1.Characteristics analysis of pediatric medicines with priority review and approval for marketing in China
Haoyu YANG ; Kan TIAN ; Xue YOU ; Hongwei DAN ; Qian WANG ; Xiaoyong YU
China Pharmacy 2025;36(5):519-523
OBJECTIVE To analyze the characteristics of pediatric medicines with priority review and approval for marketing in China, providing a reference for promoting enterprise R&D and production, as well as improving the supply guarantee mechanism for pediatric medicines. METHODS Based on publicly available data sources such as List of Approved Information for Pediatric Medications Subject to Priority Review and Approval, Pharnexcloud biomedical database, and National Medical Insurance Drug Directory, this study conducted a comprehensive analysis of the main characteristics of pediatric medicines with priority review and approval for marketing. RESULTS As of June 30, 2024, a total of 68 pediatric medicines had been approved through the priority review and approval process, covering 12 therapeutic areas, with oral dosage forms accounting for 64.71%. The median time from application to inclusion in priority review was 35.50 days, with an average of 41.69 days. The median time from inclusion in priority review to market approval was 1.24 years, with an average of 1.42 years. This included 12 domestic new medicines, 21 domestic generic medicines, 35 imported medicines, as well as 29 pediatric-specific medicines and 21 orphan medicines. Additionally, 31 of these medicines had been included in the medical insurance catalog, representing a proportion of 45.59%. CONCLUSIONS Currently, a trend of differentiated competition is emerging between domestic and imported pediatric medicines. The therapeutic areas for pediatric medicines are continuously expanding, and the dosage forms are becoming more tailored to children’s needs. However, there are still issues such as slow progress in new medicine development, insufficient stability in the medicine review and approval process, and a need to increase the proportion of medicines included in medical insurance.
2.Summary of 16-Year Observation of Reflux Esophagitis-Like Symptoms in A Natural Village in A High-Incidence Area of Esophageal Cancer
Junqing LIU ; Lingling LEI ; Yaru FU ; Xin SONG ; Jingjing WANG ; Xueke ZHAO ; Min LIU ; Zongmin FAN ; Fangzhou DAI ; Xuena HAN ; Zhuo YANG ; Kan ZHONG ; Sai YANG ; Qiang ZHANG ; Qide BAO ; Lidong WANG
Cancer Research on Prevention and Treatment 2025;52(6):461-465
Objective To investigate the screening results and factors affecting abnormal detection rates among high-risk groups of esophageal cancer and to explore effective intervention measures. Methods We investigated and collected the information on gender, education level, age, marital status, symptoms of reflux esophagitis (heartburn, acid reflux, belching, hiccup, foreign body sensation in the pharynx, and difficulty swallowing), consumption of pickled vegetables, salt use, and esophageal cancer incidence of villagers in a natural village in Wenfeng District, Anyang City, Henan Province. Changes in reflux esophagitis symptoms in the high-incidence area of esophageal cancer before and after 16 years were observed, and the relationship of such changes with esophageal cancer was analyzed. Results In 2008, 711 cases were epidemiologically investigated, including
3.Prospective Study of Disease Occurrence Spectrum in Asymptomatic Residents in Areas with High Incidence of Esophageal Cancer: 16-year Observation of 711 Cases in Natural Population
Qide BAO ; Fangzhou DAI ; Xueke ZHAO ; Jingjing WANG ; Xin SONG ; Zongmin FAN ; Yanfang ZHANG ; Zhuo YANG ; Junfang GUO ; Kan ZHONG ; Qiang ZHANG ; Junqing LIU ; Min LIU ; Lidong WANG
Cancer Research on Prevention and Treatment 2025;52(8):656-660
Objective To understand the disease spectrum of a natural village in an area with high incidence of esophageal cancer to provide a reference for precise prevention and control. Methods From 2008 to 2024, 711 asymptomatic people over the age of 35 years in a natural village with high incidence of esophageal cancer in China were surveyed, and 171 of them were subjected to gastroscopy, biopsy, and pathological examination. All participants were followed up for a long time, and their disease history was recorded. Results A total of 16 years of follow-up were performed, and 703 people were effectively followed up. In 2008, 171 people underwent gastroscopy, and 160 people had biopsy and pathological results in endoscopic screening. By 2024, 76 people had been diagnosed with malignant tumors of 12 different types, and among these people, 45 had esophageal cancer. Conclusion Esophageal cancer remains a significant cause of morbidity and mortality from malignant tumors in this region. Biopsy and pathological examination should be strengthened during gastroscopy, and follow-ups and regular check-ups should be given high importance to reduce the incidence and mortality rates of esophageal cancer.
4.The mechanism of target regulating of miR-421 to Menin/Caspase-3 pathway for depression
Yonghui LIU ; Qingjing TAN ; Qing CHEN ; Liping WEI ; Junwei YANG ; Kan YANG ; Yuguang GAO
The Journal of Practical Medicine 2024;40(4):453-459
Objective To explore the mechanism of miR-421 affecting the occurrence and development of depression.Methods A depressive rat model was established by single intraperitoneal injection of lipopolysaccharide(LPS),and depressive behavior was detected by glucose preference test and open-field test.miRNA microarray chips and RT-PCR were used to analyze the expression level of miR-421 in hippocampus of the depressed rats.TargetScan database and mi RDB database were used to predict the target genes of miR-421.Dual luciferase reporter gene assay was used to observe the binding of miR-421 to the target genes.The impact of over-expression and inhibition of miR-421 on target genes was observed,then the influence of over-expression and inhibition of target genes on downstream factors was observed,and the related mechanism of miR-421 on depression was explored.Results miRNA microarray chips and RT-PCR assay showed that miR-421 was highly expressed in the hippocampus of the depressed rats(P<0.001),Inhibition of miR-421 expression could significantly restore the body weight and exercise ability of the depressed rats(P<0.001).Binding targets of Menin and miR-421 were predicted by TargetScan database,and interaction between Menin and miR-421 was demonstrated by dual-luciferase reporter gene assay.Menin expression was down-regulated while miR-421 was overexpressed(P<0.001),whereas it was up-regulated as miR-421 was inhibited(P<0.001).qPCR indicated that expressions of Caspase-3 and NF-κB in the hippocampus of the depressed rats was significantly increased(P<0.001),and IL-1β expression in the hippo-campus was significantly increased(P<0.01).When the expression of Menin was inhibited,the expressions of Caspase-3,NF-κB and IL-1β were increased(P<0.001),while the expressions of Caspase-3,NF-κB and IL-1β were decreased when Menin was overexpressed(P<0.001).Conclusions Inhibition of miR-421 expression can increase Menin expression,decrease Caspase-3 content,and reduce neuroinflammatory response,thereby improving depressive symptoms.
5.Current status of book publishing in the field of biological weapons defense in China
Xuechun WANG ; Jiajun DU ; Xixiaoxue ZHANG ; Ting KAN ; Wenjun WU ; Yu MA ; Shanshan YANG ; Shengshu WANG ; Yao HE ; Miao LIU
Shanghai Journal of Preventive Medicine 2024;36(7):673-678
ObjectiveTo provide scientific support for the compilation of high-quality anti-nuclear, biological, and chemical (NBC) medical textbooks in China by retrieving books in the field of biological weapons defense in China, summarizing the publication time and distribution of publishing institutions, and categorizing content and key points of related books. MethodsRelevant subject terms in the field of biological weapons defense were searched through the official website of China National Digital Library and other websites, up until December 31, 2023, and were limited to books. Topic analysis was conducted on the introductions and contents of the books using the latent Dirichlet allocation (LDA) model. The number of topics was determined based on perplexity, and topics were identified according to the intertopic distance map, followed by a qualitative description of the core content of each topic. ResultsA total of 104 books were included in this study, among which four were identified as higher educational textbooks. The volume of publications increased during the periods 2002‒2004 and 2020‒2023. Research institutions accounted for the highest percentage of publishers (37.78%), and 56.67% of the publishers were military institutions. The study identified six topics: "distribution, defense, and response to biological weapons", "category, diagnosis, and treatment of biological warfare agents", "response to biological public health emergencies", "status of nuclear, biological, and chemical weapons internationally", "biosafety risk management and prevention and control", and "technologies and equipment related to biological hazard identification". ConclusionThere are few books in the field of biological weapons defense in China and the content is relatively outdated. In the future, the preparation of teaching materials should be aimed at practical emergency handling techniques for biological weapons, enhance the emphasis on biological weapons detection and biological warfare early warning, improve the fundamental theories at different training levels, and timely update the current research status in the field.
6.Development of the robotic digestive endoscope system and an experimental study on mechanistic model and living animals (with video)
Bingrong LIU ; Yili FU ; Kaipeng LIU ; Deliang LI ; Bo PAN ; Dan LIU ; Hao QIU ; Xiaocan JIA ; Jianping CHEN ; Jiyu ZHANG ; Mei WANG ; Fengdong LI ; Xiaopeng ZHANG ; Zongling KAN ; Jinghao LI ; Yuan GAO ; Min SU ; Quanqin XIE ; Jun YANG ; Yu LIU ; Lixia ZHAO
Chinese Journal of Digestive Endoscopy 2024;41(1):35-42
Objective:To develop a robotic digestive endoscope system (RDES) and to evaluate its feasibility, safety and control performance by experiments.Methods:The RDES was designed based on the master-slave control system, which consisted of 3 parts: the integrated endoscope, including a knob and button robotic control system integrated with a gastroscope; the robotic mechanical arm system, including the base and arm, as well as the endoscopic advance-retreat control device (force-feedback function was designed) and the endoscopic axial rotation control device; the control console, including a master manipulator and an image monitor. The operator sit far away from the endoscope and controlled the master manipulator to bend the end of the endoscope and to control advance, retract and rotation of the endoscope. The air supply, water supply, suction, figure fixing and motion scaling switching was realized by pressing buttons on the master manipulator. In the endoscopy experiments performed on live pigs, 5 physicians each were in the beginner and advanced groups. Each operator operated RDES and traditional endoscope (2 weeks interval) to perform porcine gastroscopy 6 times, comparing the examination time. In the experiment of endoscopic circle drawing on the inner wall of the simulated stomach model, each operator in the two groups operated RDES 1∶1 motion scaling, 5∶1 motion scaling and ordinary endoscope to complete endoscopic circle drawing 6 times, comparing the completion time, accuracy (i.e. trajectory deviation) and workload.Results:RDES was operated normally with good force feedback function. All porcine in vivo gastroscopies were successful, without mucosal injury, bleeding or perforation. In beginner and advanced groups, the examination time of both RDES and ordinary endoscopy tended to decrease as the number of operations increased, but the decrease in time was greater for operating RDES than for operating ordinary endoscope (beginner group P=0.033; advanced group P=0.023). In the beginner group, the operators operating RDES with 1∶1 motion scaling or 5∶1 motion scaling to complete endoscopic circle drawing had shorter completion time [1.68 (1.40, 2.17) min, 1.73 (1.47, 2.37) min VS 4.13 (2.27, 5.16) min, H=32.506, P<0.001], better trajectory deviation (0.50±0.11 mm, 0.46±0.11 mm VS 0.82±0.26 mm, F=38.999, P<0.001], and less workload [42.00 (30.00, 50.33) points, 43.33 (35.33, 54.00) points VS 52.67 (48.67, 63.33) points, H=20.056, P<0.001] than operating ordinary endoscope. In the advanced group, the operators operating RDES with 1∶1 or 5∶1 motion scaling to complete endoscopic circle drawing had longer completion time than operating ordinary endoscope [1.72 (1.37, 2.53) min, 1.57 (1.25, 2.58) min VS 1.15 (0.86, 1.58) min, H=13.233, P=0.001], but trajectory deviation [0.47 (0.13, 0.57) mm, 0.44 (0.39, 0.58) mm VS 0.52 (0.42, 0.59) mm, H=3.202, P=0.202] and workload (44.62±21.77 points, 41.24±12.57 points VS 44.71±17.92 points, F=0.369, P=0.693) were not different from those of the ordinary endoscope. Conclusion:The RDES enables remote control, greatly reducing the endoscopists' workload. Additionally, it gives full play to the cooperative motion function of the large and small endoscopic knobs, making the control more flexible. Finally, it increases motion scaling switching function to make the control of endoscope more flexible and more accurate. It is also easy for beginners to learn and master, and can shorten the training period. So it can provide the possibility of remote endoscopic control and fully automated robotic endoscope.
7.Surveillance results of foodborne disease in Liuzhou City in 2018 -2020
Zhenxing YANG ; Yun QIN ; Lian FENG ; Kan FENG ; Dehao LI ; Yiran LI
Journal of Public Health and Preventive Medicine 2024;35(5):37-40
Objective To investigate the epidemiological characteristics of foodborne diseases in Liuzhou City, and to provide reference for formulating the prevention and control measures of foodborne diseases. Methods The surveillance data of foodborne diseases in 25 sentinel hospitals in Liuzhou City from 2018 to 2020 were collected for statistical analysis. Results From 2018 to 2020, a total of 9 317 cases of foodborne diseases were reported in Liuzhou City, and 2 158 samples were collected for pathogen detection. A total of 311 cases were detected positive , with a detection rate of 14.41%. Norovirus had the highest detection rate (8.63%), followed by Salmonella (4.08%) and Escherichia coli (3.10%). July to October was a period of high incidence of foodborne disease( 41.17%). The proportion of patients aged 60 and over was the highest (18.49%), followed by the age group of 30-39 (18.03%). Suspicious foods were mainly meat and meat products (22.35%) and aquatic animals and their products (13.89%). The suspicious eating places were mainly families (40.43%) and restaurants (13.63%). Conclusion The high incidence of foodborne diseases in Liuzhou occurs in summer and autumn. The main pathogens are Salmonella and norovirus. Infected patients are concentrated in the age group of 60 years and above and the age group of 30 to 39 years old. The family is the main place of foodborne disease, followed by the restaurants and hotels. Suspicious foods include mainly meat and meat products and aquatic animals and their products. It is necessary to strengthen monitoring ability and food safety education to reduce the occurrence of foodborne diseases.
8.Evaluation of Simulated Weightlessness Model of Hindlimb Unloading Miniature Pigs and Their Tissue Damage
Yingxin TU ; Yilan JI ; Fei WANG ; Dongming YANG ; Dongdong WANG ; Zhixin SUN ; Yuexin DAI ; Yanji WANG ; KAN GUANGHAN ; Bin WU ; Deming ZHAO ; Lifeng YANG
Laboratory Animal and Comparative Medicine 2024;44(5):475-486
Objective To establish a weightlessness simulation animal model using miniature pigs, leveraging the characteristic of multiple systems’ tissue structures and functions similar to those of humans, and to observe pathophysiological changes, providing a new method for aerospace research. Methods Nine standard-grade miniature pigs were selected and randomly divided into an experimental group (n=7) and a control group (n=2). The experimental group was fixed using customized metal cages, with canvas slings suspending their hind limbs off the ground, and the body positioned at a -20° angle relative to the ground to simulate unloading for 30 days (24 hours a day). Data on body weight, blood volume, and blood biochemistry indicators were collected at different time points for statistical analysis of basic physiological changes. After the experiment, the miniature pigs were euthanized and tissue samples were collected for histopathological observation of the cardiovascular, skeletal and muscle systems HE and Masson staining. Statistical analysis was also conducted on the thickness of arterial vessels and the diameter of skeletal muscle fibers. Additionally, western blotting was employed to detect the expression levels of skeletal muscle atrophy-related proteins, including muscle-specific RING finger protein 1 (MuRf-1) and muscle atrophy F-box (MAFbx, as known as Atrogin-1), while immunohistochemistry was used to detect the expression of glial fibrillary acidic protein (GFAP), an indicator of astrocyte activation in the brain, reflecting the pathophysiological functional changes across systems. Results After hindlimb unloading, the experimental group showed significant decreases in body weight (P<0.001) and blood volume (P<0.01). During the experiment, hemoglobin, hematocrit, and red blood cell count levels significantly decreased (P<0.05) but gradually recovered. The expression levels of alanine aminotransferase and γ-glutamyltransferase initially decreased (P<0.05) before rebounding, while albumin significantly decreased (P<0.001) and globulin significantly increased (P<0.01). Creatinine significantly decreased (P<0.05). The average diameter of gastrocnemius muscle fibers in the experimental group significantly shortened (P<0.05), with a leftward shift in the distribution of muscle fiber diameters and an increase in small-diameter muscle fibers. Simultaneously, Atrogin-1 expression in the gastrocnemius and paravertebral muscles significantly increased (P<0.05). These changes are generally consistent with the effects of weightlessness on humans and animals in space. Furthermore, degenerative changes were observed in some neurons of the cortical parietal lobe, frontal lobe, and hippocampal regions of the experimental group, with a slight reduction in the number of Purkinje cells in the cerebellar region, and a significant enhancement of GFAP-positive signals in the hippocampal area (P<0.05). Conclusion Miniature pigs subjected to a -20° angle hind limb unloading for 30 days maybe serve as a new animal model for simulating weightlessness, applicable to related aerospace research.
9.The role of brevican regulation in the antidepressant effects of electroacupuncture in a chronic stress rat model
Cong Gai ; Zhenyu Guo ; Kai Guo ; Shixin Yang ; Yi Zhang ; Huimin Zhu ; Feifei Kan ; Hongmei Sun ; Die Hu
Journal of Traditional Chinese Medical Sciences 2024;11(4):513-521
Objective:
To investigate the mechanism of electroacupuncture (EA) for treating depression and to explore the role of brevican in the medial prefrontal cortex (mPFC) in modulating stress susceptibility and the antidepressant effects of EA in rats.
Methods:
Twenty-four Sprague–Dawley (SD) rats were equally divided into three groups: green fluorescent protein (GFP) + control, GFP + chronic unpredicted mild stress (CUMS), and short-hairpin RNA targeting on brevican (shBcan) + CUMS. Another 24 SD rats were equally divided into CUMS + GFP, CUMS + GFP + EA, and CUMS + shBcan + EA groups. Behavioral tests were conducted to assess depression-like behavior. Western blot analysis was used to evaluate the expression of brevican, aggrecan, GLuA1, and PSD95 in mPFC subregions.
Results:
Behavioral parameter evaluation show that rats in the shBcan + CUMS group exhibited a significantly reduced sucrose preference (P = .0002) and increased immobility time (P = .0011) compared to those in rats in the GFP + CUMS group. Western blotting showed that brevican expression was significantly downregulated in the PrL of the shBcan + CUMS group compared with that in the GFP + CUMS group (P = .0192). Furthermore, compared to the CUMS + GFP + EA group, the CUMS + shBcan + EA group exhibited a significantly decreased sucrose preference (P = .0334), increased immobility time (P = .0465), and increased latency to food (P = .0261). In the CUMS + shBcan + EA group, the EA-induced brevican and PSD95 overexpression was reversed, compared with that in the CUMS + GFP + EA group (P = .0454 and P = .0198, respectively).
Conclusion
EA exerts its antidepressant effects through the modulation of brevican expression in rats. Our findings highlight the important role for brevican in stress susceptibility, which could be a potential target for treating depression.
10.Vildagliptin Protects Palmitic Acid-induced Myocardial Inflammatory Damage in Diabetes Mellitus
Ruinan YANG ; Ying YU ; Kan QIN
Chinese Journal of Modern Applied Pharmacy 2024;41(11):1484-1490
OBJECTIVE
To explore the mechanism of vildagliptin, a dipeptidyl peptidase 4 inhibitor(DPP-4i), in improving the inflammatory damage of cardiomyocytes induced by diabetes mellitus.
METHODS
The AC16 cardiomyocytes cultured in vitro were randomly divided into blank group, palmitic acid(PA) group, 0.1, 1, 10 μmol·L−1 vildagliptin group, and sitagliptin group (positive control group). The cell viability was detected by CCK-8 kit. The expressions of DPP-4, p-NF-κB and IκB were detected by Western blotting. The expression level of inflammatory cytokines TNF-α and IL-6 were detected by ELISA kit. TUNEL kit was used to detect cell apoptosis.
RESULTS
After PA treatment, the cell morphology of AC16 human cardiomyocytes changed, CCK-8 results showed a decrease in cell survival rate, Western blotting results showed increased phosphorylation of NF-κB and increased expression of DPP-4 protein, and ELISA results showed increased expression level of inflammatory factors TNF-α and IL-6. The increase of TUNEL positive ratio promoted apoptosis of cardiomyocytes. After administration of DPP-4i vildagliptin, it could effectively inhibit the abnormal expression of DPP-4 protein induced by PA, improve the morphology of cardiomyocytes, and down-regulate the level of NF-κB phosphorylation. ELISA results showed that vildagliptin could improve the expression level of PA-induced inflammatory factors TNF-α and IL-6, and reduce the proportion of TUNEL positive(P<0.05).
CONCLUSION
Vildagliptin can effectively antagonize PA-induced inflammatory injury of cardiomyocytes, antagonize myocardial injury induced by diabetic cardiomyopathy by inhibiting the phosphorylation level of NF-κB, reducing the expression level of intracellular inflammatory factors and inhibiting apoptosis.


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