1.Analysis of the protection of compensation rights for research participants
Aijuan SHENG ; Xiaoqi WANG ; Liyan SUN ; Dongxiang ZHENG ; Fang LIU
Chinese Medical Ethics 2024;37(5):507-513
Life science and medical research involving human beings cannot be separated from the support of research participants.The safety,health,and rights and interests of research participants are the primary considerations in clinical research,and their rights and interests include the right of compensation,privacy protection,health and so on.Protecting the compensation rights of research participants is a necessary responsibility of the research-related departments and personnel.Based on laws and regulations and literature review,and combined with practical experience,this paper made an in-depth discussion on compensation rights.It puts forward the types of compensation(conventional compensation,research-related damage compensation),compensation principles(necessity,timeliness,appropriateness,fairness),compensation elements(method,amount,plan,consent,notification,and reference of compensation),compensation under special circumstances(compensation for participants without or with limited informed consent ability and withdraw from the study midway),protection measures of compensation right(sponsor/contract research organizations,research institutions,research management departments,(main)researchers and research teams,ethics(review)committee).The compensation rights should be implemented to protect research participants.
2.Deep learning models semi-automatic training system for quality control of transthoracic echocardiography
Sunnan QIAN ; Hexiang WENG ; Hanlin CHENG ; Zhongqing SHI ; Xiaoxian WANG ; Guanjun GUO ; Aijuan FANG ; Shouhua LUO ; Jing YAO ; Zhanru QI
Chinese Journal of Medical Imaging Technology 2024;40(8):1140-1145
Objective To explore the value of deep learning(DL)models semi-automatic training system for automatic optimization of clinical image quality control of transthoracic echocardiography(TTE).Methods Totally 1 250 TTE videos from 402 patients were retrospectively collected,including 490 apical four chamber(A4C),310 parasternal long axis view of left ventricle(PLAX)and 450 parasternal short axis view of great vessel(PSAXGv).The videos were divided into development set(245 A4C,155 PLAX,225 PSAXGV),semi-automated training set(98 A4C,62 PLAX,90 PSAXGV)and test set(147 A4C,93 PLAX,135 PSAXGV)at the ratio of 5:2:3.Based on development set and semi-automatic training set,DL model of quality control was semi-automatically iteratively optimized,and a semi-automatic training system was constructed,then the efficacy of DL models for recognizing TTE views and assessing imaging quality of TTE were verified in test set.Results After optimization,the overall accuracy,precision,recall,and F1 score of DL models for recognizing TTE views in test set improved from 97.33%,97.26%,97.26%and 97.26%to 99.73%,99.65%,99.77%and 99.71%,respectively,while the overall accuracy for assessing A4C,PLAX and PSAXGV TTE as standard views in test set improved from 89.12%,83.87%and 90.37%to 93.20%,90.32%and 93.33%,respectively.Conclusion The developed DL models semi-automatic training system could improve the efficiency of clinical imaging quality control of TTE and increase iteration speed.
3.Yiqi Huoxue Tongluo Prescription Inhibits Activation of Astrocytes to Relieve Diabetic Neuropathic Pain in Rats via ERK Signaling Pathway
Huilun YUAN ; Kai CHENG ; Qian CHEN ; Lujie WANG ; Jiajie LI ; Yuqing WANG ; Aijuan JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(23):36-46
ObjectiveTo investigate the mechanism of Yiqi Huoxue Tongluo prescription (YHTP) in the treatment of diabetic neuropathic pain (DNP). MethodNinety SPF-grade SD male rats were randomized into blank, model, low- (2.25 g·kg-1), medium- (4.5 g·kg-1), and high-dose (9 g·kg-1) YHTP, and mecobalamin (0.175 mg·kg-1) groups. Except those in the blank group, the rats in the remaining 5 groups were fed with a high-fat and high-glucose diet and subjected to intraperitoneal injection of low-dose (35 mg·kg-1) streptozotocin (STZ) to establish the model of DNP. The sciatic nerve conduction velocity in DNP rats was measured by the neurophysiological method, and the levels of interleukin-6 (IL-6), IL-1β, and tumor necrosis factor-α (TNF-α) were measured by enzyme-linked immunosorbent assay (ELISA). Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was employed to measure the mRNA levels of glial fibrillary acidic protein (GFAP) and extracellular signal-regulated kinase (ERK) in the spinal cord. Western blot was employed to measure the protein levels of GFAP and phosphorylated ERK (p-ERK), and immunofluorescence staining to measure the fluorescence intensity of GFAP and p-ERK in the spinal cord. In the cell experiments, 100 mmol·L-1 high glucose was used to induce the activation of astrocytes (CTX-TNA2) for the modeling of nerve cell injury. The cells were randomized into the normal, model, drug-containing serum (10% YQHT), inhibitor [10 mol·L-1 corynoxeine (COR)], drug-containing serum + inhibitor (10% YHTP + 10 mol·L-1 COR) groups. The levels of pro-inflammatory factors (TNF-α and IL-1β) and the anti-inflammatory factor IL-10 in CTX-TNA2 cells were determined by ELISA, and the protein levels of GFAP and p-ERK in CTX-TNA2 cells by Western blot. ResultThe animal experiments showed that compared with the blank group, the model group presented reduced mechanical withdrawal threshold (MWT), thermal work limit (TWL), and nerve conduction velocity, elevated levels of fasting blood glucose, IL-1β, TNF-α, and IL-6, and up-regulated protein levels of GFAP and p-ERK, and mRNA levels of ERK1, ERK2, GFAP (P<0.01). Compared with model group, YHTP increased the MWT, TWL, and sciatic nerve conduction velocity (P<0.01), lowered the levels of IL-1β, TNF-α, and IL-6 (P<0.01), and down-regulated the protein levels of GFAP and p-ERK, and mRNA levels of ERK1, ERK2, GFAP in the spinal cord (P<0.05, P<0.01). The cell experiments showed that compared with the blank group, the model group had decreased survival rate, elevated levels of pro-inflammatory factors, and up-regulated protein levels of ERK and GFAP (P<0.01). Compared with the model group, the YHTP-containing serum lowered the levels of IL-1β and TNF-α (P<0.05, P<0.01), elevated the level of IL-10 (P<0.01), and down-regulated the protein levels of ERK and GFAP (P<0.01). ConclusionYHTP may inhibit the activation of astrocytes by inhibiting the ERK signaling pathway to reduce inflammation and thus relieve DNP.
4.Guidelines for Ethical Review Project Entrustment of Life Science and Medical Research Involving Humans
Jiyin ZHOU ; Aijuan SHENG ; Qiang LIU ; Hui JIANG ; Meixia WANG ; Hua BAI ; Yifeng JIANG ; Lei XU ; Dan LIU ; Ningning XIONG
Chinese Medical Ethics 2023;36(5):488-491
The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.
5.Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans
Aijuan SHENG ; Meixia WANG ; Qiang LIU ; Zhongguang YU ; Hu CHEN ; Hui JIANG ; Jiyin ZHOU ; Xiaoqi WANG ; Haibin YU ; Mingjie ZI ; Yifeng JIANG ; Lei XU ; Tao SHI ; Guizhen SUN ; Dongxiang ZHENG
Chinese Medical Ethics 2023;36(5):492-498
The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.
6.Pregnenolone 16α-carbonitrile negatively regulates hippocampal cytochrome P450 enzymes and ameliorates phenytoin-induced hippocampal neurotoxicity
Shuai ZHANG ; Tingting WANG ; Ye FENG ; Fei LI ; Aijuan QU ; Xiuchen GUAN ; Hui WANG ; Dan XU
Journal of Pharmaceutical Analysis 2023;13(12):1510-1525
The central nervous system is susceptible to the modulation of various neurophysiological processes by the cytochrome P450 enzyme(CYP),which plays a crucial role in the metabolism of neurosteroids.The antiepileptic drug phenytoin(PHT)has been observed to induce neuronal side effects in patients,which could be attributed to its induction of CYP expression and testosterone(TES)metabolism in the hip-pocampus.While pregnane X receptor(PXR)is widely known for its regulatory function of CYPs in the liver,we have discovered that the treatment of mice with pregnenolone 16α-carbonitrile(PCN),a PXR agonist,has differential effects on CYP expression in the liver and hippocampus.Specifically,the PCN treatment resulted in the induction of cytochrome P450,family 3,subfamily a,polypeptide 11(CYP3A11),and CYP2B10 expression in the liver,while suppressing their expression in the hippocampus.Func-tionally,the PCN treatment protected mice from PHT-induced hippocampal nerve injury,which was accompanied by the inhibition of TES metabolism in the hippocampus.Mechanistically,we found that the inhibition of hippocampal CYP expression and attenuation of PHT-induced neurotoxicity by PCN were glucocorticoid receptor dependent,rather than PXR independent,as demonstrated by genetic and pharmacological models.In conclusion,our study provides evidence that PCN can negatively regulate hippocampal CYP expression and attenuate PHT-induced hippocampal neurotoxicity independently of PXR.Our findings suggest that glucocorticoids may be a potential therapeutic strategy for managing the neuronal side effects of PHT.
7.The relationship between cumulative fasting blood glucose exposure and all-cause mortality
Tingting LIU ; Xizhu WANG ; Qiaofeng SONG ; Aijuan LIU ; Yue DU ; Shouling WU
Chinese Journal of Endocrinology and Metabolism 2022;38(1):7-13
Objective:To investigate the relationship between cumulative fasting blood glucose(cumFPG)exposure and all-cause mortality.Methods:The prospective cohort study included 56 845 subjects of Kailuan Group who participated in physical examinations from 2006 to 2007, 2008 to 2009, and 2010 to 2011 with complete data and a median of 7.77 years of follow up. The end point event was all-cause mortality. The incidence of all-cause mortality was compared in various groups divided by four quartile of cumFPG. The Cox proportional hazards model and natural spline were used to analyze the effect of cumFPG on all-cause mortality.Results:During the average(7.77±1.05)years of follow-up, the incidence density of all-cause mortality was on the rise with the increase of cumFPG(4.93, 5.87, 8.48, and 14.02 per 1 000 person-years), with statistically significant difference by Log- rank test( P<0.001). Cox proportional hazards model showed that after adjusting for potential confounding factors(age, sex, body mass index, hypertension, baseline fasting plasma glucose), the HR value(95% CI)of all-cause mortality in the fourth quartile group was 1.28(1.15-1.42)compared to the first quartile. When cumFPG increased every standard deviation, the risk of all-cause mortality increased by 17%. Natural spline analysis exhibited a similar J curve relationship between cumFPG and all-cause mortality. Conclusion:High cumFPG is a risk factor of all-cause mortality.
8.A study on the correction between English learning efficacy and autonomous learning ability of postgraduates in universities of Traditional Chinese Medicine
Shuiyuan DAI ; Aijuan LIU ; Mingzhe LI ; Yichao WANG
Chinese Journal of Medical Education Research 2022;21(12):1739-1744
Objective:To investigate the English learning efficacy and autonomous learning proficiency of postgraduates in universities of Traditional Chinese Medicine (TCM), explore whether there is a correlation between English learning efficacy and autonomous learning ability, and to analyze the influence of English learning efficacy on autonomous learning ability.Methods:A questionnaire survey was carried out to assess the levels of English learning efficacy and English autonomous learning in two levels of belief and behavior among 207 postgraduates in TCM universities. Statistical methods such as independent sample t-test, one-way ANOVA, nonparametric Mann-Whitney U-test, and Kruskal Wallis H-test were applied to analyze the data collected in the questionnaire survey. Results:The average score of subjects' English learning efficacy was 2.82 ± 0.60 (1 ≤ ≤ 5), and the average score of subjects' English autonomous learning ability was 3.24 ± 0.53 (1 ≤ ≤ 5). The scores of their autonomous English learning in the level of belief was significantly higher than those of the level of behavior ( t =14.10, P < 0.001). The scores of autonomous learning ability of subjects in Batch 2020 were significantly lower than those in Batch 2021 ( t = 2.64, P = 0.009). Linear correlation analysis showed that there was a moderately positive correlation between English learning efficacy and autonomous learning ability. Conclusion:The English learning efficacy of postgraduates in TCM universities is at the middle-low level and their English autonomous learning ability is at the middle level. Moreover, their English autonomous learning in the level of behavior underperforms the English autonomous learning in the level of belief, and the English autonomous learning ability decreases with the increase of the grades. In addition, the English learning efficacy has a moderate positive influence on autonomous English learning ability.
9. Apatinib combined with capecitabine in the treatment of advanced triple-negative breast cancer as third-line therapy: An observational study
Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(4):433-439
AIM: To investigate the efficacy and safety of apatinib combined with capecitabine in the treatment of advanced triple-negative breast cancer (TNBC) as third-line therapy. METHODS: Sixty advanced TNBC patients, who have failed to receive second-line palliative chemotherapy, were enrolled in the Department of Oncology, Anqing Hospital Affiliated to Anhui Medical University from February 2016 to September 2019. Patients were divided into observation group (n=30, received apatinib combined with capecitabine) and control group (n=30, received capecitabine) randomly. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), 1-year survival rate, overall survival (OS) and adverse events between the two groups were observed and compared. RESULTS:ORR was 26.67% and DCR was 86.67% in the observation group, while 6.67% and 60.00% in the control group, respectively. ORR and DCR in the observation group were better than those in the control group (P=0.038; 0.020). Meanwhile, the median PFS was 7.0 months in the observation group, while it was 5.0 months in the control group, which indicated that the observation group exhibited a higher PFS than the control group (P=0.000). The 1-year survival rate and the median OS was 55.30% and 13.0 months in the observation group respectively, while those were 46.30% and 12.0 months in the control group respectively, the OS showed no significant differences between the two groups (P=0.258). In addition, we also found that there was significant differences in the adverse reaction such as hypertension between the two groups (P=0.000), yet it was mild and tolerable after symptomatic treatment. CONCLUSION:Apatinib combined with capecitabine in the advanced TNBC maintenance treatment has a certain survival benefit for those who failed in second-line therapy, and adverse reactions are tolerable and controllable.
10.Application of visual feedback training based on mirror neuron theory in upper limb function reconstruction in stroke patients
Meihong ZHU ; Meifang SHI ; Ming ZENG ; Fang SHEN ; Aijuan WANG ; Xiaoyan CHEN ; Jialing WANG
Chinese Journal of Modern Nursing 2020;26(6):749-753
Objective:To explore the effects of visual feedback training based on the mirror neuron theory in upper limb function reconstruction in stroke patients.Methods:From June 2017 to June 2018, totally 61 stroke patients hospitalized in the Rehabilitation Medical Center of the Second Hospital of Jiaxing were selected by convenient sampling and divided into the observation group ( n=31) and the control group ( n=30) according to the random number table. Patients in both groups received routine rehabilitation therapy, while patients in the observation group underwent visual feedback training on this basis. They were evaluated using Barthel Index , Fugl-Meyer Assessment (FMA) (upper limb) , and the latency and amplitude of N9 and N20 were detected using somatosensory evoked potentials (SEP) before and 8 weeks after rehabilitation intervention. Results:After the intervention, the FMA score of the upper limbs in the observation group was (47.91±6.92) , higher than (40.31±7.87) in the control group, the Barthel Index of the observation group was (77.33±11.82) , higher than (66.79±12.31) in the control group, and the differences between the two groups were statistically significant ( P<0.01) . The SEP values of the upper limbs of the hemiplegia side in the observation group were better than those in the control group, and the differences between the two groups were statistically significant ( P<0.05) . Conclusions:The visual feedback training based on the mirror neuron theory can improve the upper limb motor function in stroke patients with early hemiplegia, improve their daily living activities, increase the N9 and N20 amplitudes of SEP, shorten their latency, and enhance the excitement of the upper limb movement related brain area in the mirror neuron system.

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