消白衍生方治疗糖尿病肾病Ⅲ-Ⅳ期患者尿蛋白的疗效观察

Clinical Efficacy of Xiaobai Yansheng Formula on Proteinuria in Patients withⅢ-ⅣDKD

目的观察消白衍生方对糖尿病肾病(Diabetic kidneydisease,DKD)Ⅲ-Ⅳ期脾肾阳虚、湿热瘀阻型患者尿蛋白和肾功能的影响。方法选取2020年7月—2021年3月期间上海中医药大学附属曙光医院肾病科门诊及住院收治的DKD(Ⅲ-Ⅳ期)患者63例,按随机数字表分为治疗组33例和对照组30例。对照组予西医常规治疗加载黄葵胶囊,治疗组予西医常规治疗加载消白衍生方。治疗3个月后,观察比较两组患者临床疗效,治疗前后中医症状积分、试验室指标[血肌酐(Serum creatinine,Scr)、尿素氮(Blood Urea Nitrogen,Bun)、估算肾小球滤过率(Estimated Glomerular Filtration Rate,eGFR)、血尿酸(Uricacid,UA)、24 h尿蛋白定量(24-hour urinary protein quantity,24 h UP)、尿白蛋白肌酐比值(Urinary Albumin creatinine ratio,MA/Cr)、尿白蛋白(Urine Albumin,Ualb)、尿转铁蛋白(Urinary Transferrin,UTRF)、尿免疫球蛋白G(Urinary Immunoglobulin G,UIgG)、尿β_(2)微球蛋白(Urineβ_(2)microglobulin,Uβ_(2)-MG)、尿α1微球蛋白(Urineα1 microglobulin,Uα1-MG)、尿液N-乙酰-β-D-氨基葡萄糖苷(Urine N-acetyl-β-D-amino Glucoside,UNAG)、尿视黄醇结合蛋白(Urine Retinol-Binding Protein,URBP)]指标变化。结果治疗后治疗组总有效率81.82%(27/33)高于对照组63.33%(19/30),差异有统计学意义(P<0.01)。治疗后两组患者主、次症、总证候积分较治疗前降低,差异有统计学意义(P<0.05);且治疗组主、次症、总证候积分均低于对照组,差异有统计学意义(P<0.05)。治疗后治疗组Bun、Scr、UA指标较治疗前下降,差异有统计学意义(P<0.05,P<0.01);且治疗组Scr、UA、Bun指标均较对照组明显降低,差异有统计学意义(P<0.01)。治疗后治疗组MA/Cr、UTRF、UIgG、UNAG、24 h UP指标均较治疗前降低,差异有统计学意义(P<0.05,P<0.01);且治疗组UTRF、UIgG、UNAG、MA/Cr、24 h UP指标均较对照组降低,差异有统计学意义(P<0.05,P<0.01)。结论现代常规治疗的基础上加载消白衍生方可以降低糖尿病肾病(Ⅲ-Ⅳ期)脾肾阳虚、湿热瘀型轻、中度蛋白尿患者血肌酐、血尿素氮、血尿酸及24 h UP、MA/Cr,UTRF、UIgG、UNAG的水平,改善中医症状及证候疗效,延缓疾病发展的进程,提高患者的生活质量。

Objective To observe the effects of Xiaobai Yansheng Formula on proteinuria and kidney function in patients withⅢ-Ⅳdiabetic kidney disease(DKD)of spleen-kidney yang deficiency and blockage of dampness-heat syndromes.Methods A total of 63 outpatients and inpatients withⅢ-ⅣDKD treated at the Nephrology Department of Shuguang Hospital,Shanghai University of Traditional Chinese Medicine between July 2020 and March 2021 were randomly divided into a treatment group(n=33)and a control group(n=30)using a random number table.The control group received conventional western treatment along with Huangkui Capsules,while the treatment group received the same western treatment along with Xiaobai Yansheng Formula.After 3 months of treatment,the clinical efficacy,traditional Chinese medicine(TCM)symptom scores,and laboratory indicators[serum creatinine(Scr),blood urea nitrogen(BUN),estimated glomerular filtration rate(eGFR),uric acid(UA),24-hour urinary protein quantity(24 h UP),urinary albumin-to-creatinine ratio(MA/Cr),urine albumin(Ualb),urinary transferrin(UTRF),urinary immunoglobulin G(UIgG),urineβ2-microglobulin(Uβ2-MG),urineα1-microglobulin(Uα1-MG),urine N-acetyl-β-D-amino glucoside(UNAG),and urinary retinol-binding protein(URBP)]before and after treatment were compared between the two groups.Results:After treatment,the total effective rate in the treatment group(81.82%,27/33)was significantly higher than the control group(63.33%,19/30)(P<0.01).After treatment,the primary,secondary,and total TCM symptom scores in both groups decreased,and the treatment group was lower than the control group(P<0.05).After treatment,the BUN,Scr,and UA levels in the treatment group decreased(P<0.05,P<0.01),and the treatment group was lower than the control group(P<0.01).The MA/Cr,UTRF,UIgG,UNAG,and 24 h UP levels in the treatment group also decreased after treatment(P<0.05,P<0.01),and the UTRF,UIgG,UNAG,MA/Cr,and 24 h UP in the treatment group were lower than those in the control group(P<0.05,P<0.01).Conclusion Xiaobai Yansheng Formula combined with conventional western medicine in the treatment of proteinuria patients withⅢ-ⅣDKD of spleen-kidney yang deficiency and blockage of dampness-heat syndromes can lower the levels of Scr,BUN,UA,24 h UP,MA/Cr,UTRF,UIgG,and UNAG,improve TCM symptom and syndrome efficacy,delay disease progression,and enhance the patients'quality of life.