消白方治疗脾肾气虚、湿热瘀阻型慢性肾小球肾炎(CKD1~2期)的临床研究

Clinical research on Xiaobai Decoction in the treatment of chronic glomerulonephritis (CKD at stages 1-2) with syndrome of spleen and kidney qi deficiency and stagnant dampness-heat

目的:观察消白方结合西医常规疗法治疗脾肾气虚、湿热瘀阻型慢性肾小球肾炎(CGN)患者的临床疗效。方法:纳入120例脾肾气虚、湿热瘀阻型CGN患者[慢性肾脏病(CKD)1~2期],随机分为对照组和治疗组,每组各60例。对照组患者给予西医开放性方案治疗,治疗组患者在此基础上加用消白方口服,两组疗程均为6个月。评价两组患者的临床疗效及中医证候疗效,治疗前后检测所有患者的24 h尿蛋白定量(24 h UPro)、尿微量白蛋白/尿肌酐比值(UACR)、尿N-乙酰-β-D-葡萄糖苷酶(NAG)、尿视黄醇结合蛋白(RBP)、尿α1-微球蛋白(α1-MG)、尿β2-微球蛋白(β2-MG)及血清肌酐(Scr)和尿素氮(BUN)、肾小球滤过率估计值(eGFR)水平。结果:研究过程中,治疗组4例患者剔除或脱落,对照组5例患者剔除或脱落,最终治疗组56例、对照组55例患者纳入统计分析。(1)临床疗效:治疗后,治疗组患者的临床总有效率为92.9%,对照组为87.3%,治疗组的疗效优于对照组(P<0.05)。(2)中医证候疗效:治疗后,治疗组患者的中医证候疗效总有效率为89.3%,对照组为54.5%,治疗组的疗效优于对照组(P<0.01)。(3)实验室指标:治疗后,两组患者的24 h UPro、UACR、NAG、RBP水平较治疗前均明显降低(P<0.05),治疗组患者的α1-MG、β2-MG水平亦明显降低(P<0.05),且治疗组患者的24 h UPro、NAG、RBP、α1-MG、β2-MG水平低于对照组(P<0.05)。治疗后,治疗组患者的eGFR水平较治疗前明显升高(P<0.05)、Scr水平较治疗前明显降低(P<0.05),且治疗组患者的Scr水平低于对照组(P<0.05)。(4)相关性分析:eGFR与24 h UPro、UACR、NAG、RBP呈负相关。结论:消白方结合西医常规疗法治疗脾肾气虚、湿热瘀阻型CGN(CKD1~2期)患者,能有效改善患者的临床症状,降低尿蛋白水平,改善肾小管损伤相关指标,延缓肾功能进展。

Objective: To observe the clinical efficacy of Xiaobai Decoction combined with conventional western medicine in the treatment of chronic glomerulonephritis(CGN) with syndrome of spleen and kidney qi deficiency and stagnant dampness-heat. Methods: A total of 120 CGN patients [chronic kidney disease(CKD) at stages 1-2] with syndrome of spleen and kidney qi deficiency and stagnant dampness-heat were included and randomly divided into the control group and treatment group, 60 cases in each group. The patientsin the control group were treated with the open scheme of western medicine, and the patients in the treatment group were orally treated with Xiaobai Decoction based on above. The treatment course of both groups was 6 months.The clinical efficacy and Chinese medical syndrome efficacy of the two groups were evaluated. Before and after treatment, the levels of 24-hour urinary protein quantity(24 h UPro), ratio of urinary microalbumin to urinary creatinine(UACR), urinary N-acetyl-β-D-glucosidase( NAG), urinary retinol binding protein(RBP), urinary α1-microglobulin( α1-MG), urinary β2-microglobulin( β2-MG), serum creatinine( Scr), blood urea nitrogen( BUN) and estimated glomerular filtration rate(eGFR) were detected.Results: During the study, 4 patients in the treatment group were removed or shed off and 5 patients in the control group were removed or shed off, finally 56 patients in the treatment group and 55 patients in the control group were included for the statistical analysis.(1)Clinical efficacy:After treatment, the total clinical effective rate was92.9% in the treatment group and 87.3% in the control group, and the efficacy of the treatment group was better than that of the control group(P<0.05).(2)Chinese medical syndrome efficacy:After treatment, the total effective rate on Chinese medical syndrome was 89.3%in the treatment group and 54.5% in the control group,and the efficacy of the treatment group was better than that of the control group(P<0.01).(3)Laboratory indexes:After treatment, the levels of 24 h UPro, UACR, NAG and RBP in both groups were significantly decreased compared with those before treatment(P<0.05), the levels of α1-MG and β2-MG in the treatment group were also significantly decreased(P<0.05), and the levels of 24 h UPro, NAG, RBP, α1-MG and β2-MG in the treatment group were lower than those in the control group(P<0.05).After treatment, the level of eGFR in the treatment group was significantly increased compared with that before treatment(P<0.05), the level of Scr was significantly decreased compared with that before treatment(P<0.05), and the level of Scr in the treatment group was lower than that in the control group(P<0.05).(4)Correlation analysis: The eGFR was negatively correlated with24 h UPro, UACR, NAG and RBP.Conclusion: Xiaobai Decoction combined with conventional western medicine can effectively improve the clinical symptoms, reduce the level of urinary protein, improve the related indexes of renal tubular injury and delay the progress of renal function in treating CGN patients(CKD at stages 1-2) with syndrome of spleen and kidney qi deficiency and stagnant dampnessheat.