Objective To observe value of real-time functional MRI neurofeedback(rtfMRI-NF)for modulating brain activity changes in obese adults.Methods Twenty-two obese adults were prospectively recruited,3-week rtfMRI-NF training intervention was conducted.Barratt impulsivityness scale version 11(BIS-11),three-factor eating questionnaire(TFEQ)and food rating scales were scored before and after intervention,and whole-brain resting state fMRI(rs-fMRI)data were obtained.Clinical scale scores,rs-fMRI regional homogeneity(ReHo)values and amplitude of low frequency fluctuation(ALFF)values were compared before and after intervention.Then brain regions with differences of ReHo and ALFF values before and after intervention were explored,and correlations of values of rs-fMRI data differences and clinical scale score differences were analyzed.Results BIS-11 score,TFEQ emotional eating(TFEQ-EE)score and food rating scales scores decreased,while TFEQ cognitive restraint(TFEQ-CR)scores increased in obese adults after intervention(all P＜0.05).ReHo values in right inferior frontal gyrus,right anterior cingulate and left precuneus increased,while of left middle temporal gyrus decreased(all corrected P＜0.05).ALFF values of left precuneus increased,whereas of left middle occipital gyrus,right superior occipital gyrus,left calcarine fissure and surrounding cortex and left supramarginal and angular gyrus decreased(all corrected P＜0.05).ReHo difference in right anterior cingulate was negatively correlated with BIS-11 scores difference(r=-0.601,P＜0.05),and ALFF difference in left precuneus was negatively correlated with TFEQ-EE difference(r=-0.478,P＜0.05).Conclusion rtfMRI-NF intervention could correct disorder of cerebral functional areas in obese adults and change high-calorie food preference and poor dietary habits.

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.

Objective To observe value of real-time functional MRI neurofeedback(rtfMRI-NF)for modulating brain activity changes in obese adults.Methods Twenty-two obese adults were prospectively recruited,3-week rtfMRI-NF training intervention was conducted.Barratt impulsivityness scale version 11(BIS-11),three-factor eating questionnaire(TFEQ)and food rating scales were scored before and after intervention,and whole-brain resting state fMRI(rs-fMRI)data were obtained.Clinical scale scores,rs-fMRI regional homogeneity(ReHo)values and amplitude of low frequency fluctuation(ALFF)values were compared before and after intervention.Then brain regions with differences of ReHo and ALFF values before and after intervention were explored,and correlations of values of rs-fMRI data differences and clinical scale score differences were analyzed.Results BIS-11 score,TFEQ emotional eating(TFEQ-EE)score and food rating scales scores decreased,while TFEQ cognitive restraint(TFEQ-CR)scores increased in obese adults after intervention(all P＜0.05).ReHo values in right inferior frontal gyrus,right anterior cingulate and left precuneus increased,while of left middle temporal gyrus decreased(all corrected P＜0.05).ALFF values of left precuneus increased,whereas of left middle occipital gyrus,right superior occipital gyrus,left calcarine fissure and surrounding cortex and left supramarginal and angular gyrus decreased(all corrected P＜0.05).ReHo difference in right anterior cingulate was negatively correlated with BIS-11 scores difference(r=-0.601,P＜0.05),and ALFF difference in left precuneus was negatively correlated with TFEQ-EE difference(r=-0.478,P＜0.05).Conclusion rtfMRI-NF intervention could correct disorder of cerebral functional areas in obese adults and change high-calorie food preference and poor dietary habits.

Objective:To explore the clinical effect of non-expansion whole framework ear reconstruction for microtia (referred to as the NEWF ear reconstruction).Methods:The clinical data of congenital microtia patients underwent NEWF ear reconstruction at Department of Ear Reconstruction, Plastic Surgery Hospital, Chinese Academy of Medical Sciences were retrospectively analyzed. This advanced method used a tissue non-expansion approach, employing a double flap consisting of preauricular skin flap and fascia flaps, to fabricate and elevate the ear framework in the first stage concurrently. In the subsequent stage, residual ear tissues were utilized to reconstruct key elements such as the tragus, crus of the helix, cavum concha, and so on. At 6 months follow-up, the effectiveness of the reconstructed ear was assessed based on its aesthetic outcomes and complications. Aesthetic outcomes evaluation included 4 items: skin color (front of ear, back of ear and skin graft area were evaluated respectively), appearance of reconstructed ear substructure, scar of incision and hair condition. The individual score was 0-2 points, total scores from 0 to 10, with scores of 9-10 signifying excellent, 6-8 good, 3-5 moderate, and 0-2 poor. The data were analyzed by descriptive statistics.Results:Ear reconstruction was performed on 49 unilateral microtia cases, aged 6-33 years, including 37 males and 12 females, 34 right ears and 15 left ears. According to the Nagata classification: 30 cases were lobule-type, 5 cases were conchal-type, and 14 cases were small conchal-type. The follow-up period averaged 10.63 months, ranging from 6 to 13 months. One patient experienced exposure of the framework 1 month after the first stage surgery, then recovered well after surgery. The skin color of the front side of the reconstructed ear was close to normal, the substructure was clear, the skin graft area behind the ear recovered well, and the reconstructed ear was basically symmetrical with the healthy side. 9 cases (18.4%) had scar hyperplasia in the mastoid area behind the ear. 9 cases (18.4%) had hair growth on the front of the reconstructed ears. Aesthetic outcomes showed that excellent in 8 cases (16.3%), good in 36 cases (73.5%), moderate in 4 cases (8.2%), poor in 1 case (2.0%).Conclusion:The NEWF ear reconstruction enhances the stability of the ear framework, reduces the overall duration of treatment, making it a viable option for ear reconstruction for microtia.

Objective:To explore the clinical effect of non-expansion whole framework ear reconstruction for microtia (referred to as the NEWF ear reconstruction).Methods:The clinical data of congenital microtia patients underwent NEWF ear reconstruction at Department of Ear Reconstruction, Plastic Surgery Hospital, Chinese Academy of Medical Sciences were retrospectively analyzed. This advanced method used a tissue non-expansion approach, employing a double flap consisting of preauricular skin flap and fascia flaps, to fabricate and elevate the ear framework in the first stage concurrently. In the subsequent stage, residual ear tissues were utilized to reconstruct key elements such as the tragus, crus of the helix, cavum concha, and so on. At 6 months follow-up, the effectiveness of the reconstructed ear was assessed based on its aesthetic outcomes and complications. Aesthetic outcomes evaluation included 4 items: skin color (front of ear, back of ear and skin graft area were evaluated respectively), appearance of reconstructed ear substructure, scar of incision and hair condition. The individual score was 0-2 points, total scores from 0 to 10, with scores of 9-10 signifying excellent, 6-8 good, 3-5 moderate, and 0-2 poor. The data were analyzed by descriptive statistics.Results:Ear reconstruction was performed on 49 unilateral microtia cases, aged 6-33 years, including 37 males and 12 females, 34 right ears and 15 left ears. According to the Nagata classification: 30 cases were lobule-type, 5 cases were conchal-type, and 14 cases were small conchal-type. The follow-up period averaged 10.63 months, ranging from 6 to 13 months. One patient experienced exposure of the framework 1 month after the first stage surgery, then recovered well after surgery. The skin color of the front side of the reconstructed ear was close to normal, the substructure was clear, the skin graft area behind the ear recovered well, and the reconstructed ear was basically symmetrical with the healthy side. 9 cases (18.4%) had scar hyperplasia in the mastoid area behind the ear. 9 cases (18.4%) had hair growth on the front of the reconstructed ears. Aesthetic outcomes showed that excellent in 8 cases (16.3%), good in 36 cases (73.5%), moderate in 4 cases (8.2%), poor in 1 case (2.0%).Conclusion:The NEWF ear reconstruction enhances the stability of the ear framework, reduces the overall duration of treatment, making it a viable option for ear reconstruction for microtia.

The biological samples of oral genetic diseases and rare diseases are extremely precious. Collecting and preserving these biological samples are helpful to elucidate the mechanisms and improve the level of diagnose and treatment of oral genetic diseases and rare diseases. The standardized construction of biobanks for oral genetic diseases and rare diseases is important for achieving these goals. At present, there is very little information on the construction of these biobanks, and the standards or suggestions for the classification and coding of biological samples from oral and maxillofacial sources, and this is not conducive to the standardization and information construction of biobanks for special oral diseases. This consensus summarizes the background, necessity, principles, and key points of constructing the biobank for oral genetic diseases and rare diseases. On the base of the group standard "Classification and Coding for Human Biomaterial" (GB/T 39768-2021) issued by the National Technical Committee for Standardization of Biological Samples, we suggest 76 new coding numbers for different of biological samples from oral and maxillofacial sources. We hope the consensus may promote the standardization, and smartization on the biobank construction as well as the overall research level of oral genetic diseases and rare diseases in China.

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.

Objective:To investigate the effects of personalized intermittent energy restriction (IER) diet on sleep related gut microbiome in obese patients.Methods:In this single-arm clinical trial, a total of 35 obese patients who visited Henan Provincial People′s Hospital from April to November 2018 were recruited as research subjects. They underwent a strict 32-day IER diet intervention, divided into 4 stages of 8 days each. Nutritional recipes were formulated and nutritious meals were provided to each obese patient with timed meals, including 55% carbohydrates, 15% protein, and 30% fat per meal. In stages 1, 2, 3, and 4, patients were provided with 2/3, 1/2, 1/3, and 1/4 of their previous calorie intake every other day, respectively, with meals at 8:00 and 16:00. During the remaining time, patients were allowed unrestricted eating at home. Physiological indicators (weight, body mass index, body fat percentage, waist circumference, hip circumference, fasting blood glucose, glycosylated hemoglobin, blood pressure, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein and Pittsburgh Sleep Quality Index (PSQI) scores were observed before and after the intervention. Gut microbiota changes were analyzed using metagenomic sequencing technology, and Spearman′s correlation analysis was used to assess the correlation between significantly different bacterial species and PSQI scores.Results:After the intervention, the body weight, body mass index, and PSQI scores of obese patients were all significantly lower than before intervention [(89.92±14.98) vs (97.53±15.67) kg, (31.94±3.95) vs (34.64±4.05) kg/m 2, (3.43±1.16) vs (5.42±2.27)], the abundance of gut microbiota was significantly higher after the intervention (all P<0.05). There were 45 significantly different bacterial species before and after the intervention, of which 6 bacterial species ( Enterobacter cloacae, Escherichia coli, Odoribacter splanchnicus, Oribacterium sinus, Streptococcus gordonii, and Streptococcus parasanguinis) showed significantly positive correlations with PSQI scores ( r=0.476, 0.475, 0.369, 0.391, 0.401, 0.423) (all P<0.05), and they were mainly enriched in the glutamate and tryptophan synthesis pathways. Conclusions:The personalized IER diet intervention can improve the sleep of obese patients while reducing weight, possibly mediated by changes in gut microbiota through the glutamate and tryptophan pathways.

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.

Objective:To evaluate the feasibility and accuracy of a multi-dimensional peripheral quick contrast sensitivity function (pqCSF) measurement established based on Bayesian probability estimation algorithm.Methods:A cross-sectional study was conducted.Nineteen eyes of 12 healthy emmetropic subjects in Zhongshan Ophthalmic Center of Sun Yat-sen University from September 2017 to March 2018 were included, with an average age of (22.92±2.91) years.The average spherical power and cylindrical power were (-0.34±0.52)D and (-0.30±0.42)D, respectively, and the average uncorrected vision acuity was≥1.0.Based on the Bayesian probability algorithm, the peak contrast sensitivity γ max, the peak spatial frequency ? max, the bandwidth β and the low contrast intercept δ were used to quickly describe the contrast sensitivity function (CSF) curve of the full spatial frequency through multi-dimensional pqCSF method.The 16 peripheral visual field positions of all subjects were tested at 6°, 12°, 18° and 24° eccentricity of the superior, inferior, the temporal and nasal visual field by the pqCSF method, but the 18° eccentricity of temporal field, which was near the physiological blind spot, was excluded.The area under Log CSF (AULCSF) of different peripheral visual fields and the Log CSF of 19 spatial frequencies (distributed at equal intervals in logarithmic units) were compared.This study followed the Declaration of Helsinki, and the study protocol was approved by an Ethics Committee of Zhongshan Ophthalmic Center of Sun Yat-sen University (No.2018KYPJ017). Written informed consent was obtained from each subject prior to any examination. Results:With the increase of eccentricity in different visual fields, the AULCSF decreased gradually, and there were significant differences in AULCSF between different eccentricities (all at P<0.05). The AULCSF of the nasal and temporal visual field at 6°, 12° and 24° eccentricity was significantly larger than that of the superior and inferior visual field (all at P<0.05). As the distance from the fovea was increased, the pqCSF, the AULCSF, and the high-frequency cutoff were all decreased, and the standard deviation of AULCSF was increased gradually. Conclusions:The pqCSF method can depict a relatively complete peripheral CSF curve of a wide peripheral visual field, and reflect the function quality of the peripheral vision comprehensively and accurately.