statistical significance ( χ2=4.74, P=0.029). After treatment, fatigue (1.78±0.47 vs. 2.17±0.51, t=4.02), waist and knee weakness (1.90±0.52 vs. 2.29±0.59, t=3.54), lethargy and less food (2.03±0.55 vs. 2.65±0.70, t=4.97), thick-coated tongue (2.26±0.68 vs. 2.98±0.75, t=5.08) and total scores (7.97±2.22 vs. 10.09±2.55, t=4.48) were lower than those in the control group ( P<0.01); serum SCr [(296.12±30.27) mmol/L vs. (326.81±32.43) mmol/L, t=4.94], BUN [(12.19±3.02) mmol/L vs. (16.88±3.64) mmol/L, t=7.08], 24 hUP [(1.22±0.35) g vs. (1.75±0.42) g, t=6.92] were lower than those in the control group ( P<0.01); the level of CD3 + [(54.76±5.21) % vs. (50.03±4.90) %, t=4.72], CD4 + [(56.33±5.09) % vs. (52.18±5.33) %, t=4.02] and CD4 +/CD8 + [(1.98±0.39) vs. (1.67±0.34), t=4.28] was higher than those in the control group ( P<0.01), and the level of CD8 + [(28.43±2.58) % vs. (31.29±2.47) %, t=5.72] was lower than that of control group ( P<0.01). Serum IL-2 [(46.49±6.07) μg/L vs. (53.43±7.08) μg/L, t=5.31], CXCL9 [(16.32±3.45) μg/L vs. (19.98±3.53) μg/L, t=5.30] and hs-CRP [(11.22±3.85) mg/L vs. (15.75±3.92) mg/L, t=5.89] were lower than those in the control group ( P<0.01). During treatment, the incidence of adverse reactions was 11.76% (6/51) in the observation group and 7.84% (4/51) in the control group, without statistical significance ( χ2=0.44, P=0.505). Conclusion:Jianpi Yishen Xiezhuo Decoction can effectively improve the TCM syndrome and residual kidney function of patients with end-stage renal disease undergoing peritoneal dialysis, enhance their immunity, inhibit the expression of inflammatory factors, and improve clinical efficacy with good safety.