1.Sanren Runchang Formula Regulates Brain-gut Axis to Treat IBS-C: A Randomized Controlled Trial
Teng LI ; Xinrong FAN ; He YAN ; Zhuozhi GONG ; Mengxi YAO ; Na YANG ; Yuhan WANG ; Huikai HU ; Wei WEI ; Tao LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):154-161
ObjectiveTo observe the clinical efficacy of Sanren Runchang formula in treating constipation-predominant irritable bowel syndrome (IBS-C) by regulating the brain-gut axis and the effects of the formula on serum levels of 5-hydroxytryptamine (5-HT), vasoactive intestinal peptide (VIP), and substance P (SP). MethodsA randomized controlled design was adopted, and 72 IBS-C patients meeting Rome Ⅳ criteria were randomized into observation and control groups (36 cases).The observation group received Sanren Runchang formula granules twice daily, and the control group received lactulose oral solution daily for 4 weeks. IBS Symptom Severity Scale (IBS-SSS), IBS Quality of Life Scale (IBS-QOL), and Bristol Stool Form Scale (BSFS) were used to assess clinical symptoms, and bowel movement frequency was recorded. The Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) were employed to evaluate psychological status. ELISA was employed to measure the serum levels of 5-HT, VIP, and SP. ResultsThe total response rate in the observation group was 91.67% (33/36), which was higher than that (77.78%, 28/36) in the control group (χ2=4.50, P<0.05). After treatment, both groups showed increased defecation frequency and BSFS scores, decreased IBS-SSS total score, abdominal pain and bloating scores, IBS-QOL health anxiety, anxiety, food avoidance, and behavioral disorders scores, SAS and SDS scores, serum 5-HT and VIP levels, and increased SP levels (P<0.05, P<0.01). Moreover, the observation group showed more significant changes in the indicators above than the control group (P<0.05, P<0.01). The SP level showed no significant difference between the two groups. During the 4-week follow-up, the recurrence rate was 5.88% in the observation group and 31.25% in the control group. No adverse events occurred in observation group, and 2 cases of mild diarrhea occurred in the control group. ConclusionSanren Runchang formula demonstrated definitive efficacy in alleviating gastrointestinal symptoms and improving the psychological status and quality of life in IBS-C patients, with a low recurrence rate. The formula can regulate serum levels of neurotransmitters such as 5-HT and VIP, suggesting its potential regulatory effect on the brain-gut axis through modulating neurotransmitters and neuropeptides. However, its complete mechanism of action requires further investigation through detection of additional brain-gut axis-related biomarkers.
2.Effect of Qingfei Shenshi Decoction (清肺渗湿汤) Combined with Western Medicine on Clinical Effectiveness and Immune Function for Patients with Bronchial Asthma of Heat Wheezing Syndrome
Ying SUN ; Haibo HU ; Na LIU ; Fengchan WANG ; Jinbao ZONG ; Ping HAN ; Peng LI ; Guojing ZHAO ; Haoran WANG ; Xuechao LU
Journal of Traditional Chinese Medicine 2026;67(1):38-44
ObjectiveTo observe the clinical effectiveness and safety of Qingfei Shenshi Decoction (清肺渗湿汤) combined with western medicine for patients with bronchial asthma of heat wheezing syndrome, and to explore its potential mechanism of action. MethodsEighty-six participants with bronchial asthma of heat wheezing syndrome were randomly divided into treatment group and control group, each group with 43 participants. The control group received conventional western medicine, and the treatment group was additionally administered Qingfei Shenshi Decoction orally on the basis of the control group, 1 dose per day. Both groups were treated for 14 days. The primary outcome measure was clinical effectiveness; secondary outcome measures included traditional Chinese medicine (TCM) syndrome score, asthma control test (ACT) score, pulmonary function indices such as forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), serum inflammatory factor levels including interleukin-4 (IL-4), tumour necrosis factor-α (TNF-α), and high-sensitivity C-reactive protein (hs-CRP), and immune function indices including CD3+, CD4+, CD8+, CD4+/CD8+. All outcome measures were evaluated before and after treatment. Vital signs were monitored, and electrocardiography, blood routine, urine routine, liver function, and renal function tests were performed before and after treatment. Adverse events and reactions during the study were recorded. ResultsA total of 80 patients completed the trial with 40 in each group. The total clinical effective rate of the treatment group was 97.5% (39/40), which was significantly higher than that of the control group (85.0%, 34/40, P<0.05). After treatment, both groups showed decreased TCM syndrome scores, IL-4, TNF-α, hs-CRP, and CD8+ levels, as well as increased ACT scores, CD3+, CD4+, CD4+/CD8+, FEV1, FVC, and PEF levels (P<0.05 or P<0.01). Moreover, the improvements in these indices were more significant in the treatment group than in the control group (P<0.05 or P<0.01). No significant abnormalities in safety indicators were observed in either group, and no adverse events or reactions occurred. ConclusionQingfei Shenshi Decoction combined with conventional western medicine for patients with bronchial asthma of heat wheezing syndrome can effectively improve the clinical symptoms, pulmonary function, and clinical effectiveness, with good safety. Its mechanism may be related to reducing inflammatory factor levels and regulating T lymphocyte subsets to improve immune function.
3.In Vitro and in vivo Component Analysis of Total Phenolic Acids from Gei Herba and Its Effect on Promoting Acute Wound Healing and Inhibiting Scar Formation
Xixian KONG ; Guanghuan TIAN ; Tong WU ; Shaowei HU ; Jie ZHAO ; Fuzhu PAN ; Jingtong LIU ; Yong DENG ; Yi OUYANG ; Hongwei WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):156-167
ObjectiveBased on ultra performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry(UPLC-Q-Orbitrap-MS), to identify the in vivo and in vitro chemical components of total phenolic acids in Gei Herba(TPAGH), and to clarify the pharmacological effects and potential mechanisms of the effective part in promoting acute wound healing and inhibiting scar formation. MethodsUPLC-Q-Orbitrap-MS was used to identify the chemical components of TPAGH and ingredients absorbed in vivo after topical administration. A total of 120 ICR mice were randomly divided into the model group, recombinant human epidermal growth factor(rhEGF) group(4 mg·kg-1), and low, medium, and high dose groups of TPAGH(3.5, 7, 14 mg·kg-1), with 24 mice in each group. A full-thickness skin excision model was constructed, and each administration group was coated with the drug at the wound site, and the model group was treated with an equal volume of normal saline, the treatment was continued for 30 days, during which 8 mice from each group were sacrificed on days 6, 12, and 30. The healing of the wounds in the mice was observed, and histopathological changes in the skin tissues were dynamically observed by hematoxylin-eosin(HE), Masson, and Sirius red staining, and enzyme-linked immunosorbent assay(ELISA) was used to dynamically measure the contents of interleukin-6(IL-6), tumor necrosis factor-α(TNF-α), vascular endothelial growth factor A(VEGFA), matrix metalloproteinase(MMP)-3 and MMP-9 in skin tissues. Network pharmacology was used to predict the targets related to the promotion of acute wound healing and the inhibition of scar formation by TPAGH, and molecular docking of key components and targets was performed. Gene Ontology(GO) biological process analysis and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment analysis were carried out for the related targets, so as to construct a network diagram of herbal material-compound-target-pathway-pharmacological effect-disease for further exploring its potential mechanisms. ResultsA total of 146 compounds were identified in TPAGH, including 28 phenylpropanoids, 31 tannins, 23 triterpenes, 49 flavonoids, and 15 others, and 16 prototype components were found in the serum of mice. Pharmacodynamic results showed that, compared with the model group, the TPAGH groups showed a significant increase in relative wound healing rate and relative scar inhibition rate(P<0.05), and the number of new capillaries, number of fibroblasts, number of new skin appendages, epidermal regeneration rate, collagen deposition ratio, and Ⅲ/Ⅰ collagen ratio in the tissue were significantly improved(P<0.05, 0.01), the levels of IL-6, TNF-α, MMP-3 and MMP-9 in the skin tissues were reduced to different degrees, while the level of VEGFA was increased. Network pharmacology analysis screened 10 core targets, including tumor protein 53(TP53), sarcoma receptor coactivator(SRC), protein kinase B(Akt)1, signal transducer and activator of transcription 3(STAT3), epidermal growth factor receptor(EGFR) and so on, participating in 75 signaling pathways such as advanced glycation end-products(AGE)-receptor for AGE(AGE/RAGE) signaling pathway, phosphatidylinositol 3-kinase(PI3K)/Akt signaling pathway, mitogen-activated protein kinase(MAPK) signaling pathway. Molecular docking confirmed that the key components genistein, geraniin, and casuariin had good binding ability to TP53, SRC, Akt1, STAT3 and EGFR. ConclusionThis study comprehensively reflects the chemical composition of TPAGH and the absorbed components after topical administration through UPLC-Q-Orbitrap-MS. TPAGH significantly regulates key indicators of skin healing and tissue reconstruction, thereby clarifying its role in promoting acute wound healing and inhibiting scar formation. By combining in vitro and in vivo component identification with network pharmacology, the study explores how key components may bind to targets such as TP53, Akt1 and EGFR, exerting therapeutic effects through related pathways such as immune inflammation and vascular regeneration.
4.Herbal Textual Research and Modern Research Progress of Ostreae Concha
Hongyi ZHANG ; Bin WANG ; Jiawen LIU ; Yuan HU ; Lin CHEN ; Youping LIU ; Hongping CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):223-234
By consulting relevant literature of ancient herbal books and processing specifications, this paper made a systematic research and analysis of Ostreae Concha, including the name, producing area, harvesting, quality, historical evolution of processing, relevant processing specifications, modern processing technology, and changes in chemical composition and pharmacological effects before and after processing, in order to provide documentary evidence for the research on processing technology and the establishment of quality standards. According to the textual research, it is known that Ostreae Concha has a long history of being used in medicine, and there have been many aliases and local names in each historical period. Shennong's Classic of the Materia Medica(Shennong Bencaojing) began to use Muli as the correct name, which has continued to use to today, and there were also aliases such as Muge, Zuogu Muli and Haoke. Ostreae Concha has a wide range of localities and irregular harvesting periods. The ancients believed that its left shell was of superior quality, but this has not been seen in modern. And there were many kinds of processing methods of Ostreae Concha, such as grinding, roasting, calcining, frying, simmering, quenching and so on, and the calcining was still in use. The different editions of Chinese Pharmacopoeia from 1963 to 2020 contain only calcined Ostreae Concha, and the local processing specifications mainly include three kinds of processed products(calcined products, salt-soaked products and vinegar-soaked products). Modern processing research mainly focuses on process optimization, changes in chemical composition and pharmacological effects, and the research methods are relatively single. Overall, there are currently issues such as inconsistent processing standards, unclear process parameters and imperfect quality standards, which are not conducive to the quality control and standardized clinical use of Ostreae Concha. Therefore, it is necessary to further investigate the pharmacological substance basis of Ostreae Concha and its processed products in order to elucidate the processing mechanism, standardize the processing technology and improve the quality standard.
5.Exploring Multi-target Effect of Erzhiwan on Improving Myocardial Injury in Ovariectomized Mice Based on Non-targeted Metabolomics
Ying YANG ; Jing HU ; Pei LI ; Ruyuan ZHU ; Zhiguo ZHANG ; Haixia LIU ; Yanjing CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):74-84
ObjectiveTo explore the target of Erzhiwan in reducing myocardial injury in ovariectomized mice through non-targeted myocardial metabolomics combined with experimental verification. MethodsOvariectomized mouse model was selected, 40 female C57BL/6 mice were randomly divided into sham operation group, model group, estrogen group(estradiol valerate, 1.3×10-4 g·kg-1), Erzhiwan low and high dose groups(3.12, 9.36 g·kg-1), with 8 mice in each group. Each administration group was given the corresponding dose of Erzhiwan by gavage, and the sham operation group and model group were given equal volume of distilled water by gavage for 12 weeks. Echocardiography was used to detect cardiac function, hematoxylin-eosin(HE) staining was used to observe myocardial morphological changes, and enzyme-linked immunosorbent assay(ELISA) was used to detect the levels of estrogen, N-terminal pro-brain natriuretic peptide(NT-proBNP), hypersensitive troponin T(hs-TnT), total cholesterol(TC), triglyceride(TG), low density lipoprotein cholesterol(LDL-C), high density lipoprotein cholesterol(HDL-C), interleukin(IL)-1β, IL-18 and tumor necrosis factor-α(TNF-α). The non-targeted metabolomics of mouse myocardium were analyzed by ultra performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry(UPLC-Q-Exactive Orbitrap MS), and the differential metabolites and corresponding metabolic pathways were obtained. The mRNA expression levels of phosphatidylinositol 3-kinase(PI3K) and protein kinase B(Akt) in mouse myocardial tissues were detected by real-time fluorescence quantitative polymerase chain reaction(Real-time PCR), and the protein expression levels of PI3K, Akt, phosphorylated(p)-Akt were detected by Western blot. ResultsCompared with the sham operation group, the model group showed abnormal cardiac function, increased myocardial fiber space, cardiomyocyte atrophy, sarcoplasmic aggregation, and occasional dissolution or rupture of muscle fiber, the level of estrogen in the serum was decreased, the levels of NT-proBNP, hs-TnT, IL-1β, IL-18, TNF-α, TG, TC and LDL-C were increased, and the level of HDL-C was decreased(P<0.01). Compared with the model group, Erzhiwan could increase the level of estrogen, improve the abnormal cardiac function, reduce the pathological injury of myocardial tissue, decrease the levels of myocardial injury markers(NT-proBNP, hs-TnT) and inflammatory factors(IL-1β, IL-18, TNF-α), decrease the levels of TG, TC, LDL-C, and increased the level of HDL-C(P<0.01). The results of non-targeted myocardial metabolomics showed that 31 of the 162 differential metabolites between the model group and sham operation group were significantly adjusted after administration of Erzhiwan, which were mainly glycerol phospholipid metabolites. Pathway enrichment results showed that Erzhiwan mainly affected glycerophospholipid metabolic pathway, PI3K-Akt pathway, cyclic guanosine monophosphate(cGMP)-protein kinase G(PKG) pathway and other metabolic pathways. Compared with the sham operation group, the levels of phosphatidylcholine(PC, 11 types) and phosphatidylethanolamine(PE, 5 types) in mouse myocardial tissue of the model group were increased(P<0.05, P<0.01), and the mRNA and protein expressions of PI3K and p-Akt were decreased(P<0.05, P<0.01). Compared with the model group, the levels of PC(11 types) and PE(5 types) were decreased(P<0.05, P<0.01) in myocardial tissue of Erzhiwan group, the mRNA and protein expressions of PI3K and p-Akt were elevated(P<0.01). ConclusionErzhiwan can alleviate the pathological injury of myocardium in ovariectomized mice, improve the abnormal cardiac function, improve lipid metabolism disorder, and reduce the levels of myocardial injury markers and inflammatory factors, which involves a number of signaling and metabolic pathways in the heart, among which glycerophospholipid metabolism pathway and PI3K/Akt pathway may have key roles.
6.Anti-tumor Mechanism of Traditional Chinese Medicine with Effect of Softening Hardness and Dissipating Mass: A Review
Yue HU ; Linfeng WANG ; Yue LI ; Rui LIU ; Baojin HUA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):276-286
The global burden of malignant tumors keeps increasing, and the increased morbidity and mortality make malignant tumors one of the major challenges to global health. Currently, malignant tumors are mainly managed by surgical resection, radiotherapy, chemotherapy, targeted therapy, and immunotherapy, which, however, usually cause serious adverse reactions, such as tissue damage, immune function inhibition, and multidrug resistance, affecting the prognosis and quality of life of the patients. Traditional Chinese medicine with low toxic and side effects and multi-target, multi-system, and multi-pathway therapeutic effects has shown positive therapeutic potential in cancer treatment. In particular, the traditional Chinese medicine with the effects of softening hardness and dissipating mass, which contains a variety of active ingredients, have shown strong inhibitory effects on tumor cells. Such medicine can not only directly attack tumor cells and inhibit their proliferation and invasion but also exert therapeutic effects by inducing apoptosis, blocking tumor-related signaling pathways, and inhibiting tumor angiogenesis. In addition, traditional Chinese medicine can improve the overall efficacy of cancer treatment by regulating the immune status of the body and reversing the drug resistance of tumor cells. Traditional Chinese medicine can exert the anti-tumor effect by regulating intracellular signaling pathways, which is one of the research hotspots in this field. Signaling pathways such as signal transducer and activator of transcription 3 (STAT3), phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR), and mitogen-activated protein kinase (MAPK) play a key role in the formation and development of tumors. Traditional Chinese medicine can regulate the growth, apoptosis, and metabolic process of tumor cells by affecting the activity of these signaling pathways, thus exerting the therapeutic effects on tumors. Based on these mechanisms, a large number of experimental studies and clinical trials have proved that traditional Chinese medicine has broad prospects in anti-tumor treatment. To further verify these research results and provide a basis for the clinical application of traditional Chinese medicine and the development of new drugs, a systematic review and integrated analysis of the research reports on the anti-tumor effect of traditional Chinese medicine was carried out to summarize the anti-tumor mechanisms of traditional Chinese medicine. This review is expected to promote the wide application of traditional Chinese medicine in anti-tumor treatment worldwide and bring more hope and possibility to cancer patients.
7.Role and research progress of gut microbiota in uveitis
Yingcheng LIN ; Qiuming HU ; Min ZHOU ; Jinqing LIU
International Eye Science 2025;25(1):64-69
Uveitis is a blinding inflammatory disease that affects multiple structures within the eye, posing significant risks to patients' vision and mental health. Current treatments mainly involve glucocorticoids and immunosuppressants, which are associated with significant side effects, high relapse rates, and substantial costs. Recent research suggests that the gut microbiota may play a role in the development of uveitis through the gut-eye axis, with related metabolites also influencing disease progression. Modulating the gut microbiota or its metabolites could offer new therapeutic avenues for uveitis. This review explores the relationship between gut microbiota and various uveitis-associated diseases, such as systemic sarcoidosis, Vogt-Koyanagi-Harada syndrome, Behcet's disease, multiple sclerosis, and birdshot chorioretinopathy. It also discusses advancements in microbiota-related therapies, including probiotics and prebiotics, antibiotics, immunomodulators, phage therapy, and fecal microbiota transplantation. The aim is to provide a reference for the development of new therapies targeting specific microbial communities and genetic markers associated with uveitis, thereby promoting the realization of precision medicine.
8.Development status and ethical challenges of artificial intelligence in traditional Chinese medicine
Jiaqing DAI ; Yuxuan JIANG ; Jingnan HU ; Liu YANG ; Lifang GUO
Chinese Medical Ethics 2025;38(2):173-178
In the context of the rapid development of 5G technology, the development of artificial intelligence (AI) in traditional Chinese medicine (TCM) faces new opportunities and challenges. Focusing on how to uphold tradition while innovating in the development of AI in TCM, starting from the current development status of AI in Chinese medicine, including the integration of four diagnostic methods, syndrome differentiation and treatment, auxiliary diagnosis and treatment, research and development of Chinese herbal medicine, prevention and treatment of diseases, knowledge inheritance, and other aspects, this paper discussed the support of policies and technical advancements, as well as development opportunities such as increased demand for health. Regarding machine ethics, data ethics, regulatory review, and other aspects, it also proposed some suggestions that the training algorithm should be improved to assist medical work; data ownership should be clarified to ensure data security; and an AI ethics committee should be set up to improve the review system, aiming to maximize the advantages of smart healthcare and accelerate the modernization of TCM for the benefit of patients and the service of human health.
9.Ethical issues and countermeasures of off-label drug use in children
Limin LI ; Haipeng HU ; Xiaoqin CAO ; Xiaohong LIU
Chinese Medical Ethics 2025;38(2):227-231
Children, as a special group, frequently experience of off-label drug use worldwide. Common reasons for off-label drug use in children include the lack of data on pediatric patients during the clinical trial stage of drug development, delayed updates to drug instructions, and the non-standard professional behavior of some doctors. Off-label drug use in children is a double-edged sword. It could save lives and provide a way to explore additional functions of drugs, while it may also lead to the phenomenon of hyper-indication abuse, increasing the risk of adverse drug events. Regulating off-label drug use in children can safeguard the best treatment rights and interests of children. It is recommended to encourage pharmaceutical enterprises to conduct research and development of pediatric new drugs, simplify the approval process for drug instructions amendments, accumulate evidence-based medical evidence for off-label drug use in children, standardize the process of off-label drug use in children in medical institutions, continuously improve the standardized diagnosis and treatment capabilities of pediatricians, and actively cooperate with the families of pediatric patients in diagnosis and treatment, so as to comprehensively safeguard the rights and interests of both doctors and patients.
10.Application of Recombinant Collagen in Biomedicine
Huan HU ; Hong ZHANG ; Jian WANG ; Li-Wen WANG ; Qian LIU ; Ning-Wen CHENG ; Xin-Yue ZHANG ; Yun-Lan LI
Progress in Biochemistry and Biophysics 2025;52(2):395-416
Collagen is a major structural protein in the matrix of animal cells and the most widely distributed and abundant functional protein in mammals. Collagen’s good biocompatibility, biodegradability and biological activity make it a very valuable biomaterial. According to the source of collagen, it can be broadly categorized into two types: one is animal collagen; the other is recombinant collagen. Animal collagen is mainly extracted and purified from animal connective tissues by chemical methods, such as acid, alkali and enzyme methods, etc. Recombinant collagen refers to collagen produced by gene splicing technology, where the amino acid sequence is first designed and improved according to one’s own needs, and the gene sequence of improved recombinant collagen is highly consistent with that of human beings, and then the designed gene sequence is cloned into the appropriate vector, and then transferred to the appropriate expression vector. The designed gene sequence is cloned into a suitable vector, and then transferred to a suitable expression system for full expression, and finally the target protein is obtained by extraction and purification technology. Recombinant collagen has excellent histocompatibility and water solubility, can be directly absorbed by the human body and participate in the construction of collagen, remodeling of the extracellular matrix, cell growth, wound healing and site filling, etc., which has demonstrated significant effects, and has become the focus of the development of modern biomedical materials. This paper firstly elaborates the structure, type, and tissue distribution of human collagen, as well as the associated genetic diseases of different types of collagen, then introduces the specific process of producing animal source collagen and recombinant collagen, explains the advantages of recombinant collagen production method, and then introduces the various systems of expressing recombinant collagen, as well as their advantages and disadvantages, and finally briefly introduces the application of animal collagen, focusing on the use of animal collagen in the development of biopharmaceutical materials. In terms of application, it focuses on the use of animal disease models exploring the application effects of recombinant collagen in wound hemostasis, wound repair, corneal therapy, female pelvic floor dysfunction (FPFD), vaginal atrophy (VA) and vaginal dryness, thin endometritis (TE), chronic endometritis (CE), bone tissue regeneration in vivo, cardiovascular diseases, breast cancer (BC) and anti-aging. The mechanism of action of recombinant collagen in the treatment of FPFD and CE was introduced, and the clinical application and curative effect of recombinant collagen in skin burn, skin wound, dermatitis, acne and menopausal urogenital syndrome (GSM) were summarized. From the exploratory studies and clinical applications, it is evident that recombinant collagen has demonstrated surprising effects in the treatment of all types of diseases, such as reducing inflammation, promoting cell proliferation, migration and adhesion, increasing collagen deposition, and remodeling the extracellular matrix. At the end of the review, the challenges faced by recombinant collagen are summarized: to develop new recombinant collagen types and dosage forms, to explore the mechanism of action of recombinant collagen, and to provide an outlook for the future development and application of recombinant collagen.

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