1.Therapeutic efficacy of ruxolitinib combined with low-dose hormone in aGVHD after allogeneic hematopoietic stem cell transplantation
Yue HU ; Xupai ZHANG ; Sihan LAI ; Shan ZHANG ; Lei MA ; Xiao WANG ; Yan DENG ; Ying HAN ; Ying HE ; Guangcui HE ; Hai YI
Chinese Journal of Blood Transfusion 2026;39(4):506-512
Objective: To evaluate the efficacy and safety of ruxolitinib combined with low-dose hormone for patients with acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Methods: Thirty patients with aGVHD after allo-HSCT admitted to the Department of Hematology of the General Hospital of Western Theater Command from November 2021 to November 2024 were retrospectively analyzed. All patients were treated with low-dose hormone (methylprednisolone 0.3-1 mg kg
-d
) combined with ruxolitinib 5-10 mg d
. The efficacy and adverse reactions were observed during the follow-up period to analyze the survival outcomes of the patients. Results: A total of 30 patients with aGVHD after allo-HSCT were included in this study, consisting of 15 (50%) males and 15 (50%) females with a median age of 34 year-old (ranging from 14 to 62). Classification by disease type: there were 18 cases of acute myeloid leukemia, 4 cases of acute lymphoblastic leukemia, 4 cases of aplastic anemia, and 4 cases of myelodysplastic syndrome. Classification by aGVHD severity: there were 27 cases (90%) of Ⅱ-Ⅳ degree aGVHD and 11 cases (36.7%) of Ⅲ-Ⅳ degree aGVHD. Ruxolitinib in combination with low-dose glucocorticoid treatment yield responses in 28 (93.3%) patients, of which 27 (90%) achieved complete remission (CR), while 1 (3.3%) showed partial remission (PR). One patient (3.3%) had no response (NR), and 1 patient (3.3%) exhibited progressed disease (PD). Overall survival (OS) at 1 year of transplantation was 73.9% (95%CI 49.5% to 87.7%), progression-free survival (PFS) was 93.3% (95%CI 75.9% to 98.3%), non-relapse mortality (NRM) was 20.6% (95%CI 7.9% to 47.4%), and median survival time was 27.6 months. Conclusion: Ruxolitinib combined with low-dose hormones is safe and effective in the treatment of aGVHD after allo-HSCT.
2.Clinical Observation on Prevention of Recurrence of Common Bile Duct Stones After ERCP with Yuyin Lidan Granules
Xiao WANG ; Yong FANG ; Cong HE ; Jiali ZHANG ; Meng YU ; Jing KONG ; Yi JIANG ; Chuanqi CHENG ; Xiaosu WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):159-166
ObjectiveTo observe the clinical efficacy and safety of Yuyin Lidan granules (YYLD) in preventing the recurrence of common bile duct stones (CBDS) in patients with liver and gallbladder dampness-heat syndrome following endoscopic retrograde cholangiopancreatography (ERCP). MethodsThis randomized, parallel, controlled trial enrolled postoperative CBDS-ERCP patients who met the inclusion and exclusion criteria. Sixty-four patients were randomly assigned to an observation group or a control group, with 32 cases in each. Both groups received conventional Western medical treatment after ERCP, while the observation group additionally received YYLD for 8 weeks. The follow-up period lasted for 1 year. The efficacy indicators included bile bilirubin levels, traditional Chinese medicine (TCM) syndrome scores, clinical efficacy rate, pancreatitis and inflammation markers, postoperative liver function, and CBDS recurrence rate at 1-year follow-up, which were used to jointly evaluate the clinical efficacy and safety of both groups. ResultsA total of 56 patients completed the study and were included in the final analysis, i.e., 29 in the observation group and 27 in the control group. Baseline characteristics were comparable between the two groups. Compared with pre-treatment and with the control group after treatment, the bile bilirubin level in the observation group significantly decreased (P<0.05). After treatment, the clinical cure and marked improvement rates were higher in the observation group than in the control group, showing a statistically significant difference in overall clinical efficacy (P<0.05). Compared with pre-treatment, the primary and secondary symptoms in the observation group, as well as the primary symptom and the secondary symptom of nausea and vomiting in the control group (weeks 4 and 8), were significantly reduced (P<0.05). Compared with the control group after treatment, the observation group showed significant reductions in the primary symptom of loose stools/constipation (day 5 and week 4) and in three secondary symptoms, i.e., bitter taste and sticky dry mouth, abdominal distension and poor appetite (throughout the treatment period), and general heaviness and fatigue (day 5 and week 4), with statistical differences (P<0.05). Compared with pre-treatment, both groups showed decreased lipase and urinary amylase levels (P<0.05). However, no significant between-group differences were observed in pancreatitis or inflammation-related indices after treatment. Compared with pre-treatment, all liver function indicators in the observation group and alanine aminotransferase ( ALT ), γ-glutamyl transferase ( γ-GT ), alkaline phosphatase (ALP), and conjugated bilirubin in the control group significantly decreased at weeks 4 and 8 (P<0.05). Compared with the control group after treatment, only serum total bilirubin and unconjugated bilirubin were significantly reduced in the observation group during the treatment period (P<0.05). ConclusionYYLD combined with conventional Western medical treatment can effectively regulate bilirubin metabolism (in bile and serum), improve TCM clinical symptoms, and prevent CBDS recurrence after ERCP in patients with liver and gallbladder dampness-heat syndrome. This regimen is safe and effective and is worthy of further clinical research and promotion.
3.Current Research Status,Challenges,Differentiation and Treatment Strategies of Traditional Chinese Medicine for Gastroesophageal Reflux Disease
Fengyun WANG ; Mi LYU ; Bingduo ZHOU ; Beihua ZHANG ; Yi WANG ; Tingting XU ; Cong HE ; Xiaokang WANG ; Xin LIU ; Yang WANG ; Kaiyue HUANG ; Lusi XU ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(4):392-396
This article systematically reviews the current research status as well as diagnosis and treatment strategies of traditional Chinese medicine (TCM) for gastroesophageal reflux disease (GERD). Studies demonstrate that TCM, based on the "disease-syndrome combination" approach, exhibits multi-target advantages in alleviating symptoms of various GERD subtypes, promoting mucosal repair, regulating emotions, and facilitating the reduction of western medication. To address clinical challenges such as symptom overlap and limited therapeutic efficacy, strategies have been proposed including "treating different diseases with the same method" and integrated regulation based on viscera correlation. Future efforts should focus on elucidating the mechanisms of compound prescriptions, promoting TCM drug development under the "three-combination" evaluation framework that integrates TCM theory, human experience and clinical trial evidence, and optimizing integrated traditional and western medicine models to enhance GERD management.
4.Efficacy and safety of diquafosol sodium eye drops for children with dry eye wearing orthokeratology lens
Zhongming LI ; Yongchuan HE ; Mengyao WANG ; Ying LIU ; Yi REN
International Eye Science 2026;26(3):375-382
AIM: To evaluate the efficacy and safety of 3% diquafosol sodium eye drops in children wearing orthokeratology lenses and with dry eye disease(DED)or at risk of DED.METHODS: Randomized controlled trials. Children with DED or at risk of DED were randomly assigned in a 1:1 ratio to receive either 3% diquafosol sodium eye drops 6 times daily or a blank control at Chongqing Aier Children's Eye Hospital from November 2023 to November 2024. The primary endpoint was the change in the Dry Eye Questionnaire-5(DEQ-5)score from baseline at 12 wk. Secondary assessments included non-invasive breakup time(NIBUT), tear meniscus height, Schirmer's test, corneal fluorescein staining score, and axial length.RESULTS: A total of 80 participants(80 eyes)were enrolled(40 in each group), the average age of the participants was 11.11±1.88 years, with 43 females(54%)and 37 males(46%), and all completed the trial. After 12 wk, the DEQ-5 scores for the diquafosol sodium group and the blank control group were 1.88±2.02 and 2.88±2.79, respectively(P=0.079). The diquafosol sodium group demonstrated a significant improvement in DEQ-5 dryness symptom scores(-0.33±0.66 vs. 0.05±0.81, P=0.023)and NIBUT(6.18±3.73 vs. -1.09±4.40 s, P<0.001)at 12 wk. Additionally, the diquafosol sodium group showed no axial length elongation, in contrast to the blank control group, which exhibited elongation(0.00±0.08 vs. 0.05±0.10 mm, P=0.013). No other significant differences were found in the secondary endpoints. No adverse events occurred during the trial.CONCLUSION: Although no statistically significant improvements were noted in the overall DEQ-5 scores, the 3% diquafosol sodium eye drops significantly improved dryness symptoms and NIBUT when compared to the blank control group.
5.Concentrations characteristics of common air pollutants and health risk assessment of practitioners in hair and beauty salons in Shanghai, 2016–2024
Jiao CHEN ; Tian CHEN ; Xiaoyu WANG ; Yewen SHI ; Fengchan HAN ; Yi HE ; Xiaodong SUN ; Xianliang WANG
Journal of Environmental and Occupational Medicine 2026;43(3):326-332
Background As common public facilities essential to daily life, hair and beauty salons frequently contain various airborne toxic and hazardous pollutants potentially leading to adverse health effects for salon practitioners. Objective To characterize the indoor air pollution profiles of common contaminants in hair and beauty salons in Shanghai and to evaluate the associated health risks for practitioners, in order to provide a scientific basis for strengthening the public health management in Shanghai and protecting the health of practitioners. Methods The air quality monitoring data of hair and beauty salons in Shanghai from 2016 to 2024 were obtained from the “Health Hazard Factors Monitoring Program for Public Places” of the National Institute of Environmental Health, Chinese Center for Disease Control and Prevention. Monitoring indicators included particulate matter ≤10 μm in aerodynamic diameter (PM10), particulate matter ≤2.5 μm in aerodynamic diameter (PM2.5), formaldehyde, ammonia, benzene, toluene, and xylene. Indicator compliance rates were calculated across various years in accordance with GB 9666-1996 Hygienic standard for barber shop and beauty shop and GB 37488-2019 Hygiene indicators and limit for public places; specifically, PM2.5 was assessed against the limits stipulated in GB/T 18883-2022 Standards for indoor air quality. A questionnaire survey was conducted among salon practitioners to collect weekly working days and daily working hours. The non-carcinogenic risks associated with inhalation exposure to formaldehyde, ammonia, benzene, toluene, and xylene as well as the carcinogenic risks posed by formaldehyde and benzene were evaluated following WS/T 777-2021 Technical guide for environmental health risk assessment of chemical exposure and the U.S. Environmental Protection Agency inhalation risk model. Results The overall compliance rates of PM10, formaldehyde, ammonia, benzene, and toluene in the air of hair and beauty salons in Shanghai from 2016 to 2024 were 92.13%, 96.59%, 96.15%, 94.93%, and 94.97%, respectively; the overall compliance rate of xylene was a little lower (85.92%), and the overall compliance rate of PM2.5 was 57.18%. The P50 concentrations of PM10, PM2.5, formaldehyde, ammonia, benzene, toluene, and xylene did not exceed the corresponding limits. The P50 of non-carcinogenic risk indicator (hazard quotient, HQ) for formaldehyde, ammonia, benzene, toluene, and xylene were <1. The probabilities of non-carcinogenic risk HQ >1 for formaldehyde and xylene were 41.4% and 10.9%, respectively, which were higher than that of other pollutants. The P50 of carcinogenic risk (CR) for formaldehyde and benzene were between 1.0×10−6 and 1.0×10−4, while the probabilities of CR >1.0×10−4 were 16.9% and 14.0%, respectively. Conclusion The overall compliance rate of common pollutant concentrations in the air of hair and beauty salons in Shanghai is high, and the hygienic condition meets the requirements of national standards. The non-carcinogenic health risks posed by formaldehyde and xylene to employees (with formaldehyde being more prominent), as well as the carcinogenic risks associated with formaldehyde and benzene, deserve heightened attention in future health supervision.
6.Treatment Principles and Paradigm of Diabetic Microvascular Complications Responding Specifically to Traditional Chinese Medicine
Anzhu WANG ; Xing HANG ; Lili ZHANG ; Xiaorong ZHU ; Dantao PENG ; Ying FAN ; Min ZHANG ; Wenliang LYU ; Guoliang ZHANG ; Xiai WU ; Jia MI ; Jiaxing TIAN ; Wei ZHANG ; Han WANG ; Yuan XU ; .LI PINGPING ; Zhenyu WANG ; Ying ZHANG ; Dongmei SUN ; Yi HE ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):272-279
To explore the advantages of traditional Chinese medicine (TCM) and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications (DMC), refine key pathophysiological insights and treatment principles, and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine, hosted by the China Association of Chinese Medicine, was held in Beijing, 2024. Experts in TCM, Western medicine, and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis, diagnostic and treatment challenges, and mechanism research related to DMC, ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development, research prioritization, and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM, strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.
7.The Role and Regulatory Mechanisms of FOXO1 in Hepatic Lipid Deposition
Meng JIA ; Fang-Hui LI ; Shi-Zhan YAN ; Ai-Ju LI ; Yi-Le WANG ; Pin-Shi NI ; Jia-Han HE ; Yin-Lu LI
Progress in Biochemistry and Biophysics 2026;53(4):905-919
Metabolic associated fatty liver disease (MAFLD) is fundamentally driven by an imbalance in hepatic fatty-acid flux: the influx of fatty acids exceeds the liver’s capacity for disposal, resulting in excessive hepatic lipid accumulation, predominantly in the form of triglycerides (TGs). The occurrence and progression of MAFLD depend on disordered regulation across multiple metabolic steps, including fatty-acid uptake, de novo lipogenesis (DNL), fatty-acid oxidation (FAO), and very low-density lipoprotein (VLDL) export. Forkhead box protein O1 (FOXO1) is a key transcriptional regulator within the hepatic network coordinating glucose and lipid metabolism. Under metabolic stress and insulin resistance (IR), FOXO1 expression is frequently increased, whereas its inhibitory phosphorylation is reduced. These changes enhance FOXO1 nuclear localization and transcriptional activity, thereby reprogramming the expression of genes related to metabolism in the liver. Because hepatic lipid deposition is the central pathological feature of MAFLD, the functional status of FOXO1 directly influences hepatic lipid homeostasis. Growing evidence suggests that FOXO1 can exert bidirectional, environment-dependent effects on hepatic lipid accumulation; however, the molecular basis for this functional switch remains incompletely understood. This review systematically summarizes the biological functions and regulatory mechanisms of FOXO1 and its roles in hepatic lipid metabolism, with a particular focus on its crosstalk with insulin signaling. FOXO1 expression is shaped by RNA modifications and epigenetic regulation mediated by non-coding RNAs. Its transcriptional output is precisely governed by post-translational modifications—such as phosphorylation and acetylation—as well as by coordinated nucleocytoplasmic shuttling. Notably, these regulatory patterns vary markedly across nutritional states, degrees of insulin resistance, and stages of disease. In the fed state, insulin/IGF-1 signaling activates the PI3K-AKT pathway, promoting the inhibitory phosphorylation of FOXO1 and facilitating additional modifications, including acetylation, methylation, and ubiquitination. Together, these events drive FOXO1 export from the nucleus and dampen its transcriptional activity, suppressing gluconeogenesis and constraining lipogenic programs. Conversely, during fasting or when insulin signaling is weakened, FOXO1 inhibition is relieved. FOXO1 accumulates in the nucleus, binds to DNA, and regulates the transcription of downstream target genes. Mechanistically, FOXO1 can aggravate hepatic lipid accumulation by activating genes involved in TG synthesis while repressing FAO-related pathways, thereby favoring storage over oxidation. However, under specific conditions, FOXO1 may also alleviate the hepatic lipid burden by promoting TG hydrolysis and enhancing VLDL secretion, thereby reducing the net hepatic lipid load. In addition, lipotoxic signals mediated by ceramides and diacylglycerols (Cer/DAG) activate atypical protein kinase C (aPKC), further exacerbating the disruption of the AKT-FOXO1 axis. This vicious cycle ultimately produces a metabolic paradox in which increased hepatic glucose output coexists with persistent, insulin-independent lipogenesis, accelerating MAFLD progression. Importantly, FOXO1 regulation is not uniform: during early metabolic overload, insulin-mediated suppression may remain effective, whereas in advanced insulin resistance, the loss of AKT control permits sustained FOXO1 activity. Such stage-dependent dynamics may help explain why FOXO1 can either promote steatosis or, in certain contexts, support programs that facilitate lipid turnover. Accordingly, interventions should be liver-specific and tuned to the disease stage, aiming to curb maladaptive FOXO1 signaling while preserving its capacity to promote triglyceride hydrolysis and VLDL secretion when advantageous. Overall, this review offers an important perspective on MAFLD pathogenesis, emphasizing FOXO1 as a potential therapeutic target and providing a theoretical basis for developing liver-specific, disease-course-dependent precision interventions.
8.Randomized Controlled Study on Wenshen Yangxue Decoction Plus Endometrial Microstimulation for Polycystic Ovary Syndrome (PCOS) Infertility with Syndrome of Kidney-Yang Deficiency and Blood Stasis
Qianqian HUANG ; Qian HAN ; Mingwei XIN ; Junqin HE ; Jingshang WANG ; Xiaodan YIN ; Mengyuan LI ; Yanxiao YI ; Yanli TANG ; Yiting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):181-190
ObjectiveTo evaluate the clinical efficacy and safety of Wenshen Yangxue decoction combined with endometrial microstimulation in the treatment of infertile patients with polycystic ovary syndrome (PCOS, syndrome of kidney-Yang deficiency and blood stasis). MethodsA randomized, positive-drug parallel-controlled, open-label clinical study was conducted. A total of 240 infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis who met the inclusion and exclusion criteria were randomly assigned into 4 groups, with 60 patients in each group. The control group was treated with clomiphene citrate (50-100 mg·d-¹, orally for 5-10 consecutive days) for ovulation induction. On the basis of the therapy in the control group, the Wenshen group was additionally treated with Wenshen Yangxue decoction (250 mL, warm oral administration, twice daily, in the morning and evening), and the stimulation group received endometrial microstimulation during the early follicular phase. The combined group was treated with clomiphene citrate plus Wenshen Yangxue decoction (at the same dosages as aforementioned) and endometrial microstimulation. The course of treatment for all the groups was 3 menstrual cycles. The pregnancy rate, ovulation status, sex hormone levels, glucose metabolism indicators, coagulation function, endometrial thickness, traditional Chinese medicine (TCM) symptom scores, and adverse reactions were observed in each group. ResultsA total of 239 patients were included in the final analysis, with 59 patients in the Wenshen group and 60 patients in each of the other three groups. The pregnancy rates were 43.3%(26/60) in the combined group and 32.2%(19/60) in the Wenshen group, both significantly higher than that (10%) in the control group (χ2=17.56,P<0.01). Compared with the control group, the combined and Wenshen groups had increased mature follicle rates (P<0.01), while the Wenshen group showed a decreased luteinization rate (P<0.05). All the groups exhibited significant reductions in TCM symptom scores after treatment, and the Wenshen and combined groups had lower scores than the control group (P<0.01). No statistically significant difference was found in the incidence of adverse events among the four groups, and all the adverse events were mild. ConclusionWenshen Yangxue decoction combined with endometrial microstimulation can alleviate the TCM symptoms of infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis, promote follicular maturation and ovulation, increase the cumulative pregnancy rate, and has good safety. It can provide new clinical evidence for the integrated traditional Chinese and Western medicine treatment of PCOS infertility.
9.Randomized Controlled Study on Wenshen Yangxue Decoction Plus Endometrial Microstimulation for Polycystic Ovary Syndrome (PCOS) Infertility with Syndrome of Kidney-Yang Deficiency and Blood Stasis
Qianqian HUANG ; Qian HAN ; Mingwei XIN ; Junqin HE ; Jingshang WANG ; Xiaodan YIN ; Mengyuan LI ; Yanxiao YI ; Yanli TANG ; Yiting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):181-190
ObjectiveTo evaluate the clinical efficacy and safety of Wenshen Yangxue decoction combined with endometrial microstimulation in the treatment of infertile patients with polycystic ovary syndrome (PCOS, syndrome of kidney-Yang deficiency and blood stasis). MethodsA randomized, positive-drug parallel-controlled, open-label clinical study was conducted. A total of 240 infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis who met the inclusion and exclusion criteria were randomly assigned into 4 groups, with 60 patients in each group. The control group was treated with clomiphene citrate (50-100 mg·d-¹, orally for 5-10 consecutive days) for ovulation induction. On the basis of the therapy in the control group, the Wenshen group was additionally treated with Wenshen Yangxue decoction (250 mL, warm oral administration, twice daily, in the morning and evening), and the stimulation group received endometrial microstimulation during the early follicular phase. The combined group was treated with clomiphene citrate plus Wenshen Yangxue decoction (at the same dosages as aforementioned) and endometrial microstimulation. The course of treatment for all the groups was 3 menstrual cycles. The pregnancy rate, ovulation status, sex hormone levels, glucose metabolism indicators, coagulation function, endometrial thickness, traditional Chinese medicine (TCM) symptom scores, and adverse reactions were observed in each group. ResultsA total of 239 patients were included in the final analysis, with 59 patients in the Wenshen group and 60 patients in each of the other three groups. The pregnancy rates were 43.3%(26/60) in the combined group and 32.2%(19/60) in the Wenshen group, both significantly higher than that (10%) in the control group (χ2=17.56,P<0.01). Compared with the control group, the combined and Wenshen groups had increased mature follicle rates (P<0.01), while the Wenshen group showed a decreased luteinization rate (P<0.05). All the groups exhibited significant reductions in TCM symptom scores after treatment, and the Wenshen and combined groups had lower scores than the control group (P<0.01). No statistically significant difference was found in the incidence of adverse events among the four groups, and all the adverse events were mild. ConclusionWenshen Yangxue decoction combined with endometrial microstimulation can alleviate the TCM symptoms of infertile PCOS patients with the syndrome of kidney-Yang deficiency and blood stasis, promote follicular maturation and ovulation, increase the cumulative pregnancy rate, and has good safety. It can provide new clinical evidence for the integrated traditional Chinese and Western medicine treatment of PCOS infertility.
10.Clinical Efficacy of Yishen Jiangtang Decoction Combined with Conventional Western Medicine Treatment for Diabetic Kidney Disease with Pattern of Qi-Yin Deficiency Combined with Dampness-heat and Blood Stasis
Yunjie YANG ; Yasheng DENG ; Kaiying HE ; Qi ZHANG ; Yongxin YU ; Yaqing RUAN ; Zhuang HAN ; Qiwei CHEN ; Yi WEI ; Qiu CHEN ; Jing WU ; Mingqian JIANG ; Shiwei RUAN ; Jianting WANG ; Yuliang QIU ; Lixiang ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):157-167
ObjectiveTo observe the clinical efficacy and safety of Yishen Jiangtang decoction combined with conventional Western medicine treatment in managing stage G3A3 diabetic kidney disease (DKD) in the patients with the pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis, and to explore its mechanism of inhibiting the endoplasmic reticulum stress (ERS)-apoptosis axis and delaying renal fibrosis (RF). MethodsA single-center, randomized, parallel-controlled clinical trial was conducted. A total of 78 patients diagnosed with stage G3A3 DKD and traditional Chinese medicine (TCM) pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis and treated in the Department of Nephrology and the Department of Endocrinology of the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine from March 2025 to February 2026 were enrolled. They were randomly assigned at a 1∶1 ratio into a control group (conventional Western medicine treatment) and an experimental group (Yishen Jiangtang decoction combined with conventional Western medicine treatment), with 39 patients in each group. The treatment lasted for 12 weeks. Basic demographic data and medical history were collected before and after treatment. The two groups before and after treatment were compared in terms of the following parameters: Blood urea nitrogen (BUN), serum creatinine (SCr), estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), fasting blood glucose (FBG), triglycerides (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C). Enzyme-linked immunosorbent assay (ELISA) kits were used to measure serum glucose-regulated protein 78 (GRP78), serum cysteinyl aspartate-specific protease-3 (Caspase-3), and serum and urinary transforming growth factor-β1 (TGF-β1) levels before and after treatment. TCM symptom scores, TCM syndrome efficacy, and overall clinical efficacy were evaluated before and after treatment. Spearman correlation analysis was performed to explore the correlations of serum levels of GRP78 and Caspase-3, as well as serum and urinary levels of TGF-β1, with renal function, proteinuria, and glucose and lipid metabolism indicators in patients with DKD. In addition, safety indicators were also monitored. ResultsA total of 75 patients completed the study (38 in the control group and 37 in the experimental group). ① Baseline data: The two groups were comparable in terms of sex and age, with no statistically significant difference. ② Efficacy outcomes: Compared with baseline levels, both groups showed reductions in BUN, SCr, UACR, FBG, TG, TC, LDL-C, and TCM symptom scores (P<0.01) and increases in eGFR level (P<0.01). Moreover, the experimental group outperformed the control group in altering the indicators above (P<0.05). Regarding TCM syndrome efficacy, the total response rate in the experimental group was 83.78%, which was higher than that (57.89%) in the control group (P<0.05). Regarding overall clinical efficacy, the total response rate in the experimental group was 78.38%, which was higher than that (50.00%) in the control group (P<0.05). ③ Mechanism outcomes: Compared with baseline levels, both groups showed declined serum levels of GRP78, Caspase-3, and TGF-β1 and urinary level of TGF-β1 after treatment (P<0.01). Moreover, the experimental group showed greater declines than the control group (P<0.05). The serum levels of GRP78, Caspase-3,and TGF-β1 and the urinary level of TGF-β1 in DKD patients showed positive correlations with BUN, SCr, UACR, and FBG and negative correlations with eGFR (P<0.05). ④ Safety outcomes: Neither group showed drug-related adverse reactions, and laboratory safety parameters remained within normal ranges. ConclusionYishen Jiangtang decoction combined with conventional Western medicine treatment may safely and effectively alleviate clinical symptoms, correct glucose and lipid metabolism disorders, and protect the renal function in patients with stage G3A3 DKD and the pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis. The mechanism may be associated with inhibition of the ERS-apoptosis axis and delay of the RF process.

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