糖尿病肾病发病机制及药物研发进展

doi:10.12092/j.issn.1009-2501.2026.06.003

摘要/Abstract

摘要：

糖尿病肾病（diabetic kidney disease，DKD）是糖尿病主要的并发症之一，是一种微血管病变，临床表现为蛋白尿、估算肾小球滤过率（estimated glomerular filtration rate，eGFR）进行性下降，组织形态学改变则表现为系膜增生和基底膜增厚、肾小球硬化和纤维化，是导致终末期肾病（end stage renal disease，ESRD）的主要原因。DKD的发病机制复杂，遗传因素、能量代谢异常、免疫和炎症、血流动力学异常等因素均参与并影响DKD的形成及疾病进展，且复杂分子机制也为DKD的模型构建和新药研发带来了极大的挑战，本文综述了近年来DKD在发病机制研究、动物疾病模型研究以及新药研发等方面的相关进展，旨在为治疗DKD药物开发提供新的思路。

关键词: 糖尿病肾病, 动物模型, 药物评价

Abstract:

Diabetic kidney disease (DKD), a kind of microvascular lesion, is one of the major complications of diabetes. Clinically, it is characterized by proteinuria, mesangial proliferation and thickening of the basement membrane, glomerular sclerosis and fibrosis, and progressive decline of estimated glomerular filtration rate (eGFR), and is recognized as the main cause of end-stage renal disease (ESRD). The pathogenesis of DKD is complex, with genetic factors, abnormal energy metabolism, immunity and inflammation, and hemodynamic abnormalities all participating in and influencing the formation and progression of DKD. The complex molecular mechanism also brings great challenges to the construction of DKD models and the development of new drugs. This article reviews the recent progress in the research of the pathogenesis of DKD, animal disease models, and new drug development, aiming to provide new ideas for the development of drugs for the treatment of DKD.

Key words: diabetic kidney disease, animal model, drug evaluation

中图分类号:

R587.2
R692

刘学武, 姜德建, 杜艳华. 糖尿病肾病发病机制及药物研发进展[J]. 中国临床药理学与治疗学, 2026, 31(6): 735-751.

Xuewu LIU, Dejian JIANG, Yanhua DU. Progress in pathogenesis and drug development of diabetic kidney disease[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(6): 735-751.

图/表 7

参考文献 71

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指标分类	动物模型诊断指标	临床诊断指标
基础性指标	血糖	血糖、糖耐量、胰岛素
肾脏功能性指标	血CRE，尿CRE，血BUN，排尿量，24 h尿微量白蛋白排泄量，尿微量白蛋白和尿肌酐比值（ACR），eGFR或内生肌酐清除率	血CRE，尿CRE，血BUN，排尿量，24 h尿微量白蛋白排泄量，尿微量白蛋白和尿肌酐比值（ACR），eGFR
病理形态学	HE染色、PAS染色、Ⅰ型和Ⅳ胶原染色、电镜观察基底膜厚度	肾脏活检：HE染色、PAS染色、电镜、电镜观察基底膜厚度

指标分类	动物模型诊断指标	临床诊断指标
基础性指标	血糖	血糖、糖耐量、胰岛素
肾脏功能性指标	血CRE，尿CRE，血BUN，排尿量，24 h尿微量白蛋白排泄量，尿微量白蛋白和尿肌酐比值（ACR），eGFR或内生肌酐清除率	血CRE，尿CRE，血BUN，排尿量，24 h尿微量白蛋白排泄量，尿微量白蛋白和尿肌酐比值（ACR），eGFR
病理形态学	HE染色、PAS染色、Ⅰ型和Ⅳ胶原染色、电镜观察基底膜厚度	肾脏活检：HE染色、PAS染色、电镜、电镜观察基底膜厚度

药物名称	药品分类	适应症和研发阶段	作用靶点
厄贝沙坦	化药	上市：原发性高血压，高血压合并2型糖尿病引发的肾脏损伤	RAAS抑制剂
卡格列净	化药	上市：2型糖尿病，心力衰竭，DKD	SGLT2抑制剂
恩格列净	化药	上市：2型糖尿病，心力衰竭，慢性肾病	SGLT2抑制剂
非奈利酮	化药	上市：DKD，心力衰竭	盐皮质激素受体抑制剂
BI 685509	化药	Ⅱ期临床：糖尿病及其他慢性肾病	可溶性鸟苷酸环化酶（sGC）激动剂
BAY 3283142	化药	Ⅱ期临床：慢性肾病	可溶性鸟苷酸环化酶（sGC）激动剂
SK-08	化药	Ⅰ期临床：慢性肾病	可溶性鸟苷酸环化酶（sGC）激动剂
C66	化药	Ⅰ期临床：DKD	JNK1/2抑制剂
ZHC-116	化药	Ⅱ期临床：DKD	TGF-β1/SMAD抑制剂
硝酮嗪肠溶片	化药	Ⅱa期临床：DKD	清除自由基，保护线粒体功能，增加ATP产生，促进细胞自噬
SPH3127片	化药	Ⅱ期临床：DKD	肾素抑制剂
SC0062	化药	Ⅱ期临床：慢性肾病	高选择性内皮素受体A（ETA）拮抗剂
bremelanotide	化药	Ⅱb临床：DKD	黑素皮质素受体激动剂
LM49	化药	Ⅰ期临床：DKD	靶向PDIA6，调节IRE1α-XBP1/NF-κB
SZ2726片	化药	Ⅰ期临床：DKD	未公开
AP303片	化药	Ⅰ期临床：DKD	未公开
KBP-5074片	化药	Ⅲ临床：慢性肾病	非甾体类选择性盐皮质激素受体拮抗剂（MRA）
MY008211A片	化药	Ⅰ期临床：慢性肾病	补体因子B（CFB）抑制剂
脯氨酸恒格列净片	化药	Ⅲ期临床：慢性肾病	SGLT2抑制剂
WJ-39片	化药	Ⅰ期临床：DKD	醛糖还原酶抑制剂
UBT251	化药	Ⅱ期临床试验：慢性肾病	GLP-1R/GIPR/GCGR激动剂
注射用XTL6001	化药	Ⅰ期临床：慢性肾病	GLP-1R/GCGR/MasR三重靶点激动剂
司美格鲁肽	生物药	上市：2型糖尿病，体重管理，2型糖尿病合并慢性肾脏病	GLP-1激动剂
利拉鲁肽	生物药	上市：2型糖尿病，体重管理 Ⅲ期临床：慢性肾病	GLP-1激动剂
GMA131	生物药（单克隆抗体）	Ⅰ期临床：DKD	内皮素受体ETa的单克隆抗体
人脐带间充质干细胞注射液	生物药（干细胞）	Ⅰ期临床：DKD	抑制炎性反应、调节免疫功能
RYSW-01	生物药（干细胞）	Ⅱ期临床：慢性肾病	抑制炎性反应、调节免疫功能
RMCL-002	生物药（肾自体细胞）	Ⅱ期临床：慢性肾病	抑制炎性反应、调节免疫功能
渴络欣胶囊	中药复方	上市：DKD属气阴两虚兼夹血瘀证	益气养阴，活血化瘀
芪参益气滴丸	中药复方	上市：气血不足同时伴有血液流通不畅引发的胸闷胸痛，用于冠心病心绞痛及慢性心力衰竭 Ⅱ期临床：糖尿病肾脏疾病（气虚血瘀证）	益气通脉，活血止痛
黄蛭益肾胶囊	中药复方	上市：轻中度原发性普通型肾炎（气阴两虚或兼有血瘀症） Ⅱ期临床：糖尿病肾脏疾病	补气养阴，健脾益肾，化瘀利水
百令胶囊	中药复方	上市：慢性支气管炎、慢性肾功能不全的辅助治疗 Ⅱ期临床：糖尿病肾脏疾病（肺肾两虚证）	补肺肾，益精气
SZ1108片	中药	Ⅱ期临床：DKD	醛糖还原酶抑制剂
JMZ-2102胶囊	中药	Ⅰ期临床：慢性肾病	补肾秘精

药物名称	药品分类	适应症和研发阶段	作用靶点
厄贝沙坦	化药	上市：原发性高血压，高血压合并2型糖尿病引发的肾脏损伤	RAAS抑制剂
卡格列净	化药	上市：2型糖尿病，心力衰竭，DKD	SGLT2抑制剂
恩格列净	化药	上市：2型糖尿病，心力衰竭，慢性肾病	SGLT2抑制剂
非奈利酮	化药	上市：DKD，心力衰竭	盐皮质激素受体抑制剂
BI 685509	化药	Ⅱ期临床：糖尿病及其他慢性肾病	可溶性鸟苷酸环化酶（sGC）激动剂
BAY 3283142	化药	Ⅱ期临床：慢性肾病	可溶性鸟苷酸环化酶（sGC）激动剂
SK-08	化药	Ⅰ期临床：慢性肾病	可溶性鸟苷酸环化酶（sGC）激动剂
C66	化药	Ⅰ期临床：DKD	JNK1/2抑制剂
ZHC-116	化药	Ⅱ期临床：DKD	TGF-β1/SMAD抑制剂
硝酮嗪肠溶片	化药	Ⅱa期临床：DKD	清除自由基，保护线粒体功能，增加ATP产生，促进细胞自噬
SPH3127片	化药	Ⅱ期临床：DKD	肾素抑制剂
SC0062	化药	Ⅱ期临床：慢性肾病	高选择性内皮素受体A（ETA）拮抗剂
bremelanotide	化药	Ⅱb临床：DKD	黑素皮质素受体激动剂
LM49	化药	Ⅰ期临床：DKD	靶向PDIA6，调节IRE1α-XBP1/NF-κB
SZ2726片	化药	Ⅰ期临床：DKD	未公开
AP303片	化药	Ⅰ期临床：DKD	未公开
KBP-5074片	化药	Ⅲ临床：慢性肾病	非甾体类选择性盐皮质激素受体拮抗剂（MRA）
MY008211A片	化药	Ⅰ期临床：慢性肾病	补体因子B（CFB）抑制剂
脯氨酸恒格列净片	化药	Ⅲ期临床：慢性肾病	SGLT2抑制剂
WJ-39片	化药	Ⅰ期临床：DKD	醛糖还原酶抑制剂
UBT251	化药	Ⅱ期临床试验：慢性肾病	GLP-1R/GIPR/GCGR激动剂
注射用XTL6001	化药	Ⅰ期临床：慢性肾病	GLP-1R/GCGR/MasR三重靶点激动剂
司美格鲁肽	生物药	上市：2型糖尿病，体重管理，2型糖尿病合并慢性肾脏病	GLP-1激动剂
利拉鲁肽	生物药	上市：2型糖尿病，体重管理 Ⅲ期临床：慢性肾病	GLP-1激动剂
GMA131	生物药（单克隆抗体）	Ⅰ期临床：DKD	内皮素受体ETa的单克隆抗体
人脐带间充质干细胞注射液	生物药（干细胞）	Ⅰ期临床：DKD	抑制炎性反应、调节免疫功能
RYSW-01	生物药（干细胞）	Ⅱ期临床：慢性肾病	抑制炎性反应、调节免疫功能
RMCL-002	生物药（肾自体细胞）	Ⅱ期临床：慢性肾病	抑制炎性反应、调节免疫功能
渴络欣胶囊	中药复方	上市：DKD属气阴两虚兼夹血瘀证	益气养阴，活血化瘀
芪参益气滴丸	中药复方	上市：气血不足同时伴有血液流通不畅引发的胸闷胸痛，用于冠心病心绞痛及慢性心力衰竭 Ⅱ期临床：糖尿病肾脏疾病（气虚血瘀证）	益气通脉，活血止痛
黄蛭益肾胶囊	中药复方	上市：轻中度原发性普通型肾炎（气阴两虚或兼有血瘀症） Ⅱ期临床：糖尿病肾脏疾病	补气养阴，健脾益肾，化瘀利水
百令胶囊	中药复方	上市：慢性支气管炎、慢性肾功能不全的辅助治疗 Ⅱ期临床：糖尿病肾脏疾病（肺肾两虚证）	补肺肾，益精气
SZ1108片	中药	Ⅱ期临床：DKD	醛糖还原酶抑制剂
JMZ-2102胶囊	中药	Ⅰ期临床：慢性肾病	补肾秘精

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