1.Clinical efficacy analysis of seven pediatric patients with Acute myeloid leukemia and the t(16;21)(p11;q22) FUS::ERG fusion gene.
Lihuan SHI ; Shan HUANG ; Xing XIE ; Pengkai FAN ; Haili GAO ; Yanna MAO
Chinese Journal of Medical Genetics 2026;43(2):90-95
OBJECTIVE:
To analyze the clinical characteristics, treatment, and prognosis of seven pediatric patients with Acute myeloid leukemia (AML) positive for the t(16;21)(p11;q22) FUS::ERG fusion gene.
METHODS:
A retrospective analysis was carried out on the clinical data, treatment, and prognosis of seven AML patients with t(16;21)(p11;q22) FUS::ERG fusion gene admitted to Henan Children's Hospital between June 2015 and November 2024. Relevant literature was also reviewed. This study was approved by the Medical Ethics Committee of the Hospital (Ethics No.: 2024-102-001).
RESULTS:
Among 297 pediatric patients with AML, 7 cases (2.36%) were positive for the t(16;21)(p11;q22) FUS::ERG fusion gene, including 3 males and 4 females, with a median age of 11 years (range: 3 ~ 12 years). According to the FAB classification, these included 1 case of M2, 3 cases of M5, and 3 cases of AML-not otherwise specified (non-M3). All 7 patients were found to harbor the t(16;21)(p11;q22) translocation, with 3 cases showing additional chromosomal abnormalities. Immunophenotyping revealed universal expression of CD13, CD33, CD34, and CD117, with partial expression of CD56, CD4, CD64, CD123, CD15, CD38, CD11b, HLA-DR, cMPO, and CD16. One patient achieved complete remission (CR) after the first course of DAE (cytarabine + daunorubicin + etoposide) induction chemotherapy but relapsed and discontinued the treatment. Six patients received DAH (cytarabine + daunorubicin + homoharringtonine) induction therapy, of whom 2 achieved CR after two courses and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT), resulting in an overall CR rate of 42.86%. Five children did not receive allo-HSCT and had a median overall survival of 9 months (range: 6 ~ 18 months). Two children who underwent transplantation achieved bone marrow morphological and molecular biological relapse at 6 and 9 months post-transplantation, respectively. After receiving combined chemotherapy and donor lymphocyte infusion, one child failed to achieve remission and died at 22 months post-transplantation, while the other has been followed up to date with positive fusion gene status. Their overall survival was 25 months and 30 months, respectively.
CONCLUSION
The t(16;21)(p11;q22) FUS::ERG fusion gene is rare in pediatric AML and associated with poor prognosis. Allo-HSCT may mitigate the adverse prognostic impact of the FUS::ERG fusion gene and contribute to prolonged survival.
Humans
;
Male
;
Child
;
Female
;
Leukemia, Myeloid, Acute/drug therapy*
;
Oncogene Proteins, Fusion/genetics*
;
Translocation, Genetic
;
Retrospective Studies
;
RNA-Binding Protein FUS/genetics*
;
Chromosomes, Human, Pair 16/genetics*
;
Adolescent
;
Child, Preschool
;
Chromosomes, Human, Pair 21/genetics*
;
Prognosis
;
Treatment Outcome
2.Olfactory Receptors Expressed in The Intestine and Their Functions
Pei-Wen YANG ; Meng-Meng YUAN ; Ying ZHOU ; Peng LI ; Gui-Hong QI ; Ying YANG ; Zhong-Yi MAO ; Meng-Sha ZHOU ; Xiao-Shuang MAO ; Jian-Ping XIE ; Yi-Nan YANG ; Shi-Hao SUN
Progress in Biochemistry and Biophysics 2026;53(3):534-549
Olfactory receptors (ORs) form the largest superfamily of G protein-coupled receptors (GPCRs). Traditionally recognized for their role in the nasal olfactory epithelium, where they mediate the sense of smell, accumulating evidence has firmly established their ectopic expression in non-olfactory tissues, including the intestine, lungs, and kidneys. The intestine, as the primary site for nutrient digestion and absorption, harbors a highly complex chemical environment. To adapt to this environment, the gut employs a sophisticated network of “chemosensors” to monitor luminal contents and maintain homeostasis. Among these sensors, intestinal ORs have emerged as crucial functional components, serving as a molecular bridge that connects environmental chemical signals—such as food-derived odorants—to specific physiological responses. This discovery has significantly deepened our understanding of how dietary flavors and compounds influence intestinal physiology at the molecular level. This review systematically summarizes the expression profiles, ligand classification, and biological functions of ORs within the gastrointestinal tract. Studies indicate that intestinal ORs exhibit distinct spatial distribution patterns across different gut segments and display cell-type specificity, particularly within enterocytes and enteroendocrine cells. These receptors function as versatile sensors capable of recognizing a wide variety of ligands, including exogenous dietary components, gut microbiota metabolites such as short-chain fatty acids, and endogenous small molecules like azelaic acid. Upon activation by specific ligands, intestinal ORs trigger intracellular signaling cascades, primarily involving the AC-cAMP-PKA pathway or calcium influx channels. A major focus of this review is to elucidate the molecular mechanisms by which these receptors regulate the secretion of gut hormones. Activation of specific ORs in enteroendocrine cells has been shown to stimulate the release of hormones such as glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and serotonin (5-HT), thereby modulating systemic energy metabolism, glucose homeostasis, and gastrointestinal motility. Furthermore, the review addresses the critical roles of ORs in immune regulation and pathology. Evidence suggests that specific ORs contribute to the maintenance of intestinal immune homeostasis and may offer protection against inflammation. Beyond their involvement in inflammatory responses, ORs such as Olfr78 have been shown to regulate the differentiation and function of intestinal endocrine cells. Similarly, Olfr544 has been demonstrated to alleviate intestinal inflammation by remodeling the gut microbiome and metabolome. These findings collectively suggest that specific ORs hold promise as therapeutic targets for mitigating intestinal inflammation and maintaining gut homeostasis. Additionally, the review explores the emerging role of ORs in cancer. Although OR expression is often downregulated in tumor tissues compared to normal mucosa, activation of specific ORs by certain ligands can inhibit tumor cell proliferation and migration and induce apoptosis via pathways such as MEK/ERK and p38 MAPK. Conversely, other receptors, such as OR7C1, may serve as biomarkers for cancer-initiating cells. In conclusion, intestinal ORs represent a vital component of the gut’s sensory network. The review also discusses the translational potential of these findings. By elucidating the precise pairing relationships between dietary components and specific ORs, novel therapeutic strategies could be developed. Intestinal ORs may thus emerge as promising targets for nutritional and pharmacological interventions in metabolic diseases, inflammatory bowel diseases, and malignancies.
3.Mechanism study of Xibining Ⅱ formula in alleviating synovial inflammation and fibrosis in KOA rats via JAK2/STAT3 pathway
Jiachen SONG ; Peng WU ; Li ZHANG ; Deren LIU ; Lei SHI ; Jiangyu LIU ; Yaotian SHI ; Jun MAO
China Pharmacy 2026;37(14):1838-1844
OBJECTIVE To investigate the mechanism of Xibining Ⅱ formula in alleviating synovial inflammation and fibrosis in knee osteoarthritis (KOA) rats based on Janus kinase 2 (JAK2)/signal transducer and activator of transcription 3 (STAT3) pathway. METHODS Seventy-five male SD rats were randomly divided into sham operation group (Sham group), KOA group, Xibining Ⅱ low-dose group (XBNⅡ-L group, 4 g/kg), Xibining Ⅱ high-dose group (XBNⅡ-H group, 8 g/kg), and Xibining Ⅱ high-dose combined with STAT3 activator Colivelin trifluoroacetate (C-TFA) group [C-TFA group, 8 g/kg Xibining Ⅱ+ 1.0 mg/(kg·d) C-TFA], with 15 rats in each group. Except for the Sham group, the KOA model was established by anterior cruciate ligament transection in the other groups. After successful modeling, each group was given corresponding drugs by intragastric administration and (or) intraperitoneal injection once daily for 28 consecutive days. After the last medication, the pathological changes of synovial tissue of knee joint in each group were evaluated and the indicators were calculated. The levels of serum inflammatory factors were detected. The positive expressions of phosphorylated JAK2 (p-JAK2) and phosphorylated STAT3 (p-STAT3) in synovial tissue of the knee joint were detected. The expressions of JAK2/STAT3 pathway-related proteins and mRNAs in synovial tissue were detected. RESULTS Compared with the Sham group, the synovial lining cells in the KOA group showed significant proliferation and disordered arrangement; the Krenn score, fibrosis ratio, positive area percentage of p-JAK2 and p-STAT3, p-JAK2/JAK2 and p-STAT3/STAT3, protein expression of Collagen-Ⅰ and α -smooth muscle actin, the mRNA expression of JAK2, STAT3, Collagen-Ⅰ and α -smooth muscle actin, as well as serum levels of interleukin-1β and interleukin-18 were significantly increased ( P <0.05). Compared with the KOA group, the above pathological changes were significantly improved in each dose group of Xibining Ⅱ formula, and all indicators were significantly decreased ( P <0.05), with the XBNⅡ-H group showing better effects than the XBNⅡ-L group ( P <0.05). Compared with the XBNⅡ-H group, the above pathological damages were aggravated in the C-TFA group, and all indicators were significantly worsened ( P <0.05). CONCLUSIONS Xibining Ⅱ formula can alleviate synovial inflammation and fibrosis in KOA rats, and its mechanism may be related to inhibiting the activation of JAK2/STAT3 pathway.
4.Current awareness and optimization recommendations regarding the pneumonia with unknown etiology surveillance system among healthcare professionals in Shanghai
Qiwen FANG ; Chenyan JIANG ; Xin CHEN ; Huanyu WU ; Bihong JIN ; Xiaohuan GONG ; Shenghua MAO ; Qi QIU ; Ruobing HAN ; Huilin SHI ; Wenbin DONG ; Xin HU ; Jian CHEN ; Yaxu ZHENG
Shanghai Journal of Preventive Medicine 2026;38(6):482-487
ObjectiveTo investigate the current awareness and optimization recommendations on pneumonia with unknown etiology (PUE) surveillance among Shanghai healthcare professionals, and to provide evidence for the improvement of the surveillance system. MethodsIn December 2024, healthcare professional participants from diverse medical and health institutions were randomly selected within each stratum using a stratified cluster sampling method in all 16 districts of Shanghai for questionnaire surveys on their knowledge and suggestions for optimization of the PUE surveillance system. Descriptive statistics analyses, multivariate logistic regressions, and content analyses were used for data analyses. ResultsA total of 385 survey subjects were involved in the study, including 119 professional staffs from disease prevention and control centers and 266 from medical institutions. Those who understood the case definition for PUE correctly accounted for 67.01% (258/385). Multivariate regression model analyses showed that female gender (aOR=2.22, 95%CI: 1.36‒3.66), professionals from disease control institutions (aOR=2.02, 95%CI: 1.12‒3.72), and those who self-assessed as being familiar with the monitoring system (aOR=2.18, 95%CI:1.23‒3.89) had better understanding of the definition. Overall, 89.61% (345/385) of the survey subjects acknowledged the necessity of the surveillance system. Small number of cases meeting the case definition (54.46%, 214/379), insufficient diagnostic awareness (39.84%, 151/379), and lack of incentives for case reporting (29.29%, 111/379) were major problems for the current surveillance system, with variations observed across different types of institutions. Suggested segments for optimizing the surveillance system included monitoring purpose, case definition, form of monitoring and reporting procedure, organization mechanism, and epidemiological investigation and response. ConclusionThe necessity of PUE surveillance is commonly recognized among healthcare workers. However, the existing system falls short in terms of mastery of case definition and overall surveillance adaptability. There is an urgent need for optimization and improvement to enhance the capacity for preventing and controlling emerging and sudden respiratory infectious diseases.
5.Contamination status and dietary exposure risk assessment of arsenic, cadmium, lead and mercury in commercially available aquatic products in Shanghai
Rong SHI ; Dandan MAO ; Limei CHEN ; Yan ZHANG ; Huimin ZHANG ; Yu GAO ; Ying TIAN
Shanghai Journal of Preventive Medicine 2026;38(8):598-603
ObjectiveTo investigate the contamination status of arsenic (As), cadmium (Cd), lead (Pb), and mercury (Hg) in commercially available aquatic products in Shanghai and their distribution characteristics among different categories of aquatic products, and to assess the dietary exposure levels and non‑carcinogenic health risks of As, Cd, Pb, and Hg through aquatic product consumption among different age groups, so as to provide a scientific basis for food safety surveillance of aquatic products and dietary risk management for residents in Shanghai. MethodsFrom October to November 2021, a total of 90 aquatic product samples, including marine fish, freshwater fish, freshwater shrimp, marine crab, freshwater crab, and mollusks, were randomly collected from 16 districts of Shanghai. Sample pretreatment was performed according to GB 5009.268‒2016 (National Food Safety Standard—Determination of Multi‑elements in Foods). The concentrations of As, Cd, and Pb in aquatic products were determined by inductively coupled plasma mass spectrometry (ICP‑MS), and Hg was determined by direct mercury analyzer. Inorganic arsenic (iAs) was estimated as 3.5% of total As according to the method recommended by the European Food Safety Authority (EFSA). The contamination levels of As, Cd, Pb, and Hg in aquatic products were evaluated according to GB 2762‒2017 (National Food Safety Standard—Maximum Levels of Contaminants in Foods). A combined approach of point assessment and probabilistic assessment was applied to estimate the estimated daily intake (EDI) and non‑carcinogenic risk indicators—hazard quotient (HQ) and hazard index (HI)—for different age groups. ResultsThe detection rates of As and Hg were both 100.00% in all samples, while those of Cd and Pb were 74.44% and 25.56%, respectively. The arithmetic means (wet weight) of the four elements and estimated iAs were: As (1.432 9±3.736 5) mg·kg-1, iAs (0.050 2±0.130 8) mg·kg-1, Cd (0.082 5±0.197 8) mg·kg-1, Pb (0.006 1±0.005 5) mg·kg-1, and Hg (0.021 9±0.016 7) mg·kg-1. According to the relevant maximum residue limits, 2 out of 7 mollusk samples (28.57%) and 3 out of 20 marine fish samples (15.00%) exceeded the limit for iAs, and 2 out of 8 marine crab samples (25.00%) exceeded the limit for Cd. The estimated daily intake (EDI, μg·kg-1·d-1, by body weight) of iAs, Cd, Pb, and Hg via aquatic product consumption varied among different age groups, with the highest levels observed in children aged 3‒4 years, decreasing gradually with age to the lowest level at 12 ‒ <15 years, with a slight rebound thereafter. The point assessment results showed that the HQs of iAs, Cd, Pb, and Hg ranged from 0 to 0.25, and the cumulative HI ranged from 0.27 to 0.48, all below 1, indicating a relatively low overall risk. The probabilistic assessment results revealed that under the high‑exposure scenario (P97.5), the HQs of iAs (1.101‒1.281) and Cd (1.175‒1.366) exceeded 1 in children aged 3‒9 years, suggesting potential health risks, while the HQs of Pb and Hg were all below 1, indicating relatively lower risks. ConclusionHg and As are ubiquitously detected in commercially available aquatic products in Shanghai, while the detection rates of Cd and Pb are relatively low. The overall non-carcinogenic risk is at an acceptable level, but children aged 3‒9 years may have potential health risks from iAs and Cd under high-percentile exposure levels. It is recommended to strengthen the monitoring of toxic elements in key aquatic products such as marine fish, mollusks, and marine crabs, and to implement targeted dietary risk management measures for sensitive populations, including children.
6.Revision of Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine-Edema-based on literature research and Delphi method
Xinxin MAO ; Bingxuan ZHANG ; Shuqing SHI ; Yumeng LI ; Qingqiao SONG
International Journal of Traditional Chinese Medicine 2025;47(7):886-891
Based on the Delphi method, this study conducted an expert questionnaire survey on the diagnostic criteria of edema in TCM by integrating preliminary literature research, aiming to further standardize the revision of Edema diagnosis in Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine (ZY/T001.1-94). Relevant literature on TCM edema was comprehensively retrieved from CNKI, Wanfang Data, VIP and CBM from 1994 to July 1, 2021. The content extracted from the literature was integrated with the diagnostic criteria outlined in the 1994 Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine to establish the questionnaire item pool; two rounds of Delphi expert surveys were conducted to identify content requiring revisions. Subsequently, the degree of concentration and coordination of the expert opinions were analyzed to determine items for inclusion in the revised draft. Ultimately, the finalized revised diagnostic criteria for edema were developed through expert panel discussions. Results showed expert participation rates of 84.21% and 78.13% in respective survey rounds. The progressive increase in Kendall's coefficient of concordance (Kendall's W=0.169 in Round 1 to Kendall's W=0.368 in Round 2) quantitatively validated enhanced expert consensus (both the degree of concentration and coordination) and systematic alignment of revision proposals for diagnostic items. The study findings demonstrated an urgent need for improving the diagnostic criteria section of the the 1994 Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine, and the proposed revisions would be expected to enhance the applicability and specificity of edema diagnostic standards in clinical practice.
7.Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.
Yanfeng YANG ; Penghu WEI ; Jianwei SHI ; Ying MAO ; Jianmin ZHANG ; Ding LEI ; Zhiquan YANG ; Shiwei SONG ; Ruobing QIAN ; Wenling LI ; Yongzhi SHAN ; Guoguang ZHAO
Chinese Medical Journal 2025;138(4):430-440
BACKGROUND:
To evaluate the efficacy and safety of the first cohort of people in China treated with a responsive neurostimulation system (Epilcure TM , GenLight MedTech, Hangzhou, China) for focal drug-resistant epilepsy in this study.
METHODS:
This multicenter, before-and-after self-controlled study was conducted across 8 centers from March 2022 to June 2023, involving patients with drug-resistant epilepsy who were undergoing responsive neurostimulation (RNS). The study was based on an ongoing multi-center, single-blind, randomized controlled study. Efficacy was assessed through metrics including median seizure count, seizure frequency reduction (SFR), and response rate. Multivariable linear regression analysis was conducted to explore the relationships of basic clinical factors and intracranial electrophysiological characteristics with SFR. The postoperative quality of life, cognitive function, depression, and anxiety were evaluated as well.
RESULTS:
The follow-up period for the 19 participants was 10.7 ± 3.4 months. Seizure counts decreased significantly 6 months after device activation, with median SFR of 48% at the 6th month (M6) and 58% at M12 ( P <0.05). The average response rate after 13 months of treatment was 42%, with 21% ( n = 4) of the participants achieving seizure freedom. Patients who have previously undergone resective surgery appear to achieve better therapeutic outcomes at M11, M12 and M13 ( β <0, P <0.05). No statistically significant differences were observed in patients' scores of quality of life, cognition, depression and anxiety following stimulation when compared to baseline measurements. No serious adverse events related to the devices were observed.
CONCLUSIONS:
The preliminary findings suggest that Epilcure TM exhibits promising therapeutic potential in reducing the frequency of epileptic seizures. However, to further validate its efficacy, larger-scale randomized controlled trials are required.
REGISTRATION
Chinese Clinical Trial Registry (No. ChiCTR2200055247).
Humans
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Female
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Male
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Drug Resistant Epilepsy/therapy*
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Adult
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Young Adult
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Middle Aged
;
China
;
Adolescent
;
Treatment Outcome
;
Quality of Life
;
Single-Blind Method
;
Seizures
;
Electric Stimulation Therapy/methods*
8.Effect of different phosphorus application on morphological traits, active ingredients and rhizosphere soil microbial community of Polygala tenuifolia.
Huan GUO ; Tong WEI ; Wen-Hua CUI ; Huan SHI ; Fu-Ying MAO ; Xian GU ; Yun-Sheng ZHAO ; Xiao-Feng LIANG
China Journal of Chinese Materia Medica 2025;50(14):3898-3908
To investigate the effects of phosphorus fertilizer on the morphological traits, active ingredients and rhizosphere soil microbial community of Polygala tenuifolia. The phosphorus fertilizer was calculated in terms of P_2O_5. Five treatments were set up: 0(CK), 17(P1), 34(P2), 51(P3), and 68(P4) kg per Mu(1 Mu≈667 m~2). A randomized block design was adopted. Samples of P. tenuifolia and its rhizosphere soil were collected under different superphosphate fertilizer treatments. Illumina high-throughput sequencing was used to analyze the rhizosphere soil microbial community, 9 morphological traits were measured and the content of 11 active ingredients were determined. The results showed that the whole plant weight, shoot fresh weight, root weight, and root peel thickness were the highest under P1 treatment, increasing by 34.41%, 38.80%, 39.21%, and 3.17% respectively compared to CK. Under P2 treatment, the plant height, stem diameter, root thickness, and core thickness were significantly higher than CK. Phosphorus fertilizer had a significant impact on the content of tenuifolin, sibiricose A5, sibiricose A6, arillanin A, 3,6'-disinapoyl sucrose, and polygalaxanthone Ⅲ. Correlation analysis results showed that the relative abundance of Arthrobacter, Bacillus, norank_f_Vicinamibacteraceae, norank_o_Vicinamibacterales, MND1 and other bacteria, as well as the relative abundance of Neocosmospora, Paraphoma and other fungi were positively correlated with root diameter, wood core diameter, the whole plant weight, root weight, shoot fresh weight of P. tenuifolia. Bacillus, Neocosmospora, Subulicystidium were significantly positively correlated with oligosaccharides such as 3,6'-disinapoyl sucrose, sibiricose A5、sibiricose A6、glomeratose A、arillanin A and tenuifoliside C. Arthrobacter, Humicola, Aspergillus, Paraphoma were positively correlated with tenuifolin and norank_f_Vicinamibacteraceae, norank_o_Vicinamibacterales, Fusarium were positively correlated with polygalaxanthone Ⅲ. Evidently, appropriate phosphorus application is conducive to the growth and quality improvement of P. tenuifolia, and can increase the abundance of beneficial microorganisms in the soil.
Rhizosphere
;
Phosphorus/pharmacology*
;
Soil Microbiology
;
Polygala/anatomy & histology*
;
Fertilizers/analysis*
;
Bacteria/metabolism*
;
Soil/chemistry*
;
Microbiota/drug effects*
;
Plant Roots/metabolism*
9.A new perspective on quality control of traditional Chinese medicine based on characteristics of "physical phase structure".
Zhong-Huan QU ; Yan-Jun YANG ; Bing YANG ; Ru-Yu SHI ; Mao-Mao ZHU ; Lu SUN ; Xiao-Bin JIA ; Liang FENG
China Journal of Chinese Materia Medica 2025;50(13):3579-3588
Quality control is a key link in the modernization process of traditional Chinese medicine(TCM). Studies have shown that the effects of active components in TCM depend on not only their chemical composition but also their suitable physical forms and states. The physical phase structures, such as micelles, vesicles, gels, and nanoparticles, can improve the solubility, delivery efficiency, and targeting precision of active components. These structures significantly enhance the pharmacological activity while reducing the toxicity and side effects, demonstrating functional activity surpassing that of active components and highlighting the key effects of "structures" on "functions" of active components. Taking the physical phase structure as a breakthrough point, this paper outlines the common types of TCM physical phase structures. Furthermore, this paper explores how to realize the quality upgrading of TCM through the precise regulation of physical phase structures based on the current applications and potential of TCM physical phase structures in processing to increase the efficacy and reduce the toxicity, compounding and decocting processes, drug delivery systems, and quality control, aiming to provide novel insights for the future quality control of TCM.
Quality Control
;
Drugs, Chinese Herbal/standards*
;
Medicine, Chinese Traditional/standards*
;
Humans
;
Drug Delivery Systems
10.Evaluation and Regulation of Medical Artificial Intelligence Applications in China.
Mao YOU ; Yue XIAO ; Han YAO ; Xue-Qing TIAN ; Li-Wei SHI ; Ying-Peng QIU
Chinese Medical Sciences Journal 2025;40(1):3-8
Amid the global wave of digital economy, China's medical artificial intelligence applications are rapidly advancing through technological innovation and policy support, while facing multifaceted evaluation and regulatory challenges. The dynamic algorithm evolution undermines the consistency of assessment criteria, multimodal systems lack unified evaluation metrics, and conflicts persist between data sharing and privacy protection. To address these issues, the China National Health Development Research Center has established a value assessment framework for artificial intelligence medical technologies, formulated the country's first technical guideline for clinical evaluation, and validated their practicality through scenario-based pilot studies. Furthermore, this paper proposes introducing a "regulatory sandbox" model to test technical compliance in controlled environments, thereby balancing innovation incentives with risk governance.
Artificial Intelligence/legislation & jurisprudence*
;
China
;
Humans
;
Algorithms

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