目的 探讨海昆肾喜胶囊联合培哚普利治疗非透析3～4期慢性肾脏病的临床疗效及安全性，为临床治疗提供循证依据。方法 回顾性分析2023年1月—2026年3月武汉市第一医院肾内科收治的98例非透析3～4期慢性肾脏病患者临床资料，根据既往治疗方案分为对照组和治疗组，每组各49例。对照组患者给予口服培哚普利叔丁胺片，每次4 mg，1次/d。在对照组的基础上治疗组餐后1 h服用海昆肾喜胶囊，每次2粒，3次/d。两组用药12周。观察对比两组疗效情况；比较两组中医症状积分、血肌酐（Scr）、尿素氮（BUN）、24 h尿蛋白定量（24 h UTP）、肾小球滤过率（eGFR）、肿瘤坏死因子-α（TNF-α）、血清转化生长因子-β1（TGF-β1）、白细胞介素-23（IL-23）、可溶性胸腺细胞分化抗原-1（sThy-1）水平。结果 治疗后，治疗组总有效率97.96%，显著高于对照组83.67%（P＜0.05）。治疗后，两组患者肢体困重积分、气短懒言积分、倦怠乏力积分、腰膝酸软积分均较同组治疗前显著降低（P＜0.05）；治疗后，与对照组对比，治疗组肢体困重积分、气短懒言积分、倦怠乏力积分、腰膝酸软积分均更低（P＜0.05）。治疗后，两组Scr、BUN、24 hUTP水平均较同组治疗前显著降低，而eGFR显著升高（P＜0.05）；治疗后，与对照组对比，治疗组Scr、BUN、24 hUTP水平均更低，且治疗组eGFR水平更高（P＜0.05）。治疗后，两组血清TGF-β1、IL-23、TNF-α、sThy-1水平均显著降低（P＜0.05）；治疗后，与对照组对比，治疗组TGF-β1、IL-23、TNF-α、sThy-1水平均更低（P＜0.05）。结论 海昆肾喜胶囊与培哚普利协同治疗非透析3～4期慢性肾脏病效果良好，疗效优于单用培哚普利，可显著降低尿蛋白水平，有效改善肾功能及降低炎性反应，值得临床应用。

Objective To investigate the clinical efficacy and safety of Haikun Shenxi Capsules combined with perindopril in treatment of non-dialysis stage 3-4 chronic kidney disease, and to provide evidence-based support for clinical practice. Methods A retrospective analysis was conducted on the clinical data of 98 patients with non-dialysis stage 3-4 chronic kidney disease who were admitted to the Nephrology Department of Wuhan First Hospital from January 2023 to March 2026. These patients were divided into control group and treatment group according to their previous treatment plans, with 49 patients in each group. The control group patients were given oral Perindopril tert-Butylamine Tablets, 4 mg each time, once daily. On the basis of control group, the treatment group patients took Haikun Shenxi Capsules1 h after meals, 2 capsules each time, 3 times daily. Both groups were treated for 12 weeks. The therapeutic effects of two groups were observed and compared, and the scores of traditional Chinese medicine symptoms, serum creatinine (Scr), blood urea nitrogen (BUN), 24 h urine protein quantification (24 h UTP), glomerular filtration rate (eGFR), tumor necrosis factor-α (TNF-α), serum transforming growth factor-β1 (TGF-β1), interleukin-23 (IL-23), and soluble thymocyte differentiation antigen-1 (sThy-1) levels were compared between two groups. Results After treatment, the total effective rate of treatment group was 97.96%, significantly higher than that of the control group (83.67%) (P < 0.05). After treatment, the scores of limb heaviness, shortness of breath and laziness of speech, fatigue and weakness, and soreness and weakness of the waist and knees in both groups were significantly lower than those before treatment in the same group (P < 0.05). After treatment, compared with control group, the scores of limb heaviness, shortness of breath and laziness of speech, fatigue and weakness, and soreness and weakness of the waist and knees in treatment group were all lower (P < 0.05). After treatment, the levels of Scr, BUN, and 24 h UTP in both groups were significantly lower than those before treatment in the same group, but eGFR significantly increased (P < 0.05). After treatment, compared with control group, the levels of Scr, BUN, and 24 h UTP in the treatment group were all lower, and the eGFR level in treatment group was higher (P < 0.05). After treatment, the levels of serum TGF-β1, IL-23, TNF-α, and sThy-1 in both groups were significantly lower (P < 0.05). After treatment, compared with control group, the levels of TGF-β1, IL-23, TNF-α, and sThy-1 in treatment group were all lower (P < 0.05). Conclusion The combination therapy of Haikun Shenxi Capsules and perindopril for non-dialysis stage 3-4 chronic kidney disease shows good results, and its efficacy is superior to that of using perindopril alone, and can significantly reduce the level of urine protein, effectively improve renal function and reduce inflammatory responses. This treatment method is worthy of clinical application.

R983

湖北省中医药管理局中医药科研项目（ZY2023F055）