加味参芪地黄汤治疗气阴两虚肾络瘀阻型血清抗M型磷酯酶A2受体抗体阳性膜性肾病低中风险患者的临床疗效观察

Clinical effect of modified shenqi dihuang decoction in the treatment of membranous nephropathy with low and medium risk of serum anti-M-type phosphoesterase A2 receptor antibody positive in patients with qi-yin deficiency and kidney stasis

目的探讨加味参芪地黄汤治疗气阴两虚肾络瘀阻型血清抗M型磷酯酶A2受体(M-type phospholipase A2 receptor,PLA2R)抗体阳性膜性肾病低中风险患者的临床疗效。方法选取2020年10月至2021年10月首都医科大学附属北京中医医院收治的60例血清PLA2R抗体阳性低中风险膜性肾病患者,采用随机数字表法分为治疗组和对照组,每组30例。对照组采用常规西药治疗,治疗组在对照组的治疗基础上予加味参芪地黄汤治疗。两组均治疗24周。比较两组进入高危组例数、血栓栓塞发生风险,以及治疗前后血清ALB、24 h尿蛋白定量和血清PLA2R抗体指标变化及中医证候评分,比较两组中西医治疗的临床疗效。结果与对照组比较,治疗组进入高危组及发生血栓栓塞类事件总例数较少[2例(6.7%)比8例(26.7%),0例(0.0%)比4例(13.3%)],差异有统计学意义(P<0.05)。治疗后,治疗组血清ALB在第8周[(32.27±4.10)g/L]、第16周[(33.53±4.69)g/L]及第24周[(35.33±4.63)g/L]均较治疗前[(30.85±4.19)g/L]明显升高,差异有统计学意义(P<0.05),对照组血清ALB在第24周高于治疗前[(32.60±3.98)g/L比(29.72±2.24)g/L],差异有统计学意义(P<0.05)。治疗后,两组24 h尿蛋白定量均低于本组治疗前,治疗组24 h尿蛋白定量在第16周[(2274.83±1669.53)mg]和第24周[(1883.23±1905.88)mg]时均低于对照组[(3160.37±2438.51)mg,(3013.47±2784.83)mg],差异有统计学意义(P<0.05)。治疗组血清PLA2R抗体滴度在第8周、第16周及第24周时均低于本组治疗前[(68.27±39.61)Ru/ml,(47.07±44.87)Ru/ml,(36.87±54.20)Ru/ml比(89.53±35.91)Ru/ml],且均低于对照组[(88.80±79.61)Ru/ml,(74.50±88.22)Ru/ml,(71.57±90.74)Ru/ml],差异均有统计学意义(P<0.05)。治疗组的中医疗效和西医疗效均明显高于对照组(93.3%比60.0%,80.0%比46.7%),差异均有统计学意义(P<0.05)。结论加味参芪地黄汤治疗气阴两虚肾络瘀阴型血清PLA2R抗体阳性的低中风险膜性肾病患者安全有效,可早期缓解膜性肾病病情。

Objective To investigate the clinical efficacy of modified shenqi dihuang decoction in the treatment of membranous nephropathy with low and medium risk of serum anti-M-type phospholipase A2 receptor(PLA2R)antibody positive in patients with qi-yin deficiency and kidney stasis.Methods A total of 60 patients with low and medium risk membranous nephropathy with serum PLA2R antibody positive admitted to Beijing Hospital of Traditional Chinese Medicine,Capital Medical University from October 2020 to October 2021 were selected and divided into treatment group and control group by random number table method,with 30 cases in each group.The control group was treated with conventional western medicine,and the treatment group was treated with modified shenqi dihuang decoction on the basis of the treatment in the control group.Both groups were treated for 24 weeks.The number of patients progressing to the high-risk group,the risk of thromboembolism,the changes of serum ALB,24 h urinary protein,serum PLA2R antibody and TCM syndrome score before and after treatment were compared between the two groups,and the clinical efficacy of TCM and western medicine treatment was compared between the two groups.Results Compared with the control group,the total number of patients progressing into the high-risk group and thromboembolic events in the treatment group was less[two cases(6.7%)vs.eight cases(26.7%),0 cases(0.0%)vs.four cases(13.3%)],the difference was statistically significant(P<0.05).After treatment,the serum ALB of the treatment group was significantly increased at the 8th weeks[(32.27±4.10)g/L],16th weeks[(33.53±4.69)g/L]and24th weeks[(35.33±4.63)g/L]compared with that before treatment[(30.85±4.19)g/L],the difference was statistically significant(P<0.05).The serum ALB of the control group at the 24th weeks was higher than that before treatment[(32.60±3.98)g/L vs.(29.72±2.24)g/L],the difference was statistically significant(P<0.05).After treatment,the 24 h urinary protein quantity in both groups was lower than that before treatment.And the 24 h urinary protein quantity of the treatment group at the 16th weeks[(2274.83±1669.53)mg]and 24th weeks[(1883.23±1905.88)mg]were lower than those of the control group[(3160.37±2438.51)mg,(3013.47±2784.83)mg],the differences were statistically significant(P<0.05).The serum PLA2R antibody titer of the treatment group at the 8th,16th and 24th weeks were lower than those before treatment[(68.27±39.61)Ru/ml,(47.07±44.87)Ru/ml,(36.87±54.20)Ru/ml vs.(89.53±35.91)Ru/ml],and were lower than those of the control group[(88.80±79.61)Ru/ml,(74.50±88.22)Ru/ml,(71.57±90.74)Ru/ml],the differences were statistically significant(P<0.05).The curative effect of TCM and western medicine treatment in the treatment group were significantly higher than those in the control group(93.3%vs.60.0%,80.0%vs.46.7%),the differences were statistically significant(P<0.05).Conclusions Modified shenqi dihuang decoction is safe and effective in the treatment of low and medium risk patients with membranous nephropathy with serum PLA2R antibody positive of kidney collateral stasis type of qi-yin deficiency,and can relieve the condition of membranous nephropathy early.