健脾祛湿和络方治疗难治性膜性肾病的临床观察

目的探讨健脾祛湿和络方治疗脾虚水湿血瘀证难治性膜性肾病患者的有效性及安全性。 方法入选病例来自2013年10月至2017年1月就诊于中国中医科学院西苑医院肾病科门诊及住院的18例经肾穿刺明确诊断为特发性膜性肾病(IMN)、经标准治疗无效、中医辨证属脾虚水湿血瘀证的难治性膜性肾病患者。健脾祛湿和络方由生黄芪、炒白术、汉防己、当归等成分组成，疗程24周，随访24周。随访期间，完全缓解患者停用健脾祛湿和络方，其余患者继续本方治疗。主要观察指标为24 h尿蛋白定量，次要疗效指标为中医证积分变化、血清白蛋白、血肌酐、估算的肾小球滤过率(eGFR)。同时观察不良事件的发生。采用SPSS 21. 0软件包进行统计学分析。 结果健脾祛湿和络方治疗至24周时较基线水平，尿蛋白下降(t＝4.493，P＝0.041)、中医证候积分降低( t＝－13.872，P＝0.033)，血白蛋白升高(t＝2.434, P＝0.018)，并随着治疗周期延长，其疗效更显著：随访至48周时与24周的24 h尿蛋白定量、中医证候积分下降差值、血白蛋白升高差值比较差异有统计学意义(F＝29.45，P＝0.043; F＝64.32，P＝0.010；F＝54.24，P＝0.028)。随访48周的西医指标总缓解率高于24周的总缓解率(83.3%与66.7%，χ² ＝15.635，P<0.05)。48周的总有效率高于24周的总有效率(94.4%与88.9%，χ²＝1.843，P>0.05)。 结论健脾祛湿和络方治疗难治性膜性肾病在降低尿蛋白及减轻临床症状方面疗效显著，且有更好的安全性。

Efficacy of the traditional Chinese medicine Jianpi-Qushi-Heluo formula in treatment of patients with refractory idiopathic membranous nephropathy

ObjectiveTo evaluate the efficacy and safety of the traditional Chinese medicine (TCM) Jianpi-Qushi-Heluo formula (JPQSHLF) in the treatment of patients with refractory membranous nephropathy of the TCM spleen-deficiency dampness blood-stasis syndrome. MethodsThe selected 18 cases, admitted to the Department of Nephrology, Xiyuan Hospital of China Academy of Chinese Medical Sciences from October 2013 to January 2017, were diagnosed as idiopathic membranous nephropathy (IMN) by renal biopsy. As standard treatment proved to be invalid, the disease in these patients was also called refractory membranous nephropathy, belonging to the TCM spleen-deficiency dampness blood-stasis syndrome. The JPQSHLF was composed of astragalus root, fried atractylodes, Stephania tetrandra, and angelica, etc. The JPQSHLF was administered orally twice a day for 24 weeks, and the patients were followed up for 24 weeks. The main observation was 24h urine protein quantitation, while the secondary observations were TCM syndrome score changes, serum albumin, serum creatinine, and estimated glomerular filtration rate (eGFR), and the occurrences of adverse events were also observed. The SPSS 21.0 software was used for statistical analysis. ResultsThe JPQSHLF reduced urinary protein significantly (-2.96±2.24, P<0.05), decreased TCM syndrome scores (-16.88±5.61, P<0.05), increased serum albumin level (10.35±5.83, P<0.05). And with the extension of the treatment cycle, its efficacy was more significant. After 48 weeks of the treatment, the differences in 24 h urine protein quantitation decline, TCM syndrome scores decline (-3.99±2.64, F=29.45; 18.14±6.37, F=64.32) and serum albumin elevation (15.08±7.81, F=54.24) were all greater than those after 24 weeks of the treatment (P< 0.05), but the differences in serum creatinine and eGFR levels were not statistically significant (P> 0.05). The total remission rate of indices in western medicine after 48 weeks of treatment was higher than that after 24 weeks of treatment (83.3% vs 66.7%, χ²=15.635, P< 0.05). The total effective rate after 48 weeks of treatment was higher than that after 24 weeks of treatment (94.4% vs 88.9%, χ²=1.843, P> 0.05). ConclusionDuring the treatment of refractory membranous nephropathy, the JPQSHLF had significant efficacy in reducing urinary protein and alleviating clinical symptoms, and had better safety as well.