Department of Endocrinology, Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
The First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, China.
Front Endocrinol (Lausanne). 2023 Jun 19;14:1166880. doi: 10.3389/fendo.2023.1166880. eCollection 2023.
We aimed to explore the value of Huobahuagen tablet (HBT) in improving decreased renal function for patients with diabetic kidney disease (DKD) over time.
This was a single-center, retrospective, real-world study on eligible 122 DKD patients who continued to use HBT + Huangkui capsule (HKC) therapy or HKC therapy without interruption or alteration in Jiangsu Province Hospital of Chinese Medicine from July 2016 to March 2022. The primary observation outcomes included estimated glomerular filtration rate (eGFR) at baseline and 1-, 3-, 6-, 9-, and 12-month follow-up visits and changes in eGFR from baseline (ΔeGFR). Propensity score (PS) and inverse probability treatment weighting (IPTW) were used to control for confounders.
eGFR was significantly higher in the HBT + HKC group than in the HKC alone group at the 6-, 9-, and 12-month follow-up visits ( = 0.0448, 0.0002, and 0.0037, respectively), indicating the superiority of HBT + HKC over HBT alone. Furthermore, the ΔeGFR of the HBT + HKC group was significantly higher than that of the HKC alone group at the 6- and 12-month follow-up visits ( = 0.0369 and 0.0267, respectively). In the DKD G4 patients, eGFR was higher in the HBT + HKC group at the 1-, 3-, 6-, 9-, and 12-month follow-up visits compared with baseline, with statistically significant differences at the 1-, 3-, and 6- month follow-up visits ( = 0.0256, 0.0069, and 0.0252, respectively). The fluctuations in ΔeGFR ranged from 2.54 ± 4.34 to 5.01 ± 5.55 ml/min/1.73 m. Change in the urinary albumin/creatinine ratio from baseline did not exhibit a significant difference between the two groups at any of the follow-up visits ( > 0.05 for all). Adverse event incidence was low in both groups.
The findings of this study based on real-world clinical practice indicate that HBT + HKC therapy exhibited better efficacy in improving and protecting renal function with a favorable safety profile than HKC therapy alone. However, further large-scale prospective randomized controlled trials are warranted to confirm these results.
本研究旨在探讨活脑化淤片（HBT）在改善糖尿病肾病（DKD）患者肾功能下降方面的价值。
这是一项单中心、回顾性、真实世界研究，纳入了 2016 年 7 月至 2022 年 3 月期间在江苏省中医院继续使用活脑化淤片+黄葵胶囊（HKC）治疗或 HKC 治疗而未中断或改变治疗方案的 122 例 DKD 患者。主要观察结局包括基线及 1、3、6、9 和 12 个月随访时的估算肾小球滤过率（eGFR）以及从基线变化的 eGFR（ΔeGFR）。采用倾向评分（PS）和逆概率处理加权（IPTW）来控制混杂因素。
与单独使用 HKC 相比，HBT+HKC 组在 6、9 和 12 个月随访时 eGFR 显著更高（=0.0448、0.0002 和 0.0037），提示 HBT+HKC 组优于 HBT 组。此外，在 6 和 12 个月随访时，HBT+HKC 组的ΔeGFR 显著高于 HKC 组（=0.0369 和 0.0267）。在 DKD G4 患者中，与基线相比，HBT+HKC 组在 1、3、6、9 和 12 个月随访时的 eGFR 更高，在 1、3 和 6 个月随访时差异有统计学意义（=0.0256、0.0069 和 0.0252）。ΔeGFR 的波动范围为 2.54±4.34 至 5.01±5.55 ml/min/1.73 m。两组在任何随访时的尿白蛋白/肌酐比值变化均无显著差异（均>0.05）。两组的不良事件发生率均较低。
基于真实世界临床实践的研究结果表明，与单独使用 HKC 相比，HBT+HKC 治疗在改善和保护肾功能方面显示出更好的疗效，且安全性良好。然而，仍需要进一步的大规模前瞻性随机对照试验来证实这些结果。
