1.Ethical reflections on the clinical application of medical artificial intelligence
Fangfang CUI ; Zhonglin LI ; Xianying HE ; Wenchao WANG ; Yuntian CHU ; Xiaobing SHI ; Jie ZHAO
Chinese Medical Ethics 2025;38(2):159-165
Medical artificial intelligence (AI) is a new type of application formed by the combination of machine learning, computer vision, natural language processing, and other technologies with clinical medical treatment. With the continuous iteration and development of relevant technologies, medical AI has shown great potential in improving the efficiency of diagnosis and treatment, and service quality, but it also increases the possibility of triggering ethical issues. Ethical issues resulting from the clinical application of medical AI were analyzed, including the lack of algorithmic interpretability and transparency of medical AI, leading to information asymmetry and cognitive discrepancies; the concerning status of security and privacy protection of medical data; and the complex and unclear division of responsibilities due to the collaborative participation of multiple subjects in the clinical application of medical AI, resulting in increased difficulty in the identification of medical accidents and clarification of responsibilities. The paper proposed the principles of not harming patients’ interests, physician’s subjectivity, fairness and inclusiveness, and rapid response. It also explored the strategies and implementation paths for responding to the ethical issues of medical AI from multiple perspectives, including standardizing the environment and processes, clarifying responsibility attribution, continuously assessing the impact of data protection, guaranteeing data security, ensuring model transparency and interpretability, carrying out multi-subject collaboration, as well as the principles of being driven by ethical values and adhering to the “human health-centeredness.” It aimed to provide guidance for the healthy development of medical AI, ensuring technological progress while effectively managing and mitigating accompanying ethical risks, thereby promoting the benign development of medical AI technology and better serving the healthcare industry and patients.
2.The Current Status of Research on The Association Between TMEM43 Gene and Hearing Loss
Progress in Biochemistry and Biophysics 2025;52(2):269-278
Transmembrane proteins (TMEM) are a type of membrane protein. Most proteins in this family are located in the phospholipid bilayer of the cell membrane, while a smaller portion is found in the membranes of cellular organelles. Transmembrane protein 43 (TMEM43) is a member of the TMEM protein family and is encoded by the TMEM43 gene. This protein consists of 400 amino acids and has 4 transmembrane domains and 1 membrane-associated domain. TMEM43 is localized to various biological membranes within the cell, such as the cell membrane and nuclear membrane, where it forms transmembrane channels for various ions. Additionally, TMEM43 is expressed in many species, showing high genetic similarity, especially with the four transmembrane domains being highly conserved. Current studies on the TMEM43 gene are still in its early stages, mainly focusing on its association with arrhythmogenic right ventricular cardiomyopathy (ARVC) and cancer. However, recent studies suggest that pathogenic mutations in TMEM43 may cause auditory neuropathy spectrum disorder (ANSD). Patients with TMEM43 p.Ser372Ter exhibited late-onset progressive ANSD. Impact of TMEM43 pathogenic mutations on individual hearing was likely mediated through effects on gap junction (GJ) structures on glia-like supporting cells (GLS), cell membranes. The TMEM43 p.Arg372Ter pathogenic mutation primarily affected the structure and function of TMEM43 protein, leading to premature termination of protein translation and the production of a truncated protein. Abnormal TMEM43 protein significantly reduced K+ influx in GLS cells, disrupting the endolymphatic K+ circulation and cochlear microenvironment homeostasis. When K+ circulation was obstructed, the endocochlear potential (EP) became abnormal, impairing the physiological function of hair cells and potentially leading to hearing impairment. However, it is important to note that studies on the mechanism is limited, and more experimental evidence is needed to confirm this hypothesis. Currently, there is a significant gap in research on TMEM43 and hearing loss, with many issues remaining unresolved. While TMEM43 has been studied in relation to hearing loss in humans, zebrafish, mice, and rats, the research is still preliminary. Detailed investigations into the molecular pathogenic mechanisms, the impact of mutations on hearing damage, and related therapeutic strategies are needed. Additionally, as a newly identified hearing loss-related gene, the mutation frequency and incidence of hearing disorders associated with TMEM43 have not been effectively quantified. For example, the ClinVar database listed 829 mutation sites for the TMEM43 gene, with only three mutations related to auditory neuropathy: c.605A>T (p.Asn202Ile), c.889T>A (p.Phe297Ile), and c.1114C>T (p.Arg372Ter). Aside from the aforementioned TMEM43 c.1114C>T (p.Arg372Ter) mutation observed in patients, the other two mutations were experimentally induced and have not been found in patients. Consequently, these mutations have been classified as unknown significance. We reviewed the current understanding of TMEM43 and hearing loss, analyzed its role in ear development and sound conduction, and explored the impact of TMEM43 gene variations on hearing loss, aiming to provide new insights for future research and precision medicine related to TMEM43.
3.Oxidative Stress of Qidan Tangshen Granules (芪丹糖肾颗粒) in Treatment of 95 Patients with Early Diabetic Kidney Disease with Qi Deficiency,Blood Stasis,and Kidney Deficiency Syndrome:A Double-Blind,Double-Simulated,Randomized Controlled Trial
Jie ZHANG ; Yilei CONG ; Tengfei WU ; Qin LIU ; Yue YUAN ; Shilei CUI ; Hua YANG
Journal of Traditional Chinese Medicine 2025;66(7):695-703
ObjectiveTo evaluate the clinical efficacy and safety of Qidan Tangshen Granules (芪丹糖肾颗粒, QTG) in the treatment of early diabetic kidney disease (DKD) with qi deficiency, blood stasis, and kidney deficiency syndrome, and to explore its mechanism. MethodsA double-blind, double-simulated method was used to enroll 200 patients with early DKD and qi deficiency, blood stasis, and kidney deficiency syndrome. Patients were randomly assigned in a 1∶1 ratio to the treatment group (100 cases) and the control group (100 cases). The treatment group received QTG plus a valsartan capsule simulant, while the control group received valsartan capsules plus a QTG simulant, both for 12 weeks. The primary outcome was the urinary albumin-to-creatinine ratio (UACR). Secondary outcomes included estimated glomerular filtration rate (eGFR), fasting blood glucose (FBG), 2-hour postprandial blood glucose (PBG), glycated hemoglobin (HbA1c), and traditional Chinese medicine (TCM) syndrome scores (including individual symptom scores for fatigue, dull complexion, soreness and weakness of the waist and knees, headache and chest pain, irritability, spontaneous sweating, thirst and polydipsia, polyphagia, polyuria, numbness of the limbs, and the total TCM syndrome score). Oxidative stress markers including serum 8-hydroxy-2'-deoxyguanosine (8-OHDG), 3-nitrotyrosine (3-NT), and superoxide dismutase (SOD) were also assessed. Clinical efficacy and TCM syndrome efficacy were evaluated after treatment, and routine blood tests, urinalysis, and liver function tests were conducted and adverse reaction during the tria was recorded to assess safety. ResultsA total of 191 patients completed the study (95 in the treatment group and 96 in the control group). The treatment group showed significant reductions in UACR, FBG, PBG, and HbA1c levels after treatment (P<0.05 or P<0.01). The single TCM symptom scores except for polyphagia and total TCM syndrome scores significantly decreased (P<0.05 or P<0.01). Compared to the control group, the treatment group had signi-ficantly lower UACR, FBG, PBG levels, and total TCM syndrome scores, sinlge symptoms scores except for polyphagia and limb numbness (P<0.05 or P<0.01). Among 40 randomly selected patients (21 cases in the treatment group and 19 cases in the control group) for oxidative stress analysis, there were no significant differences in SOD, 3-NT, and 8-OHDG levels before and after treatment within or between groups (P>0.05). The overall effective rate in the treatment group was 64.2% (61/95) and 39.6% (38/96) in the control group, while the TCM syndrome efficacy rates were 80.0% (76/95) and 24.0% (23/96), respectively, with the treatment group showing superior efficacy (P<0.01). No significant differences were observed in routine blood tests, urinalysis, or liver function indices before and after treatment in either group (P>0.05). The incidence of adverse reactions was 8.4% (8/95) in the treatment group and 9.4% (9/96) in the control group, with no statistically significant difference (P>0.05). ConclusionQTG can effectively reduce UACR and blood glucose levels, alleviate clinical symptoms, and improve clinical efficacy in patients with early DKD with qi deficiency, blood stasis, and kidney deficiency syndrome. The treatment is well-tolerated and safe, with no significant impact on oxidative stress markers.
4.Concept,Organizational Structure,and Medical Model of the Traditional Chinese Medicine Myocardial Infarction Unit
Jun LI ; Jialiang GAO ; Jie WANG ; Zhenpeng ZHANG ; Xinyuan WU ; Ji WU ; Zicong XIE ; Jingrun CUI ; Haoqiang HE ; Yuqing TAN ; Chunkun YANG
Journal of Traditional Chinese Medicine 2025;66(9):873-877
The traditional Chinese medicine (TCM) myocardial infarction (MI) unit is a standardized, regulated, and continuous integrated care unit guided by TCM theory and built upon existing chest pain centers or emergency care units. This unit emphasizes multidisciplinary collaboration and forms a restructured clinical entity without altering current departmental settings, offering comprehensive diagnostic and therapeutic services with full participation of TCM in the treatment of MI. Its core medical model is patient-centered and disease-focused, providing horizontally integrated TCM-based care across multiple specialties and vertically constructing a full-cycle treatment unit for MI, delivering prevention, treatment, and rehabilitation during the acute, stable, and recovery phases. Additionally, the unit establishes a TCM-featured education and prevention mechanism for MI to guide patients in proactive health management, reduce the incidence of myocardial infarction, and improve quality of life.
5.Analysis of risk prevention behaviors and influencing factors of HIV infection among young students with MSM
Chinese Journal of School Health 2025;46(9):1323-1327
Objective:
To explore the potential category patterns of risk prevention and control behaviors of HIV infection among young students who have sex with men (MSM) and their impact on HIV infection and late detection, aiming to optimize intervention strategies.
Methods:
From September 2017 to December 2024, a total of 1 637 MSM young students in Tianjin were recruited through both online and offline channels. Latent class analysis was applied to classify 11 HIV risk prevention and control behaviors [condom use during the most recent anal sex in the past 6 months, consistent condom use, use of water based lubricants, abstinence from recreational drugs, regular on site professional testing, fixed sexual partners, partner testing, awareness of partner s HIV testing results, testing before sexual activity, nucleic acid testing, and use of pre exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)]. Multivariate Logistic regression analyzed associations between demographic characteristics/intervention services factors and latent classes. Differences in HIV infection and late detection across behavior patterns were compared.
Results:
HIV risk prevention and control behaviors among MSM students were classified into three latent classes:condom dependent group (38.42%), low prevention group (27.73%), and comprehensive prevention group (33.85%). Students who received condom promotion/testing services were more likely to belong to the comprehensive prevention group ( OR =5.58), while those who received peer education were less likely to the comprehensive prevention group ( OR =0.43) (both P <0.01). Among the MSM student population, the HIV infection rate was 4.83%, with 2.26% of cases detected late. The HIV infection rate (1.45%) and late detection proportion (0.82%) in the comprehensive prevention group were lower than those in the low prevention group (7.89% and 3.83%, respectively) ( χ 2=16.20, 7.31, both P <0.01).
Conclusions
HIV risk prevention and control behaviors among MSM young students exhibit significant heterogeneity. Comprehensive prevention strategies can effectively reduce HIV infection and late detection risks. It is necessary to optimize peer education content and improve the accessibility of diversified prevention measures such as PrEP/PEP to enhance HIV prevention and control.
6.The mechanism of epigallocatechin gallate enhancing the sensitivity of hepatocellular carcinoma cells to lenva-tinib
Chuanfang SONG ; Jiang AI ; Chao WEN ; Jie ZHANG ; Jianghe CUI
China Pharmacy 2025;36(18):2256-2261
OBJECTIVE To investigate the potential mechanism of epigallocatechin gallate (EGCG) enhancing the sensitivity of hepatocellular carcinoma (HCC) cells to lenvatinib based on the phosphoinositide 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway. METHODS Five human HCC cell lines (HepG2, Huh-7, SMMC-7721, SNU-368 and SNU-739) were used to evaluate the effects of lenvatinib alone and in combination with EGCG on survival rates, clone number, proliferation rate, invasion number and the expressions of mRNAs and proteins related to the PI3K/Akt signaling pathway. The PI3K activator insulin-like growth factor-1 (IGF-1) was introduced to investigate the effect of activating the PI3K/Akt signaling pathway on the sensitization effect of EGCG. RESULTS Compared with the control group, lenvatinib (10 μmol/L) and different concentrations of EGCG+ lenvatinib (1, 5 and 10 μg/mL EGCG+10 μmol/L lenvatinib) significantly reduced the survival rates and clone numbers of all five HCC cell lines in a dose-dependent manner (P<0.05). Lenvatinib (10 μmol/L) and EGCG+lenvatinib (10 μg/mL EGCG+10 μmol/L lenvatinib) also markedly inhibited the proliferation rate and invasion numbers of these cells, and decreased the mRNA expressions of PI3K, Akt, mammalian target of rapamycin (mTOR), P70S6K and 4EBP, and the phosphorylation levels of PI3K and Akt, as well as the protein expressions of mTOR and B cell lymphoma-2 (Bcl-2) in HepG2 cells or all five HCC cells; conversely, the mRNA and protein expressions of phosphatase and tensin homologue deleted on chromosome 10(PTEN), and the protein expressions of caspase-3 and cleaved caspase-3 were significantly upregulated, with more pronounced effects observed in the EGCG+lenvatinib group than in the lenvatinib group (P<0.05). Compared with the lenvatinib group and the EGCG+lenvatinib group, the clone number, proliferation rate and invasion number of HepG2 cells in the EGCG+lenvatinib+IGF-1 group (10 μg/mL EGCG+10 μmol/L lenvatinib+50 ng/mL IGF-1) were significantly increased (P<0.05). CONCLUSIONS EGCG can enhance the sensitivity of HCC cells to lenvatinib, and its underlying mechanism may be related to the inhibition of the activation of PI3K/Akt signaling pathway activation.
7.Analysis of pre-exposure prophylaxis awareness, willingness, uptake patterns, barriers and needs among MSM students and its influencing factors
Chinese Journal of School Health 2024;45(1):55-59
Objective:
To explore the pre-exposure prophylaxis (PrEP) awareness, willingness, uptake patterns, barriers and needs among Chinese student men who have sex with men (MSM), so as to provide relevant evidence for targeted interventions with PrEP.
Methods:
A proportional sampling method was used to conduct a cross sectional survey of MSM aged 16 years and older residing in 21 provinces, municipalities, and autonomous regions in mainland China between October 20 and December 20, 2021, to collect information on demographic and sexual behavioral characteristics, and 923 students of them were selected as the subjects of this study. The chi-square test and Fisher s test were used for univariate analysis, followed by multivariate Logistic regression to analyze the influencing factors of PrEP awareness and uptake.
Results:
According to the cascade analysis method, the awareness, willingness, uptake and adherence rates of PrEP among the student MSM were obtained as 88.95%, 67.36%, 13.20% and 45.21 %, respectively. HIV testing more than once in the last 3 months, and all of them were aware of the HIV test results of their sexual partners, and those with high frequency of condom use had a higher rate of awareness ( OR =2.32, 1.79, 1.69, P <0.05). Willingness rates were higher for those from the pilot city, using substances, and HIV testing more than once in the last 3 months ( OR =2.13, 1.65, 1.69, P <0.05). Higher rates of uptake were found among those from high risk and pilot areas, presence of commercial sex, substance use, and high literacy ( OR =5.60, 3.54,2.81, 1.92, 4.54, P <0.05). Adherence rates were higher among those who used one pill per day or both ( OR =12.77, 13.26, P <0.05). The barriers and needs faced by student MSM were primarily personal concerns about medication side effects, preventative effects, and confidence in sexual behavioral styles, and the high cost of medication and related service costs.
Conclusions
The student MSM population in China is characterized by high awareness, low willingness, low uptake, and low adherence to PrEP. Targeted interventions should be considered and tailored by the departments to facilitate PrEP promotion among student MSM.
8.Discussion of the methodology and implementation steps for assessing the causality of adverse event
Hong FANG ; Shuo-Peng JIA ; Hai-Xue WANG ; Xiao-Jing PEI ; Min LIU ; An-Qi YU ; Ling-Yun ZHOU ; Fang-Fang SHI ; Shu-Jie LU ; Shu-Hang WANG ; Yue YU ; Dan-Dan CUI ; Yu TANG ; Ning LI ; Ze-Huai WEN
The Chinese Journal of Clinical Pharmacology 2024;40(2):299-304
The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.
9.Clinical trial of omeprazole enteric-coated capsules in the treatment of children with chronic gastritis and peptic ulcer
San-Li FAN ; Hai-Yan HU ; Cui JIN ; Jing-Jie BAI ; Fang DONG ; Jin-Fang SUN ; Yan QIN ; Xiao-Ling MENG ; Hui-Qin XUE
The Chinese Journal of Clinical Pharmacology 2024;40(7):973-976
Objective To observe the effect of omeprazole enteric-coated capsules on clinical symptoms and serum inflammatory factor levels in children with chronic gastritis and peptic ulcer.Methods Children with chronic gastritis and peptic ulcer were divided into treatment group and control group by random number table method.The control group was given triple therapy of ranitidine hydrochloride tablets,amoxicillin and clarithromycin,while the treatment group was treated with omeprazole enteric-coated capsules combined with amoxicillin and clarithromycin.Clinical efficacy,symptom relief time,and changes in serum motilin(MOT),gastrin(GAS)and inflammatory factors[interlrukin-6(IL-6)and interlrukin-8(IL-8)]were compared between the two groups.Results There were 48 cases in treatment group and 48 cases in control group.After treatment,the total effective rates in treatment group and control group were 93.74%(45 cases/48 cases)and 85.42%(41 cases/48 cases),with significant difference(P<0.05).After treatment,the disappearance time of ulcer induced pain in treatment group and control group were(1.51±0.26)and(2.08±0.42)d;the disappearance time of acid regurgitation were(2.29±0.40)and(2.93±0.33)d;the disappearance time of burning sensation were(2.37±0.21)and(2.85±0.54)d;the length of hospital stay were(6.21±1.07)and(6.94±1.25)d;serum MOT levels were(298.48±35.15)and(273.58±31.25)pg·mL-1;serum GAS levels were(167.28±19.46)and(128.32±18.61)ng·L-1;IL-6 levels were(58.67±5.39)and(76.14±6.63)mg·mL-1;IL-8 levels were(50.08±5.16)and(58.68±5.49)mg·mL-1.The above indexes were significantly different between control group and treatment group(all P<0.05).The total incidence of adverse drug reactions in treatment group and control group were 8.33%and 12.50%,with no statistical significance(P>0.05).Conclusion Omeprazole enteric-coated capsules in the treatment of children with chronic gastritis and peptic ulcer can effectively alleviate various clinical symptoms and improve clinical efficacy.At the same time,it can lower serum levels of inflammatory factors and improve inflammation,with good effect.
10.Clinical trial of empagliflozin and linagliptin in the treatment of patients with type 2 diabetes mellitus with heart failure
Guang-Hui CHENG ; Xin-Jun LI ; Ying-Jie LI ; Hui WANG ; Dan-Dan CUI ; Hai-Yang ZHANG ; Zi-Jian WANG
The Chinese Journal of Clinical Pharmacology 2024;40(8):1131-1135
Objective To compare the efficacy and safety of empagliflozin and linagliptin in the treatment of patients with type 2 diabetes mellitus(T2DM)with heart failure(HF).Methods Patients with T2DM and HF were randomly into control group and treatment group.Both groups were treated with individualized anti-HF and metformin-based hypoglycemic therapy.On this basis,the control group was given linagliptin orally(5 mg each time,once a day),while the treatment group was given oral administration of empagliflozin 10 mg every day.Patients in both groups were treated continuously for 6 months.The clinical efficacy and blood glucose indicators[fasting blood glucose(FBG),2 h postprandial blood glucose(2 h PBG),hemoglobin A1c(HbA1c)],cardiac molecular markers[N-terminal pro-brain natriuretic peptide(NT-proBNP),fibroblast growth factor 23(FGF23),copeptin(CPP)]and caridac function indicators[left ventricular end-diastolic diameter(LVEDD),left ventricular ejection fraction(LVEF),left ventricular remodeling index(LVRI)]before and after treatment were compared,and the adverse drug reactions were recorded.Results There were 40 cases in treatment group and 40 cases in control group.After treatment,the total effective rates in treatment group and control group were 97.50%(39 cases/40 cases)and 80.00%(32 cases/40 cases),with no significant difference(P<0.05).The FBG levels in treatment group and control group were(7.64±1.18)and(7.83±1.24)mmol·L-1;2 h PBG levels were(8.97±1.46)and(9.04±1.35)mmol·L-1;HbA1c levels were(7.58±1.27)%and(7.65±1.42)%,all with no significant difference(all P>0.05).The NT-proBNP levels in treatment group and control group were(612.53±204.62)and(1 045.24±316.75)pg·mL-1;FGF23 levels were(362.74±62.61)and(493.27±74.64)μg·L-1;CPP levels were(12.58±3.43)and(16.87±4.36)pmol·L-1;LVEDD values were(51.19±2.36)and(53.35±2.24)mm;LVEF values were(52.69±3.38)%and(50.28±3.75)%;LVRI values were(2.62±0.29)and(2.96±0.33)kg·L-1,all with significant difference(all P<0.05).The incidence rates of adverse reactions in treatment group and control group were 5.00%(2 cases/40 cases)and 10.00%(4 cases/40 cases),with no significant difference(P>0.05).Conclusion Both empagliflozin and linagliptin can effectively reduce the blood glucose in patients with T2DM complicated with HF.Empagliflozin can better promote the improvement of cardiac function in patients without significantly increase the incidence of adverse drug reactions.


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