Yang Yang, Li Xiang, Zou Honghong, Li Manna, Wang Li, Luo Kaiping, Yan Wenjun, Li Yebei, Zhou Baoqin, Kang Wenling, Wang Lijuan, Xu Shizhang, Xu Gaosi
Department of Nephrology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China.
Jiangxi Key Laboratory of Molecular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Front Pharmacol. 2025 Mar 4;16:1496967. doi: 10.3389/fphar.2025.1496967. eCollection 2025.
Kunxian (KX) has been reported to be effective in treating Immunoglobulin A nephropathy (IgAN) and autoimmune disorders, such as lupus nephritis, but there is a lack of controlled trial on its effectiveness and safety for treating IgAN.
This multicenter, prospective cohort study was conducted with individuals aged 18-60 years with biopsy-confirmed primary IgAN, proteinuria greater than 0.75 g/d, and estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m. Patients were treated with KX or Mycophenolate mofetil (MMF) after receiving a stable dose of an angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks.
67 patients were assigned to the KX group and 72 to the MMF group. The mean (standard deviation) eGFR was 87.75 (15.94) mL/min/1.73 m, and the mean (standard deviation) proteinuria was 1.70 (0.74) g/d. Patients in the KX group had a greater reduction in proteinuria than those in the MMF group did. Complete remission occurred in 43 patients (64.2%) in the KX group and 37 patients (51.4%) in the MMF group (hazard ratio [HR] 0.612, 95% CI 0.385-0.972, = 0.038). Overall response occurred in 59 participants (88.1%) in the KX group and 59 participants (81.9%) in MMF group (HR 0.658, 95% CI 0.447-0.970, = 0.034). Adverse events were observed in 6 patients (8.9%) in the KX group and 5 patients (6.9%) in the MMF group with no significant difference.
Compared with MMF, KX was safe and significantly decreased proteinuria in IgAN.
据报道，昆仙（KX）在治疗免疫球蛋白A肾病（IgAN）和自身免疫性疾病（如狼疮性肾炎）方面有效，但缺乏关于其治疗IgAN有效性和安全性的对照试验。
本多中心前瞻性队列研究纳入年龄在18至60岁之间、经活检确诊为原发性IgAN、蛋白尿大于0.75 g/d且估计肾小球滤过率（eGFR）大于60 mL/min/1.73 m²的个体。患者在接受稳定剂量的血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂至少4周后，接受KX或霉酚酸酯（MMF）治疗。
67例患者被分配至KX组，72例患者被分配至MMF组。平均（标准差）eGFR为87.75（15.94）mL/min/1.73 m²，平均（标准差）蛋白尿为1.70（0.74）g/d。KX组患者的蛋白尿减少幅度大于MMF组。KX组43例患者（64.2%）完全缓解，MMF组37例患者（51.4%）完全缓解（风险比[HR]0.612，95%置信区间0.385 - 0.972，P = 0.038）。KX组59例参与者（88.1%）总体缓解，MMF组59例参与者（81.9%）总体缓解（HR 0.658，95%置信区间0.447 - 0.970，P = 0.034）。KX组6例患者（8.9%）和MMF组5例患者（6.9%）观察到不良事件，无显著差异。
与MMF相比，KX在IgAN中安全且能显著降低蛋白尿。
