1.Comprehensive evaluation of powder-liquid double-chamber bag products: a systematic review
Fei SHU ; Rui SUN ; Kai SONG ; Yuanlin ZHANG ; Jiaming YAN ; Lixin SHU
Journal of Pharmaceutical Practice and Service 2025;43(2):92-96
Objective To evaluate the advantages of powder-liquid double-chamber bag products compared with traditional powder injection. Methods The systematic review method was used to collect the literature on powder-liquid double-chamber bag, extract common evaluation indicators, evaluate the use value of powder-liquid double-chamber bag products, and conduct a comprehensive comparison with traditional powder injection products. Results A total of 23 articles were included in the literature. The effectiveness indicators used for evaluation were the stability of the liquid medicine, the accuracy of the preparation concentration, and the residual amount of the liquid medicine; the safety indicators were the incidence of insoluble particles and the incidence of punctures and scratches. The economic indicators were preparation cost, occupied volume of preparation supplies, waste weight, hospitalization cost and incidence of blood infection. The applicability indicators were preparation time, average occupation of medical staff, packaging weight and storage and transportation volume, environmental adaptability, and ease of waste disposal. Accessibility indicators are the number of manufacturers, raw material supply capacity, and patient affordability. Through the evaluation of literature evidence, it was found that the stability and concentration accuracy of the powder-liquid double-chamber bag were higher than those of the traditional powder injection, and the domestic supply had been achieved. The double-chamber bag method can reduce the infusion reaction and shorten the preparation time of the liquid medicine. Conclusion Compared with traditional powder injectabler products, powder-liquid double-chamber bags have advantages in the dimensions of effectiveness, safety, economy, suitability and innovation, and the accessibility dimension meets the requirements.
2.The effect of rutaecarpine on improving fatty liver and osteoporosis in MAFLD mice
Yu-hao ZHANG ; Yi-ning LI ; Xin-hai JIANG ; Wei-zhi WANG ; Shun-wang LI ; Ren SHENG ; Li-juan LEI ; Yu-yan ZHANG ; Jing-rui WANG ; Xin-wei WEI ; Yan-ni XU ; Yan LIN ; Lin TANG ; Shu-yi SI
Acta Pharmaceutica Sinica 2025;60(1):141-149
Metabolic-associated fatty liver disease (MAFLD) and osteoporosis (OP) are two very common metabolic diseases. A growing body of experimental evidence supports a pathophysiological link between MAFLD and OP. MAFLD is often associated with the development of OP. Rutaecarpine (RUT) is one of the main active components of Chinese medicine Euodiae Fructus. Our previous studies have demonstrated that RUT has lipid-lowering, anti-inflammatory and anti-atherosclerotic effects, and can improve the OP of rats. However, whether RUT can improve both fatty liver and OP symptoms of MAFLD mice at the same time remains to be investigated. In this study, we used C57BL/6 mice fed a high-fat diet (HFD) for 4 months to construct a MAFLD model, and gave the mice a low dose (5 mg·kg-1) and a high dose (15 mg·kg-1) of RUT by gavage for 4 weeks. The effects of RUT on liver steatosis and bone metabolism were then evaluated at the end of the experiment [this experiment was approved by the Experimental Animal Ethics Committee of Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences (approval number: IMB-20190124D303)]. The results showed that RUT treatment significantly reduced hepatic steatosis and lipid accumulation, and significantly reduced bone loss and promoted bone formation. In summary, this study shows that RUT has an effect of improving fatty liver and OP in MAFLD mice.
3.Update on the treatment navigation for functional cure of chronic hepatitis B: Expert consensus 2.0
Di WU ; Jia-Horng KAO ; Teerha PIRATVISUTH ; Xiaojing WANG ; Patrick T.F. KENNEDY ; Motoyuki OTSUKA ; Sang Hoon AHN ; Yasuhito TANAKA ; Guiqiang WANG ; Zhenghong YUAN ; Wenhui LI ; Young-Suk LIM ; Junqi NIU ; Fengmin LU ; Wenhong ZHANG ; Zhiliang GAO ; Apichat KAEWDECH ; Meifang HAN ; Weiming YAN ; Hong REN ; Peng HU ; Sainan SHU ; Paul Yien KWO ; Fu-sheng WANG ; Man-Fung YUEN ; Qin NING
Clinical and Molecular Hepatology 2025;31(Suppl):S134-S164
As new evidence emerges, treatment strategies toward the functional cure of chronic hepatitis B are evolving. In 2019, a panel of national hepatologists published a Consensus Statement on the functional cure of chronic hepatitis B. Currently, an international group of hepatologists has been assembled to evaluate research since the publication of the original consensus, and to collaboratively develop the updated statements. The 2.0 Consensus was aimed to update the original consensus with the latest available studies, and provide a comprehensive overview of the current relevant scientific literatures regarding functional cure of hepatitis B, with a particular focus on issues that are not yet fully clarified. These cover the definition of functional cure of hepatitis B, its mechanisms and barriers, the effective strategies and treatment roadmap to achieve this endpoint, in particular new surrogate biomarkers used to measure efficacy or to predict response, and the appropriate approach to pursuing a functional cure in special populations, the development of emerging antivirals and immunomodulators with potential for curing hepatitis B. The statements are primarily intended to offer international guidance for clinicians in their practice to enhance the functional cure rate of chronic hepatitis B.
4.Mechanism of Tougu Xiaotong Capsules regulating Malat1 and mi R-16-5p ceRNA to alleviate "cholesterol-iron" metabolism disorder in osteoarthritis chondrocytes.
Chang-Long FU ; Yan-Ming LIN ; Shu-Jie LAN ; Chao LI ; Zi-Hong ZHANG ; Yue CHEN ; Ying-Rui TONG ; Yan-Feng HUANG
China Journal of Chinese Materia Medica 2025;50(15):4363-4371
From the perspective of competitive endogenous RNA(ceRNA) constructed by metastasy-associated lung adenocarcinoma transcript 1(Malat1) and microRNA 16-5p(miR-16-5p), the improvement mechanism of Tonggu Xiaotong Capsules(TGXTC) on the imbalance and disorder of "cholesterol-iron" metabolism in chondrocytes of osteoarthritis(OA) was explored. In vivo experiments, 60 8-week-old C57BL/6 mice were acclimatized and fed for 1 week and then randomly divided into two groups: blank group(12 mice) and modeling group(48 mice). The animals in modeling group were anesthetized by 5% isoflurane inhalation, which was followed by the construction of OA model. They were then randomly divided into model group, TGXTC group, Malat1 overexpression group, and TGXTC+Malat1 overexpression(TGXTC+Malat1-OE) group, with 12 mice in each group. The structural changes of mouse cartilage tissues were observed by Masson staining after the intervention in each group. RT-PCR was employed to detect the mRNA levels of Malat1 and miR-16-5p in cartilage tissues. Western blot was used to analyze the protein expression of ATP-binding cassette transporter A1(ABCA1), sterol regulatory element-binding protein(SREBP), cytochrome P450 family 7 subfamily B member 1(CYP7B1), CCAAT/enhancer-binding protein homologous protein(CHOP), acyl-CoA synthetase long-chain family member 4(ACSL4), and glutathione peroxidase 4(GPX4) in cartilage tissues. In vitro experiments, mouse chondrocytes were induced by thapsigargin(TG), and the combination of Malat1 and miR-16-5p was detected by double luciferase assay. The fluorescence intensity of Malat1 in chondrocytes was determined by fluorescence in situ hybridization. The miR-16-5p inhibitory chondrocyte model was constructed. RT-PCR was used to analyze the levels of Malat1 and miR-16-5p in chondrocytes under the inhibition of miR-16-5p. Western blot was adopted to analyze the regulation of TG-induced chondrocyte proteins ABCA1, SREBP, CYP7B1, CHOP, ACSL4, and GPX4 by TGXTC under the inhibition of miR-16-5p. The results of in vivo experiments showed that,(1) compared with model group, TGXTC group exhibited a relatively complete cartilage layer structure. Compared with Malat1-OE group, TGXTC+Malat1-OE group showed alleviated cartilage surface damage.(2) Compared with model group, TGXTC group had a significantly decreased Malat1 mRNA level and an increased miR-16-5p mRNA level in mouse cartilage tissues(P<0.01).(3) Compared with the model group, the protein levels of ABCA1 and GPX4 in the cartilage tissue of mice in the TGXTC group increased, while the protein levels of SREBP, CYP7B1, CHOP and ACSL4 decreased(P<0.01). The results of in vitro experiments show that,(1) dual-luciferase was used to evaluate that miR-16-5p has a targeting effect on the Malat1 gene.(2)Compared with TG+miR-16-5p inhibition group, TG+miR-16-5p inhibition+TGXTC group had an increased mRNA level of miR-16-5p and an decreased mRNA level of Malat1(P<0.01).(3) Compared with TG+miR-16-5p inhibition group, TG+miR-16-5p inhibition+TGXTC group exhibited increased expression of ABCA1 and GPX4 proteins and decreased expression of SREBP, CYP7B1, CHOP, and ACSL4 proteins(P<0.01). The reasults showed that TGXTC can regulate the ceRNA of Malat1 and miR-16-5p to alleviate the "cholesterol-iron" metabolism disorder of osteoarthritis chondrocytes.
Animals
;
MicroRNAs/metabolism*
;
RNA, Long Noncoding/metabolism*
;
Chondrocytes/drug effects*
;
Drugs, Chinese Herbal/pharmacology*
;
Mice, Inbred C57BL
;
Mice
;
Osteoarthritis/drug therapy*
;
Iron/metabolism*
;
Male
;
Cholesterol/metabolism*
;
Humans
;
Capsules
;
RNA, Competitive Endogenous
5.Mechanism of traditional Chinese medicine treatment of hepatic fibrosis by restoring circadian rhythms.
Meng-Ru ZHANG ; Ruo-Nan JIANG ; Shu-Hua XIONG ; Hong-Yan WU ; De-Song KONG ; Li CHEN
China Journal of Chinese Materia Medica 2025;50(16):4407-4414
Hepatic fibrosis is a key pathological process in the development of chronic liver disease to cirrhosis, and its core mechanism involves the activation of hepatic stellate cells(HSC) and abnormal deposition of extracellular matrix(ECM). Although existing treatments, such as antiviral drugs, can delay disease progression, they have the problem of single therapeutic targets and cannot reverse fibrosis. Accordingly, multidimensional intervention strategies are urgently needed. Recent studies have shown that circadian rhythm disorders aggravate hepatic fibrosis by regulating metabolism, immunity, and inflammation. Traditional Chinese medicine(TCM) plays a unique role in restoring the circadian clock via multi-target and holistic regulation. This paper establishes a three-dimensional network by systematically integrating biological clock, metabolism, and immunity for the first time to elucidate the scientific connotation of the theory of time-concerned treatment of TCM, and proposes a new strategy for the development of time-targeted compound prescriptions, providing innovative ideas for the treatment of hepatic fibrosis.
Humans
;
Liver Cirrhosis/metabolism*
;
Drugs, Chinese Herbal/therapeutic use*
;
Circadian Rhythm/drug effects*
;
Animals
;
Medicine, Chinese Traditional
;
Hepatic Stellate Cells/drug effects*
6.The analysis of invention patents in the field of artificial intelligent medical devices.
Ting ZHANG ; Juan CHEN ; Yan LU ; Dongzi XU ; Shu YAN ; Zhaolian OUYANG
Journal of Biomedical Engineering 2025;42(3):504-511
The emergence of new-generation artificial intelligence technology has brought numerous innovations to the healthcare field, including telemedicine and intelligent care. However, the artificial intelligent medical device sector still faces significant challenges, such as data privacy protection and algorithm reliability. This study, based on invention patent analysis, revealed the technological innovation trends in the field of artificial intelligent medical devices from aspects such as patent application time trends, hot topics, regional distribution, and innovation players. The results showed that global invention patent applications had remained active, with technological innovations primarily focused on medical image processing, physiological signal processing, surgical robots, brain-computer interfaces, and intelligent physiological parameter monitoring technologies. The United States and China led the world in the number of invention patent applications. Major international medical device giants, such as Philips, Siemens, General Electric, and Medtronic, were at the forefront of global technological innovation, with significant advantages in patent application volumes and international market presence. Chinese universities and research institutes, such as Zhejiang University, Tianjin University, and the Shenzhen Institute of Advanced Technology, had demonstrated notable technological innovation, with a relatively high number of patent applications. However, their overseas market expansion remained limited. This study provides a comprehensive overview of the technological innovation trends in the artificial intelligent medical device field and offers valuable information support for industry development from an informatics perspective.
Artificial Intelligence
;
Patents as Topic
;
Humans
;
Inventions
;
China
;
Brain-Computer Interfaces
;
Telemedicine
;
Equipment and Supplies
;
Robotics
;
Algorithms
7.Analysis of the global registration status of clinical trials for artificial intelligence medical device.
Yan LU ; Juan CHEN ; Ting ZHANG ; Shu YAN ; Dongzi XU ; Zhaolian OUYANG
Journal of Biomedical Engineering 2025;42(3):512-519
The rapid development of artificial intelligence technology is driving profound changes in medical practice, particularly in the field of medical device application. Based on data from the U.S. clinical trials registry, this study analyzes the global registration landscape of clinical trials involving artificial intelligence-based medical devices, aiming to provide a reference for their clinical research and application. A total of 2 494 clinical trials related to artificial intelligence medical devices have been registered worldwide, with participation from 66 countries or regions. The United States leads with 908 trials, while for other countries or regions, including China, each has fewer than 300 trials. Germany, the United States, and Belgium serve as central hubs for international collaboration. Among the sponsors, 63.96% are universities or hospitals, 22.36% are enterprises, and the remainder includes individuals, government agencies and others. Of all trials, 79.99% are interventional studies, 94.67% place no restrictions on participant gender, and 69.69% exclude children. The targeted diseases are primarily neurological and mental disorders. This study systematically reveals the global distribution characteristics and research trends of artificial intelligence medical device clinical trials, offering valuable data support and practical insights for advancing international collaboration, resource allocation, and policy development in this field.
Artificial Intelligence
;
Humans
;
Clinical Trials as Topic/statistics & numerical data*
;
Equipment and Supplies
;
Registries
;
United States
8.Preliminary application of human-computer interaction CT imaging AI recognition and positioning technology in the treatment of type C1 distal radius fractures.
Yong-Zhong CHENG ; Xiao-Dong YIN ; Fei LIU ; Xin-Heng DENG ; Chao-Lu WANG ; Shu-Ke CUI ; Yong-Yao LI ; Wei YAN
China Journal of Orthopaedics and Traumatology 2025;38(1):31-40
OBJECTIVE:
To explore the accuracy of human-computer interaction software in identifying and locating type C1 distal radius fractures.
METHODS:
Based on relevant inclusion and exclusion criteria, 14 cases of type C1 distal radius fractures between September 2023 and March 2024 were retrospectively analyzed, comprising 3 males and 11 females(aged from 27 to 82 years). The data were assigned randomized identifiers. A senior orthopedic physician reviewed the films and measured the ulnar deviation angle, radial height, palmar inclination angle, intra-articular step, and intra-articular gap for each case on the hospital's imaging system. Based on the reduction standard for distal radius fractures, cases were divided into reduction group and non-reduction group. Then, the data were sequentially imported into a human-computer interaction intelligent software, where a junior orthopedic physician analyzed the same radiological parameters, categorized cases, and measured fracture details. The categorization results from the software were consistent with manual classifications (6 reduction cases and 8 non-reduction cases). For non-reduction cases, the software performed further analyses, including bone segmentation and fracture recognition, generating 8 diagnostic reports containing fracture recognition information. For the 6 reduction cases, the senior and junior orthopedic physicians independently analyzed the data on the hospital's imaging system and the AI software, respectively. Bone segments requiring reduction were identified, verified by two senior physicians, and measured for displacement and rotation along the X (inward and outward), Z (front and back), and Y (up and down) axes. The AI software generated comprehensive diagnostic reports for these cases, which included all measurements and fracture recognition details.
RESULTS:
Both the manual and AI software methods consistently categorized the 14 cases into 6 reduction and 8 non-reduction groups, with identical data distributions. A paired sample t-test revealed no statistically significant differences (P>0.05) between the manual and software-based measurements for ulnar deviation angle, radial ulnar bone height, palmar inclination angle, intra-articular step, and joint space. In fracture recognition, the AI software correctly identified 10 C-type fractures and 4 B-type fractures. For the 6 reduction cases, a total of 24 bone fragments were analyzed across both methods. After verification, it was found that the bone fragments identified by the two methods were consistent. A paired sample t-tests revealed that the identified bone fragments and measured displacement and rotation angles along the X, Y, and Z axes were consistent between the two methods. No statistically significant differences(P>0.05) were found between manual and software measurements for these parameters.
CONCLUSION
Human-computer interaction software employing AI technology demonstrated comparable accuracy to manual measurement in identifying and locating type C1 distal radius fractures on CT imaging.
Humans
;
Male
;
Female
;
Radius Fractures/surgery*
;
Middle Aged
;
Adult
;
Aged
;
Aged, 80 and over
;
Tomography, X-Ray Computed/methods*
;
Retrospective Studies
;
Software
;
Wrist Fractures
9.Application of OpenSim musculoskeletal model in biomechanics research of orthopedics and traumatology.
Rui LI ; Yang LIU ; Zhao-Jie ZHANG ; Xin-Wei ZHANG ; Yan-Zhen ZHANG ; Yan-Qi HU ; Can YANG ; Shu-Shi MAO ; Jia-Ming QIU
China Journal of Orthopaedics and Traumatology 2025;38(3):319-324
OpenSim is an open source, free motion simulation and gait analysis software, which can be used to dynamically simulate and analyze the complex motion of the human body, and is widely used in human biomechanical research. Since OpenSim can analyze multi-dimensional motion data such as muscle strength, joint torque, and muscle synergistic activation during human movement, it can be used to study the biomechanical mechanism of musculoskeletal imbalance diseases and various treatment methods in TCM orthopedics, and has a broad application prospect in the field of TCM orthopedics. By the analysis of the basic characteristics, elements, analysis process, and application prospects of OpenSim, it is concluded that OpenSim musculoskeletal model has a large application space in the field of traditional Chinese medicine orthopedic, which is helpful to explain the pathogenesis and mechanism of diseases, and promote the precision diagnosis and treatment of orthopedics diseases;the application of OpenSim musculoskeletal model can solve the problem that the previous research paid attention to the bone malalignment and not enough attention to the tendon, and provide a new method for the research of orthopedic diseases. At present, there are still problems in the promotion and application of OpenSim, such as large equipment requirements and high operation threshold. Therefore, multidisciplinary cooperation, clinical research, and data sharing are the basic research strategies in this field.
Humans
;
Biomechanical Phenomena
;
Orthopedics
;
Traumatology
;
Software
;
Medicine, Chinese Traditional
;
Musculoskeletal System
;
Models, Biological
10.A convenient research strategy for functional verification of epigenetic regulators during spermatogenesis.
Shan LI ; Ying YUAN ; Ke-Yu ZHANG ; Yi-Dan GUO ; Lu-Tong WANG ; Xiao-Yuan ZHANG ; Shu ZHANG ; Qi YAN ; Rong ZHANG ; Jie CHEN ; Feng-Tang YANG ; Jing-Rui LI
Asian Journal of Andrology 2025;27(2):261-267
Spermatogenesis is a fundamental process that requires a tightly controlled epigenetic event in spermatogonial stem cells (SSCs). The mechanisms underlying the transition from SSCs to sperm are largely unknown. Most studies utilize gene knockout mice to explain the mechanisms. However, the production of genetically engineered mice is costly and time-consuming. In this study, we presented a convenient research strategy using an RNA interference (RNAi) and testicular transplantation approach. Histone H3 lysine 9 (H3K9) methylation was dynamically regulated during spermatogenesis. As Jumonji domain-containing protein 1A (JMJD1A) and Jumonji domain-containing protein 2C (JMJD2C) demethylases catalyze histone H3 lysine 9 dimethylation (H3K9me2), we firstly analyzed the expression profile of the two demethylases and then investigated their function. Using the convenient research strategy, we showed that normal spermatogenesis is disrupted due to the downregulated expression of both demethylases. These results suggest that this strategy might be a simple and alternative approach for analyzing spermatogenesis relative to the gene knockout mice strategy.
Spermatogenesis/physiology*
;
Animals
;
Male
;
Mice
;
Epigenesis, Genetic
;
Jumonji Domain-Containing Histone Demethylases/metabolism*
;
Histones/metabolism*
;
RNA Interference
;
Testis/metabolism*
;
Methylation
;
Mice, Knockout
;
Histone Demethylases

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