探讨火把花根片联合黄葵胶囊治疗高或极高进展风险糖尿病肾病患者的临床疗效及安全性。

将江苏省中医院2021年3月至2023年3月门诊或病房收治的高或极高进展风险的糖尿病肾病患者作为研究对象，采用随机数字表法分为对照组和观察组，各55例。对照组给予黄葵胶囊治疗，观察组在对照组治疗的基础上联合火把花根片治疗，2组均治疗6个月。比较2组治疗前后的尿微量蛋白/肌酐比值（UACR）、估算的肾小球滤过率（eGFR）、血肌酐、胱抑素C、肾功能及尿蛋白的疗效评估及不良反应情况。

观察组治疗后UACR和血肌酐下降，eGFR升高（P均<0.05），胱抑素C呈下降趋势，但无统计学意义（P>0.05）；对照组治疗后UACR、血肌酐和eGFR均呈下降趋势，但差异无统计学意义（P均>0.05），胱抑素C上升（P<0.05）。观察组UACR、eGFR、胱抑素C治疗前后的改善幅度（ΔUACR、ΔeGFR和Δ胱抑素C）均明显优于对照组（P均<0.05）。在肾功能疗效评估方面，治疗后观察组显效14例，有效8例，稳定18例，无效12例，总有效率为76.92%；对照组显效6例，有效6例，稳定11例，无效28例，总有效率为45.1%；2组总有效率差异有统计学意义（P<0.05）。在尿蛋白疗效评估方面，治疗后观察组近期缓解14例，显效10例，有效16例，无效12例，总有效率为76.92%；对照组近期缓解8例，显效6例，有效19例，无效18例，总有效率为64.71%；观察组治疗蛋白尿的总有效率高于对照组，但差异无明显统计学意义（P>0.05）。在安全性评价中，观察组患者与对照组患者的不良反应率无明显统计学意义（7.69% vs 3.92%，P>0.05）。

火把花根片联合黄葵胶囊对高或极高进展风险的糖尿病肾病患者临床疗效显著，安全性较好，在降低尿蛋白和保护肾功能方面具有显著优势，值得临床推广。

To evaluate the clinical efficacy and safety of Huobahuagen tablets combined with Huangkui capsules in treating diabetic kidney disease patients with a high or extremely high risk of disease progression.

Diabetic kidney disease patients with a high or extremely high risk of disease progression admitted to the outpatient ward of Jiangsu Provincial Hospital of Traditional Chinese Medicine from March 2021 to March 2023 were included as the research subjects. They were randomly divided into either a control group or an observation group, with 55 cases in each group. The control group was treated with Huangkui capsules alone, while the observation group was treated with Huobahuagen tablets combined with Huangkui capsules. Both groups were treated for six months. The efficacy with regard to urine microalbumin/creatinine ratio (UACR), estimated glomerular filtration rate (eGFR), blood creatinine, cystatin C, renal function, and urinary protein was compared between the two groups. Adverse reactions were also compared.

After treatment, UACR and blood creatinine decreased significantly, eGFR increased significantly (P<0.05), and cystatin C showed a decreasing trend in the observation group, but there was no statistically significant difference (P>0.05). In contrast, UACR, blood creatinine, and eGFR showed a downward trend in the control group after treatment, though the difference was not statistically significant (P>0.05), and cystatin C increased significantly (P<0.05). The improvement of UACR, eGFR, and cystatin C (ΔUACR, ΔeGFR, and ΔCystatin C) after treatment in the observation group (ΔUACR, ΔeGFR, and ΔCystatin C) were significantly better than those of the control group (P<0.05). In terms of renal function, the observation group had 14 cases of significant improvement, 8 cases of improvement, 18 cases of no significant change, and 12 cases of ineffectiveness after treatment, with a total effective rate of 76.92%. In the control group, 6 cases showed significant improvement, 6 were effective, 11 were stable, and 28 were ineffective, with a total effective rate of 45.1%. The difference in overall effective rate with regard to renal function between the two groups was statistically significant (P<0.05). In terms of urinary protein, in the observation group after treatment, there were 14 cases of short-term remission, 10 cases of significant improvement, 16 cases of effectiveness, and 12 cases of ineffectiveness, with a total effective rate of 76.92%. In the control group, there were eight cases of short-term remission, 6 cases of significant improvement, 19 cases of effectiveness, and 18 cases of ineffectiveness, with a total effective rate of 64.71%. The overall effective rate with regard to proteinuria in the observation group was higher than that of the control group, but the difference was not statistically significant (P>0.05). There was no statistically significant difference in adverse reaction rate between the observation and control groups (7.69% vs 3.92%, P>0.05).

The combination of Huobahuagen tablets and Huangkui capsules has significant clinical efficacy and safety in treating diabetic nephropathy patients with a high or extremely high risk of disease progression. The combination treatment has significant advantages in reducing urinary protein and protecting renal function.