1.Effect of Berberine-Baicalin Combination on Fecal Microbiota Transplantation-induced Type 2 Diabetes Mellitus Due to Internal Accumulation of Dampness-heat in Mice from Perspectives of Gut Microbiota and Metabolomics
Mengjie CHEN ; Yimin LIU ; Yun ZHOU ; Keming YU ; Min XIA ; Hongning LIU ; Yanhua JI ; Zhijun ZENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):52-64
ObjectiveTo investigate the mechanisms by which the combination of berberine (BBR) and baicalin (BAI) ameliorates type 2 diabetes mellitus (T2DM) due to internal accumulation of dampness-heat from the perspectives of gut microbiota and metabolomics. MethodsAntibiotics were used to induce pseudo-sterile mice. Thirty pseudo-sterile mice were randomized into a normal fecal microbiota transplantation group (n=10) and a T2DM (syndrome of internal accumulation of dampness-heat) fecal microbiota transplantation group (n=20). The mice were then administrated with suspensions of fecal microbiota from healthy volunteers and a patient with T2DM due to internal accumulation of dampness-heat by gavage, respectively. Each mouse received 200 µL suspension every other day for a total of 15 times to reshape the gut microbiota. The T2DM model mice were then assigned into a model group (n=8) and a BBR-BAI group (n=11). BBR was administrated at a dose of 200 mg·kg-1, and BAI was administrated in a ratio of BBR-BAI 10∶1 based on preliminary research findings. The administration lasted for 8 consecutive weeks. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), insulin (INS), triglycerides (TG), total cholesterol (CHOL), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels were measured to evaluate the effects of the BBR-BAI combination on glucose and lipid metabolism and liver function in T2DM mice. Hematoxylin-eosin staining was employed to observe pathological changes in the colon tissue. The expression of claudin-1, zonula occludens-1 (ZO-1), and occludin in the colon tissue was determined by Western blot. Real-time quantitative polymerase chain reaction(Real-time PCR) was employed to assess the levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in the colon tissue. The fecal microbiota composition and differential metabolites were analyzed by 16S rRNA sequencing and ultra-high performance liquid chromatography-quadrupole-time of flight tandem mass spectrometry (UPLC-Q-TOF-MS), respectively. ResultsThe BBR-BAI combination lowered the FBG, HbA1c, and INS levels (P<0.05, P<0.01) and alleviated insulin resistance (P<0.01) in T2DM mice. Additionally, BBR-BAI elevated the levels of ZO-1, occludin, and claudin-1 (P<0.05, P<0.01) and down-regulated the expression levels of TNF-α, IL-1β, and IL-6 in the colon (P<0.05, P<0.01). The results of 16S rRNA sequencing showed that BBR-BAI increased the relative abundance of Ligilactobacillus, Phascolarctobacterium, and Akkermansia (P<0.05), while significantly decreasing the relative abundance of Alistipes, Odoribacter, and Colidextribacter (P<0.05). UPLC-Q-TOF-MS identified 28 differential metabolites, which were primarily involved in arachidonic acid metabolism and α-linolenic acid metabolism. ConclusionBBR-BAI can ameliorate T2DM due to internal accumulation of dampness-heat by modulating the relative abundance of various bacterial genera in the gut microbiota and the expression of fecal metabolites.
2.Antidepressant Mechanisms of Polygalae Radix: A Review
Liming LIU ; Shuaijun PENG ; Pan SU ; Yucheng LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):300-309
Depression is a high-incidence mental disorder with complex causes and multifaceted pathogenic mechanisms. Its pathogenesis has not yet been fully elucidated, which has hindered the development of novel and highly effective antidepressant drugs. This condition severely affects human physical and mental health while imposing a significant socio-economic burden. At present, several hypotheses exist regarding the pathogenesis of depression, including monoamine neurotransmitter imbalances, neurotrophic factor deficiencies, neural plasticity impairments, glutamate dysregulation, neuroinflammatory disorders, gut microbiota imbalances, and mitochondrial autophagy dysfunction. Currently, most clinical antidepressants are monoamine neurotransmitter reuptake inhibitors. Although they exhibit certain therapeutic effects, they are associated with significant drawbacks, such as severe adverse reactions and poor patient compliance. In contrast, traditional Chinese medicine (TCM), characterized by its multi-targeted effects, mild efficacy, and minimal side effects, has demonstrated significant advantages in the treatment of depression. Chinese medicine Polygalae Radix possesses the functions of calming the mind, enhancing cognitive functions, harmonizing the heart and kidneys, and dispelling phlegm to open orifices. It is often included in compound prescriptions for the clinical treatment of depression. Based on current hypotheses regarding the pathogenesis of depression, this paper systematically reviews research progress on the antidepressant mechanisms of Polygalae Radix from multiple perspectives, including its active components, its use in herbal pairings, and its inclusion in TCM compound prescriptions. This review aims to provide a scientific basis for the clinical application of Polygalae Radix in antidepressant therapy and to serve as a reference for the modernization of its antidepressant research.
3.Anti-osteoporosis Effect of Isorhamnetin: A Review
Shilong MENG ; Xu ZHANG ; Yawei XU ; Yang YU ; Wei LI ; Yanguang CAO ; Xiaolin SHI ; Wei ZHANG ; Kang LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):347-352
Osteoporosis is a common senile bone metabolism disease, clinically characterized by decreased bone mass, destruction of bone microstructure, increased bone fragility, and easy fracture. It tends to occur in the elderly and postmenopausal women, seriously threatening the quality of life and physical and mental health of the elderly. At present, the treatment of osteoporosis is mainly based on oral western medicines, such as calcium, Vitamin D, and bisphosphonates. Still, there are drawbacks such as a long medication cycle and many adverse reactions. In recent years, due to the advantages of multi-component, multi-pathway, and multi-target, some traditional Chinese medicines and effective ingredients can regulate the osteogenic and osteoclastic differentiation process in both directions and are widely used in the prevention and treatment of osteoporosis. Hippophae rhamnoides is a commonly used herbal medicine, and its fruits are rich in flavonoids, polyphenols, fatty acids, vitamins, and trace elements, which have been proven to have a good anti-osteoporosis effect. Isorhamnetin is the main effective ingredient of Hippophae rhamnoides fruits, which has many pharmacological effects such as anti-inflammation, anti-oxidative stress, anti-aging, and anti-tumor. Studies have shown that isorhamnetin can participate in the regulation of bone metabolism and has a good anti-osteoporosis effect. However, the pharmacological effects and related mechanisms of isorhamnetin against osteoporosis have not been systematically summarized. Therefore, this paper reviewed the pharmacological effects and related mechanisms of isorhamnetin against osteoporosis by referring to relevant literature to provide more basis for the development and application of isorhamnetin.
4.Reevaluation of systematic evluation of Xianling gubao capsules for knee osteoarthritis
Dongdong CAO ; Jixin CHEN ; Weijie YU ; Tianci GUO ; Yu ZHANG ; Puyu NIU ; Aifeng LIU
China Pharmacy 2025;36(2):232-238
OBJECTIVE To conduct a reevaluation of the systematic review (SR)/meta-analysis on the use of Xianling gubao capsules (XLGBC) for knee osteoarthritis (KOA), and provide evidence-based support for the clinical use of the drugs. METHODS Computerized searches including CNKI, Wanfang Data, VIP, China Biomedical Literature Database, the Cochrane Library, PubMed, Embase and Web of Science were conducted to collect systematic reviews (SR) or meta-analyses of XLGBC for the treatment of KOA from the inception to May 31st, 2024. The report quality, methodological quality, risk of bias and evidence quality were assessed using the PRISMA 2020 statement, AMSTAR 2 scale, ROBIS tool and GRADE tool, respectively. A comprehensive quality analysis of the quantitative results from the SR/meta-analysis was also performed. RESULTS A total of five SR/meta-analyses were included. The evaluation results based on the PRISMA 2020 statement showed that one study report was relatively complete (21 points), while four studies had deficiencies (18-20 points). The assessment using the AMSTAR 2 scale indicated that the methodological quality of all five studies was rated as very low. According to the ROBIS tool evaluation, the risk of comprehensive bias in all five studies was classified as high. GRADE tool evaluation revealed that among 49 outcome indicators, 5 (10.2%) were rated as moderate-quality evidence (10.2%), 12 as low-quality evidence (24.5%), and 32 as very low-quality evidence (65.3%). The results of comprehensive quality analysis showed that the clinical efficacy, visual analogue scale score, pain relief time, comprehensive indexes of knee joint function, the levels of inflammatory factors and the incidence of adverse events in patients with XLGBC combined with conventional treatment were significantly better than conventional treatment alone (P<0.05). CONCLUSIONS Compared with conventional treatment, XLGBC in combination with conventional treatment for KOA may have some efficacy and safety advantages. However, due to the low quality of evidence for the outcome indicators included in the studies, the conclusions should be interpreted with caution.
5.Reevaluation of systematic evluation of Xianling gubao capsules for knee osteoarthritis
Dongdong CAO ; Jixin CHEN ; Weijie YU ; Tianci GUO ; Yu ZHANG ; Puyu NIU ; Aifeng LIU
China Pharmacy 2025;36(2):232-238
OBJECTIVE To conduct a reevaluation of the systematic review (SR)/meta-analysis on the use of Xianling gubao capsules (XLGBC) for knee osteoarthritis (KOA), and provide evidence-based support for the clinical use of the drugs. METHODS Computerized searches including CNKI, Wanfang Data, VIP, China Biomedical Literature Database, the Cochrane Library, PubMed, Embase and Web of Science were conducted to collect systematic reviews (SR) or meta-analyses of XLGBC for the treatment of KOA from the inception to May 31st, 2024. The report quality, methodological quality, risk of bias and evidence quality were assessed using the PRISMA 2020 statement, AMSTAR 2 scale, ROBIS tool and GRADE tool, respectively. A comprehensive quality analysis of the quantitative results from the SR/meta-analysis was also performed. RESULTS A total of five SR/meta-analyses were included. The evaluation results based on the PRISMA 2020 statement showed that one study report was relatively complete (21 points), while four studies had deficiencies (18-20 points). The assessment using the AMSTAR 2 scale indicated that the methodological quality of all five studies was rated as very low. According to the ROBIS tool evaluation, the risk of comprehensive bias in all five studies was classified as high. GRADE tool evaluation revealed that among 49 outcome indicators, 5 (10.2%) were rated as moderate-quality evidence (10.2%), 12 as low-quality evidence (24.5%), and 32 as very low-quality evidence (65.3%). The results of comprehensive quality analysis showed that the clinical efficacy, visual analogue scale score, pain relief time, comprehensive indexes of knee joint function, the levels of inflammatory factors and the incidence of adverse events in patients with XLGBC combined with conventional treatment were significantly better than conventional treatment alone (P<0.05). CONCLUSIONS Compared with conventional treatment, XLGBC in combination with conventional treatment for KOA may have some efficacy and safety advantages. However, due to the low quality of evidence for the outcome indicators included in the studies, the conclusions should be interpreted with caution.
6.Palpitations, Shortness of Breath, Weakness in Limbs, Edema, and Dyspnea: A Rare Inflammatory Myopathy with Positive Aniti-mitochondrial Antibodies and Cardiac Involvement
Chunsu LIANG ; Xuchang ZHANG ; Ning ZHANG ; Lin KANG ; Xiaohong LIU ; Jiaqi YU ; Yingxian LIU ; Lin QIAO ; Yanli YANG ; Xiaoyi ZHAO ; Ruijie ZHAO ; Na NIU ; Xuelian YAN
Medical Journal of Peking Union Medical College Hospital 2025;16(1):248-255
This article presents a case study of a patient who visited the Geriatric Department of Peking Union Medical College Hospital due to "palpitations, shortness of breath for more than 2 years, limb weakness for 6 months, edema, and nocturnal dyspnea for 2 months". The patient exhibited decreased muscle strength in the limbs and involvement of swallowing and respiratory muscles, alongside complications of heart failure and various arrhythmias which were predominantly atrial. Laboratory tests revealed the presence of multiple autoantibodies and notably anti-mitochondrial antibodies. Following a comprehensive multidisciplinary evaluation, the patient was diagnosed with anti-mitochondrial antibody-associated inflammatory myopathy. Treatment involved a combination of glucocorticoids and immunosuppressants, along with resistance exercises for muscle strength and rehabilitation training for lung function, resulting in significant improvement of clinical symptoms. The case underscores the importance of collaborative multidisciplinary approaches in diagnosing and treating rare diseases in elderly patients, where careful consideration of clinical manifestations and subtle abnormal clinical data can lead to effective interventions.
7.Mechanism of Action of Kaixinsan in Ameliorating Alzheimer's Disease
Xiaoming HE ; Xiaotong WANG ; Dongyu MIN ; Xinxin WANG ; Meijia CHENG ; Yongming LIU ; Yetao JU ; Yali YANG ; Changbin YUAN ; Changyang YU ; Li ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):20-29
ObjectiveTo investigate the mechanism of action of Kaixinsan in the treatment of Alzheimer's disease (AD) based on network pharmacology, molecular docking, and animal experimental validation. MethodsThe Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform(TCMSP) and the Encyclopedia of Traditional Chinese Medicine(ETCM) databases were used to obtain the active ingredients and targets of Kaixinsan. GeneCards, Online Mendelian Inheritance in Man(OMIM), TTD, PharmGKB, and DrugBank databases were used to obtain the relevant targets of AD. The intersection (common targets) of the active ingredient targets of Kaixinsan and the relevant targets of AD was taken, and the network interaction analysis of the common targets was carried out in the STRING database to construct a protein-protein interaction(PPI) network. The CytoNCA plugin within Cytoscape was used to screen out the core targets, and the Metascape platform was used to perform gene ontology(GO) functional enrichment analysis and Kyoto encyclopedia of genes and genomes(KEGG) pathway enrichment analysis. The “drug-active ingredient-target” interaction network was constructed with the help of Cytoscape 3.8.2, and AutoDock Vina was used for molecular docking. Scopolamine (SCOP) was utilized for modeling and injected intraperitoneally once daily. Thirty-two male C57/BL6 mice were randomly divided into blank control (CON) group (0.9% NaCl, n=8), model (SCOP) group (3 mg·kg-1·d-1, n=8), positive control group (3 mg·kg-1·d-1 of SCOP+3 mg·kg-1·d-1 of Donepezil, n=8), and Kaixinsan group (3 mg·kg-1·d-1 of SCOP+6.5 g·kg-1·d-1 of Kaixinsan, n=8). Mice in each group were administered with 0.9% NaCl, Kaixinsan, or Donepezil by gavage twice a day for 14 days. Morris water maze experiment was used to observe the learning memory ability of mice. Hematoxylin-eosin (HE) staining method was used to observe the pathological changes in the CA1 area of the mouse hippocampus. Enzyme linked immunosorbent assay(ELISA) was used to determine the serum acetylcholine (ACh) and acetylcholinesterase (AChE) contents of mice. Western blot method was used to detect the protein expression levels of signal transducer and activator of transcription 3(STAT3) and nuclear transcription factor(NF)-κB p65 in the hippocampus of mice. ResultsA total of 73 active ingredients of Kaixinsan were obtained, and 578 potential targets (common targets) of Kaixinsan for the treatment of AD were screened out. Key active ingredients included kaempferol, gijugliflozin, etc.. Potential core targets were STAT3, NF-κB p65, et al. GO functional enrichment analysis obtained 3 124 biological functions, 254 cellular building blocks, and 461 molecular functions. KEGG pathway enrichment obtained 248 pathways, mainly involving cancer-related pathways, TRP pathway, cyclic adenosine monophosphate(cAMP) pathway, and NF-κB pathway. Molecular docking showed that the binding of the key active ingredients to the target targets was more stable. Morris water maze experiment indicated that Kaixinsan could improve the learning memory ability of SCOP-induced mice. HE staining and ELISA results showed that Kaixinsan had an ameliorating effect on central nerve injury in mice. Western blot test indicated that Kaixinsan had a down-regulating effect on the levels of NF-κB p65 phosphorylation and STAT3 phosphorylation in the hippocampal tissue of mice in the SCOP model. ConclusionKaixinsan can improve the cognitive impairment function in SCOP model mice and may reduce hippocampal neuronal damage and thus play a therapeutic role in the treatment of AD by regulating NF-κB p65, STAT3, and other targets involved in the NF-κB signaling pathway.
8.Clinical Efficacy of Modified Huangqi Chifengtang in Treatment of IgA Nephropathy Patients and Exploration of Dose-effect Relationship of Astragali Radix
Xiujie SHI ; Meiying CHANG ; Yue SHI ; Ziyan ZHANG ; Yifan ZHANG ; Qi ZHANG ; Hangyu DUAN ; Jing LIU ; Mingming ZHAO ; Yuan SI ; Yu ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):9-16
ObjectiveTo explore the dose-effect relationship and safety of high, medium, and low doses of raw Astragali Radix in the modified Huangqi Chifengtang (MHCD) for treating proteinuria in immunoglobulin A (IgA) nephropathy, and to provide scientific evidence for the clinical use of high-dose Astragali Radix in the treatment of proteinuria in IgA nephropathy. MethodsA total of 120 patients with IgA nephropathy, diagnosed with Qi deficiency and blood stasis combined with wind pathogen and heat toxicity, were randomly divided into a control group and three treatment groups. The control group received telmisartan combined with a Chinese medicine placebo, while the treatment groups were given telmisartan combined with MHCD containing different doses of raw Astragali Radix (60, 30, 15 g). Each group contained 30 patients, and the treatment period was 12 weeks. Changes in 24-hour urinary protein (24 hUTP), traditional Chinese medicine (TCM) syndrome scores, effective rate, and renal function were observed before and after treatment. Safety was assessed by monitoring liver function and blood routine. ResultsAfter 12 weeks of treatment, 24 hUTP significantly decreased in the high, medium, and low-dose groups, as well as the control group (P<0.05, P<0.01). The TCM syndrome scores in the high, medium, and low-dose groups also significantly decreased (P<0.01). Comparisons between groups showed that the 24 hUTP in the high-dose group was significantly lower than in the medium, low-dose, and control groups (P<0.05, P<0.01), and the 24 hUTP in the medium-dose group was significantly lower than in the control group (P<0.05). The TCM syndrome scores in the high and medium-dose groups were significantly lower than in the low-dose and control groups (P<0.05, P<0.01). The total effective rates for proteinuria in the high, medium, low-dose, and control groups were 92.59% (25/27), 85.19% (23/27), 60.71% (17/28), and 57.14% (16/28), respectively. The effective rates in the high and medium-dose groups were significantly higher than in the low-dose and control groups (χ2=13.185, P<0.05, P<0.01). The effective rates for TCM syndrome scores in the high, medium, low-dose, and control groups were 88.89% (24/27), 81.48% (22/27), 71.43% (20/28), and 46.43% (13/28), respectively. The efficacy of TCM syndrome scores in the high and medium-dose groups was significantly higher than in the control group (χ2=14.053, P<0.01). Compared with pre-treatment values, there was no statistically significant difference in eGFR and serum creatinine in the high and medium-dose groups. However, eGFR significantly decreased in the low-dose and control groups after treatment (P<0.05), and serum creatinine levels increased significantly in the control group (P<0.05). No statistically significant differences were observed in urea nitrogen, uric acid, albumin, total cholesterol, triglycerides, liver function, and blood routine before and after treatment in any group. ConclusionThere is a dose-effect relationship in the treatment of IgA nephropathy with high, medium, and low doses of raw Astragali Radix in MHCD. The high-dose group exhibited the best therapeutic effect and good safety profile.
9.Identification of Chemical Constituents of Bidens pilosa and Analysis of Its Anti-gastric Cancer Cell Proliferation Activity in Vitro
Yu HAN ; Chang LIU ; Jiao LIU ; Tao ZHANG ; Zhongmei ZOU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):154-164
ObjectiveTo study the chemical constituents of Bidens pilosa and the in vitro antiproliferative activity of some compounds against gastric cancer cells. MethodsThe chemical constituents were isolated and purified by methods such as silica gel column chromatography, preparative thin layer chromatography, medium pressure preparation chromatography, semi-preparative high performance liquid chromatography(HPLC) and recrystallization, their structures were identified on the basis of physicochemical properties, spectral data and circular dichroism spectra. Thiazole blue(MTT) assay was used to determine the in vitro inhibitory activityies of some isolated compounds against human gastric cancer SGC-7901 cells, and molecular docking was used to predict their potential targets. ResultsTwenty-five compounds were isolated from the petroleum ether fraction of B. pilosa and identified as bidpillignan A(
10.Practice and reflection on ethical review of multicentre studies in a tertiary hospital
Lingling YU ; Wei LIU ; Pengjun ZHANG
Chinese Medical Ethics 2025;38(1):58-62
ObjectiveTo analyse the implementation of mutual recognition of ethical review in a tertiary hospital, providing ideas for exploring ethical review of multicenter studies. MethodsThe ethical review of multicenter studies conducted by the hospital from 2018 to 2022 was analyzed. ResultsA total of 1,582 projects were reviewed in the hospital from 2018 to 2022, of which 773 (48.9%) were multicentre studies. In multicenter study projects, 70.4% of the studies were conducted as a participating unit. Mutual recognition of ethical review and fast review were implemented for all participating projects. After a rapid review of 24 studies, the presiding committee recommended submitting them for conference review. The reasons for the transfer to conference review included issues with the study protocol (11 projects), informed consent (12 projects), and other supporting documents (5 projects). Twenty-one studies were eventually approved by the ethics committee after modification, and 3 studies were not approved by the ethics committee because the sponsor refused to modify the study protocols. ConclusionFor participating in multicentre studies, the ethics committees of participating units implement mutual recognition of ethical reviews and adopt a rapid review approach to review all study data, which can achieve both quality and efficiency.

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