1.Exploration of ethical governance paths in medical science and technology in the era of deep technologization
Bingyang YAO ; Huihui WANG ; Qingjiang CHEN
Chinese Medical Ethics 2025;38(4):476-482
In the era of deep technologization with the flourishing development of newquality productive forces, China’s medical science and technology innovation has transitioned from “following” to “leading”, and the ethical governance environment of medical science and technology has undergone profound changes. However, the traditional ethical governance system of medical science and technology faces several issues, such as outdated ethical governance concepts, inadequate ethical norms, excessive hidden ethical risks, and numerous loopholes in governance systems, which fail to effectively respond to the diverse and complex ethical risk challenges. To this end, it is essential to promote the transformation of ethical governance thinking in medical science and technology based on the reality of newquality productivity forces and deep technologization, as well as to shift unilateral, extensive, and single governance into comprehensive, precise, and early-warning governance. Additionally, it is necessary to cultivate an ethical governance concept that prioritizes ethics and prevention, establish a diverse and collaborative ethical governance model, set up a prevention mechanism focused on major ethical risks, as well as enhance the systems of ethical communication, review, and feedback in medical science and technology.
2.Effect of early stage glycosylated hemoglobin level on two-year prognosis in patients with first time onset of acute ischemic stroke
Huihui YAO ; Lin SHU ; Sha LI ; Xiaotong YANG ; Linli YAO ; Bishuang LI ; Aiming TAN
Chongqing Medicine 2024;53(19):2987-2991
Objective To explore the relationship between the early stage HbA1c level and two-year prognosis in the patients with first time onset of acute ischemic stroke(AIS).Methods A total of 513 inpa-tients with first time AIS in this hospital during 2018-2019 were selected as the study subjects.The clinical data,biochemical indicators and discharge situation were collected.The multivariate logistic regression was used to analyze the influencing factors of adverse reactions outcome within 2 years.The Kaplan-Meier survival curve was used to analyze the all-cause mortality and stroke recurrence situation within 2 years.Results The sex,age,TOAST type,,diseases history such as diabetes,arrhythmia and coronary heart disease,medication history such as antidiabetic drugs,lipid-lowering drugs and anticoagulants,BMI,Urea,Crea,ALT,SBP,fasting blood glucose(FBG),total cholesterol(TC),triglyceride(TG),HDL-C,NIHSS score at admission,discharge mode,NIHSS score at discharge,hospitalization duration and hospitalization costs had statistical difference a-mong the patients with different HbA1c levels(P<0.05).The multivariate logistic regression analysis showed that HbA1c>7.4%was the independent risk factor for adverse outcome within 2 years(OR=4.470,95%CI:1.105-18.087,P=0.036).The Kaplan-Meier survival curve analysis showed that the survival time within 2 years had statistical difference among the patients with different HbA1c levels(P=0.009).The higher the HbA1c level,the shorter the survival time.Conclusion The high HbA1c level has the influence on the stroke recurrence and all-cause mortality within 2 years in the patients with first onset occurrence of AIS.
3.Ethical exploration of clinical research empowered by remote collection of digital health technology
Zhonglin CHEN ; Xingyi LI ; Yu FENG ; Huihui HAN ; Yao YAO ; Mengjie YANG ; Xumin HOU
Chinese Medical Ethics 2024;37(6):693-698
In recent years,with the gradual maturity of achievable remote collection of digital health technology,more and more clinical research have applied this technology to improve the quality of data collection and reduce the burden on subjects.However,its technological characteristics of detachment from the diagnostic and treatment environment and real-time transmission of sensitive information also pose corresponding risks to the protection of subjects'rights and interests and data standardization management,among which personal information protection and data control permissions are more prominent issues.Based on risk analysis and regulatory review,this paper explored the responsibilities of multiple parties,including the sponsors,researchers,clinical trial institutions,and ethics committee,as well as proposed five elements of special concern for ethical review,with a view to providing a reference for promoting the standardized development of digital health technology in clinical research.
4.Safety and efficacy of the day surgery model for the treatment of unilateral primary aldosteronism
Kaixuan ZHANG ; Jiwen SHANG ; Yanghao TAI ; Xue YAO ; Huihui QIAO ; Kang WANG
Chinese Journal of Urology 2024;45(8):582-586
Objective:To explore the safety and feasibility of adrenal tumor resection under day surgery mode for the treatment of unilateral primary aldosteronism (UPA).Methods:The clinical data of 83 patients who underwent adrenalectomy for the treatment of UPA from January 2020 to January 2023 were retrospectively analyzed. There were 42 males (50.6%)and 41 females (49.4%), age (49.0±12.3)years old. Body mass index (25.4±3.6)kg/m 2. There were 17 patients with diabetes, 58 patients with preoperative hypertension, and the duration of hypertension was 8.2(1, 15)years. Systolic blood pressure was 151.8(137.0, 160.0)mmHg (1 mmHg=0.133 kPa), and diastolic blood pressure was 97.4(87.0, 107.0)mmHg. 20 cases had severe preoperative hypokalemia, with preoperative blood potassium levels of (2.9±0.6)mmol/L. The ratio of preoperative plasma aldosterone to renin activity was 54.1(13.0, 77.2). Tumors were located on the left side in 47 cases (56.6%)and on the right side in 36 cases (43.4%). The maximum diameter of the tumor is 1.5(1.0, 1.7)cm. Patients diagnosed with unilateral primary aldosteronism were included, and patients diagnosed with adrenal pheochromocytoma, adrenal malignancy, or severe cardiovascular disease that cannot tolerate surgery were excluded. The patient was admitted to the hospital on the same day, underwent surgery on the same day, and was evaluated after extubation within one day after surgery. The patient had no fever or lower back pain after surgery, was able to freely get out of bed, and had no obvious abnormalities in blood routine, electrolyte and other test indicators. The patient was discharged from the hospital and received continuous care outside the hospital. The patient was guided to undergo regular outpatient follow-up. Evaluate the efficacy using the Primary Aldosterone Hyperaldosteronism Surgical Outcome (PASO)criteria. Results:The patients had a mean length of hospital stay of 43.0(40.3, 44.6)hours, an operation time of 89.6(70.0, 103.0)minutes, and an operation cost of 23 820.2 (21 150.8, 24 948. 3)yuan. The postoperative free position time was 29.5(20.8, 39.7)hours, the postoperative time for fluid placement of the diet was 25.2(20.1, 27.8) hours, and 42.2(37.9, 41.9)hours of postoperative drain removal. The overall postoperative clinical remission rate was 85.5%. There were four postoperative complications, accounting for 4.8% of cases. These included two cases of interosseous vein thrombosis, one case of delayed healing, and one case of peritoneal rupture. No case of readmission was reported within 30 days.Conclusions:UPA adrenal tumour resection in ambulatory mode is safe and effective when strict inclusion and exclusion criteria are followed, adequate preoperative preparation is carried out, and expert physician assessment is provided.
5.The Role and Positioning of Clinical Trial Ethics Review under Pharmaceutical Innovation Strategy
Zhonglin CHEN ; Gan HE ; Yu FENG ; Huihui HAN ; Yao YAO ; Ning ZHENG
Chinese Medical Ethics 2023;36(2):180-185
Ethical review runs through the whole process of drug clinical trials, and is a critical step to ensure the rights and interests of subjects. This paper analyzed and discussed the role and positioning of ethical review in new drug clinical trials, cleared the principles of ethical review, identified the responsibilities of ethical review, and clarified the authority of ethical review approval documents. The ethical review should primarily focus on the ethics of the clinical trials, not replace other professional institutions to review the clinical trials’ legality and scientific nature. Ethical approval is only one of the necessary conditions for conducting clinical trials, not the only factor. It is recommended to strengthen the publicity and popularization of scientific and technological ethics awareness, improve the clinical trial approval mechanism, and optimize the phrasing of ethical review approval documents. It is warranted to further optimize the quality of ethical review, improve the construction of ethical review system, ultimately achieve the unity of promoting innovation and preventing risks, so as to effectively realize the benign interaction between high-quality development of scientific and technological innovation and high-level safety.
6.Effect of case three-dimensional teaching method integrated with multimedia teaching on practice teaching of liver infectious diseases
Yajing ZHOU ; Lin HUA ; Cen ZI ; Yu YAO ; Pinqing LI ; Huihui MENG ; Li QIAO ; Fang LUO
Chinese Journal of Medical Education Research 2022;21(8):1051-1054
Objective:To explore the effect of case three-dimensional teaching method (CTTM) combined with multimedia teaching on the practice teaching of liver infectious diseases.Methods:Twenty-five interns of liver infectious diseases received by The Second Hospital of Nanjing from May 2019 to January 2020 were taken as the control group, and 25 interns of liver infectious diseases received from February 2020 to October 2020 were taken as the observation group. The control group was given the conventional teaching mode including the conventional case teaching and the conventional multimedia teaching, while the observation group was given CTTM integrated with multimedia teaching method, and both groups were taught for 4 weeks. After teaching, the examination results of liver infectious disease related theory and practice, the changes of core competence before and after teaching, and the recognition of teaching were compared between the two groups. SPSS 25.0 was used for t test and chi-square test. Results:After teaching, the examination results of liver infectious disease related theory [(92.45±7.23) vs. (81.21±7.11)] and practice [(93.27±6.68) vs. (81.23±6.26)] in the observation group were higher than those in the control group. There was no significant difference in the scores of core competence between the two groups before teaching; after teaching, the scores of autonomous learning, problem analysis and solving, doctor-patient communication and teamwork ability of the two groups were higher than those before teaching, and the scores of observation group were significantly higher than those of the control group ( P<0.05). The recognition rates of interns in the observation group were higher than those in the control group in the improvement of learning initiative, the consolidation of theoretical knowledge, the enhancement of practical ability and the improvement of learning efficiency ( P<0.05). Conclusion:In the teaching of liver infectious disease interns, CTTM integrated with multimedia teaching method can not only improve the examination results, and enhance the core competence, but also improve the recognition of interns on the teaching mode.
7.Detection of varicella-zoster virus in different specimens from patients with acute herpes zoster
Yanhua LIANG ; Yao YANG ; Huihui MO
Chinese Journal of Dermatology 2022;55(10):889-891
Objective:To investigate positive rates of varicella-zoster virus (VZV) DNA in blood and saliva samples, as well as in swab samples from lesions and clothes in contact with lesions in patients with acute herpes zoster, and to explore their clinical significance.Methods:Patients with confirmed herpes zoster were collected from Department of Dermatology, Shenzhen Hospital, Southern Medical University from April 2019 to August 2020. Fluorescence-based quantitative PCR was performed to detect VZV DNA in blood and saliva samples, lesion and cloth swab samples from the patients before and after antiviral treatment. Chi-square test was used to compare the positive rate of VZV DNA in saliva samples between patients with herpes zoster on the head, face and neck and those without involvement of the head, face or neck, and changes in the positive rate of VZV DNA in different specimens were analyzed before and after treatment.Results:A total of 86 patients with herpes zoster were collected, including 26 males and 60 females aged 52.65 ± 14.83 years, with a disease duration being 5.23 ± 2.10 days. The positive rate of VZV DNA in the saliva samples was significantly higher in the 24 patients with herpes zoster on the head, face and neck (41.67%, 10/24) than in the 62 patients without involvement of the head, face or neck (12.90%, 8/62; χ2 = 7.63, P < 0.05) . Both pre- and post-treatment blood samples were collected from 37 patients, saliva samples from 35, lesion swab samples from 28, and cloth swab samples from 27. Before the treatment, the positive rates of VZV DNA in the blood, saliva, lesion and cloth swab samples were 86.49% (32/37) , 22.86% (8/35) , 92.86% (26/28) and 88.89% (24/27) respectively, which decreased to 51.35%, 8.57%, 89.29% and 85.18%, respectively, after 6.82 ± 2.23 days of treatment. The positive rate of VZV DNA significantly differed before and after treatment only in the blood samples ( χ2 = 9.60, P = 0.003) , while showed no significant difference in the other specimens (all P > 0.05) . Conclusion:The positive rate of VZV DNA in the saliva samples was significantly higher in the patients with acute herpes zoster on the head, face and neck than in those without involvement of the head, face or neck, and that in the cloth swab samples was relatively high before and after antiviral treatment.
8.Analysis and Discussion on the Ethical Pre-review Model of Clinical Trials under the Pharmaceutical Innovation Strategy
Zhonglin CHEN ; Gan HE ; Yu FENG ; Huihui HAN ; Yao YAO ; Ning ZHENG
Chinese Medical Ethics 2022;35(11):1214-1217
With the implementation of the national biomedical innovation strategy, new requirements for ethical review of clinical trials have been put forward, and more attention has been paid to the ethical pre-review. Based on the current situation of clinical trials and ethical review of new drugs in China, this paper discussed the concept, advantages and necessity of ethical pre-review, sorted out the problems and challenges in the implementation of ethical pre-review at this stage, and put forward the following suggestions on how to better implement ethical pre-review in clinical trials under the pharmaceutical innovation strategy: the complete definition of "ethical pre-review" should be made clearly; ethical review should be carried out on the basis of necessary reference; the scope of application of ethical pre-review should be clarified; after the ethical pre-review, the statement of the approval document should be standardized and accurate.
9.Anxiety and associated factors among medical college students during COVID-19 epidemic
MA Shaoyong, CHEN Yan, WANG Fangfang, WANG Huihui, JIN Yuelong, YAO Yingshui
Chinese Journal of School Health 2021;42(9):1351-1355
Objective:
To analyze anxiety and its influencing factors of medical college students during the epidemic of COVID-19, so as to provide theoretical basis for targeted mental health promotion.
Methods:
Participants were selected through convenient sampling in 2 medical colleges, and general situation questionnaires, anxiety self rating scale(SAS), were csuected through questionnaire stars among to 6 276 medical college students anonymously through online platforms such as WeChat and QQ during the COVID-19 epidemic.
Results:
SAS scores of medical students was(38.52±7.76), anxiety detection rate was 8.9%. Anxiety detection rate varied significantly by gender, the frequency of protection alerting by the counselor, college level, residence, self reported health status, confirmed cases in the community, personal attention, disinfection, perceived risk of infection,as well as panic in the outbreak of COVID-19 (all P <0.05). Multivariate Logistic analysis showed that undergraduate( OR = 1.25 ), high perceived risk of infection( OR =1.71); extreme panic ( OR =2.75) were associated with high detection rate of anxiety. Female students( OR =0.62), rural residents( OR =0.80), moderate health status( OR =0.06), in good health( OR =0.11), in excellent health( OR =0.30); know or don t know there were COVID-19 patients in their residential areas( OR =0.67), close attention to COVID-19 1-2 times/d( OR = 0.47 ), or frequently( OR =0.38); moderate inevitable disinfection( OR =0.53), few inevitable disinfection ( OR =0.32) were associated with low detection rate of anxiety.
Conclusion
During the epidemic of COVID-19, anxiety among the medical college students was high, which varies by gender and college level. Psychological adjustment, appropriate attention and positive attitude towards COVID-19 should be promoted among medical college students. School counsellors should pay more attention and care to students while providing COVID-19 information through various ways.
10.Research progress in chronic hepatitis B and functional cure based on immune mechanism
Xiaoyue BI ; Cheng CHENG ; Huihui LU ; Minghui LI ; Yao XIE
Chinese Journal of Experimental and Clinical Virology 2021;35(3):317-321
The functional cure of hepatitis B means that patients have good clinical outcomes, which is the ideal endpoint of hepatitis B antiviral treatment. Whether chronic hepatitis B patients can achieve functional cure is related to the nature of the virus itself, such as virus species, virus replication and expression of related proteins, on the other hand, it is also related to the host body's immunity, including innate immunity and specific immunity. Immune factors play a vital role in the functional cure of hepatitis B. Antiviral drugs, including interferon, often play an antiviral role by regulating immunity. This paper reviews the relationship between hepatitis B and functional cure from the perspective of immunity, in order to provide the basis for the clinical pursuit of functional cure, hoping to provide guidance for clinical practice.


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