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All patients were divided into the treatment group (Group A, n = 63) and the control group (Group B, n = 63) using a stratified randomization method with sealed envelopes. Group A received conventional basic treatment combined with modified Ermiao Pills, while Group B received only conventional basic treatment. Clinical assessments were conducted on enrollment day and at week 8 of treatment to evaluate TCM syndrome scores [including polydipsia, limb edema, sticky mouth, and epigastric distension], detect urinary protein profiles [24 - hour urine protein (24hUpro), urinary albumin (UAlb), urinary kidney injury molecule-1 (UKim - 1), urinary N - acetyl - β - D - glucosidase (UNAG)], analyze metabolomics parameters [palmitic acid, L - carnitine, phosphatidylcholine (PC), diacylglycerol (DG)], assess renal function[blood creatinine (Scr), blood urea nitrogen (BUN)], and evaluate safety indicators [red blood cells (RBC), alanine aminotransferase (ALT), albumin (Alb), glycated hemoglobin (HbA1c)]. The clinical efficacy of both groups was compared.Results: After treatment, compared with group B, the scores of polydipsia, limb edema, sticky mouth, epigastric and abdominal distension in group A, as well as the levels of 24hUpro, UAlb, UM - 1, UNAG, palmitic acid, Scr, BUN, were decreased (P < 0.05), while the levels of L - carnitine, PC and Dg were increased (P <0.05). Compared with group B, the total effective rate of group A increased (P <0.05).Conclusion: For the first time in a single - center randomized controlled trial, the combination of modified Ermiao pills and conventional treatment based on the ""damp - heat injuring kidney"" theory has been demonstrated to significantly improve refractory proteinuria in diabetic nephropathy, regulate metabolomic indicators, and protect renal function with high safety. Palmitic acid, L - carnitine, PC, and Dg may serve as potential therapeutic targets for modified Ermiao pills in treating refractory proteinuria of diabetic nephropathy., authors=ZHAO Hang1, DAI Wei1, WU Wei1, authorsList=ZHAO Hang, DAI Wei, WU Wei, authorCompany=1 The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210008, China, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=南京市卫生科技发展专项资金项目 (YKK24077); 南京中医药大学自然科学基金项目 (XZR2020054)), CN=ArticleExt(id=1304438797182198204, articleId=1304438796871819707, tenantId=1146029695717560320, journalId=1302318977290174537, language=CN, title=基于“湿热伤肾”学说探究加味二妙丸对糖尿病肾脏疾病难治性蛋白尿临床疗效和作用机制, columnId=1303760933084484510, journalTitle=中医药学报, columnName=临床研究, runingTitle=null, highlight=null, articleAbstract=目的: 基于“湿热伤肾”学说探究加味二妙丸改善糖尿病肾脏疾病难治性蛋白尿的疗效和作用机制。 方法: 选取2022年1月—2025年1月于南京大学医学院附属鼓楼医院中医科以及肾内科的糖尿病肾脏疾病患者126例。采用随机数字表法分为治疗组和对照组,每组63例。对照组给予常规基础治疗。治疗组在常规基础治疗上应用加味二妙丸治疗。分别于入组当天及治疗8周,评估患者中医证候积分情况[口渴多饮、肢体浮肿、口中黏腻、脘腹胀满]、检测尿蛋白谱指标[24 h尿蛋白(24 h UPro)、尿白蛋白(UAlb)、尿肾损伤分子- 1(UKim - 1)、尿N -乙酰- β - D -葡萄糖苷酶(UNAG)]、代谢组学指标[棕榈酸、左旋肉碱、磷脂酰胆碱(PC)、二酰甘油(Dg)]、肾功能指标[血肌酐(Scr)、血尿素氮(BUN)]、安全性指标[红细胞(RBC)、丙氨酸氨基转移酶(ALT)、白蛋白(Alb)、糖化血红蛋白(HbA1c)]水平。对比两组临床疗效。 结果: 治疗后,与对照组比较,治疗组口渴多饮、肢体浮肿、口中黏腻、脘腹胀满积分、24 h UPro、UAlb、UKim - 1、UNAG、棕榈酸、Scr、BUN水平均降低(P < 0.05,P <0.01),左旋肉碱、PC、Dg水平升高(P < 0.05,P < 0.01)。与对照组比较,治疗组总有效率升高(P <0.01)。 结论: 基于“湿热伤肾”学说在常规基础治疗上,应用加味二妙丸首次在单中心随机对照研究中证实其可显著改善糖尿病肾脏疾病难治性蛋白尿,调节代谢组学指标并保护肾功能,且安全性高;棕榈酸、左旋肉碱、PC、Dg可能是加味二妙丸治疗糖尿病肾脏疾病难治性蛋白尿的药物靶标。, authors=赵航1, 戴玮1, 吴薇1, authorsList=赵航, 戴玮, 吴薇, authorCompany=1 南京大学医学院附属鼓楼医院,江苏 南京 210008, 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基于“湿热伤肾”学说探究加味二妙丸对糖尿病肾脏疾病难治性蛋白尿临床疗效和作用机制
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中医药学报 | 临床研究 2026,54(1): 67-73
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中医药学报 |临床研究 2026 , 54 (1) : 67 -73
基于“湿热伤肾”学说探究加味二妙丸对糖尿病肾脏疾病难治性蛋白尿临床疗效和作用机制
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赵航1, 戴玮1, 吴薇1
作者信息
    1 南京大学医学院附属鼓楼医院,江苏 南京 210008
通讯作者:
* 戴玮(1980-),男,硕士,主治医师,主要从事慢性病相关临床工作。
作者简介:
赵航(1982-),女,硕士,主治医师,主要从事慢性肾脏病相关临床工作。
Study on Clinical Efficacy and Mechanism of Modified Ermiao Pills in Improving Refractory Proteinuria of Diabetic Kidney Disease Based on "Damp - Heat Damaging Kidney" Theory
  • ZHAO Hang1, DAI Wei1, WU Wei1
  • Affiliations
      1 The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210008, China
    doi: 10.19664/j.cnki.1002-2392.260013
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    目的: 基于“湿热伤肾”学说探究加味二妙丸改善糖尿病肾脏疾病难治性蛋白尿的疗效和作用机制。 方法: 选取2022年1月—2025年1月于南京大学医学院附属鼓楼医院中医科以及肾内科的糖尿病肾脏疾病患者126例。采用随机数字表法分为治疗组和对照组,每组63例。对照组给予常规基础治疗。治疗组在常规基础治疗上应用加味二妙丸治疗。分别于入组当天及治疗8周,评估患者中医证候积分情况[口渴多饮、肢体浮肿、口中黏腻、脘腹胀满]、检测尿蛋白谱指标[24 h尿蛋白(24 h UPro)、尿白蛋白(UAlb)、尿肾损伤分子- 1(UKim - 1)、尿N -乙酰- β - D -葡萄糖苷酶(UNAG)]、代谢组学指标[棕榈酸、左旋肉碱、磷脂酰胆碱(PC)、二酰甘油(Dg)]、肾功能指标[血肌酐(Scr)、血尿素氮(BUN)]、安全性指标[红细胞(RBC)、丙氨酸氨基转移酶(ALT)、白蛋白(Alb)、糖化血红蛋白(HbA1c)]水平。对比两组临床疗效。 结果: 治疗后,与对照组比较,治疗组口渴多饮、肢体浮肿、口中黏腻、脘腹胀满积分、24 h UPro、UAlb、UKim - 1、UNAG、棕榈酸、Scr、BUN水平均降低(P < 0.05,P <0.01),左旋肉碱、PC、Dg水平升高(P < 0.05,P < 0.01)。与对照组比较,治疗组总有效率升高(P <0.01)。 结论: 基于“湿热伤肾”学说在常规基础治疗上,应用加味二妙丸首次在单中心随机对照研究中证实其可显著改善糖尿病肾脏疾病难治性蛋白尿,调节代谢组学指标并保护肾功能,且安全性高;棕榈酸、左旋肉碱、PC、Dg可能是加味二妙丸治疗糖尿病肾脏疾病难治性蛋白尿的药物靶标。
    “湿热伤肾”学说  /  加味二妙丸  /  糖尿病肾脏疾病  /  难治性蛋白尿
    Objective: To explore the clinical efficacy and mechanism of modified Ermiao Pills in improving refractory proteinuria of diabetic kidney disease(DKD) based on the ""Damp - Heat Damaging Kidney"" theory.Methods: A total of 126 patients with diabetic kidney disease were selected from the TCM department and nephrology department of Gulou Hospital affiliated to Nanjing University Medical School from January 2022 to January 2025. All patients were divided into the treatment group (Group A, n = 63) and the control group (Group B, n = 63) using a stratified randomization method with sealed envelopes. Group A received conventional basic treatment combined with modified Ermiao Pills, while Group B received only conventional basic treatment. Clinical assessments were conducted on enrollment day and at week 8 of treatment to evaluate TCM syndrome scores [including polydipsia, limb edema, sticky mouth, and epigastric distension], detect urinary protein profiles [24 - hour urine protein (24hUpro), urinary albumin (UAlb), urinary kidney injury molecule-1 (UKim - 1), urinary N - acetyl - β - D - glucosidase (UNAG)], analyze metabolomics parameters [palmitic acid, L - carnitine, phosphatidylcholine (PC), diacylglycerol (DG)], assess renal function[blood creatinine (Scr), blood urea nitrogen (BUN)], and evaluate safety indicators [red blood cells (RBC), alanine aminotransferase (ALT), albumin (Alb), glycated hemoglobin (HbA1c)]. The clinical efficacy of both groups was compared.Results: After treatment, compared with group B, the scores of polydipsia, limb edema, sticky mouth, epigastric and abdominal distension in group A, as well as the levels of 24hUpro, UAlb, UM - 1, UNAG, palmitic acid, Scr, BUN, were decreased (P < 0.05), while the levels of L - carnitine, PC and Dg were increased (P <0.05). Compared with group B, the total effective rate of group A increased (P <0.05).Conclusion: For the first time in a single - center randomized controlled trial, the combination of modified Ermiao pills and conventional treatment based on the ""damp - heat injuring kidney"" theory has been demonstrated to significantly improve refractory proteinuria in diabetic nephropathy, regulate metabolomic indicators, and protect renal function with high safety. Palmitic acid, L - carnitine, PC, and Dg may serve as potential therapeutic targets for modified Ermiao pills in treating refractory proteinuria of diabetic nephropathy.
    "Damp - Heat Damaging Kidney" theory  /  Modified Ermiao Pills  /  Diabetic kidney disease  /  Refractory proteinuria
    赵航, 戴玮, 吴薇. 基于“湿热伤肾”学说探究加味二妙丸对糖尿病肾脏疾病难治性蛋白尿临床疗效和作用机制. 中医药学报, 2026 , 54 (1) : 67 -73 . DOI: 10.19664/j.cnki.1002-2392.260013
    ZHAO Hang, DAI Wei, WU Wei. Study on Clinical Efficacy and Mechanism of Modified Ermiao Pills in Improving Refractory Proteinuria of Diabetic Kidney Disease Based on "Damp - Heat Damaging Kidney" Theory[J]. Acta Chinese Medicine and Pharmacology, 2026 , 54 (1) : 67 -73 . DOI: 10.19664/j.cnki.1002-2392.260013

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    doi: 10.19664/j.cnki.1002-2392.260013
    • 接收时间:2025-05-21
    • 首发时间:2026-09-09
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    2种不同金属材料的力学参数

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    species
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    Genus
    种数
    Number of
    species
    占总种数比例
    Percentage of total
    species (%)
    鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
    小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
    多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
    红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
    小菇属 Mycena 11 5.26
    光柄菇属 Pluteus 5 2.39
    红菇属 Russula 17 8.13
    栓菌属 Trametes 5 2.39
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