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.

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.

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.

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.

Objective To explore the effect of fish oil fat emulsion as perioperative nutritional support on patients with liver cirrhosis and portal hypertension.Methods Randomized controlled clinical trial was performed between September 2011 and September 2017 in patients with liver cirrhosis and portal hypertension who underwent pericardial devascularization and splenectomy.Hypocaloric total parenteral nutritional support (TPN) started from the first day after the operation for 5 consecutive days.Patients were divided into experimental group and control group according to thetype of fat emulsion used.43 patients in experimental group were applied for fish oil fat emulsion injection (10％ Omegaven) + medium long chain structure fat emulsion (20％STG) and 42 patients in control group were applied for medium long chain structure fat emulsion (20％STG).Liver function (total bilirubin and alanine aminotransferase),nutrition index (serum albumin and prealbumin),inflammatory mediators (TNF-α,IL-6 and IL-10) were measured before and after the operation,and the clinical outcomes were observed.Results There was no statistically significant difference in liver function and nutritional indices between the experimental group and the control group (P＞0.05).The inflammatory mediators like TNF-u,IL-6 and IL-10 on the first day after surgery were significantly higher than those before surgery in both groups [experiment group:(225.54±54.78) vs.(61.49±16.47),(74.94±6.36) vs.(39.84±2.77),(77.53±11.4) vs.(46.05±6.13) ng/L;control group:(229.26±62.15) vs.(63.48±13.76),(77.23±7.83)vs.(40.64±3.34),(73.89±7.97)vs.(44.88±5.72) ng/L;P＜ 0.01].With the progress of time,the proinflammatory factors like TNF-α and IL-6 decreased after the operation and the range of decrease was higher in experiment group than in control group [d4-d 1:(-56.88± 31.63) vs.(-35.96±20.02),(-13.52±5.20) vs.(-6.38±2.84) ng/L;d7-d1:(-150.67±42.58) vs.(-132.79±53.35),(-27.04±8.97) vs.(-20.85±6.38) ng/L;P＜ 0.05].The range of increase in anti-inflammatory media IL-10 was higher in experiment group than in the control group (d4-d1:(14.22±13.08) vs.(5.64±3.58) ng/L;d7-d1:(17.78±5.58) vs.(-37.96±11.43) ng/L;P＜0.05).The incidence of grade Ⅲ complications and total complications (4.7％ vs.21.4％,23.3％ vs.45.2％) and hospitalization time [(10.12 ±1.48) vs.(12.33±2.04) d] in the experimental group were significantly lower than those in the control group (P＜0.05).Conclusions In patients with liver cirrhosis and portal hypertension,perioperative nutritional support of fish oil fat emulsion can reduce systemic inflammatory response and operative complications and promote rapid recovery through its two-way regulation of inflammatory mediators.

Objective To evaluate the efficacy and safety of XELOX regimen combined with hepatic artery chemoembolization in the treatment of gastric cancer with liver metastasis.Methods 50 cases of gastric cancer with liver metastasis were randomly divided into two groups,the experimental group (25 cases) received chemotherapy regimen of XELOX first:Xeloda tablets 1 000 mg/m2,orally,twice a day,days1-14;Oxaliplatin 130 mg/m2,intravenous drip,day 1.Hepatic artery chemoembolization was performed one a week later,and a cycle consists of 4 weeks.The control group (25 cases) received chemotherapy regimen of XELOX,3 weeks as a cycle.All patients were evaluated for efficacy and toxicity every 2 cycles.Results In the experimental group,the overall response rate was 56％,the tumor control rate was 80％,the increase rate of Karnofsky was 60％,and 10 patients got chance of tumor resection.In the control group,the overall response rate was 32％,the tumor control rate was 52％,the increase rate of Karnofsky was 48％,and 6 patients got chance of operation.The overall response rate,tumor control rate,surgical treatment rate and the increase rate of Karnofsky in the experimental group were significantly different from those in the control group (P ＜0.05).The median total survival time was 12.5 months in the experimental group and 10.5 months in the control group (P ＜0.05).There was no significant difference in toxicity and side effects between the two groups.Conclusion XELOX regimen combined with hepatic artery chemoembolization is effective and safe in the treatment of gastric cancer with liver metastasis.

Since human society entered the 21st century, the rapid development of medical technology also gave birth to a series of negative effects:medical service technology first, trust crisis of the doctor-patient relation-ship, and medical industry money worship. Especially in recent years, due to the lack of humanistic spirit in medi-cal institutions, the doctor -patient relationship is of the worst state in the history. Therefore, it is urgent to strengthen the medical humanities education in the construction of hospital culture. Aiming at the problems existing in the current medical industry, this paper expounds the importance of strengthening the humanistic education in the construction of hospital culture.

Objective To investigate the pretreatment and post-treatment effect of reduced glutathione (GSH) on acute ischemia-reperfusion injury (IRI) of rat kidney. Methods Fifty adult SD rats were divided into 5 groups: control group (Sham group), ischemia reperfusion group (I/R group), GSH pretreatment group (pre-treatment group), and GSH post-processing group (post-treatment group), with ten rates in each group. Animals in pre-treatment group were injected 4% GSH 100 mg/kg intraperitoneally at 24th , 16th , 8th hour and 45th minute before surgery. Animals in post-treatment group were administrated GSH with the same dosage at 45th minute, 6th, 12th and 18th hour after surgery. Creatinine (Cr), urea nitrogen (BUN) level, the total superox-ide dismutase (T-SOD) activity, malondialdehyde (MDA) and nitric oxide (NO) levels in serum were measured at 24th hour after surgery. Histopathological changes were checked by H. E staining. Results Damage on kid-ney structure of animals in pre-treatment group was less than that in I/R group. There was little pathological change on kidney of those in pre-treatment group. Serum Cr, BUN, MDA and NO levels were all decreased but T-SOD activity increased in pre-treatment and post-treatment group when compared with those in I/R group (P <0.05), (P < 0.05). T - SOD activity in post-treatment group was higher than that in pre-treatment group (P <0.05). Conclusion GSH can protect rats against acute renal ischemia-reperfusion injury within 24 hours before and after kidney ischemia-reperfusion , especially after ischemia-reperfusion.