Du Yiran, Liu Yuning, Chen Zhiyan, Liang Yingnan, Li Xia, Wang Ying, Lv Jie, Liu Zhongjie, Wang Zhen, Chen Weihong, Liu Qingqing, Li Xiaowen, Chen Zhenjie, Zhou Jingwei
Department of Nephrology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Xiyuan Hospital, Department of Nephrology, China Academy of Chinese Medical Sciences, Beijing, China.
Front Immunol. 2025 Apr 22;16:1543581. doi: 10.3389/fimmu.2025.1543581. eCollection 2025.
At present, the side effects of hormonal and immunosuppressant therapy for intermediate-to-high risk primary membranous nephropathy (PMN) are relatively large, and the remission rate is limited, so more safe and effective regimens are needed.
This study is a clinical prospective case series study. 31 patients were finally included. The intervention was cyclophosphamide (CTX) combined with "Shuli Fenxiao formula(SLFX formula)", and the patients were treated for 24 weeks. The observation nodes were baseline, 2 weeks、12weeks and 24weeks after treatment.
At 12 weeks of treatment, 38.7% of patients achieved partial response. At 24 weeks of treatment, 61.3% of patients achieved partial response and 24.5% achieved complete response. All Anti-phosholipase A2 Receptor Antibody (Anti-PLA2R) seropositive patients achieved immune remission. 24-hour urine total protein quantification (24hUTP) decreased from a median of 6.1 (IQR, 4.6-8.4) g/d to 2.7 (IQR, 0.6-8.7) g/d (P<0.001). Serum albumin (ALB) increased from 27.2 ± 6.4 g/L to 31.9 ± 8.0 (P<0.05). Within 24 weeks of follow-up after discharge, no patients relapsed. During the treatment follow-up period, 6 adverse events occurred in 31 patients, 1 patient developed heart failure during the treatment period, which was not considered to be clearly associated with treatment regimen or nephrotic syndrome (NS), 3 patients were infected, and 2 patients had liver impairment.
The results suggest that the combination of CTX and SLFX formula dramatically decreased Anti-PLA2R titers and 24hUTP levels, increased ALB in short term. The combination was safe and had few adverse effects. It has the potential to be used as a potential option for the clinical treatment of intermediate-to-high risk PMN patients, particularly for elderly patients with contraindications to corticosteroid use or those with refractory disease.
http://itmctr.ccebtcm.org.cn/, identifier ITMCTR2025000355.
目前，激素及免疫抑制剂治疗中高危原发性膜性肾病（PMN）的副作用相对较大，缓解率有限，因此需要更安全有效的治疗方案。
本研究为临床前瞻性病例系列研究。最终纳入31例患者。干预措施为环磷酰胺（CTX）联合“疏利分消方（SLFX方）”，患者接受治疗24周。观察节点为基线、治疗后2周、12周和24周。
治疗12周时，38.7%的患者达到部分缓解。治疗24周时，61.3%的患者达到部分缓解，24.5%的患者达到完全缓解。所有抗磷脂酶A2受体抗体（Anti-PLA2R）血清阳性患者均实现免疫缓解。24小时尿总蛋白定量（24hUTP）从中位数6.1（IQR，4.6 - 8.4）g/d降至2.7（IQR，0.6 - 8.7）g/d（P<0.001）。血清白蛋白（ALB）从27.2±6.4 g/L升至31.9±8.0（P<0.05）。出院后24周随访期间，无患者复发。在治疗随访期间，31例患者发生6例不良事件，1例患者在治疗期间发生心力衰竭，认为与治疗方案或肾病综合征（NS）无明确关联，3例患者发生感染，2例患者出现肝功能损害。
结果表明，CTX与SLFX方联合可显著降低Anti-PLA2R滴度和24hUTP水平，短期内提高ALB水平。该联合用药安全，不良反应少。它有潜力作为中高危PMN患者临床治疗的潜在选择，特别是对于有糖皮质激素使用禁忌证的老年患者或难治性疾病患者。
