Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: A multicenter, double-blind, placebo-controlled, randomized trial.

BACKGROUND: Yiqi Peiyuan (YQPY) prescription, a composite prescription of traditional Chinese medicine, has been used to prevent or delay the continued deterioration of renal function after acute kidney injury (AKI) in some institutions and has shown considerable efficacy. OBJECTIVE: This is the first randomized controlled trial to assess efficacy and safety of YQPY for improving short-term prognosis in adult patients with AKI. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This is a prospective, double-blind, multicenter, randomized, and placebo-controlled clinical trial. A total of 144 enrolled participants were randomly allocated to two groups according to a randomization schedule. Participants, caregivers and investigators assessing the outcomes were blinded to group assignment. Patients in the YQPY group received 36 g YQPY granules twice a day for 28 days. Patients in the placebo group received a placebo in the same dose as the YQPY granules. MAIN OUTCOME MEASURES: The primary outcome was the change in the estimated glomerular filtration rate (eGFR) between baseline and after 4 and 24 weeks of treatment. The secondary outcomes were the change of serum creatinine (Scr) level between baseline and after treatment, and the incidence of endpoint events, defined as eGFR increasing by more than 25% above baseline, eGFR >75 mL/min per 1.73 m2 or the composite endpoint, which was defined as the sum of patients meeting either of the above criteria. RESULTS: Data from a total of 114 patients (59 in the YQPY group and 55 in the control group) were analyzed. The mean changes in eGFR and Scr in weeks 4 and 24 had no difference between the two groups. In further subgroup analysis (22 in the YQPY group and 31 in the control group), the mean change in eGFR after treatment for 4 weeks was 27.39 mL/min per 1.73 m2 in the YQPY group and 5.78 mL/min per 1.73 m2 in the placebo group, and the mean difference between groups was 21.61 mL/min per 1.73 m2 (P < 0.001). Thirteen (59.1%) patients in the YQPY group and 5 (16.1%) in the placebo group reached the composite endpoints (P = 0.002). During the intervention, 2 and 4 severe adverse events were reported in the YQPY and placebo groups, respectively. CONCLUSION: The YQPY granules can effectively improve the renal function of patients 4 weeks after the onset of AKI, indicating that it has good efficacy for improving short-term renal outcomes in patients with AKI. The YQPY granules may be a promising therapy for adults with AKI. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100051723. Please cite this article as: Wu JJ, Zhang TY, Qi YH, Zhu MY, Fang Y, Qi CJ, Cao LO, Lu JF, Lu BH, Tang LM, Shen JX, Mou S. Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: a multicenter, double-blind, placebo-controlled, randomized trial. J Integr Med. 2024; 22(3): 279-285.

[Analysis of associated factors for remission and relapse in proliferative and membranous lupus nephritis patients: a 4-year follow-up study].

OBJECTIVE: To explore the related factors of remission and relapse in lupus nephritis (LN) patients. METHODS: A retrospective study was conducted for proliferation and membrane LN patients diagnosed from 2003 to 2010. Their clinical, laboratory and pathological parameters were collected. According to the response to treatment, they were divided into 3 groups of complete remission (CR), partial remission (PR) and no response (NR). Those in remission were divided into 2 groups of relapsing and non-relapsing during maintenance period. Associated factors for remission and relapse were analyzed. RESULTS: (1) Among a total of 105 patients, there were 99 females and 6 males with an average follow-up period of (51 ± 30) months. Eighty-six patients achieved remission after 6-month treatment. (2) The outcomes were CR (n = 36), PR (n = 50) and NR (n = 19). Proteinuria in PR group was higher than that in CR group (4.7 (3.1-7.6) vs 1.7 (1.4-3.8), P < 0.01) while proteinuria of CR group was lower than that of NR group (1.7 (1.4-3.8) vs 3.0 (2.3-5.9), P < 0.01). Serum albumin level of CR group was significantly higher than those of PR (30.6 (27.8-34.6) vs 22.4 (19.3-29.4), P < 0.01) and NR groups (30.6 (27.8-34.6) vs 23.1 (18.9-28.6), P < 0.01). Serum creatinine was significantly higher in NR group than those of CR (128.9 (69.9-184.3) vs 58.1 (53.0-70.9), P < 0.01) and PR group (128.9 (69.9-184.3) vs 67.5 (53.5-129.1), P < 0.05). Acute index (AI) and chronic index (CI) were lower in CR group than those of PR and NR groups. (3) A total of 86 cases achieved remission (CR/PR) while 20 cases (23.3%) had relapse. During the maintenance period, the relapse rate was higher in the group on prednisone alone than those on combined therapy of prednisone plus immunosuppressant (P < 0.05). Sixty patients (90.9%) in non-relapse group and 12 cases (60.0%) in recurrence group had good compliance. CONCLUSIONS: Initial proteinuria, serum creatinine, serum albumin, estimated glomerular filtration rate and AI were related with remission of induction period. Prednisone-alone therapy is an independent risk factor for relapse during maintenance period. Poor compliance of patients may be one of the risk factors for relapse during maintenance period. It may be useful to maintain sustained remission and reduce relapse in LN patients by improving their compliance and using steroids plus immunosuppressant during maintenance period.

[Icodextrin improve angiogenesis of peritoneal membrane in continuous ambulatory peritoneal dialysis patients].

OBJECTIVE: To observe the effect of icodextrin on peritoneal membrane angiogenesis in continuous ambulatory peritoneal dialysis (CAPD) patients. METHODS: This was a randomized double-blind perspective study of CAPD patients at our center between January 2006 to December 2006. The patients were randomized to receive either 7.5% icodextrin (ICO, n = 27) or glucose (GLU, n = 27) solution at night for 4 weeks. Peritoneal membrane function was defined as dialysate dwell for 4 hours to plasma ratio of creatinine (4 h D/Pcr) at baseline. Ultrafiltration volume, creatinine clearance (Ccr), VEGF and IL-6 in peritoneal effluent during the long night dwell (UF) dialysate were measured at baseline and after 4 weeks. The VEGF appearance was used to adjust the influences of dwell time and ultrafiltration volume. RESULTS: A total of 54 patients were enrolled. The baseline conditions showed no difference between the groups. After 2 and 4 weeks of therapy, both net UF and peritoneal creatinine clearance of long dwell were significantly higher in the ICO group than the GLU group. VEGF in night dwell PD solution was positively correlated with D/PCr (r = 0.68, P < 0.01)and negatively correlated to 4 hour ultrafiltration volume (r = -0.51, P < 0.01). The VEGF appearance was comparable between two groups at baseline. After a follow-up of 4 weeks, the VEGF appearance had an increasing tendency in the GLU group and a decreasing tendency in the ICO group but there was no significant difference. The ΔVEGF appearance (VEGF appearance in 4 week-VEGF appearance at baseline) was different between the GLU and ICO groups (9.5 ± 20.2 vs -13.4 ± 26.1, P < 0.01). IL-6 in night dwell dialysate had no difference between two groups. CONCLUSION: As compared with glucose-based solution, 7.5% icodextrin significantly decreases the local VEGF level in dialysate.

[Diagnostic value of CT peritoneography for non-infectious complications of peritoneal dialysis].

OBJECTIVE: To assess the diagnostic value of CT peritoneography for peritoneal complications of continuous ambulatory peritoneal dialysis (CAPD). METHODS: CT peritoneography in 11 CAPD patients with clinically suspected dialysis-related complications was prospectively studied. The CAPD patients were all treated in Renji Hospital from 2005 to 2007. CT images were reviewed according to the evidence of peritoneal leaks, hernias, loculate pleural fluid collections, and adhesions. RESULTS: Abnormal findings were found in 9 of 11 CAPD cases including inguinal hernias (3 cases), umbilical hernia (1 case), hydrocele (1 case), leaks in catheter tunnel (2 cases), and peritoneal adhesions (2 cases). Parts of them were confirmed by surgical operation. CONCLUSION: CT peritoneography is useful for the evaluation of complications related to CAPD, and it offers excellent tissue contrast and multiplanar imaging for assessment of the complications.

[Relationship of brain natriuretic peptide to renal function and left ventricular hypertrophy in patients with chronic kidney disease].

OBJECTIVE: To clarify the association of brain natriuretic peptide * BNP) with renal function and cardiac dysfunction in non-dialysis-dependent patients with chronic kidney disease (CKD). METHODS: Fluorescence immuno-assay was used to detect the whole blood concentration of BNP in a cohort of 203 CKD patients and 16 hypertensive controls. Color ultrasonography was conducted to determine the left ventricular mass index (LVMI). Estimated glomerular filtration rate (eGFR) was examined. The relationship of BNP to eGFR and LVMI in these patients. RESULTS: There was a trend that the BNP level increased with the decrease of the level of eGFR [9.35 (7.35-15.00) vs 54.40 (15.10-173.00) ng/L, P < 0.01]. Spearman correlation showed that BNP level was correlated negatively with eGFR (r = -0.417, P < 0.01). Multiple regression analysis showed that eGFR was the independent determinant of BNP (beta = -0. 293, P < 0.01), and lgBNP concentration increased by 0.293 ng/L per 1 ml x min(-1) x (1.73 m2)(-1) reduction in lgGFR. The incidence of LV hypertrophy was much higher in the CKD patients than in the controls (53.2% vs 10.0%, P < 0.05). BNP level was greater in the patients with LV hypertrophy [93.05 (37.70-272.00) vs 17.30 (7.20-63.70) ng/L, P < 0.01], and LVMI had an independent effect on BNP concentration ( beta = 0.266, P < 0.01). lgBNP level increased by 0.266 ng/L per 1 g/m2 increase in lgLVMI. CONCLUSION: The declining eGFR level independently elevates the BNP level in non-dialysis-dependent CKD patients. Although renal dysfunction itself may affects the BNP concentration, LV hypertrophy is a powerful independent determinant of BNP.