1.National biological standards for antibiotics: an overview
Bufang MA ; Hui LIU ; Xuan JIN ; Yanchun FENG ; Jin LI
Journal of China Pharmaceutical University 2026;57(1):108-114
National biological standards for antibiotics are critical components of the antibiotic quality control system and serve as reference materials for measuring and calibrating the biological activity of antibiotics. This article systematically reviews the classification, definition of potency units, and current research status of commercially available national antibiotic biological standards in China. At present, these standards can be categorized based on chemical structure, number of components, and development methods. The definition of potency units has evolved from an early “arbitrarily assigned unit” to “being represented by the mass of the antibiotic salt” and, more recently, to the current mainstream approach of “being represented by the mass of the active ingredient”. This evolution reflects a shift in quality control philosophy from primarily biological analysis to a system dominated by chemical analysis supplemented by biological methods. Current research focuses on optimizing potency determination methods, studying the unification of content and potency, and implementing dual quality control of both the potency and the ratio/content of active components in multi-component antibiotics. For complex multi-component antibiotics, the microbiological assay based on biological activity remains irreplaceable in quality control. Future efforts should emphasize further method optimization, ensuring batch-to-batch consistency of standards, and advancing precision quality control as key research priorities for antibiotic biological standards.
2.Research advances and challenges in antimicrobial resistance surveillance technologies
Feng LIU ; Caixia DANG ; Ziqian ZHAO ; Yang WANG ; Yuanyong XU ; Hui CHEN
Journal of Public Health and Preventive Medicine 2026;37(3):128-132
Antimicrobial resistance (AMR) poses a critical global health threat. This review systematically examines AMR surveillance technology advances, from conventional culture methods to modern molecular diagnostics (e.g., whole-genome sequencing) and artificial intelligence-assisted approaches. It focuses on the current application of mass spectrometry, machine learning predictive models, and real-time surveillance networks. To address challenges including inadequate technical standardization, clinical translation barriers, and data-sharing limitations, we propose integrated "genotype-phenotype" strategies and global standardization framework, while exploring future applications of CRISPR-based portable detection, single-cell sequencing, and blockchain technologies.
3.Identification of core genes of osteoarthritis by bioinformatics
Xuekun ZHU ; Heng LIU ; Hui FENG ; Yunlong GAO ; Lei WEN ; Xiaosong CAI ; Ben ZHAO ; Min ZHONG
Chinese Journal of Tissue Engineering Research 2025;29(3):637-644
BACKGROUND:At present,osteoarthritis has become a major disease affecting the quality of life of the elderly,and the therapeutic effect is poor,often focusing on preventing the disease process,and the pathogenesis of osteoarthritis is still not fully understood.Bioinformatics analysis was carried out to explore the main pathogenesis of osteoarthritis and related mechanisms of gene coding regulation. OBJECTIVE:To screen core differential genes with a major role in osteoarthritis by gene expression profiling. METHODS:Datasets were downloaded from the Gene Expression Omnibus(GEO):GSE114007,GSE117999,and GSE129147.Differential genes in the GSE114007 and GSE117999 data collections were screened using R software,performing differential genes to weighted gene co-expression network analysis.The module genes most relevant to osteoarthritis were selected to perform protein interaction analysis.Candidate core genes were selected using the cytocape software.The candidate core genes were subsequently subjected to least absolute shrinkage and selection operator regression and COX analysis to identify the core genes with a key role in osteoarthritis.The accuracy of the core genes was validated using an external dataset,GSE129147. RESULTS AND CONCLUSION:(1)A total of 477 differential genes were identified,265 differential genes associated with osteoarthritis were obtained by weighted gene co-expression network analysis,and 8 candidate core genes were identified.The least absolute shrinkage and selection operator regression analysis finally yielded a differential gene ASPM with core value that was externally validated.(2)It is concluded that abnormal gene ASPM expression screened by bioinformatics plays a key central role in osteoarthritis.
4.Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial.
Shengde LI ; Anxin WANG ; Lin SHI ; Qin LIU ; Xiaoling GUO ; Kun LIU ; Xiaoli WANG ; Jie LI ; Jianming ZHU ; Qiuyi WU ; Qingcheng YANG ; Xianbo ZHUANG ; Hui YOU ; Feng FENG ; Yishan LUO ; Huiling LI ; Jun NI ; Bin PENG
Chinese Medical Journal 2025;138(5):579-588
BACKGROUND:
Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke.
METHODS:
This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days.
RESULTS:
There were 57 and 60 patients finally included in the ANP and placebo groups, respectively for modified intention-to-treat analysis. The median age was 66.0 years, and the median NIHSS score at baseline was 12.0. The changes in cerebral infarct volume at day 14 were 0.3 mL and 0.4 mL in the ANP and placebo groups, respectively (median difference: -7.1 mL; interquartile range [IQR]: -18.3 to 2.3 mL, P = 0.30). The changes in cerebral edema volume of the ANP and placebo groups on day 14 were 11.4 mL and 4.0 mL, respectively ( median difference: 3.0 mL, IQR: -1.3 to 9.9 mL, P = 0.15). The rates of SAE within 90 days were similar in the ANP (3/57, 5%) and placebo (7/60, 12%) groups ( P = 0.36). Changes in serum mercury and arsenic concentrations were comparable. In patients with large artery atherosclerosis, ANP reduced the cerebral infarct volume at 14 days (median difference: -12.3 mL; IQR: -27.7 to -0.3 mL, P = 0.03).
CONCLUSIONS:
ANP showed a similar safety profile to placebo and non-significant tendency to reduce cerebral infarct volume in patients with moderate-to-severe stroke. Further studies are warranted to assess the efficacy of ANP in reducing cerebral infarcts and improving clinical prognosis.
TRAIL REGISTRATION
Clinicaltrials.gov , No. NCT04475328.
Aged
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Female
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Humans
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Male
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Middle Aged
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Double-Blind Method
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Drugs, Chinese Herbal/adverse effects*
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Ischemic Stroke/drug therapy*
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Pilot Projects
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Stroke/drug therapy*
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Treatment Outcome
5.Immunotherapy for Lung Cancer
Pei-Yang LI ; Feng-Qi LI ; Xiao-Jun HOU ; Xue-Ren LI ; Xin MU ; Hui-Min LIU ; Shou-Chun PENG
Progress in Biochemistry and Biophysics 2025;52(8):1998-2017
Lung cancer is the most common malignant tumor worldwide, ranking first in both incidence and mortality rates. According to the latest statistics from the International Agency for Research on Cancer (IARC), approximately 2.5 million new cases and around 1.8 million deaths from lung cancer occurred in 2022, placing a tremendous burden on global healthcare systems. The high mortality rate of lung cancer is closely linked to its subtle early symptoms, which often lead to diagnosis at advanced stages. This not only complicates treatment but also results in substantial economic losses. Current treatment options for lung cancer include surgery, radiotherapy, chemotherapy, targeted drug therapy, and immunotherapy. Among these, immunotherapy has emerged as the most groundbreaking advancement in recent years, owing to its unique antitumor mechanisms and impressive clinical benefits. Unlike traditional therapies such as radiotherapy and chemotherapy, immunotherapy activates or enhances the patient’s immune system to recognize and eliminate tumor cells. It offers advantages such as more durable therapeutic effects and relatively fewer toxic side effects. The main approaches to lung cancer immunotherapy include immune checkpoint inhibitors, tumor-specific antigen-targeted therapies, adoptive cell therapies, cancer vaccines, and oncolytic virus therapies. Among these, immune checkpoint inhibitors and tumor-specific antigen-targeted therapies have received approval from the U.S. Food and Drug Administration (FDA) for clinical use in lung cancer, significantly improving outcomes for patients with advanced non-small cell lung cancer. Although other immunotherapy strategies are still in clinical trials, they show great potential in improving treatment precision and efficacy. This article systematically reviews the latest research progress in lung cancer immunotherapy, including the development of novel immune checkpoint molecules, optimization of treatment strategies, identification of predictive biomarkers, and findings from recent clinical trials. It also discusses the current challenges in the field and outlines future directions, such as the development of next-generation immunotherapeutic agents, exploration of more effective combination regimens, and the establishment of precise efficacy prediction systems. The aim is to provide a valuable reference for the continued advancement of lung cancer immunotherapy.
6.Efficacy of Differential Dosage of Pueraria in Gegen Qinliantang on Acute Enteritis Model in Mice
Ruiying ZHANG ; Ping WANG ; Di ZHANG ; Hongfa CHENG ; Ying ZHANG ; Zhu DENG ; Hui FENG ; Min LIU ; Yang TANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):197-204
ObjectiveTo investigate whether there are differences in the efficacy of Gegen Qinliantang with different contents of Puerariae Lobatae Radix on the acute enteritis (AE) model mice and provide a scientific basis for the interpretation of Gegen Qinliantang in the treatment of "Xie Re Li". MethodsA total of 112 male BALB/c mice were randomly divided into a blank group,model group,single Puerariae Lobatae Radix group,non-Puerariae Lobatae Radix group,regular dose Gegen Qinliantang group (regular dose group),half-dose Puerariae Lobatae Radix group,and doubled-dose Puerariae Lobatae Radix group, with 16 mice in each group. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of the colon tissue. Western blot was employed to detect the expression of ZO-1 (a protein in the tight junction) and Occludin in the colon tissue, as well as the changes of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β). ResultsCompared with the blank group,the DAI scores of the mice in the model group were significantly higher (P<0.05),and the histopathological sections of their colon tissues showed mucosal damage,glandular atrophy,disordered arrangement,and a large number of inflammatory cells infiltration,and the expression of ZO-1 and Occludin proteins in their colon tissues was significantly down-regulated (P<0.05,P<0.01). The expression of inflammatory factors TNF-α and IL-1β was significantly up-regulated (P<0.05,P<0.01). Compared with the model group,the DAI scores of mice in all dosing groups decreased significantly (P<0.05),with the most significant effect in the regular dose group. After 7 d of drug administration,the regular dose group had the best impact on the repair of colonic mucosa in the AE mouse model. The regular dose group significantly down-regulated the expression of TNF-α (P<0.05) and significantly up-regulated the expression of ZO-1 protein (P<0.05). The doubled-dose Puerariae Lobatae Radix group significantly down-regulated the expression of IL-1β protein (P<0.01),and there was no significant difference between all dosing groups and the model group in terms of the expression of Occludin protein. After 14 d of drug administration,the best effect on the repair of colonic mucosa in the AE mouse model was observed in the doubled dose Puerariae Lobatae Radix group. All groups except the non-Puerariae Lobatae Radix group significantly down-regulated the expression of TNF-α (P<0.01). Meanwhile,the regular dose group and doubled-dose Puerariae Lobatae Radix group significantly elevated the expression level of Occludin protein (P<0.01). The doubled-dose Puerariae Lobatae Radix group also significantly inhibited the expression of IL-1β protein (P<0.05) and up-regulated ZO-1 protein expression (P<0.05). ConclusionGegen Qinliantang can reduce the pathological damage of colon tissue, protect the barrier function and structure of intestinal epithelial cells, and reduce the expression of inflammatory factors, so as to achieve the therapeutic effect of AE model mice. When comparing the therapeutic efficacy of Gegen Qinliantang containing different Gegen contents, Gegen Qinliantang with the proportion of the original formula of Zhongjing was the most effective in AE model mice.
7.Efficacy of Differential Dosage of Pueraria in Gegen Qinliantang on Acute Enteritis Model in Mice
Ruiying ZHANG ; Ping WANG ; Di ZHANG ; Hongfa CHENG ; Ying ZHANG ; Zhu DENG ; Hui FENG ; Min LIU ; Yang TANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):197-204
ObjectiveTo investigate whether there are differences in the efficacy of Gegen Qinliantang with different contents of Puerariae Lobatae Radix on the acute enteritis (AE) model mice and provide a scientific basis for the interpretation of Gegen Qinliantang in the treatment of "Xie Re Li". MethodsA total of 112 male BALB/c mice were randomly divided into a blank group,model group,single Puerariae Lobatae Radix group,non-Puerariae Lobatae Radix group,regular dose Gegen Qinliantang group (regular dose group),half-dose Puerariae Lobatae Radix group,and doubled-dose Puerariae Lobatae Radix group, with 16 mice in each group. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of the colon tissue. Western blot was employed to detect the expression of ZO-1 (a protein in the tight junction) and Occludin in the colon tissue, as well as the changes of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β). ResultsCompared with the blank group,the DAI scores of the mice in the model group were significantly higher (P<0.05),and the histopathological sections of their colon tissues showed mucosal damage,glandular atrophy,disordered arrangement,and a large number of inflammatory cells infiltration,and the expression of ZO-1 and Occludin proteins in their colon tissues was significantly down-regulated (P<0.05,P<0.01). The expression of inflammatory factors TNF-α and IL-1β was significantly up-regulated (P<0.05,P<0.01). Compared with the model group,the DAI scores of mice in all dosing groups decreased significantly (P<0.05),with the most significant effect in the regular dose group. After 7 d of drug administration,the regular dose group had the best impact on the repair of colonic mucosa in the AE mouse model. The regular dose group significantly down-regulated the expression of TNF-α (P<0.05) and significantly up-regulated the expression of ZO-1 protein (P<0.05). The doubled-dose Puerariae Lobatae Radix group significantly down-regulated the expression of IL-1β protein (P<0.01),and there was no significant difference between all dosing groups and the model group in terms of the expression of Occludin protein. After 14 d of drug administration,the best effect on the repair of colonic mucosa in the AE mouse model was observed in the doubled dose Puerariae Lobatae Radix group. All groups except the non-Puerariae Lobatae Radix group significantly down-regulated the expression of TNF-α (P<0.01). Meanwhile,the regular dose group and doubled-dose Puerariae Lobatae Radix group significantly elevated the expression level of Occludin protein (P<0.01). The doubled-dose Puerariae Lobatae Radix group also significantly inhibited the expression of IL-1β protein (P<0.05) and up-regulated ZO-1 protein expression (P<0.05). ConclusionGegen Qinliantang can reduce the pathological damage of colon tissue, protect the barrier function and structure of intestinal epithelial cells, and reduce the expression of inflammatory factors, so as to achieve the therapeutic effect of AE model mice. When comparing the therapeutic efficacy of Gegen Qinliantang containing different Gegen contents, Gegen Qinliantang with the proportion of the original formula of Zhongjing was the most effective in AE model mice.
8.Research progress on strategies to target intestinal microbiota to improve drug resistance in tumor immunotherapy
Hui-ling LI ; Bi-qing LIU ; Ying-nan FENG ; Xin HU ; Lan ZHANG ; Xian-zhe DONG
Acta Pharmaceutica Sinica 2025;60(2):260-268
A growing body of research points out that gut microbiota plays a key role in tumor immunotherapy. By optimizing the composition of intestinal microbiota, it is possible to effectively improve immunotherapy resistance and enhance its therapeutic effect. This article comprehensively analyzes the mechanism of intestinal microbiota influencing tumor immunotherapy resistance, expounds the current strategies for targeted regulation of intestinal microbiota, such as traditional Chinese medicine and plant components, fecal microbiota transplantation, probiotics, prebiotics and dietary therapy, and explores the potential mechanisms of these strategies to improve patients' resistance to tumor immunotherapy. At the same time, the article also briefly discusses the prospects and challenges of targeting intestinal microbiota to improve tumor immunotherapy resistance, which provides a reference for related research to help the strategy research of reversing tumor immunotherapy resistance.
9.Echocardiographic diagnosis of partial pulmonary venous ectopic drainage with double connections of the right upper pulmonary vein:a case report
Chinese Journal of Ultrasonography 2025;34(1):46-48
Partial anomalous pulmonary venous connection(PAPVC)is a rare congenital heart disease in which at least one pulmonary vein does not flow back into the left atrium,but drains into the systemic circulatory venous system or directly into the right atrium. In this article,a 51-year-old female patient was diagnosed as special abnormal pulmonary vein drainage after undergoing echocardiography due to discomfort in the precardiac area,the right superior pulmonary vein was connected to the superior vena cava and the right atrium at the same time. After surgery,the patient's symptoms was relieved and the cardiac structure and function gradually improved. Based on the understanding of this case,and combined with previous literature to analyze the pathophysiology and ultrasonic diagnostic characteristics of this disease,in order to improve the vigilance of examiners,encourage clinical sonographers to pay attention to echocardiology investigations of abnormal pulmonary vein drainage disease,and effectively improve the diagnosis of PAPVC,thereby effectively reduce the missed diagnosis rate.
10.Risk factors for inadequate vertical margin in endoscopic resection of small rectal neuroendocrine tumors
Jianning LIU ; Lihong GAN ; Peng LIU ; Hui LIU ; Kaige ZHANG ; Qi FENG ; Ling YAO ; Gen HUANG ; Nian FANG
Chinese Journal of Digestive Endoscopy 2025;42(3):202-206
Objective:To identify risk factors influencing clinical efficacy of endoscopic resection of small rectal neuroendocrine tumor (NETs).Methods:A retrospective analysis was conducted on patients with rectal NETs ≤10 mm who underwent endoscopic resection from 2013 to 2022. Patients were divided into the endoscopic submucosal dissection (ESD) group and the endoscopic mucosal resection with ligation (EMRL) group according to the treatment methods. After comparing the baseline data, propensity score matching was performed to compare the rates of R1 resection and adequacy of vertical margin distance.Results:A total of 186 patients were included in this study, with 139 receiving ESD and 47 receiving EMRL. The R1 resection rates were 12.2% (17/139) and 2.1% (1/47) in the ESD and EMRL group, respectively ( χ2=3.027, P=0.082). A significant difference in vertical margin adequacy was observed between the two groups [69.1% (96/139) VS 85.1% (40/47), χ2=4.598, P=0.032]. After propensity score matching, 46 pairs of cases were included, and there were no significant differences in the R1 resection rate [6.5% (3/46) VS 2.2% (1/46), χ2=0.261, P=0.609] and vertical margin adequacy [78.3% (36/46) VS 84.8% (39/46), χ2=0.649, P=0.420] between the two groups. Univariate and multivariate Logistic regression analyses revealed that operator experience and preoperative biopsy were independent risk factors for inadequate margin. Conclusion:Treatment method may not be the key factor affecting the distance of the vertical margin after endoscopic resection, but preoperative biopsy and operator experience have a significant impact on margins. Biopsy before endoscopic resection should be avoided, and less experienced doctors are recommended to use EMRL method for small NETs due to its ease of execution.


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