1.Clinical comprehensive evaluation of four nucleoside (acid) analogues in the treatment of chronic hepatitis B
Jiayi QIN ; Kuifen MA ; Wenya SHAN ; Lijuan ZHAO ; Lin LIU ; Liangping WANG
China Pharmacy 2026;37(7):859-863
OBJECTIVE To conduct a comprehensive clinical evaluation of four nucleoside (acid) analogues that have been approved and marketed in China, such as entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, and tenofovir amibufenamide. METHODS According to the Guideline for the Administration of Clinical Comprehensive Evaluation of Drugs (2021 edition, trial implementation), a comprehensive search was conducted across databases including CNKI, Wanfang Data, VIP, PubMed, the Cochrane Library, Embase, as well as relevant official websites. Drug package inserts, guidelines, consensus statements, and relevant literature for the four drugs were collected and subjected to a comprehensive evaluation across six dimensions: safety, efficacy, cost-effectiveness, innovativeness, suitability, and accessibility. RESULTS The scores for entecavir in terms of safety, efficacy, cost-effectiveness, innovativeness, suitability, and accessibility-along with its comprehensive score-were 13, 14, 13, 10, 18, and 6, totaling 74 points. For tenofovir disoproxil fumarate, the respective scores were 13, 17, 18, 8, 18, and 7, totaling 81 points. For tenofovir alafenamide fumarate, the scores were 14, 20, 12, 8, 18, and 5, totaling 77 points. Finally, for tenofovir amibufenamide, the scores were 10.5, 17, 10, 6, 15, and 4, totaling 62.5 points. CONCLUSIONS Tenofovir disoproxil fumarate, with the highest score, is recommended as the first-line option, suitable for adults, children, and pregnant women. However, caution is warranted for potential renal impairment. Tenofovir alafenamide fumarate is recommended as a second-line alternative, particularly for individuals at high risk for bone and renal damage. Entecavir has a score similar to tenofovir alafenamide fumarate but requires dosing on an empty stomach and dose adjustment based on renal function of patients. Tenofovir amibufenamide received the lowest score and is considered a weak recommendation. The clinical application of these nucleoside (acid) analogues should be individualized based on the patient’s age, physiological status, and risk factors.
2.Research progress on mechanism of active ingredients of traditional Chinese medicine in ameliorating skeletal muscle atrophy
Qin JIANG ; Wenya GUO ; Ying ZHOU ; Jian ZHOU ; Zhenyu ZHANG ; Yanchun GONG ; Lihua YAO ; Yuhua LI
China Pharmacy 2026;37(15):2057-2062
Skeletal muscle atrophy refers to a pathological condition characterized by muscle fiber atrophy as well as decreased muscle mass and muscle strength induced by various predisposing factors. It falls under the category of “flaccidity syndrome” in traditional Chinese medicine, and its pathogenesis is mainly associated with disturbed protein homeostasis, mitochondrial dysfunction and oxidative stress injury. Active ingredients of traditional Chinese medicine exerts synergistic regulatory effects via multiple pathways, thus possessing unique advantages in the clinical prevention and treatment of skeletal muscle atrophy. This paper reviews the mechanisms by which active ingredients of traditional Chinese medicine alleviate skeletal muscle atrophy. Existing studies have demonstrated that such active ingredients can ameliorate skeletal muscle atrophy through multiple approaches: regulating protein metabolic balance (geniposide, matrine, schisandrin A, etc.) and oxidative stress (astragaloside Ⅳ, Gastrodia elata polysaccharide, Angelica sinensis polysaccharide, etc.), improving mitochondrial function (parthenolide, berberine, curcumin, etc.), facilitating myogenesis and myogenic differentiation (cucurbitacin Ⅱb, saikosaponin A, saikosaponin D, etc.), suppressing inflammatory response (ursolic acid, triptolide, emodin, etc.), ameliorating insulin resistance (akebiasaponin D, etc.). In the future, active ingredients of traditional Chinese medicine are expected to achieve breakthroughs in clinical treatment for skeletal muscle atrophy, providing novel ideas and strategies for the prevention and treatment of degenerative disorders.
3.Interpretation of Reporting Items for Practice Guidelines in Healthcare for Chinese Patent Medicines (RIGHT for CPM)
Liaoyao WANG ; Hejing PAN ; Le ZHANG ; Wenya WANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):211-218
The clinical practice guidelines for Chinese patent medicines (CPM) provide reference for the selection of national drug catalogs, the formulation of prescription collections in medical institutions, and the clinical use of CPM, constituting an important part of traditional Chinese medicine (TCM) guidelines. As a crucial part of Chinese drug supply guarantee system, CPM plays an important role in the treatment, prevention, and healthcare of many disease categories, whereas the application of CPM has problems of misuse and even abuse. To standardize the application of CPM, a research team at Zhejiang Chinese Medical University developed the Reporting Items for Practice Guidelines in Healthcare for Chinese Patent Medicines (RIGHT for CPM) based on the RIGHT checklist framework. The RIGHT for CPM checklist gathers key information from published CPM guidelines, existing TCM reporting checklists, and the RIGHT checklist and its extensions to form an initial pool of reporting items. Seventeen experts from different disciplines were invited to conduct two rounds of Delphi surveys, and the final checklist was reviewed and approved for publication by 18 leading experts in TCM research and guideline reporting from China and abroad. The RIGHT for CPM checklist adds 16 sub-items and revises 2 sub-items on the basis of the RIGHT checklist, highlighting the characteristics of CPM guideline reporting. It considers CPM selection and inclusion criteria, policy access, indications and symptoms, drug combination instructions, drug use in special populations, precautions, and recommendations of Western medical physicians, among others. This can further improve the quality and transparency of CPM guideline reporting, promote standardized reporting of CPM guidelines, and facilitate the rational clinical use of CPM. This article interprets the development process of the RIGHT for CPM checklist and the items that highlight the characteristics of CPM guidelines, with a view to promoting the application of the RIGHT for CPM checklist.
4.Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines: A Scoping Analysis
Yajing LI ; Miaomiao LI ; Le ZHANG ; Wenya WANG ; Hui ZHAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):227-238
ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines (CPMs), aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs (Angong Niuhuang Wan, Jufang Zhibao Wan, Suhexiang Wan, Pien Tze Huang, Niuhuang Qingxin Wan, Qinggong Shoutao Wan, Compound Realgar Natural Indigo Tablets, Xihuang Wan, Dingkun Wan, Babao Wan, and Guilingji Capsules) were selected. A total of 365 related studies were included in this review, comprising 331 clinical studies (of which 291 were randomized controlled trials), 30 systematic reviews and Meta-analyses, 3 expert consensus, and 1 rapid health technology assessment. Among the 11 CPMs, 2(Angong Niuhuang Wan and Jufang Zhibao Wan) had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus (frequency of 7), Bovisc Alculus (7), and Borneol (5). The dosage forms included pills, capsules, oral liquid, tablets, and lozenges. The diseases treated by these CPMs mainly included malignant tumors, cerebrovascular diseases, gynecological diseases, and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases, and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred, of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies, incomplete information on medicine package, and non-standard clinical research designs remain to be addressed in the future.
5.Hydrogel scaffolds loaded with bone marrow mesenchymal stem cells/resveratrol liposomes for traumatic brain injury treatment
Wenya CHI ; Yan YUAN ; Weilin LI ; Tongyu WU ; Yuan YU
Journal of Pharmaceutical Practice and Service 2025;43(2):67-74
Objective To prepare a thermosensitive hydrogel scaffold loaded with bone marrow mesenchymal stem cells(BMSCs) and resveratrol liposomes (RSV-LIP) to form a therapeutic unit and evaluate its treatment efficacy for traumatic brain injury (TBI). Methods BMSCs were extracted from rats, and RSV-LIP was prepared and characterized. Cell models were constructed to investigate the pharmacological effects of BMSCs combined with RSV-LIP. BMSCs and RSV-LIP were then loaded into the hydrogel, and a TBI mouse model was established to evaluate the therapeutic effects of the hydrogel. Results The RSV-LIP had a particle size of 127.8 nm, a Zeta potential of −4.9 mV, an encapsulation efficiency of 78.50%, and a drug loading content of 2.37%. Live-dead staining indicated good biocompatibility of the hydrogel. The combination of BMSCs and RSV-LIP significantly inhibited TNF-α and reduced ROS levels, promoting cell migration in scratch assays. Compared to the control group, the hydrogel group showed significantly lower mNSS scores (P<0.01), higher hanging scores (P<0.001), and reduced stepping errors (P<0.001). Conclusion The combination of BMSCs and RSV-LIP exhibited antioxidative stress, anti-inflammatory, and neurogenic cell migration-promoting effects. When loaded into a hydrogel scaffold and locally implanted, it could improve the motor and sensory functions in TBI mice.
6.Methacrylated dermal extracellular matrix hydrogel promotes repair of abdominal wall defects
Zhongyu LIU ; Wenya LI ; Yonghong FAN ; Shuang LYU ; Juan PEI ; Yaqin CHEN ; Beiyu LIU ; Hongyu SUN
Chinese Journal of Tissue Engineering Research 2025;29(10):2074-2082
BACKGROUND:Synthetic polymers,such as polypropylene and polyester,used for the treatment of abdominal wall defects not only lack biodegradability and bioactivity but also fail to meet the demands of complex and irregular wounds.Therefore,finding bioactive materials with low immunogenicity and good histocompatibility has become a hot spot in the repair of abdominal wall defects. OBJECTIVE:To prepare methacryloyl modified dermal extracellular matrix hydrogel and explore its potential application in abdominal wall defect. METHODS:(1)The porcine dermis was acellular with 0.25%trypsin and 1%Triton X-100 in turn to obtain the dermal extracellular matrix.After pepsin digestion and methacrylic anhydride modification,the methacrylated dermal extracellular matrix hydrogel was formed by photocrosslinking.The microscopic morphology of the hydrogel was observed by scanning electron microscope,and its rheological properties,swelling properties and other physical and chemical properties were tested.(2)Mice fibroblasts(L929)were inoculated into methacrylated dermal extracellular matrix hydrogel to detect the cell compatibility.(3)Totally 12 SD rats were randomly divided into two groups(n=6)to create abdominal wall defect model with peritoneum preserved.The defect site of the polypropylene group was filled with polypropylene material,and the hydrogel group was filled with methacrylated dermal extracellular matrix hydrogel.The wound skin of both groups was covered with polypropylene material.The wound healing was observed and histological analysis was carried out. RESULTS AND CONCLUSION:(1)Enzymatic hydrolysis had a good decellularization effect on porcine dermis after decellularization,and the original glycosaminoglycans and collagen were well retained.Scanning electron microscope observation revealed that the dermal extracellular matrix hydrogel presented loose and porous structure.The aperture was between 70 and 120 μm.The swelling ratio was(16.88±3.24)%and the water absorption was(94.24±1.11)%.The rheological property test showed that the methacrylated dermal extracellular matrix hydrogel was stable and had shear thinning characteristics,with injectability.(2)CCK-8 assay and live/dead staining showed that methacrylated dermal extracellular matrix hydrogel had good cell compatibility.(3)The results of animal experiments showed that the skin wound healing rate of the experimental group was higher than that of the control group at 7,10,and 14 days after operation(P<0.05).Hematoxylin-eosin and Masson staining of skin and muscle tissue exhibited that compared with the polypropylene group,the skin wound epithelialization,hair follicle formation,collagen fiber arrangement,and neovascularization were better in the hydrogel group 14 days after surgery.The skin wound new tissue structure was similar to the normal tissue at 28 days after surgery,and scar hyperplasia was less.A small amount of muscle regeneration was observed on day 28 after operation.(4)The results show that the methacrylated dermal extracellular matrix hydrogel can promote wound skin healing and muscle tissue regeneration in rats with abdominal wall defect.
7.Scientific basis for acupuncture combined with neural stem cells for repairing spinal cord injury
Xiaomeng HUANG ; Zhilan ZHANG ; Wenya SHANG ; Jing HUANG ; Huilin WEI ; Bing LI ; Yafeng REN
Chinese Journal of Tissue Engineering Research 2025;29(19):4111-4121
BACKGROUND:Spinal cord injury is a neurological disorder caused by traumatic or non-traumatic events,often leading to severe functional impairment below the injured segment.In recent years,neural stem cell transplantation has been considered to have significant therapeutic potential in regulating the inflammatory response after spinal cord injury,inhibiting excessive proliferation of glial scars,and promoting nerve regeneration. OBJECTIVE:To review and discuss the potential mechanism of action of acupuncture and neural stem cell transplantation therapy in inhibiting spinal cord injury-induced secondary injury,and to delve into the scientific basis for its treatment of spinal cord injury. METHODS:PubMed,Elsevier,WanFang,and CNKI databases were searched using"spinal cord injury,acupuncture,neural stem cells,SDF-1α/CXCR4 axis"as Chinese and English search terms.Totally 96 articles were finally included.The research findings of acupuncture combined with neural stem cells in the treatment of spinal cord injury were summarized and analyzed,and the mechanism of this combination therapy in the treatment of secondary injury after spinal cord injury was summarized. RESULTS AND CONCLUSION:(1)The stromal-derived factor 1α(SDF-1α)/chemokine receptor 4(CXCR4)axis plays a crucial role in neural stem cell transplantation for spinal cord injury.This signaling mechanism not only affects neural stem cell migration,proliferation,and differentiation,but is also a key factor in determining the efficiency of stem cell homing to the injury site.Therefore,the regulation of targeting this axis is of great significance in enhancing the therapeutic effect of spinal cord injury.(2)Acupuncture,as a traditional Chinese medicine therapy,shows unique advantages in the regulation of secondary injury in spinal cord injury.It can effectively reduce secondary injury after spinal cord injury by regulating inflammatory response,inhibiting apoptosis,improving microcirculation,reducing glial scar formation,and counteracting oxidative stress.(3)Acupuncture was also able to influence the expression and function of the SDF-1α/CXCR4 axis,thereby enhancing the homing and survival ability of neural stem cells and promoting nerve regeneration and functional recovery.(4)The therapy combining acupuncture and stem cell transplantation is an innovative treatment strategy for spinal cord injury and suitable for repairing neural circuits.It combines the wisdom of traditional Chinese medicine with the advantages of modern biotechnology,providing a new treatment option for spinal cord injury patients.However,this combination therapy is still in the research and exploration stage,and its long-term efficacy and safety need to be further verified.(5)Taken together,acupuncture and neural stem cell transplantation for the treatment of spinal cord injury has great potential for clinical application,but in-depth research and optimization of treatment options are still needed.In the future,we look forward to further revealing the efficacy mechanism and optimal indications of this therapy through more clinical trials and mechanism studies,so as to bring better hope of recovery and more efficient therapeutic effects to spinal cord injury patients.
8.Influencing factors and optimization methods of pre-treatment for microbiological counting method of proprietary Chinese medicine
Nong XIAO ; Shiyi LU ; Wenya TANG ; Minli JU ; Gangfeng XU ; Minghua YANG
Journal of Pharmaceutical Practice and Service 2025;43(8):373-376
Due to the diverse composition and complex physicochemical and biological characteristics, the pre-treatment of microbiological counting method (preparation of test solution) in microbiological limit test were interfered by many factors, which ultimately affected the repeatability and accuracy of test results. Improving the accuracy of microbiological test is of practical significance to ensure the safety and effectiveness of non-sterile preparations. In this paper, the key factors and optimization methods involved in the pre-treatment of proprietary Chinese medicines were systematically analyzed and summarized.
9.Protective Effect of Gegen Qianliantang on Intestinal Mucosal Barrier in Ulcerative Colitis Mice via STAT3/NF-κB Axis Regulating Th1/Treg Differentiation
Beilei DENG ; Anan WANG ; Wenya FENG ; Lixin WANG ; Tiansong ZHANG ; Chengyong MA ; Xiutian GUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):12-21
ObjectiveTo explore the protective effect and mechanism of Gegen Qianliantang (GQT) on intestinal mucosal barrier function in dextran sulfate sodium (DSS)-induced ulcerative colitis (UC) model mice. MethodsA UC model was established in C57BL/6 mice using a 2.5% DSS solution. Mice were randomly divided into five groups (n=8 per group): blank group, model group, mesalazine sustained-release granule group (0.52 g·kg-1), high-dose GQT group (2.23 g·kg-1), and low-dose GQT group (1.12 g·kg-1). Fecal characteristics and body weight changes were observed before and after treatment. The body weight loss and disease activity index (DAI) of UC mice were calculated to evaluate symptom severity. Hematoxylin-eosin (HE) staining and Alizarin blue-periodic acid-Schiff (AB-PAS) staining were used to detect histological changes in colon tissue. Immunohistochemistry was used to detect the expression of zonula occludens-1 (ZO-1) and mucin 2 (MUC2). Enzyme-linked immunosorbent assay (ELISA) was used to detect serum levels of pro-inflammatory cytokines interferon-γ (IFN-γ), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), IL-17A, and anti-inflammatory cytokine IL-10. Flow cytometry was used to detect the activation of helper T lymphocyte subsets (Th1, Th17), regulatory T cells (Treg), and regulatory B cells (Breg) in spleen and colon tissues. Western blot was used to detect the expression levels of T-bet, forkhead box protein P3(FoxP3), nuclear transcription factor(NF)-κB p65, phosphorylated NF-κB p65 (p-NF-κB p65), signal transducer and activator of transcription 3(STAT3), and phosphorylated STAT3 (p-STAT3). ResultsCompared with the model group, both high- and low-dose GQT groups significantly improved the body weight loss and DAI scores (P<0.05), alleviated colonic inflammation, and showed optimal efficacy in the high-dose group. AB-PAS staining showed that compared with the model group, both the high- and low-dose GQT groups significantly increased goblet cell proliferation and mucin secretion, indicating improved mucosal barrier function. GQT upregulated the expression of ZO-1 and MUC2 in colon tissue (P<0.05), suppressed IFN-γ, IL-6, and TNF-α secretion (P<0.05), elevated IL-10 secretion (P<0.05), but had no significant effect on IL-17A. At the same time, high- and low-dose GQT intervention increased the activation of CD4+ FoxP3+ Treg cells (P<0.05) and suppressed activation of CD4+ IFN-γ+ Th1 cells (P<0.05). Western blot showed that GQT downregulated T-bet, NF-κB p65, and STAT3 protein expression (P<0.05), upregulated FoxP3 (P<0.05), and also reduced phosphorylation levels of p-NF-κB p65 and p-STAT3 (P<0.05). ConclusionGQT can upregulate the activation of CD4+ FoxP3+ Treg cells, reduce the activation of CD4+ IFN-γ+ Th1 cells, inhibit the secretion of IFN-γ, IL-6, and TNF-α, and increase the secretion of IL-10. It enhances the expression of MUC2 and ZO-1 in colon tissue, thereby alleviating inflammatory damage to the intestinal mucosa and restoring mucosal barrier integrity. These effects may be related to its regulation of NF-κB p65 and STAT3 signaling pathways, ultimately regulating the activation of transcription factors T-bet and FoxP3.
10.Study on the anti-hepatitis mechanism of Abrus pulchellus subsp. cantoniensis (Hance) Verdc. and Abrus pulchellus subsp. mollis (Hance) Verdc. based on serum pharmacochemistry and network pharmacology
Qiaowen ZHOU ; Xue WANG ; Mingjuan HUANG ; Li LI ; Wenya CHEN ; Zhengtao WANG ; Zijia ZHANG ; Lanlan FAN
China Pharmacy 2025;36(22):2772-2777
OBJECTIVE To compare the anti-hepatitis mechanisms of Abrus pulchellus subsp. cantoniensis (Hance) Verdc. (AC) and Abrus pulchellus subsp. mollis(Hance) Verdc. (AM). METHODS SD rats were randomly divided into blank group, AC- treated group, and AM-treated group, with each group consisting of 10 rats. The rats’ orbital venous blood was collected at 5, 15, 30 minutes, and 1, 1.5, 2, 4, 6, 8, 12 hours after gavage administration of 24 g/kg of the corresponding drug (calculated by crude drug) or water, respectively. Ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry technology was utilized to identify the prototype components present in the serum. The network pharmacology method was adopted to predict the anti-hepatitis active components, key targets, and signaling pathways of AC and AM. Additionally, molecular docking technology was utilized to verify the binding activity of the core active components with key targets. RESULTS A total of 35 prototype components migrating to the blood of AC and AM were identified in the serum of administered rats, among which 24 were common components. The active components in AC, such as acetylanguidine, physcion, soyasaponin A3 and soyasaponin Ⅰ, as well as those in AM, including vicenin 3, acetylanguidine,soyasaponin Ⅰ and schaftoside, all acted on key targets such as steroid receptor coactivator, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha, epidermal growth factor receptor (EGFR), and protein kinase B1(Akt1). These components modulated pathways in cancer, EGFR tyrosine kinase inhibitor resistance, and the phosphoinositide 3-kinase (PI3K) -Akt pathway, thereby exerting anti-hepatitis effects. Furthermore, the binding energies between these active components and their key targets were all less than -5 kJ/mol. CONCLUSIONS There are differences in the active components of AC and AM against hepatitis, but their mechanisms of action are similar. Both may exert their anti-hepatitis effects through pathways in cancer, EGFR tyrosine kinase inhibitor resistance, and the PI3K-Akt pathway.

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