1.Efficacy and safety of Babaodan Capsule in patients with chronic hepatitis B virus infection comorbid with gallbladder polyps
Qianqian NIU ; Huan CHEN ; Ying ZHENG ; Chunyan GOU ; Chen XU ; Li LI ; Xinxin WANG ; Jianping LIU ; Zhaolan LIU ; Xiuhui LI
Journal of Clinical Hepatology 2026;42(2):304-311
ObjectiveTo investigate the efficacy and safety of Babaodan Capsule (BBD) in the treatment of patients with chronic hepatitis B virus (HBV) infection with damp-heat in the liver and gallbladder comorbid with gallbladder polyps. MethodsA randomized, double-blinded, placebo-controlled single-center trial was conducted among 120 patients with chronic HBV infection who were admitted to Beijing YouAn Hospital, Capital Medical University, from August 2020 to April 2023, and they were divided into treatment group (BBD) and control group (placebo), with 60 patients in each group. The course of treatment was 24 weeks, and follow-up assessments were conducted every 4 weeks. The primary outcome measures were the number and maximum diameter of gallbladder polyps (assessed by ultrasound), and the secondary outcome measures included traditional Chinese medicine (TCM) syndrome score, blood lipid levels, and liver function parameters. The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups; the Wilcoxon rank-sum test was used for comparison of ranked data between two groups; the generalized estimating equation was used to analyze repeated measures data. ResultsAfter 8 weeks of treatment, the treatment group had a significantly smaller diameter of polyps and a significantly lower number of polyps than the control group (Z=-1.76 and -1.80, both P<0.05), and after 24 weeks of treatment, the treatment group had a significantly higher polyp reduction rate than the control group (30.51% vs 10.91%, P<0.05). The subgroup analysis showed that patients receiving combined antiviral therapy, male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps tended to achieve significantly greater benefits. At week 8 of treatment, the treatment group had a significantly better TCM syndrome score than the control group (Z=-2.35, P<0.05); after treatment, compared with the control group, the treatment group had a significantly greater increase in high-density lipoprotein (Z=-1.85, P<0.05) and significantly lower levels of alanine aminotransferase (Z=-2.06, P <0.05), aspartate aminotransferase (Z=-2.13, P<0.05), total bilirubin (Z=-2.12, P<0.05), and direct bilirubin (Z=-3.09, P<0.05). No serious adverse events were reported in either group. ConclusionBBD can effectively reduce the size of gallbladder polyps, improve TCM syndrome score, and reduce the level of bilirubin in patients with chronic HBV infection with damp-heat in the liver and gallbladder, with a favorable safety profile, and it may be more suitable for patients receiving combined antiviral therapy and specific subgroups (male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps.
2.Evidence-based evaluation and hierarchical management of off-label use of 5-aminolevulinic acid in photodynamic therapy
Jing MA ; Tingting LIU ; Xiaoshuang GOU ; Xue YANG ; Chen LI ; Fang LIU ; Yao LIU
China Pharmacy 2026;37(8):1056-1061
OBJECTIVE To provide reference for medical institutions to establish the record management mode and review rules of off-label use of 5-aminolevulinic acid (ALA) in photodynamic therapy based on the level of evidence. METHODS All ALA-containing outpatient prescriptions in the rational drug use system in our hospital from January 1, 2024 to December 31, 2025 were retrospectively collected. Based on the drug instructions, the current status of off-label use of ALA in photodynamic therapy was identified . The relevant studies in Micromedex, PubMed, CNKI, Wanfang Data and other databases were systematically searched as the relevant evidence-based evidence of ALA off-label use. According to the Off-label Drug Use Filing Standard of the hospital,the evidence-based evaluation method was used to evaluate the evidence-based evidence of ALA off-label use and carry out hierarchical management. RESULTS A total of 1 803 effective prescriptions were included, of which 676 (37.49%) were off-label use, distributed in the dermatology department (564 prescriptions,83.43%) and the plastic surgery department (112 prescriptions,16.57%). All 676 prescriptions were off-indications medication, involving ten types of skin diseases, primarily including moderate to severe acne (39.94%), skin warts (25.44%), Bowen’s disease (11.98%), and others. According to evidence-based evidence,off-label uses such as moderate to severe acne, actinic keratosis, and Bowen’s disease were managed according to the evidence categoryⅠ orⅡ.The uses of extramammary Paget’s disease and rosacea were managed according to the evidence category Ⅲ.The uses of lichen sclerosus and keloids were managed according to the evidence category Ⅳ.The results of evidence-based evaluation showed that 92.01% of off-label use in our hospital had high-level evidence-based support ( evidence category was gradeⅠ-Ⅱ). CONCLUSIONS Off-label uses supported by high-level evidence, such as moderate to severe acne, skin warts, and Bowen’s disease, can be managed under filing category Ⅰ or Ⅱ. For the use of lichen sclerosus and keloids, evidence-based evidence is insufficient and should be strictly restricted.The vast majority of ALA off-label use in our hospital has sufficient evidence-based basis.
3.Biomechanical characteristics of walking in patients with idiopathic scoliosis:cross-sectional analysis of three-dimensional motion capture
Yanyun GOU ; Meijin HOU ; Zheng JIANG ; Shaoqing CHEN ; Xiang CHEN ; Yuzhan GAO ; Xiangbin WANG
Chinese Journal of Tissue Engineering Research 2025;29(3):471-477
BACKGROUND:The biomechanical analysis of scoliosis cases is limited,with only independent analysis focusing on the spine or lower limbs,thus lacking a comprehensive evaluation of the multidimensional body.As a result,it becomes challenging to reflect the movement relationship between the trunk and lower limbs during daily activities,which hinders comprehensive clinical treatment guidance. OBJECTIVE:To explore the relationship between different segments of the spine and the kinematics/kinetics of the lower limbs during gait activities by measuring spinal kinematics in scoliosis patients,to provide a comprehensive and multi-level assessment of the biomechanical differences between scoliosis patients and the normal population,consequently offering evidence-based guidance for the prevention and treatment of scoliosis. METHODS:A cross-sectional study was conducted from July 2020 to June 2021 at the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine in Fuzhou University City.A total of 28 scoliosis patients and 28 normal individuals in the same age group were included.Three-dimensional motion capture system was used to capture gait kinematic data at a sampling frequency of 100 Hz.Two force plates(AMTI 400600,sampling frequency 1 500 Hz)were embedded in a 10-meter-long 2.4-meter-wide level ground walkway(with an effective data collection length of 4 m)to collect kinetic data.The differences in spatial-temporal parameters,kinematics,and kinetics of gait between the two groups were compared.Immediately after inclusion,all subjects underwent full spinal X-ray measurements to compare the differences between the scoliosis and normal groups. RESULTS AND CONCLUSION:(1)Patients with scoliosis exhibited reduced relative rotational range of motion between the shoulder and trunk,as well as between the thorax and pelvis,compared to the normal group(P<0.05).However,the rotational range of motion in the pelvis was larger in patients with scoliosis compared to the normal group(P<0.05).(2)Patients with scoliosis showed decreased range of motion in the hip and knee joints,as well as reduced peak torque in hip joint flexion and extension,and lower peak values of ground reaction forces in the concave and convex directions,in comparison to the normal group(P<0.05).(3)Patients with scoliosis demonstrated greater asymmetry indices in knee joint range of motion,relative rotational range of motion between the shoulder and trunk,and between the thorax and pelvis,when compared to the normal group(P<0.05).(4)These findings illustrate a rigid movement pattern among the shoulder,thorax,and pelvis in patients with scoliosis during level walking.There is a reduction in range of motion in the hip and knee joints,as well as decreased peak torque values in hip joint flexion and extension,and ground reaction forces in the concave and convex directions.These characteristics can serve as foundational elements for assessing rehabilitation and developing treatment plans.
4.Results of treating bleeding disorders with Mongolian medicine Gurgem-8
Gou Qing ; Khaliun B ; Chen Shana ; Tsend-Ayush D
Mongolian Journal of Health Sciences 2025;85(1):201-206
Background:
From the perspective of Mongolian medicine, hemorrhagic disease is a symptom of bleeding from any part
of the body. This disease was compared to the immune thrombocytopenia disease of modern medicine. The treatment of
this disease using two medical methods and the prevention of complications and relapses are issues facing the healthcare
sector. In this regard, we have chosen this topic to clarify and prove the mechanism of action of the Mongolian drug Gurgem-8, which is widely used to treat bleeding disorders.
Aim:
To evaluate the therapeutic efficacy of Gurgem-8, in haemostatic treatment.
Materials and Methods:
The study was conducted using a randomized, controlled (active), open label, single centered
clinical trial method. The study was conducted in two phases. First, an acute toxicity study of the Gurgem-8, was conducted in accordance with OECD guideline 423 and evaluated according to GHS classification. A chronic toxicity study
was also conducted on Wistar rats (n=20) given the Gurgem-8, at doses of 500 mg/kg, 100 mg/kg, and 150 mg/kg daily
for 60 days. Second, a clinical study was conducted on a total of 74 patients, who were randomly divided into 2 groups.
The treatment group was given 3 grams of the Gurgem-8, daily, and the comparison group was given 4 capsules of Sheng
Xue Xiao Ban Jiao Nang 3 times a day. The results were determined by laboratory methods. The study was conducted
with the approval of the Research Ethics Committee of Mongolian National University od Medical Sciences (2024.01.19
№2024/3-01).
Results:
In the acute toxicity study, Turmeric-8 was found to be of low toxicity according to the GHS classification. No
mortality was observed in the chronic toxicity test. As a result of the clinical study, there were significant differences in the
blood hemoglobin (χ2=73.923, P<0.001), platelet (χ2=62.465, P<0.001), erythrocyte (χ2=77.113, P<0.001) and leukocyte
(χ2=14.771, P<0.001) cell counts between the Gurgem-8, drug group and the comparison group. It was also determined
that the platelet (χ2=138.3, P<0.001), erythrocyte (χ2=85.405, P<0.001) and leukocyte (χ2=10.961, P=0.027) cell counts
were directly related to the treatment period and the group. When determining the effect on immune cells, there was no
significant difference in the lymphocyte cell content before and after treatment (CD4+: t=0.233, P=0.817; CD8+: t=-0.264, P=0.793; CD4/CD8:Z=-0.119, P=0.905). However, the CD4/CD8 ratio was statistically significantly increased in
each of the Gurgem-8, drug group and the comparison group (P<0.001, P=0.001).
Conclusion
In immune thrombocytopenia diseases, the Gurgem-8, has the effect of reducing hemoglobin levels in the
blood, increasing platelet counts, reducing CD4+ and CD8+ T cell counts, and increasing the CD4/CD8 ratio.
5.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
6.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
7.Effects of Zuogui Jiangtang Qingzhi Formula on the cGAS/STING/TBK1 signaling pathway in mice with type 2 diabetes mellitus combined with non-alcoholic fatty liver disease
Yangyang GOU ; Jiahui MA ; Cong CHEN
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):370-378
Objective:
To investigate how Zuogui Jiangtang Qingzhi Formula (ZGJTQZF), a traditional Chinese medicine compound for lowering blood glucose levels and clearing lipids based on Zuogui Pill, regulates the cyclic GMP-AMP synthase (cGAS)/stimulator of interferon genes (STING)/TANK-binding kinase 1 (TBK1) signaling pathway to improve type 2 diabetes mellitus combined with non-alcoholic fatty liver disease.
Methods:
According to fasting blood glucose (FBG) levels, body weight, and sex, 40 MKR mice, with half being male and the other half female, were randomly divided into four groups: blank, model, ZGJTQZF (29.6 g/kg), metformin + simvastatin ([65.0+ 2.6] mg/kg), 10 mice per group, and a normal group consisting of 10 age-matched FVB mice. Mice in all groups, except in the normal and blank groups, were fed a high-fat diet for 8 weeks to induce the disease model. Each group received daily gavage of the respective treatments for 8 weeks after successful modeling. Various parameters were measured, including FBG, liver function (alanine aminotransferase [ALT] and aspartate transaminase [AST]), and blood lipids (triglyceride [TG] and total cholesterol [TC]). Serum levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) were determined using enzyme-linked immunosorbent assays. Histological liver changes were examined using transmission electron and optical microscope. cGAS, STING, and TBK1 protein and mRNA expression levels in liver tissues were detected using Western blotting and real-time PCR, respectively.
Results:
Compared with the normal group, the model group exhibited significant fat accumulation in hepatocytes and liver damage. Additionally, FBG, ALT, AST, serum TNF-α, IL-6, cGAS, STING and TBK1 expression levels in liver tissues were significantly elevated (P<0.05). Treatment with ZGJTQZF and metformin + simvastatin significantly improved FBG, ALT, AST, TG, TC, TNF-α, and IL-6 (P<0.01). Histologically, hepatic steatosis was notably alleviated. Expression of protein and mRNA of cGAS, STING, and TBK1 in liver tissues was significantly reduced (P<0.05).
Conclusion
ZGJTQZF improves lipid and glucose metabolism, mitigates liver injury, and reduces inflammatory markers in MKR mice. These effects may be mediated through the regulation of the cGAS/STING/TBK1 signaling pathway.
8.Five patients undergoing 5G remote robot-assisted thoracoscopic surgery
Zhuang ZUO ; Xu TANG ; Wenlong CHEN ; Dacheng JIN ; Wei CAO ; Yunjiu GOU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(05):594-597
Objective To evaluate the safety and feasibility of remote robot-assisted thoracoscopic surgery utilizing 5G technology. Methods Clinical data from five patients who underwent 5G remote robot-assisted thoracoscopic surgery at the Thoracic Surgery Center of Gansu Provincial People's Hospital from May to October 2024 were retrospectively analyzed. Results Finally, five patients were included. There were 2 males and 3 females at median age of 50 (42-63) years. All five surgeries (including 1 patient of lobectomy, 3 patients of partial lung resection and 1 patient of mediastinal lesion resection) were successfully completed without conversion to thoracotomy, complications, or mortality. The median intraoperative signal delay across the patients was 39 (37-42) ms. The median psychological load score for the surgeons was 9 (3-13). The median operation time was 100 (80-122) minutes with a median intraoperative blood loss of 100 (30-200) mL. Catheter drainage lasted a median of 4 (3-5) days, and the median drainage volumes on the first, second, and third postoperative day were 200 (100-300) mL, 150 (60-220) mL, and 80 (30-180) mL, respectively. The median postoperative hospital stay was 4 (3-7) days, and the median pain scores on the third postoperative day were 3 (1-4), 3 (0-3), and 1 (0-3), respectively. Conclusion 5G remote robot-assisted thoracoscopic surgery is safe and effective, with good surgical experience, smooth operation and small intraoperative delay.
9.Multi-source adversarial adaptation with calibration for electroencephalogram-based classification of meditation and resting states.
Mingyu GOU ; Haolong YIN ; Tianzhen CHEN ; Fei CHENG ; Jiang DU ; Baoliang LYU ; Weilong ZHENG
Journal of Biomedical Engineering 2025;42(4):668-677
Meditation aims to guide individuals into a state of deep calm and focused attention, and in recent years, it has shown promising potential in the field of medical treatment. Numerous studies have demonstrated that electroencephalogram (EEG) patterns change during meditation, suggesting the feasibility of using deep learning techniques to monitor meditation states. However, significant inter-subject differences in EEG signals poses challenges to the performance of such monitoring systems. To address this issue, this study proposed a novel model-calibrated multi-source adversarial adaptation network (CMAAN). The model first trained multiple domain-adversarial neural networks in a pairwise manner between various source-domain individuals and the target-domain individual. These networks were then integrated through a calibration process using a small amount of labeled data from the target domain to enhance performance. We evaluated the proposed model on an EEG dataset collected from 18 subjects undergoing methamphetamine rehabilitation. The model achieved a classification accuracy of 73.09%. Additionally, based on the learned model, we analyzed the key EEG frequency bands and brain regions involved in the meditation process. The proposed multi-source domain adaptation framework improves both the performance and robustness of EEG-based meditation monitoring and holds great promise for applications in biomedical informatics and clinical practice.
Humans
;
Electroencephalography/methods*
;
Meditation
;
Calibration
;
Neural Networks, Computer
;
Brain/physiology*
;
Rest/physiology*
;
Deep Learning
;
Signal Processing, Computer-Assisted
10.Serratia marcescens TF-1 for biodegradation of chlorobenzene contaminants in soil and its application in in-situ remediation of chemical industrial sites.
Fang GOU ; Yunchun SHI ; Hao CHEN ; Wenting FU ; Liangjie LI ; Zhilin XING ; Jiangfeng GUO
Chinese Journal of Biotechnology 2025;41(6):2483-2497
Chlorobenzene contaminants (CBs) pose a threat to the eco-environment, and functional strains hold considerable potential for the remediation of CB-contaminated sites. To deeply explore the application potential of functional bacteria in the in-situ bioremediation of CBs, this study focused on the biodegradation characteristics and degradation kinetics of CB and 1, 2-dichlorobenzene (1, 2-DCB) in soil by the isolated strain Serratia marcescens TF-1. Additionally, an in-situ remediation trial was conducted with this strain at a chemical industrial site. Batch serum bottle experiments showed that the degradation rate of CB at the concentrations ranging from 20 to 200 mg/L by TF-1 was 0.22-0.66 mol/(gcell·h), following the Haldane model, with the optimal concentration at 23.12 mg/L. The results from simulated soil degradation experiments indicated that the combined use of TF-1 and sodium succinate (SS) significantly enhanced the degradation of CBs, with the maximum degradation rate of CB reaching 0.104 d-1 and a half-life of 6.66 d. For 1, 2-DCB, the maximum degradation rate constant was 0.068 7 d-1, with a half-life of 10.087 d. The in-situ remediation results at the chemically contaminated site demonstrated that the introduction of bacterial inoculant and SS significantly improved the removal of CBs, achieving the removal rates of 84.2%-100% after 10 d. CB, 1, 4-dichlorobenzene (1, 4-DCB), and benzo[a]pyrene were completely removed. Microbial diversity analysis revealed that the in-situ remediation facilitated the colonization of TF-1 and the enrichment of indigenous nitrogen-fixing Azoarcus, which may have played a key role in the degradation process. This study provides a theoretical basis and practical experience for the in situ bioremediation of CBs-contaminated sites.
Chlorobenzenes/isolation & purification*
;
Biodegradation, Environmental
;
Soil Pollutants/isolation & purification*
;
Serratia marcescens/metabolism*
;
Industrial Waste
;
Soil Microbiology


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