清热消癥方改善糖尿病肾脏疾病患者蛋白尿及对血清sTNFR1、sTNFR2的影响  

Improvement of proteinuria and effects on serum sTNFR1 and sTNFR2 in patients with diabetic kidney disease by Qingre Xiaozheng Formula

作　　者：王梦迪 刘梦超 赵文景[1] 周静威[2] 王耀献[3] WANG Meng-di;LIU Meng chao;ZHAO Wen-jing;ZHOU Jing-wei;WANG Yao-xian(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beiing 100010,China;Dongzhimen Hospital,Bejjing University of Chinese Medicine,Beijing 100700,China;Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]北京中医药大学东直门医院,北京100700 [3]北京中医药大学,北京100029

出　　处：《中华中医药杂志》2022年第10期6183-6188,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家自然科学基金项目(No.81904105)。

摘　　要：目的:探索清热消癥方在减少糖尿病肾脏疾病(DKD)患者蛋白尿方面的有效性和安全性,并对其疗效机制进行初步探索。方法:将符合本研究要求的60例DKD患者按1∶1随机分为对照组和试验组,每组30例,分别接受西医常规治疗、西医常规配合清热消癥方治疗,疗程共24周,以24 h尿蛋白(24 h UTP)为主要疗效指标,以肾功能[肾小球滤过率(eGFR)、血肌酐(Scr)、血尿素氮(BUN)]、内热积分及生活质量评分[躯体健康总分(PCS)和心理健康总分(MCS)]为次要疗效指标,检测患者治疗前后血清肿瘤坏死因子-α(TNF-α)和可溶性肿瘤坏死因子1、2型受体(sTNFR1、sTNFR2)水平,并进行安全性评价。结果:试验组患者24 h UTP的下降程度显著高于对照组(P<0.01)。试验组患者治疗前后的肾功能差异无统计学意义,而对照组患者Scr较治疗前显著升高(P<0.05)。试验组患者内热积分较治疗前显著降低、生活质量评分显著提高(P<0.05,P<0.01)。试验组患者治疗前后血清各炎症因子水平差异无统计学意义,而对照组患者血清sTNFR1水平较治疗前显著升高(P<0.05),且其增加程度显著高于试验组(P<0.05)。患者在试验期间未发生与药物直接相关的不良反应。结论:在西医常规治疗的基础上配合清热消癥方可以更为有效地改善DKD患者的蛋白尿,延缓肾功能进展,改善临床症状,提高生活质量,减轻炎症状态可能是其作用机制之一,然而其远期疗效仍需要进一步研究。Objective:To study the efficacy and safety of Qingre Xiaozheng Formula in reducing proteinuria in patients with diabetic kidney disease(DKD),and to conduct a preliminary exploration of its efficacy mechanism.Methods:A total of 60 patients who met the standard were randomly allocated at a 1∶1 ratio to either the control group or the experimental group,which will receive the basic treatment or the basic treatment combined with Qingre Xiaozheng Formula,respectively.The duration was 24 weeks.The main efficacy index was 24-hour urinary protein(24 h UTP).Renal function(eGFR,Scr,BUN),syndrome scores and quality of life scores(PCS,MCS)were taken as secondary efficacy indexes,and serum TNF-α,sTNFR1 and sTNFR2 were detected before and after treatment.Safety evaluation were also performed.Results:The decrease of 24 h UTP was significantly higher in the experimental group than in the control group(P<0.01).There was no significant difference in renal function before and after treatment in the experimental group,while the serum creatinine of the control group after treatment was significantly higher than before treatment(P<0.05).The inner heat syndrome score in the experimental group were significantly reduced after treatment,and the quality of life scores were significantly improved(P<0.05,P<0.01).There was no significant difference in inflammatory factors before and after treatment in the experimental group,but serum sTNFR1 was significantly increased after treatment in the control group(P<0.05),and the increase degree was higher than that in experimental group(P<0.05).Patients did not experience any adverse reactions directly related to the drugs during the trial.Conclusion:Qingre Xiaozheng Formula combined routine treatment can effectively reduce urinary protein excretion,delay the progress of renal function,relieve symptoms,and improve the quality of life of DKD patients.Reducing inflammation response may be one of its mechanisms,while further research still needs to be done.

关 键 词：清热消癥方 糖尿病肾脏疾病 蛋白尿 微炎症 

分 类 号：R259[医药卫生—中西医结合] R277.5[医药卫生—中医内科学]