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Volume 32 ， Issue 3 ， 2026
- Abstract：Objective:To evaluate the efficacy and safety of Qiming Granule as an early treatment for patients with nerve injury associated with non-proliferative diabetic retinopathy (NPDR).Methods:This was a multicenter, randomized, non-inferiority, active-controlled clinical trial. Patients with NPDR complicated with nerve injury, regardless of whether they presented with fundus abnormalities, were randomly assigned in a 1:1 ratio via a randomized number table to orally receive either 4.5 g of Qiming Granule or 0.5 g of calcium dobesilate (CaD), both 3 times daily for 24 weeks. The primary endpoints were changes in retinal nerve fiber layer (RNFL) thickness and foveal avascular zone (FAZ) area from baseline to week 24. The secondary endpoints included changes in RNFL thickness and FAZ area from baseline to week 12, and visual function questionnaire (NEI-VFQ-25) and health survey questionnaire (SF-36 scale), CM syndrome element scale score and the rates of abnormal full-field electroretinogram (ERG), abnormal dilated fundus, and abnormal visual acuity at treatment of weeks 12 and 24. Adverse drug reactions (ADRs) were detected.Results:A total of 82 patients were enrolled in the study. Changes in RNFL thickness from baseline to week 24 in the Qiming Granule and CaD groups were –1.53±9.88 μm and –4.61±9.23 μm, respectively (a difference of 3.08 μm [97.5% CI: –2.11 to 8.25]). Changes in FAZ area from baseline to week 24 were –0.08±0.39 mm2 and 0.01±0.05 mm2, respectively (a difference of –0.09 mm2 [97.5% CI: –0.26 to 0.08]). Non-inferiority was achieved for both primary endpoints. There were no significant differences between the two groups in secondary endpoints, including changes in RNFL thickness and FAZ area from baseline to week 12, rates of abnormal ERG, dilated fundus, and visual acuity results at weeks 12 and 24, as well as NEI-VFQ-25, SF-36 scale, and CM syndrome element scale scores at week 24. ADRs were detected in 4 (9.76%) and 1 (2.44%) patients in the Qiming Granule and CaD groups, respectively. No serious ADRs occurred.Conclusion:Qiming Granule demonstrates non-inferiority in terms of efficacy and safety as an early treatment for nerve injury associated with NPDR. (Registration No. ISRCTN39825773)Keywords：Qiming Granule;non-proliferative diabetic retinopathy;nerve injury;randomized controlled trial;Chinese medicine0|0|0Updated：2026-02-14
- Abstract：Objective:To assess the efficacy and safety profile of Aurantii Fructus Immaturus flavonoid (AFIF) tablets in the treatment of patients with functional dyspepsia (FD).Methods:In this phase Ⅲ, randomized, controlled clinical trial, participants diagnosed with FD from 7 medical centers across China were assigned by stratified block randomization to either AFIF treatment group (3 AFIF tablets, 0.29 g per tablet) or placebo group on the same schedule in a 3:1 ratio. The primary endpoint was the complete disappearance of 4 core FD symptoms, including postprandial fullness, early satiety, upper abdominal pain, and upper abdominal burning, following a 4-week treatment regimen (3 times daily). Secondary endpoints included the individual symptom disappearance rates and gastric emptying function after 4 weeks, as well as the disappearance rates for all 4 individual symptoms of FD at 4 weeks after treatment. Subgroup analyses included 3 clinical symptoms and 4 Chinese medicine patterns. Safety assessments included monitoring treatment-emergent adverse events (AEs), serious adverse events (SAEs), intervention-related AEs, and any AEs leading to discontinuation.Results:Of the enrolled patients, 299 in the AFIF group and 99 in the control group were induded in the full analysis set (FAS) and safety set (SS). After 4 weeks of treatment, the complete disappearance of all 4 core FD symptoms was achieved in 31.44% (94 cases) of patients in the AFIF group compared to 6.06% (6 cases) in the placebo group (P <0.01). At 4 weeks after end of treatment, the rates of symptom disappearance were 23.43% (67 cases) in the AFIF group and 2.22% (2 cases) in the placebo group (P <0.01). Individual symptom disappearance rates were significantly higher in the AFIF group at both week 4 and 4 weeks after treatment (all P <0.01). Additionally, the patients in the AFIF group exhibited a significantly greater improvement in gastric emptying at 2 h post-meal [66.55% (50.03, 84.55)] compared to the placebo group [51.10% (44.75, 68.93), P = 0.027]. At weeks 4 and 4 weeks after treatment, in the FAS, the disappearance rates of all 4 core FD symptoms remained higher in the AFIF group compared to the placebo group (all P <0.05). The per protocol set results similarly aligned with those observed in the FAS. Intervention-related AEs were reported in 6.02% (18 cases) of the AFIF group and 8.08% (8 cases) in the placebo group, with no SAEs recorded in either group. The patients in the AFIF group showed significantly higher complete symptom resolution rates of all 4 core FD symptoms at 4 weeks and 4 weeks after treatment across most subgroups, compared to the placebo group (all P <0.05). All AEs related to AFIF Tablets were mild.Conclusion:AFIF tablets demonstrated robust efficacy in alleviating the symptoms of FD, with a favorable safety profile. (Registration No. CTR20132482)Keywords：Chinese medicine;Aurantii Fructus Immaturus;functional dyspepsia;phase Ⅲ trial;efficacy;safety;randomized controlled trial0|0|0Updated：2026-02-14
- Abstract：Objective:To investigate the inhibitory effects and underlying mechanisms of Qideng Mingmu Capsule (QD) on retinal neovascularization (RNV).Methods:Seven-day-old C57BL/6J mice were assigned to the following groups: control, oxygen-induced retinopathy (OIR), low-, medium-, high-dose QD (225, 450, and 900 mg/g daily), and angiopoietin 1 (Ang1), 20 mice in each group. Except for the control group, an OIR model was induced by exposing mice to a hyperoxic environment for 5 d (postnatal days 7–12), followed by a normoxic environment for 5 d (postnatal days 12–17). From day 12, the treatment groups received QD orally or Ang1 via binocular intravitreal injection. On day 17, hematoxylin and eosin staining and fluorescein isothiocyanate-dextran staining were performed to evaluate RNV growth. Immunofluorescence staining, immunohistochemistry, and Western blotting were used to analyze the expressions of Ang/tyrosine kinase with immunoglobulin and epidermal growth factor homology domain-2 (Tie2) signaling pathway, hypoxia-inducible factor-1α (HIF-1α), and retinal vascular maturation markers. In addition, the effects of QD on the viability of rat retinal microvascular endothelial cells (rRMECs) was assessed.Results:QD significantly inhibited RNV formation, reduced RNV density, increased the expressions of Ang1, Tie2, and phosphorylated protein kinase B, and decreased the expression of Ang2 (P<0.05 or P<0.01). QD also enhanced retinal vascular pericyte coverage, reduced HIF-1α expression, and increased vascular endothelial cadherin levels (P<0.05 or P<0.01). Furthermore, no adverse effects were observed on the viability of rRMECs after QD intervention.Conclusions:QD effectively inhibited RNV formation, promoted neovascular maturation and remodeling, and protected retinal function by modulating the Ang/Tie2 signaling pathway. Therefore, QD may serve as a promising therapeutic option for retinal neovascular diseases.Keywords：Qideng Mingmu Capsule;Chinese medicine;angiopoietin;tyrosine kinase receptor;retinal neovascularization;oxygen-induced retinopathy0|0|0Updated：2026-02-14
- Abstract：Objective:To evaluate the effects of Sanren Decoction (SRD) on metabolic dysfunction-associated steatotic liver disease (MASLD) induced by high-fat diet (HFD) based on the protective effect of hepatocyte mitochondrial function.Methods:Thirty-six male C57BL/6 mice were randomly assigned to 4 groups using stratified sampling based on body weight, including control, HFD, low-dose (10.09 g/kg) and high-dose (20.18 g/kg) SRD groups (n=9). MASLD model was induced in mice via a 16-week HFD. Liver histopathology was assessed using haematoxylin and eosin (HE) and Oil red O staining, while hepatic triglycerides (TG), serum alanine aminotransferase (ALT), fasting blood glucose (FBG), and fasting serum insulin levels were measured using commercial kits. Hepaticmetabolic profiling were analyzed and differential metabolite analysis was performed using partial least squares discriminant analysis and Kyoto Encyclopedia of Genes and Genomes pathways. Mitochondrial microstructure was assessed by electron microscopy. The protein expressions of respiratory chain complexes Ⅰ–Ⅴ were determined by Western blot analysis, while the activities of complexes Ⅰ and Ⅱ were measured using commercial kits.Results:In the HFD-induced MASLD model, 4-week SRD treatment improved hepatic steatosis, inflammation, and hepatocyte ballooning (P<0.05). High-dose SRD treatment significantly reduced hepatic TG, ALT levels, and improved insulin sensitivity (both P<0.05). Low-dose SRD significantly reduced hepatic TG and FBG (P<0.05). Metabolomic analysis showed that differential liver metabolites were enriched in tricarboxylic acid cycle (TAC) pathway in mice of high-dose SRD and HFD groups. Electron microscopy showed that high-dose SRD improved mitochondrial morphology and enhanced adenosine triphosphate production and fatty acid oxidation activity (both P<0.05). Additionally, high-dose SRD significantly decreased the contents of hydrogen peroxide and malondialdehyde in liver tissue and increased the content of superoxide dismutase (both P<0.05). Treatment with high-dose SRD resulted in a significant increase in both protein expression and activity of mitochondrial complex Ⅱ. Additionally, high-dose SRD enhanced the protein expression of mitochondrial complex Ⅰ (both P<0.05).Conclusion:SRD exhibited hepatoprotective effects in MASLD, improving liver morphology, metabolism, and mitochondrial function, suggesting its potential as a therapeutic strategy for MASLD.Keywords：Sanren Decoction;metabolic dysfunction-associated steatotic liver disease;mitochondrial function;metabolomic analysis;Chinese medicine2|0|0Updated：2026-02-14
- Abstract：Objective:To investigate therapeutic effects of Huanglian Jiedu Decoction (HLJDD) on metabolic-associated fatty liver disease (MAFLD) and explore its underlying mechanisms.Methods:Q-Orbitrap liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to identify the incoming blood compounds of HLJDD. In vivo, high-fat diet (HFD)-induced MAFLD rats received HLJDD (5.4, 2.7, 1.35 g/kg) or silybin (37.8 mg/kg) once daily for 6 weeks. The rats fed with normal diets were served as control. Serum lipids were biochemically determined; and hepatic steatosis and lipid accumulation were evaluated with H&E and Oil red O stainings. In vitro, palmitic acid (PA)-treated HepG2 cells were co-incubated with 10% HLJDD drug-containing serum. Intracellular triglyceride (TG), total cholesterol (TC) and nonesterified fatty acids (NEFA) levels were detected and lipid droplet changes in HepG2 cells were observed by Oil red O staining. RT-qPCR and Western blot were employed to assess the expressions of lipid metabolic-related genes [diacylglycerol acyltransferase 2 (DGAT2), stearoyl-coenzyme A desaturase 1 (SCD1)] and components of the inositol-requiring enzyme 1alpha/X-box-binding protein-1 spliced (IRE1α/XBP1s) signaling pathway.Results:A total of 43 active compounds of HLJDD were identified. In HFD-fed rats, HLJDD treatment significantly improved hepatic TG and TC and increased HDL-C level (P<0.05 or P<0.01), and also markedly reduced serum levels of TG, TC, LDL-C, ALT, and AST (P<0.05 or P<0.01). H&E and Oil red O stainings further revealed that HLJDD effectively alleviated hepatic steatosis and attenuated lipid accumulation in the liver tissues. In PA-treated HepG2 cells, HLJDD treatment significantly reduced intracellular levels of TG, TC, and NEFA (P<0.05 or P<0.01), as well as lipid accumulation. More importantly, HLJDD treatment exerted therapeutic effects in both HFD-fed rats and PA-induced HepG2 cells by down-regulating lipid metabolic-related genes DGAT2, SCD1 and suppressing the IRE1α/XBP1s pathway related protein expressions (P<0.05 or P<0.01).Conclusion:HLJDD ameliorates MAFLD by modulating lipid metabolism through IRE1α/XBP1s signaling pathway, providing pharmacological evidence for its clinical application.Keywords：metabolic-associated fatty liver disease;Huanglian Jiedu Decoction;inositol-requiring enzyme 1alpha/X-box-binding protein-1 spliced signaling pathway;Chinese medicine1|0|0Updated：2026-02-14
- Abstract：Objective:To investigate the therapeutic effects of aqueous infusion of Cotinus coggygria Scop. leaves (CCLAI) on the dextran sulphate sodium (DSS)-induced ulcerative colitis (UC) in mice.Methods:A total of 56 C57BL16J mice were divided into 7 groups, including control, DSS model, CCLAI4, CCLAI6, DSS + CCLAI4, DSS + CCLAI6 and DSS + mesalamine groups (n=8). Induction of UC was conducted by 7-day treatment of 3% DSS in mice. CCLAI in 2 different doses (4% and 6%) or mesalamine (250 mg/kg) was administered to C57BL/6J mice orally for 7 consecutive days. The mice in the control group received only tap water. Clinical parameters, antioxidant and anti-inflammatory activities, and histopathological changes in the colon mucosa were examined. Cell proliferatipn index in colon section was determined by immunonistochemical analysis. Colonic cyclooxygenase (COX)-2 and inducible nitric oxide synthase (iNOS) expression levels were detected by Western blot.Results:CCLAI treatment inhibited DSS-induced colon shortening and significantly improved the Disease Activity Index score (P<0.05 or P<0.01). We also found a significant decrease in myeloperoxidase levels, oxidative stress parameters, and neutrophil infiltration index in the experimental groups receiving CCLAI compared to the control group (all P<0.01). In addition, it was observed that CCLAI administration for 7 days decreased the pro-inflammatory cytokines levels including interleukin (IL)-1β, IL-6, interferon-γ, and tumor necrosis factor-α in the colon tissues of mice receiving DSS (P<0.05). Further, CCLAI treatment reduced the COX-2 and iNOS levels with an accompanying decrease in prostaglandin E2 and nitric oxide levels, respectively. Additionally, CCLAI treatment markedly decreased the histological lesion score, which was consistent with the reduction of the pro-inflammatory cytokine levels.Conclusion:CCLAI treatment significantly improved the DSS-induced UC in mice by diminishing histopathological damage in the colonic mucosa and markedly decreased the inflammatory response through inhibiting the formation of inflammatory cytokines and markers of oxidative stress.Keywords：Cotinus coggygria Scop;antioxidant activity;anti-inflammatory activity;ulcerative colitis;dextran sulphate sodium2|0|0Updated：2026-02-14
- Abstract：Objective:To explore whether polysaccharide of Danggui Buxue Decoction (formula polysaccharide, FP) could attenuate colorectal cancer (CRC) via modulating intestinal microflora and metabolites.Methods:A total of 30 male C57BL/6 mice were randomly assigned to 3 groups according to body weight, including normal control, CRC model and FP groups (n=10). Dextran sulfate sodium and azoxymethane were used to induce CRC model. The mice in FP group were treated with FP [0.9 g/(kg•d)] for 8 weeks. Then the coloretal length, weight and tumors number of colorectal tissues were observed. Colonic tissues were stained with hematoxylin and eosin to evaluate the histological changes. Tight junction proteins including claudin 1 and zonula occludens-1 (ZO-1) were detected using immunohistochemistry. Serum concentrations of endothelial cell specific molecule-1 and carcino embryonic antigen were determined using enzyme-linked immunosorbent assays. Toll-like receptor 4 (TLR4)/nuclear transcription factor-κB (NF-κB) p65 signal-related mRNA and proteins expressions were detected using real-time polymerase chain reaction and Western blot, respectively. Feces samples were detected with 16S rRNA and liquid chromatography-mass spectrometry and non-targeted metabolomics sequencing was used to analyze the composition of intestinal microbiota and metabolic changes.Results:FP significantly inhibited colorectal tumor growth, attenuated body weight loss, repaired colonic structure, improved intestinal barrier dysfunction, reduced colonic inflammatory cytokine levels and inhibited TLR4/NF-κB pathway related mRNA and protein expressions (all P<0.01). Moreover, FP altered the gut microbiota composition of CRC mice dramatically, characterized by a reduction of Firmicutes-Bacteroidetes ratio at the phylum level. FP suppressed Lachnospiraceae_NK4A136_group, Odoribacter and Romboutsia (P<0.05 or P<0.01), and elevated the abundance of Dubosiella, Candidatus_Saccharimonas and Alloprevotella at the genus level (P<0.01). Non-targeted metabolomics sequencing detected significant differences in metabolites, and the functions of differential metabolites were focused on regulating amino acid metabolism, lipid metabolism and metabolism of cofactors and vitamins.Conclusions:FP attenuates colonic injury and intestinal inflammatory response in CRC mice, repairs disrupted-intestinal microbiota, and improves metabolites. This research provides experimental basis for application of FP as a potential therapeutic agent for CRC.Keywords：Danggui Buxue Decoction;polysaccharide;colorectal cancer;intestinal microflora;metabolites;Chinese medicine1|0|0Updated：2026-02-14
Original Article
- Abstract：Objective:To evaluate the effects and safety of auricular acupressure combined with periocular thumbtack needle (AATN) therapy for premyopia children.Methods:This multi-center, randomized, controlled trial was conducted in 8 Chinese hospitals, and 298 premyopic children aged 6 to 10 years were recruited between October 2020 and February 2022. Eligible participants were randomly assigned to the treatment group or the control group via a simple randomization method. All the participants in both groups were provided with standard intensive eye health instruction through phone calls, WeChat or hospital visits once a week, and the children in the treatment group received AATN therapy additionally. Following 12-week treatment, participants were followed up at 3-month intervals, with the entire study extending over a 9-month duration from baseline to the final assessment. The primary outcome was the mean change in spherical equivalent (SE) from baseline to 36 weeks. The secondary outcomes included the rate of children with stable myopia (MSR), uncorrected visual acuity (UCVA), axial length (AL), corneal curvature (CC), accommodative amplitude (AMP) and intraocular pressure (IOP) at baseline, 6,12, 24 and 36 weeks. Safety assessment included analysis of treatment-related adverse events (AEs), such as allergic reactions and skin damage.Results:Totally, 298 children with premyopia were included, 151 in the treatment group and 147 in the control group. At the 36th week, the SE was –0.81±0.55 D in the control group and –0.65±0.44 D in the treatment group (P=0.002). The treatment group demonstrated superior SE control efficacy compared with the control group, with differences of –0.29±0.37 D and –0.49±0.44 D, respectively (P<0.01). The children in the treatment group achieved a MSR of 57.78% with more favorable outcome than 37.10% in the control group (P<0.01). The adjusted mean change in AMP from baseline to 9th month was 8.85±4.02 in the control group and 9.85±3.41 in the treatment group (P=0.018). AL increased by a mean of 0.35±0.28 mm in the control group and 0.20±0.42 mm in the treatment group (P=0.004). No significant differences in UCVA or CC were found between the two groups (P>0.05) and no AEs were reported.Conclusion:AATN therapy was effective for controlling the onset of myopia and SE, enhancing ocular accommodation, and mitigating AL. (Registration No. ChiCTR2000039299)Keywords：myopia;Chinese medicine;auricular acupressure;thumbtack needle;children;randomized controlled trial2|0|0Updated：2026-02-14
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