Traditional Chinese herbal medicine Qingre Xiaozheng formula improves renal outcomes in patients with diabetic kidney disease: a retrospective study

Abstract

Objective: To assess the benefits of Qingre Xiaozheng formula (, QRXZF) as an adjunct to standard Western medical management on renal outcomes in patients with diabetic kidney disease (DKD).

Methods: This retrospective study included patients with DKD who received the QRXZF between May 2017 and May 2021. A total of 144 patients with DKD, 24 h urinary total protein (24 h-UTP) ≥ 0.5 g, and estimated glomerular filtration rate (eGFR) ≥ 30 mL/min per 1.73 m² were divided into the treatment group or the control group based on whether they received QRXZF treatment. The long-term renal outcomes of patients with DKD were analyzed to evaluate the effectiveness of the QRXZF. Differences in overall survival (OS) were assessed using Kaplan-Meier curve analysis. Cox proportional hazards regression analysis was used to determine the independent risk factors for renal endpoints.

Results: The mean follow-up period was (28±15) months. Nine (12.5%) patients in the treatment group and 27 (37.5%) patients in the control group met the renal endpoints. Multivariate Cox regression analysis showed that 24 h-UTP ≥ 3.5 g [hazard ratio (HR) = 4.70, 95% confidence interval (CI) (1.83, 12.05), P = 0.001], combined coronary artery disease [HR = 3.39, 95% CI (1.65, 6.98), P = 0.001], total cholesterol [HR = 1.34, 95% CI (1.05, 1.70), P = 0.019] and low-density lipoprotein [HR = 1.65, 95% CI (1.111, 2.45), P = 0.013] were independent prognostic factors for renal endpoints in patients with DKD. Compared with the treatment group, the risk of renal endpoint events increased 2.68-fold in the control group [HR = 2.68, 95% CI (1.19, 6.02); P = 0.017]. We included 48 patients with 24 h-UTP ≥ 3.5 g in a further stratification analysis of patients with DKD. The independent risk factor for the renal endpoints in patients with 24h-UTP ≥ 3.5 g was smoking history [HR = 5.52, 95% CI (1.131, 26.92), P = 0.035]. Compared with the treatment group, the risk of renal endpoint events increased 3.01-fold in the control group [HR = 3.01, 95% CI (1.05, 8.67); P = 0.041].

Conclusions: The results show that QRXZF treatment improved renal outcomes and reduced proteinuria in patients with DKD. These results indicate that Traditional Chinese Medicine is likely to have a positive therapeutic effect on established and advanced DKD. Further well-designed clinical trials with longer follow-up periods are required.

Keywords: Qingre Xiaozheng formula; diabetic nephropathies; renal outcome; retrospective studies.

Figure 1. Kaplan-Meier estimates of survival during follow-up in diabetic kidney disease between the treatment group and the control group (Log Rank P = 0.023)

Treatment group: received conventional Western Medicine plus QRXZF (oral administration, 1 dose/day divided into 2 portions for morning and evening intake, 24-week course); Control group: received conventional Western Medicine only. QRXZF: Qingre Xiaozheng formula.

Figure 2. Forest plots of multivariate analysis of renal endpoint events

Sex, age, group, 24h-UTP, coronary heart disease, SBP, albumin, blood urea nitrogen, cholesterol and LDL-C were all adjusted except the variable itself. 24h-UTP: 24 h urinary total protein; SBP: systolic blood pressure; LDL-C: low density lipoprotein cholesterol.

Figure 3. Kaplan-Meier survival estimates during follow-up in patients with diabetic kidney disease and 24 h-urinary total protein ≥ 3.5 g, between the treatment group and the control group (Log Rank P = 0.023)

Treatment group: received conventional Western Medicine plus QRXZF (oral administration, 1 dose/day divided into 2 portions for morning and evening intake, 24-week course); control group: received conventional Western Medicine only. QRXZF: Qingre Xiaozheng formula.

Figure 4. Forest plots of multivariate analysis of renal endpoint events for patients with diabetic kidney disease and 24 h-urinary total protein ≥3.5 g

Sex, age, group, smoking, and systolic blood pressure were all adjusted except the variable itself. SBP: systolic blood pressure.