目的 评价参乌益肾片延缓慢性肾脏病（CKD） 3～5期估算肾小球滤过率（eGFR）下降的临床疗效。方法 采用真实世界回顾性的队列观察，选择南京中医药大学附属医院（江苏省中医院）医疗数据库中2021年2月—2024年7月的患者数据，以采用参乌益肾片治疗作为暴露因素，采用倾向性评分匹配（PSM）所纳入的协变量，包括年龄、性别、基线、是否患有血压、糖尿病、高尿酸血症、高脂血症及合并用药情况，对比使用参乌益肾片和未使用的患者eGFR变化情况及终点事件发生风险。结果 PSM后用药组和对照组各671例，治疗36个月后，用药组eGFR变化为0.78 mL·min^-1·1.73 m^-2[95%置信区间（CI） ： 0.74，0.87]，对照组变化为-5.00 mL·min^-1·1.73 m^-2（95% CI： -5.08～-4.92） ，组间差值为5.79 mL·min^-1·1.73 m^-2（95% CI： 5.68～5.89，P＝0.005 9）。CKD3期用药组和对照组eGFR变化分别为1.06 mL·min^-1·1.73 m^-2（95% CI： 1.04～1.14）和0.55 mL·min^-1·1.73 m^-2（95% CI： 0.50～0.63） ，组间差值为0.51 mL·min^-1·1.73 m^-2（95% CI： 0.43～0.59，P＝ 0.006 1） ；CKD 4期分别变化-0.58 mL·min^-1·1.73 m^-2 （95% CI： -0.70～-0.49）和-2.37 mL·min^-1·1.73 m^-2 （95% CI： -2.62～-2.25） ，组间差值为1.79 mL·min^-1·1.73 m^-2（95% CI： 1.58～2.00，P＝ 0.005 7） ； CKD5期分别为4.01mL·min^-1·1.73 m^-2（95% CI：3.90～4.12）和-0.32 mL·min^-1·1.73 m^-2（95% CI： -0.39～-0.26），组间差值为4.33 mL·min^-1·1.73 m^-2（95% CI： 4.20～4.46，P＝0.005 8）。以eGFR下降50%为终点事件在CKD 3～5期患者生存分析中，随着时间的推移，两组患者的生存概率逐渐下降，用药组比对照组终点事件发生显著降低，P＜0.00 1，终点事件发生风险降低80%[风险比（HR） ＝0.20，95% CI： 0.13～0.33]。两组患者在肝功能、血钾水平和血红蛋白的对比中无统计学差异。结论 参乌益肾片能有效延缓CKD 3～5期患者eGFR下降，降低eGFR下降风险，且安全性良好。

Objectives To evaluate the clinical efficacy of Shenwuyishen Tablets in delaying the decline of estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease (CKD) stages 3-5. Methods A real-world retrospective cohort observation was conducted using patient data from the medical database of Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Provincial Hospital of Chinese Medicine) from February 2021 to July 2024. The treatment with Shenwu Yishen Tablets was selected as the exposure factor, Using the propensity score matching (PSM) method, Match on variables such as age, gender, baseline eGFR, presence of hypertension, diabetes, hyperuricemia, hyperlipidemia, and concomitant medications, compared changes in eGFR and the risk of endpoint events between patients treated with Shenwu Yishen Tablets and those who did not receive the treatment. Results After PSM, there were 671 cases in both treatment group and control group. After 36 months of treatment, the change in eGFR was 0.78 mL·min^-1·1.73 m^-2 in the medication group (95% CI: 0.74-0.87) compared to -5.00 mL·min^-1·1.73 m^-2 in the control group (95% CI: -5.22--5.06), with a between-group difference of 5.79 mL·min^-1·1.73 m^-2 (95% CI: 5.68-5.89, P = 0.005 9). In the CKD stage 3 treatment group and control group, the changes in eGFR were 1.06 mL·min^-1·1.73 m^-2 (95% CI: 1.04-1.14) and 0.55 mL·min^-1·1.73 m^-2 (95% CI: 0.50-0.63), with an intergroup difference of 0.51 mL·min^-1·1.73 m^-2 (95% CI: 0.43-0.59, P =.006 1). In CKD stage 4, the changes were -0.58 mL·min^-1·1.73 m^-2 (95% CI: -0.70--0.49) and -2.37 mL·min^-1·1.73 m^-2 (95% CI: -2.62--2.25), with an intergroup difference of 1.79 mL·min^-1·1.73 m^-2 (95% CI: 1.58-2.00, P =.005 7). In CKD stage 5, the changes were 4.01 mL·min^-1·1.73 m^-2 (95% CI: 4.01-4.23) and -0.32 mL·min^-1·1.73 m^-2 (95% CI: -0.39--0.26), with an intergroup difference of 4.33 mL·min^-1·1.73 m^-2 (95% CI: -4.20--4.46, P =.005 8). In the survival analysis of patients with CKD stages 3-5, using a 50% decline in eGFR as the endpoint event, the survival probabilities of both groups gradually decreased over time. The treatment group showed a significantly lower incidence of the endpoint event compared to the control group (P<0.000 1), with an 80% reduction in the risk of endpoint event (HR = 0.20, 95% CI: 0.13-0.33). No statistically significant differences were observed between the two groups in terms of liver function, serum potassium levels, or hemoglobin levels. Conclusion Shenwu Yishen Tablets can effectively delay the decline in eGFR in patients with CKD stages 3-5, reduce the risk of eGFR deterioration, and demonstrate good safety profile.

R965

国家自然科学基金委青年基金项目（71804025）