1.Development of Patient Self-Reported Core Outcome Set in Community Studies on Heat-Sensitive Moxibustion for Primary Hypertension
Jianyu YOU ; Shuqing LI ; Guihua DENG ; Xu ZHOU
Journal of Traditional Chinese Medicine 2025;66(1):34-41
ObjectiveTo establish the self-reported core outcome set (COS) for patients with an example of a community study on heat-sensitive moxibustion for primary hypertension (PH), to provide a reference for the selection of effectiveness evaluation indicators in community study on heat-sensitive moxibustion. MethodsA systematic literature search was conducted to collect outcomes used in randomized controlled trials and systematic review of heat-sensitive moxibustion for PH (Jan 2021), and additional outcomes were added through patient and expert questionnaires (Feb 2021) to create a pool of outcome entries. A multidisciplinary expert Delphi survey was conducted to screen outcomes applicable to patient self-reporting (Apr 2021), and the importance of outcome indicators was rated on a 5-Point Likert Scale. Finally, patient self-reported COS was determined through a consensus conference (June 2021). ResultsA pool of patient self-reported indicators in the community study of heat-sensitive moxibustion treatment for PH was generated by standardizing and combining the outcome indicators based on the results of the literature search and the questionnaire survey, which consisted of totally 100 measurement tools or contents, excluding 51 indicators or measurement tools required measurement by specialized physicians or hospital equipment, and 49 items were retained to enter the initial list of indicator entries. For the first round of Delphi survey, the mean score for expert familiarity was 0.819, the mean score for basis of judgment was 0.710, and the expert authority coefficient was 0.765, with a total of 21 indicator measurement tools or contents deleted (significance score ≤ 75 or coefficient of variation > 0.25), 28 retained, and 3 new expert-added indicator entries added. In the second round of Delphi survey, the average score for expert familiarity was 0.859, the average score for basis for judgment was 0.763, and the expert authority coefficient was 0.811, with a total of 11 indicator measurement tools or contents deleted and 20 retained involving 5 domains. Following an expert consensus meeting, 8 outcome indicators were finalized for inclusion in the patient self-reported COS, including 6 indicators of effectiveness evaluation such as quality-of-life scores, blood pressure, traditional Chinese medicine symptom scores, cost-benefit, cardiovascular and cerebrovascular events, and adverse reactions/events, and 2 indicators of factors influencing effectiveness such as sensation of heat-sensitive moxibustion, and adherence. ConclusionIn this study, we initially established a criteria for evaluating the effectiveness in the community study on heat-sensitive moxibustion by constructing patient self-reported COS in the community study on heat-sensitive moxibustion for PH, which can provide a scientific research paradigm for the subsequent development of the community study on heat-sensitive moxibustion.
2.A three-party evolutionary game analysis of patient privacy protection in live surgery
Han TIAN ; Jinping WU ; Yan ZHANG ; Jianyu ZHOU
Chinese Medical Ethics 2025;38(1):123-130
With the rapid development of network technology, live surgery has become the new way of surgery teaching. However, the issue of patient privacy protection caused by live surgery has received widespread attention. Based on the evolutionary game theory, this paper constructed an evolutionary game model from the three-party perspectives of doctors, patients, and government and analyzed the game behaviors of the three parties in the process of live surgery. Matlab software was utilized to conduct dynamic simulation and numerical simulation analysis. It was found that the factors affecting the choice of doctors’ strategies included protection costs, the cost of privacy leakage, the benefits of protection, high-traffic benefits, and other aspects; the factors affecting the choice of patient strategies encompassed surgical costs, the risk of privacy leakage, additional benefits, and other aspects; the factors affecting the choice of government strategies embodied regulatory costs and the improvement of credibility. To realize a win-win situation among doctors, patients, and the government, the three parties need to work together to ensure that patient privacy is not violated and find a balance between expanding the influence of medical education and protecting patient privacy.
3.Analysis of distortion product otoacoustic emissions results of noise-exposed workers at a metal shipbuilding enterprise
Jieting ZHOU ; Jianyu GUO ; Hairu YANG ; Linyan SHU ; Zhixing FAN ; Jia TANG ; Xinqiang NIE ; Guoyong XU ; Hansheng LIN ; Bin XIAO
China Occupational Medicine 2025;52(1):99-105
Objective To evaluate the role of distortion product otoacoustic emissions (DPOAE) testing in evaluating early hearing loss among noise-exposed workers. Methods A total of 174 noise-exposed workers in a metal shipbuilding enterprise were selected as the research subjects by the convenience sampling method. Pure tone audiometry (PTA), DPOAE and the level of noise exposure were conducted on the workers. The rank correlation analysis was used to analyze the correlation between DPOAE amplitude and PTA threshold. The multilevel model was used to analyze the effects of gender, age, noise exposure intensity, cumulative noise exposure (CNE), hearing loss classification and PTA threshold on DPOAE results. Results At the frequencies of 0.50, 1.00, 2.00, 3.00, 4.00, 6.00 and 8.00 kHz, the DPOAE amplitude was negatively correlated with the PTA threshold (rank correlation coefficients were -0.12, -0.48, -0.47, -0.18, -0.23, -0.44, -0.19, respectively, all P<0.01). At the most frequencies, DPOAE amplitude was negatively correlated with age and CNE (all P<0.05). The results of multilevel model analysis showed that there were significant differences in DPOAE amplitudes at certain frequencies across gender, age, noise intensity, CNE, and hearing loss classification (all P<0.05). Significant differences in DPOAE responses were found among different CNE and hearing loss groups (all P<0.01). Conclusion DPOAE testing can objectively reflect the hearing status of noise-exposed workers and could be considered for inclusion in routine hearing monitoring to facilitate early detection of noise-induced hearing loss.
4.Study on medical damage liability dispute cases involving breach of the duty to inform
Yan ZHANG ; Jinping WU ; Han TIAN ; Jianyu ZHOU
Chinese Medical Ethics 2025;38(5):582-587
ObjectiveTo understand the current situation of medical damage liability disputes involving breach of the duty to inform in China, analyze the factors influencing the types of medical staff’s breach of the duty to inform, and explore the notification problems of medical staff in clinical practice. On these foundations, suggestions were proposed to improve the performance of the duty to inform and reduce medical disputes. MethodsUsing public cases from the China Judgements Online as the data source, the relationship between risk points and types of breach of duty to inform was analyzed using the Chi-square test. Logistic regression analysis was performed to explore the influencing factors of the types of breach of the duty to inform, and qualitative research summarized the specific contents of breach of the duty to inform. ResultsThere were differences in the effects of factors, including whether the patient was hospitalized, whether surgery was performed, whether Intensive Care Unit (ICU) treatment was required, the level of the medical institution, and whether a consultation occurred, on the types of breach of the duty to inform (P<0.05). Whether surgery was performed was an influencing factor for the types of breach of the duty to inform. Qualitative research showed that the contents of breach of duty to inform primarily involve risk, treatment plan, and deficiencies in disease notification. ConclusionStrengthening the performance of the medical staff’s duty to inform should mainly focus on the medical side, coordinating with multiple parties and taking measures to improve the performance of the duty to inform, to reduce unnecessary medical disputes.
5.Progress on mRNA tumor vaccine with non-viral delivery system
Jiao ZHOU ; Jianyu ZHENG ; Sizhen WANG ; Feng YANG
Journal of Pharmaceutical Practice and Service 2025;43(3):109-116
At the end of 2020, the FDA issued emergency use authorization for two mRNA vaccines(BNT162b2 and mRNA-
6.A rapid method for detecting prfA and hly toxin genes of Listeria monocytogenes using double nucleic acid colloidal gold strips.
Yan LIU ; Jianyu YANG ; Yujiao ZHOU ; Wenbo DING ; Xianyu ZHANG ; Linran GAO ; Beizhen PAN ; Jifei YANG ; Yundong ZHAO
Journal of Southern Medical University 2025;45(2):387-394
OBJECTIVES:
To detect prfA and hly toxin genes of Listeria monocytogenes using polymerase chain reaction (PCR) and colloidal gold technology.
METHODS:
L. monocytogenes DNA was extracted by boiling method. With prfA and hly of L. monocytogenes as the target genes, the 5' ends of upstream and downstream primers of prfA gene were labeled with 6-FAM and biotin, and the 5' ends of upstream and downstream primers of hly gene were labeled with digoxin and biotin, respectively, to establish the toxin gene detection method. Using cloning transformation, sequencing analysis, cloning of positive control products, the detection kid was developed and its specificity, sensitivity, reproducibility and stability were tested, followed by verification with sample testing.
RESULTS:
The concentration of L. monocytogenes DNA extracted by boiling method was 148.81±0.97 ng/μL, and the A260/A280 ratio ranged from 1.8 to 2.0. The PCR products showed a 100% homology with the gene sequences in GenBank database after cloning, transformation and sequencing. The colloidal gold strip yielded positive results only for L. monocytogenes samples without cross-reactions with Staphylococcus aureus, Escherichia coli or Bacillus cereus, and its minimum detection limit was 10-2 ng/μL, demonstrating a 10-fold greater sensitivity of the test than agarose gel electrophoresis. The test also showed good reproducibility of the results when performed by different operators with good stability of the test strips after storage for 6 to 12 months. The test results showed that this kit could accurately and quickly detect L.monocytogenes in the test samples.
CONCLUSIONS
The detection kit developed in this study can simultaneously detect prfA and hly toxin genes of L. monocytogenes with good specificity, sensitivity, reproducibility and stability for use in food safety inspection.
Listeria monocytogenes/isolation & purification*
;
Gold Colloid
;
Bacterial Toxins/genetics*
;
Polymerase Chain Reaction/methods*
;
Hemolysin Proteins/genetics*
;
Bacterial Proteins/genetics*
;
DNA, Bacterial/genetics*
;
Food Microbiology
;
Heat-Shock Proteins
7.Establishment and evaluation of method for rapid detection of Bacillus cereus cytK and nhe toxin genes by dual nucleic acid test strips
Jifei YANG ; Beizhen PAN ; Yan LIU ; Yujiao ZHOU ; Jianyu YANG ; Xianyu ZHANG ; Wenbo DING ; Haoyu LI ; Liyuan SUN
Journal of Jilin University(Medicine Edition) 2025;51(2):516-525
Objective:To establish a method of dual nueleic acid test strips for rapid detection of Bacillus cereus cytK and nhe toxin genes based on polymerase chain reaction(PCR)and colloidal gold technique,and to evaluate its specificity,sensitivity,repeatability and stability.Methods:Bacillus cereus DNA was extracted by boiling method.Specific primers were designed with Bacillus cereus cytK and nhe as the target genes.Clonal transformation was used to identify the PCR products.The optimal labeling amounts of colloidal gold-labeled streptavidin,quality control line(C line),cytK detection line(T1)and nhe detection line(T2)were determined.The nucleic acid test strips were assembled and its specificity,sensitivity,reproducibility and stability were evaluated.Results:The DNA concentration of Bacillus cereus was 248 mg·L-1,and the purities were 1.8-2.0.After cloning and plasmid sequencing,the similarities between the PCR products and the sequences of cytK and nhe registered in the GenBank database were 100%.Under the condition of pH 7.0,the optimal amount of streptavidin labeling per 200 μL of colloidal gold solution was 6.0 μL;the optimal marking amount was 2.00 g·L-1 for the quality control line(C line),0.550 g·L-1 for cytK gene detection line(T1)and 0.2 g·L-1 for nhe gene detection line(T2).In the specificity test,positive result on the test strips was seen only for Bacillus cereus,and no cross-reactivity was observed for Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa and Bacillus subtilis,which were consistent with the electrophoresis results.Sensitivity assay showed that even when DNA concentration was reduced to 10-2 mg·L-1,three bands(C line,T1 line and T2 line)could be observed,and the detection limit of the test strip was one-tenth of agarose gel electrophoresis(10-1 mg·L-1).The nucleic acid test strips were verified by different operators in different laboratories,and the results were consistent.The stability of the test strips was verified at the 6th,9th and 12th months,and the results showed good stability.Conclusion:The dual nucleic acid test strip method established in this study can simutaneously detect the cytK and nhe toxin genes of Bacillus cereus with high sensitivity and specificity,achieving short-term visual detection.
8.Establishment of LAMP combined with CRISPR/Cas12a system for detecting tlh gene of Vibrio parahaemolyticus and its evaluation
Yujiao ZHOU ; Jifei YANG ; Yan LIU ; Wenbo DING ; Xianyu ZHANG ; Jianyu YANG ; Linran GAO ; Yundong ZHAO ; Liyuan SUN
Journal of Jilin University(Medicine Edition) 2025;51(5):1399-1406
Objective:To establish a rapid detection method for pathogenic microorganisms by combining loop-mediated isothermal amplification(LAMP)and clustered regularly interspaced short palindromic repeats(CRISPR)/CRISPR-associated protein 12a(Cas12a)(CRISPR-Cas12a)system,and to evaluate its efficacy for detecting the thermolabile hemolysin(tlh)gene of Vibrio parahaemolyticus(Vp).Methods:Using the tlh gene of Vp as the target gene,LAMP primers and CRISPR RNA(crRNA)were designed to construct and optimize the optimal concentration ratio of each component in the LAMP-CRISPR detection system.Bacillus cereus,Staphylococcus aureus,and Escherichia coli were used as control groups,and the specificity,sensitivity,reproducibility and positive conformity rate were verified to establish a rapid LAMP-CRISPR/Cas12a method for detecting the tlh gene of Vp.Results:The method specifically detected Vp,while Bacillus cereus,Staphylococcus aureus,and Escherichia coli yielded negative results.The DNA extraction concentration of Vp was 190.67 mg·L-1 with an A(260)/(A280)ratio of 1.84.Under the reaction conditions of 37℃ with 80 cycles for 40 min using quantitative PCR(qPCR)method,when the concentrations of Cas12a protein and crRNA in the LAMP-CRISPR/Cas12a system were 50 nmol·L-1,the visual brightness and relative fluorescence intensity peaks were high.The sensitivity of LAMP CRISPR/Cas12a for detecting Vp DNA concentration could reach 10-6 mg·L-1.The reproducibility test results showed that different experimenters had consistent results in different experimental environments and times.Conclusion:The established LAMP-CRISPR/Cas12a method can rapidly detect the tlh gene of Vp with high sensitivity and specificity,and can achieve short-term visual detection in the field.
9.Childhood schwannoma with back pain as initial manifestation:a case report
Lei LI ; Dagan FU ; Jianyu DUAN ; Yan XU ; Wei ZHOU
Journal of Clinical Medicine in Practice 2025;29(16):103-105,111
Back pain is relatively common in pediatric clinical practice and often exhibits benign and self-limiting characteristics.However,persistent back pain may be secondary to inflammation,in-fection,tumors,or congenital diseases,warranting sufficient attention.This article reported a case of childhood back pain primarily presenting as nocturnal scapular region pain,who was diagnosed as in-traspinal cellular schwannoma via magnetic resonance imaging(MRI)and postoperative pathology.In this case,it is suggested that clinicians should pay attention to special clinical features of back pain in children,be vigilant for potential organic lesions,reasonably select imaging examinations,and en-hance diagnostic accuracy through multidisciplinary collaboration,thereby enabling early intervention and favorable prognosis.
10.Mid to long-term clinical outcomes improvement through dual antiplatelet therapy after coronary artery bypass grafting: Interpretation of DACAB-FE trial
Jianyu QU ; Si CHEN ; Zhijian WANG ; Kang ZHOU ; Yuan ZHAO ; Ran DONG ; Dongmei SHI ; Nianguo DONG ; Zhe ZHENG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(08):1096-1100
Coronary artery bypass grafting (CABG) is one of the most effective revascularization treatments for coronary heart disease. Secondary prevention strategies, which rely on antiplatelet and lipid-lowering drugs, are crucial after CABG to ensure the durability of revascularization treatment effects and prevent adverse cardiovascular and cerebrovascular events in the medium to long term. Previous research conducted by Professor Zhao Qiang's team from Ruijin Hospital of Shanghai Jiao Tong University, known as the DACAB study, indicated that dual antiplatelet therapy (DAPT, specifically ticagrelor+aspirin) after CABG can enhance venous graft patency. However, it remains uncertain whether DAPT can further improve the medium to long-term clinical outcomes of CABG patients. Recently, the team reported the medium to long-term follow-up results of the DACAB study, termed the DACAB-FE study, finding that DAPT administered after CABG can reduce the incidence of major cardiovascular events over five years and improve patients' medium to long-term clinical outcomes. This article will interpret the methodological highlights and significant clinical implications of the DACAB-FE study.

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