膜肾方辅助治疗原发性膜性肾病脾肾气虚证临床研究

Effect of Moshen Decoction for the patients with idiopathic membranous nephropathy and spleen-kidney qi deficiency syndrome

目的评价膜肾方结合西医常规疗法治疗原发性膜性肾病(IMN)脾肾气虚证临床疗效,探讨其作用机制。方法将符合入选标准的2018年1月-2021年1月本院62例IMN患者,采用简单随机分组法分为2组,每组31例。对照组予以激素+环磷酰胺治疗,观察组在对照组基础上口服膜肾方。2组均连续治疗6个月。分别于治疗前后进行中医证候评分,采用ELISA法检测BUN、SCr、胱抑素C(Cys-C)、抗磷脂酶A2受体抗体(PLA2R)和E-钙黏蛋白(E-cadherin,EC)水平,免疫比浊法检测血清补体C1q;收集24 h尿液,采用全自动生化分析仪进行24 h尿蛋白定量检测,记录治疗期间的不良反应,评价临床疗效。结果观察组总有效率为93.55%(29/31)、对照组为74.19%(23/31),2组比较差异有统计学意义(χ^(2)=4.29,P=0.038)。治疗后,观察组下肢浮肿、乏力纳差、面色无华评分及总分低于对照组(t值分别为10.07、10.80、4.34、4.57,P值均<0.001);血清Cys-C水平[(0.51±0.05)mg/L比(0.55±0.06)mg/L,t=2.85]、24 h尿蛋白定量[(0.95±0.19)g比(1.38±0.23)g,t=13.32]低于对照组(P<0.01);血清PLA2R[(17.53±1.84)Ru/ml比(19.62±2.05)Ru/ml,t=4.22]、EC[(2.74±0.26)μg/L比(3.05±0.37)μg/L,t=3.82]及补体C1q[(152.34±15.62)mg/L比(169.33±16.77)mg/L,t=4.13]水平低于对照组(P<0.01)。治疗期间,观察组不良反应发生率为12.90%(4/31)、对照组为16.13%(5/31),2组比较差异无统计学意义(χ^(2)=0.13,P=0.781)。结论膜肾方结合西医常规疗法可有效减少IMN脾肾气虚证患者的蛋白尿,提高临床疗效,其作用机制可能与降低尿蛋白及补体C1q、PLA2R、EC水平有关。

Objective To evaluate the curative effect of Moshen Decoction combined with routine western medicine on idiopathic membranous nephropathy(IMN)of spleen-kidney qi deficiency syndrome and explore its influences on renal function,C1q,PLA2R and E-cadherin levels.Methods A total of 62 patients with IMN meeting inclusion criteria in the hospital were enrolled between January 2018 and January 2021.According to simple random grouping method,they were divided into control group(hormones combined with cyclophosphamide)and observation group(Moshen Decoction on basis of control group),31 in each group.Both groups were treated continuously for 6 months.Before and after treatment,TCM syndromes were scored.The levels of blood urea nitrogen(BUN),serum creatinine(SCr),cystatin C(Cys-C),anti-phospholipase A2 receptor(PLA2R)and E-cadherin(EC)were detected by ELISA.The level of serum complement C1q was detected by immunoturbidimetry.The 24 h urine was collected for quantitative determination by full-automatic biochemical analyzer.The adverse events during treatment were observed and recorded.And clinical curative effect was evaluated.Results The differences in total response rate between observation group and control group were statistically significant[93.55%(29/31)vs.74.19%(23/31);χ^(2)=4.29,P=0.038].After treatment,scores of TCM syndromes(edema of lower limbs,fatigue and poor appetite,lusterless complexion)in observation group were significantly lower than those in the control group(t=10.07,10.80,4.34,4.57,P<0.001).After treatment,levels of serum Cys-C[(0.51±0.05)mg/L vs.(0.55±0.06)mg/L,t=2.85],24 h urine protein quantification[(0.95±0.19)g vs.(1.38±0.23)g,t=13.32]in observation group were lower than those in the control group(P<0.01),and levels of serum PLA2R[(17.53±1.84)Ru/ml vs.(19.62±2.05)Ru/ml,t=4.22],EC[(2.74±0.26)μg/L vs.(3.05±0.37)μg/L,t=3.82]and complement C1q[(152.34±15.62)mg/L vs.(169.33±16.77)mg/L,t=4.13]in observation group were significantly lower than those in the control group(P<0.01).During treatment,there was no significant difference in incidence of adverse events between observation group and control group[12.90%(4/31)vs.16.13%(5/31);χ^(2)=0.13,P=0.781].Conclusion Moshen Decoction combined with routine western medicine can improve renal function and clinical curative effect in patients with IMN of spleen-kidney qi deficiency syndrome.Its mechanism of action may be related to reducing urine protein,complement C1q,PLA2R and EC.