1.Allogeneic lung transplantation in miniature pigs and postoperative monitoring
Yaobo ZHAO ; Ullah SALMAN ; Kaiyan BAO ; Hua KUI ; Taiyun WEI ; Hongfang ZHAO ; Xiaoting TAO ; Xinzhong NING ; Yong LIU ; Guimei ZHANG ; He XIAO ; Jiaoxiang WANG ; Chang YANG ; Feiyan ZHU ; Kaixiang XU ; Kun QIAO ; Hongjiang WEI
Organ Transplantation 2026;17(1):95-105
Objective To explore the feasibility and reference value of allogeneic lung transplantation and postoperative monitoring in miniature pigs for lung transplantation research. Methods Two miniature pigs (R1 and R2) underwent left lung allogeneic transplantation. Complement-dependent cytotoxicity tests and blood cross-matching were performed before surgery. The main operative times and partial pressure of arterial oxygen (PaO2) after opening the pulmonary artery were recorded during surgery. Postoperatively, routine blood tests, biochemical blood indicators and inflammatory factors were detected, and pathological examinations of multiple organs were conducted. Results The complement-dependent cytotoxicity test showed that the survival rate of lymphocytes between donors and recipients was 42.5%-47.3%, and no agglutination reaction occurred in the cross-matching. The first warm ischemia times of D1 and D2 were 17 min and 10 min, respectively, and the cold ischemia times were 246 min and 216 min, respectively. Ultimately, R1 and R2 survived for 1.5 h and 104 h, respectively. Postoperatively, in R1, albumin (ALB) and globulin (GLB) decreased, and alanine aminotransferase increased; in R2, ALB, GLB and aspartate aminotransferase all increased. Urea nitrogen and serum creatinine increased in both recipients. Pathological results showed that in R1, the transplanted lung had partial consolidation with inflammatory cell infiltration, and multiple organs were congested and damaged. In R2, the transplanted lung had severe necrosis with fibrosis, and multiple organs had mild to moderate damage. The expression levels of interleukin-1β and interleukin-6 increased in the transplanted lungs. Conclusions The allogeneic lung transplantation model in miniature pigs may systematically evaluate immunological compatibility, intraoperative function and postoperative organ damage. The data obtained may provide technical references for subsequent lung transplantation research.
2.Reconceptualizing Critical Illness in Cancer Through the Lens of Host Unregulated Response
Yun CHU ; Shiyi GONG ; Xin DING ; Hua ZHAO ; Huan CHEN ; Qing ZHANG ; Xiaoting WANG
Medical Journal of Peking Union Medical College Hospital 2026;17(1):1-9
Onco-critical care has emerged as an important subspecialty at the intersection of critical care medicine and oncology, attracting increasing attention in recent years. With continuous innovations in cancer therapies, patient survival has improved significantly; however, the incidence of associated critical complications has also increased. The reasons for cancer patients requiring intensive care unit admission are diverse and can be broadly categorized into three groups: progression of the underlying malignancy, treatment-related complications, and coexisting classical critical illnesses. Traditional critical care concepts and practices face limitations in addressing the multidimensional and heterogeneous challenges of onco-critical care. Based on the core mechanism of critical illness development—host/organ unregulated response (HOUR)—this article systematically elaborates on how this framework advances understanding and clinical practice into onco-critical care, with emphasis on its manifestations in neuroendocrine, immune-inflammatory, and coagulation-metabolic pathways. The review summarizes recent advances in clinical assessment and phenotyping systems for onco-critical illness and discusses a multidisciplinary, integrated management strategy centered on the "Disease Control, Host Response Modulation, Organ Support" triad. Finally, major challenges and future directions in this field are outlined. By integrating existing evidence and theoretical insights, this review aims to provide new perspectives and a theoretical foundation for the clinical management of onco-critical illness, thereby promoting its evolution toward precision and standardization.
3.Standards for the Application of Hemodynamic Monitoring Technology in Critical Care
Hua ZHAO ; Hongmin ZHANG ; Xin DING ; Huan CHEN ; Jun DUAN ; Wei DU ; Bo TANG ; Yuankai ZHOU ; Dongkai LI ; Xinchen WANG ; Cui WANG ; Gaosheng ZHOU ; Xiaoting WANG
Medical Journal of Peking Union Medical College Hospital 2026;17(1):73-85
With the rapid advancement of hemodynamic indices and monitoring technologies, their classification methods and application processes have become increasingly complex. Currently, no unified standard hasbeen established, making it difficult to fully meet the clinical requirements for hemodynamic management. To assist in hemodynamic monitoring assessment and therapeutic decision-making in critically ill patients, the Critical Hemodynamic Therapy Collaborative Group, in conjunction with the Critical Ultrasound Study Group, has jointly developed the Standard for the Application of Hemodynamic Monitoring Techniques in Critical Care. The first part of this standard systematically categorizes hemodynamic indicators into flow indicators, pressure and its derivative indicators, and tissue perfusion indicators, while elaborating on the clinical application of each. The second part establishes a standardized clinical implementation pathway for hemodynamic monitoring. It proposes a tiered monitoring strategy-comprising basic, advanced, indication-specific, and special scenario monitoring-tailored to different clinical settings. It emphasizes the central role of critical care ultrasound across all levels of monitoring and establishes hemodynamic assessment standards for organs such as the brain, kidneys, and gastrointestinal tract. This standard aims to provide a unified framework for clinical practice, teaching, training, and research in critical care medicine, thereby promoting standardized development within the discipline.
4.Diabetic Kidney Disease and Gut-kidney Axis: A Review
Yingchao WANG ; Yexin CHEN ; Hua ZHANG ; Jiangteng LIU ; Zhichao RUAN ; Xingru PAN ; Weijun HUANG ; Jinxi ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):310-320
With the rising incidence of diabetes, diabetic kidney disease (DKD) has become a significant global health burden. Although current prevention and treatment strategies can partially delay the progression of DKD, the risk of patients advancing to end-stage renal disease remains high. Since the concept of the "gut-kidney axis" was first introduced at the International Congress on Dialysis in 2011, research on the role of gut microbiota in the pathogenesis of DKD has received increasing attention. This review summarizes the current research on gut microbiota, explores the mechanisms through which it contributes to DKD development, and outlines clinical approaches for DKD prevention and treatment based on the "gut-kidney axis" theory. Evidence indicates that dietary interventions, intake of probiotics or prebiotics, use of metformin and novel antidiabetic drugs, and application of traditional Chinese medicine (TCM) compound formulas can effectively improve gut microbiota composition, influence metabolite production, and restore the intestinal mucosal barrier. These interventions can further regulate intestinal innate immunity and inflammatory responses, thereby modulating the progression of DKD. Despite challenges posed by the traditional oral administration of water-decocted TCM compound formulas and the complexity of their ingredients, increasing evidence suggests that TCM may indirectly affect the occurrence and development of DKD by modulating gut microbiota. This finding provides a new perspective on the potential mechanisms of TCM in DKD treatment and may offer novel strategies for DKD prevention and therapy.
5.Mechanisms of Mahuang Lianqiao Chixiaodoutang in Improving Obesity-type Polycystic Ovary Syndrome in Rats Based on PI3K/Akt Signaling Pathway
Shiwei HU ; Biran ZHU ; Jinrong ZHANG ; Luyao RUAN ; Ji KUANG ; Jianghuan HUA ; Zhe LIU ; Yanyue YAO ; Ji WANG ; Min ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):21-31
ObjectiveTo investigate the mechanisms by which Mahuang Lianqiao Chixiaodoutang (MLC) improves obesity-type polycystic ovary syndrome (PCOS) through the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway. MethodsThirty-six female Sprague-Dawley (SD) rats were randomly divided into a blank control group (Con) and an obesity-type PCOS model preparation group. The model was induced by gavage with letrozole (1 mg·kg-1) combined with a high-fat diet (HFD). After model establishment, the obesity-type PCOS model preparation group was further divided into the model group (Mod, normal saline), metformin group (Met, 0.3 g·kg-1), low-dose MLC group (MLC-L, 4.3 g·kg-1), medium-dose MLC group (MLC-M, 8.6 g·kg-1), and high-dose MLC group (MLC-H, 17.2 g·kg-1). Active components of MLC and targets of obesity-type PCOS were screened from databases, a protein-protein interaction (PPI) network was constructed, and gene ontology(GO)and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed. The gut microbiota structure was analyzed based on 16S rRNA sequencing and correlated with network pharmacology pathways. Body weight and estrous cycle were dynamically monitored. Ovarian morphology was observed by hematoxylin-eosin (HE) staining. Cell apoptosis was detected by terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL). Enzyme-linked immunosorbent assay (ELISA) was used to detect levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), anti-Müllerian hormone (AMH), testosterone (T), and estradiol (E2). Western blot was used to detect the protein expression levels of phosphorylated PI3K/PI3K (p-PI3K/PI3K), phosphorylated Akt/Akt (p-Akt/Akt), B-cell lymphoma-2 (Bcl-2), and Bcl-2-associated X protein (Bax). ResultsNetwork pharmacology screening identified 124 active components of MLC and 408 overlapping targets between the herbal formula and the disease. Core targets such as Akt1 and Bcl-2 were revealed. As indicated by 16S rRNA sequencing, the abundances of Lachnospiraceae, Lachnoclostridium, and Dorea were increased in the MLC groups (P<0.05), while the abundance of Veillonella was decreased (P<0.05). KEGG correlation analysis integrating network pharmacology and gut microbiota data showed significant enrichment of the PI3K/Akt signaling pathway. Animal experiments showed that, compared with the Mod group, body weight decreased to normal levels in the Met, MLC-M, and MLC-H groups. The estrous cycle became regular. The number of corpora lutea increased and cystic follicles decreased. Serum levels of T, FSH, and LH/FSH were reduced (P<0.05, P<0.01), while the E2 level was increased (P<0.01). Ovarian cell apoptosis was reduced (P<0.01), and the protein expression levels of p-PI3K/PI3K, p-Akt/Akt, and Bcl-2 in ovarian tissue were significantly increased, whereas Bax protein expression was significantly decreased (P<0.05, P<0.01). ConclusionMLC can regulate gut microbiota structure, effectively improve ovarian pathology in rats with obesity-type PCOS, and inhibit ovarian granulosa cell apoptosis. The mechanism may be associated with upregulation of the PI3K/Akt signaling pathway.
6.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
7.Mechanisms of Mahuang Lianqiao Chixiaodoutang in Improving Obesity-type Polycystic Ovary Syndrome in Rats Based on PI3K/Akt Signaling Pathway
Shiwei HU ; Biran ZHU ; Jinrong ZHANG ; Luyao RUAN ; Ji KUANG ; Jianghuan HUA ; Zhe LIU ; Yanyue YAO ; Ji WANG ; Min ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):21-31
ObjectiveTo investigate the mechanisms by which Mahuang Lianqiao Chixiaodoutang (MLC) improves obesity-type polycystic ovary syndrome (PCOS) through the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway. MethodsThirty-six female Sprague-Dawley (SD) rats were randomly divided into a blank control group (Con) and an obesity-type PCOS model preparation group. The model was induced by gavage with letrozole (1 mg·kg-1) combined with a high-fat diet (HFD). After model establishment, the obesity-type PCOS model preparation group was further divided into the model group (Mod, normal saline), metformin group (Met, 0.3 g·kg-1), low-dose MLC group (MLC-L, 4.3 g·kg-1), medium-dose MLC group (MLC-M, 8.6 g·kg-1), and high-dose MLC group (MLC-H, 17.2 g·kg-1). Active components of MLC and targets of obesity-type PCOS were screened from databases, a protein-protein interaction (PPI) network was constructed, and gene ontology(GO)and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed. The gut microbiota structure was analyzed based on 16S rRNA sequencing and correlated with network pharmacology pathways. Body weight and estrous cycle were dynamically monitored. Ovarian morphology was observed by hematoxylin-eosin (HE) staining. Cell apoptosis was detected by terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL). Enzyme-linked immunosorbent assay (ELISA) was used to detect levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), anti-Müllerian hormone (AMH), testosterone (T), and estradiol (E2). Western blot was used to detect the protein expression levels of phosphorylated PI3K/PI3K (p-PI3K/PI3K), phosphorylated Akt/Akt (p-Akt/Akt), B-cell lymphoma-2 (Bcl-2), and Bcl-2-associated X protein (Bax). ResultsNetwork pharmacology screening identified 124 active components of MLC and 408 overlapping targets between the herbal formula and the disease. Core targets such as Akt1 and Bcl-2 were revealed. As indicated by 16S rRNA sequencing, the abundances of Lachnospiraceae, Lachnoclostridium, and Dorea were increased in the MLC groups (P<0.05), while the abundance of Veillonella was decreased (P<0.05). KEGG correlation analysis integrating network pharmacology and gut microbiota data showed significant enrichment of the PI3K/Akt signaling pathway. Animal experiments showed that, compared with the Mod group, body weight decreased to normal levels in the Met, MLC-M, and MLC-H groups. The estrous cycle became regular. The number of corpora lutea increased and cystic follicles decreased. Serum levels of T, FSH, and LH/FSH were reduced (P<0.05, P<0.01), while the E2 level was increased (P<0.01). Ovarian cell apoptosis was reduced (P<0.01), and the protein expression levels of p-PI3K/PI3K, p-Akt/Akt, and Bcl-2 in ovarian tissue were significantly increased, whereas Bax protein expression was significantly decreased (P<0.05, P<0.01). ConclusionMLC can regulate gut microbiota structure, effectively improve ovarian pathology in rats with obesity-type PCOS, and inhibit ovarian granulosa cell apoptosis. The mechanism may be associated with upregulation of the PI3K/Akt signaling pathway.
8.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
9.Clinical Efficacy and Mechanisms of Qigui Didang Decoction in Treatment of Stage Ⅲ-Ⅳ Diabetic Kidney Disease with Kidney Collateral Stasis Syndrome in Real World
Yingchao WANG ; Jiaqi WANG ; Zongjiang ZHAO ; Hua ZHANG ; Jiannan ZHOU ; Jiangteng LIU ; Zhichao RUAN ; Weijun HUANG ; Jinxi ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):162-169
ObjectiveTo investigate the clinical efficacy and mechanisms of Qigui Didang decoction in the treatment of kidney collateral stasis syndrome in patients with stage Ⅲ-Ⅳ diabetic kidney disease (DKD) in a real-world setting. MethodsPatients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome admitted to Beijing Aerospace General Hospital from January 2022 to December 2024 were selected for clinical study. According to treatment methods, patients were divided into the Qigui Didang decoction group (Qigui Didang decoction + conventional treatment) and the control group (conventional treatment alone). A 1∶1 propensity score matching (PSM) method was used to reduce bias caused by confounding factors. Clinical efficacy, traditional Chinese medicine (TCM) symptom scores, renal function indicators, mRNA expression related to pathway mechanisms, glycolipid metabolism indices, and adverse reactions were compared between the two groups. ResultsA total of 120 patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome were included, including 62 cases in the Qigui Didang Decoction group and 58 cases in the control group. Before matching, there were statistically significant differences between the two groups in DKD stage, baseline urinary albumin-to-creatinine ratio (UACR), 24-hour urine total protein (24 h-UTP), and estimated glomerular filtration rate (eGFR) (P<0.05). After matching, 47 cases were included in each group, and there was no statistically significant difference in baseline data between the two groups. After matching, the total clinical effective rate of the Qigui Didang decoction group was significantly higher than that of the control group (χ2=4.681, P<0.05). Compared with data before treatment, the scores of primary and secondary TCM symptoms in the Qigui Didang decoction group were significantly decreased (P<0.05). Compared with data before treatment, serum creatinine (SCr), 24 h-UTP, and UACR levels were significantly decreased, while eGFR was significantly increased in the Qigui Didang decoction group (P<0.05). Compared with data before treatment, the mRNA expression of silent information regulator 1 (Sirt1) was significantly upregulated, while the mRNA expression of nuclear factor-kappa B (NF-κB) and tumor suppressor protein p53 (p53) was significantly downregulated in the Qigui Didang decoction group (P<0.05). Compared with data before treatment, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2 hPG), glycated hemoglobin A1c (HbA1c), total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C) levels were decreased, while high-density lipoprotein cholesterol (HDL-C) levels were increased (P<0.05). There was no statistically significant difference in adverse reactions between the two groups. ConclusionQigui Didang decoction combined with conventional treatment can significantly improve renal function, glycolipid metabolism, and TCM syndromes in patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome, with good safety. The mechanism may be related to the regulation of the Sirt1/NF-κB/p53 signaling pathway.
10.Clinical Efficacy and Mechanisms of Qigui Didang Decoction in Treatment of Stage Ⅲ-Ⅳ Diabetic Kidney Disease with Kidney Collateral Stasis Syndrome in Real World
Yingchao WANG ; Jiaqi WANG ; Zongjiang ZHAO ; Hua ZHANG ; Jiannan ZHOU ; Jiangteng LIU ; Zhichao RUAN ; Weijun HUANG ; Jinxi ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):162-169
ObjectiveTo investigate the clinical efficacy and mechanisms of Qigui Didang decoction in the treatment of kidney collateral stasis syndrome in patients with stage Ⅲ-Ⅳ diabetic kidney disease (DKD) in a real-world setting. MethodsPatients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome admitted to Beijing Aerospace General Hospital from January 2022 to December 2024 were selected for clinical study. According to treatment methods, patients were divided into the Qigui Didang decoction group (Qigui Didang decoction + conventional treatment) and the control group (conventional treatment alone). A 1∶1 propensity score matching (PSM) method was used to reduce bias caused by confounding factors. Clinical efficacy, traditional Chinese medicine (TCM) symptom scores, renal function indicators, mRNA expression related to pathway mechanisms, glycolipid metabolism indices, and adverse reactions were compared between the two groups. ResultsA total of 120 patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome were included, including 62 cases in the Qigui Didang Decoction group and 58 cases in the control group. Before matching, there were statistically significant differences between the two groups in DKD stage, baseline urinary albumin-to-creatinine ratio (UACR), 24-hour urine total protein (24 h-UTP), and estimated glomerular filtration rate (eGFR) (P<0.05). After matching, 47 cases were included in each group, and there was no statistically significant difference in baseline data between the two groups. After matching, the total clinical effective rate of the Qigui Didang decoction group was significantly higher than that of the control group (χ2=4.681, P<0.05). Compared with data before treatment, the scores of primary and secondary TCM symptoms in the Qigui Didang decoction group were significantly decreased (P<0.05). Compared with data before treatment, serum creatinine (SCr), 24 h-UTP, and UACR levels were significantly decreased, while eGFR was significantly increased in the Qigui Didang decoction group (P<0.05). Compared with data before treatment, the mRNA expression of silent information regulator 1 (Sirt1) was significantly upregulated, while the mRNA expression of nuclear factor-kappa B (NF-κB) and tumor suppressor protein p53 (p53) was significantly downregulated in the Qigui Didang decoction group (P<0.05). Compared with data before treatment, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2 hPG), glycated hemoglobin A1c (HbA1c), total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C) levels were decreased, while high-density lipoprotein cholesterol (HDL-C) levels were increased (P<0.05). There was no statistically significant difference in adverse reactions between the two groups. ConclusionQigui Didang decoction combined with conventional treatment can significantly improve renal function, glycolipid metabolism, and TCM syndromes in patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome, with good safety. The mechanism may be related to the regulation of the Sirt1/NF-κB/p53 signaling pathway.

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