OBJECTIVES: To explore the value of serum cystatin C (CysC) levels in evaluating renal prognosis in IgA nephropathy (IgAN) patients. METHODS: We retrospectively collected the clinical data of IgAN patients diagnosed by renal biopsy at Guangdong Provincial People's Hospital from January, 2014 to December, 2018. Based on baseline serum CysC levels, the patients were divided into high serum CysC (>1.03 mg/L) group and normal serum CysC (≤1.03 mg/L) group. The composite endpoint for poor renal prognosis was defined as ≥50% decline in estimated glomerular filtration rate (eGFR) and/or progression to end-stage renal disease (ESRD). Lasso regression, multivariate Cox regression and Kaplan-Meier survival analysis were used to identify the risk factors and compare renal survival rates between the two groups. Smooth curves fitting and threshold effect analysis were used to explore the relationship between serum CysC levels and the outcomes. A nomogram model was constructed and its predictive performance was evaluated using concordance index, calibration curve, receiver operating characteristic (ROC) curve and the area under curve (AUC). RESULTS: A total of 356 IgAN patients were enrolled, who were followed up for 4.65±0.93 years. The composite endpoint occurred in 74 patients. High serum CysC was identified as an independent risk factor for poor renal prognosis in IgAN (HR=2.142, 95% CI 1.222 to 3.755), and the patients with high serum CysC levels had a lower renal survival rate (Log-rank χ²=47.970, P<0.001). In patients with serum CysC below 2.12 mg/L, a higher CysC level was associated with an increased risk of poor renal prognosis (β=3.487, 95% CI: 2.561-4.413, P<0.001), while above this level, the increase of the risk was not significant (β=0.676, 95% CI: -0.642-1.995, P=0.315). The nomogram model based on serum CysC and 3 other independent risk factors demonstrated good internal validity with a concordance index of 0.873 (95% CI: 0.839-0.907) and an AUC of 0.909 (95% CI: 0.873-0.945). CONCLUSIONS Serum CysC levels are associated with renal prognosis in IgAN patients, and high serum CysC an independent risk factor for poor renal prognosis.
Humans ; Glomerulonephritis, IGA/diagnosis* ; Cystatin C/blood* ; Prognosis ; Risk Factors ; Retrospective Studies ; Glomerular Filtration Rate ; Kidney Failure, Chronic ; Male ; Female ; Adult ; Nomograms ; Middle Aged

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.

Objective To adapt to the requirements of medical technology innovation under the new situation.To explore the establishment of a scientific,standardized,and reasonable management institution and system.It aims to actively promote the development of Investigator Initiate Trials(IITs)in medical and health institutions.Methods By conducting a literature review,policy interpretation,and examing work practices,this study identified the pain points and difficulties in IIT management.It sorted out the core requirements and elements needed for effective IIT management and proposed measures.Results The study proposed the development of five support systems for IIT management.A functional responsibility system for implementing classified and tiered management of IITs with clear delineation of responsibilities and authority;A quality supervision system that introduces a third-party co-management mechanism to fill the gaps of IIT quality management in the three-level quality control system;A fund support system that reduces or waives the hospital management fees for IITs,and incorporate the IIT undertaking into the annual evaluation metrics for optimized SMO;A collaborative innovation system that connect with external enterprises and coordinates internal departments to jointly promote the efficient operation of IITs;A risk early warning system that establishes IIT risk assessment criteria and conducts real-time dynamic supervision,strengthening IIT data management,and ensuring IIT data security.Conclusions Currently,IIT management generally lacks sufficient attention in China,and there is no complete framework or practice.By constructing the five IIT system construction scheme.It is conducive to optimizing the process,improving efficiency,ensuring quality and reducing risk,which has certain reference significance for the improvement and development of IIT management.

Objective To analyze the correlation between inflammation,nutritional indicators and hy-poproteinemia in patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Meth-ods The clinical data of patients with AECOPD admitted to the Department of Respiratory and Critical Care Medicine of the First Affiliated Hospital of Xiamen University from January 2020 to September 2022 were ret-rospectively analyzed,and the patients were divided into the hypoproteinemia group(n=73)and the non-hy-poproteinemia group(n=141)according to whether the serum albumin(ALB)was lower than 35 g/L.The clinical data,inflammatory indicators and nutritional indicators of the two groups were compared,Spearman correlation analysis was performed,and binary logistic regression analysis was performed to analyze the influ-encing factors of patients with AECOPD complicated with hypoproteinemia.Results There were statistically significant differences in age,length of hospital stay,and body weight between the two groups(P＜0.05).There were no significant differences in gender,number of hospitalizations in the past 1 year,height,diabetes,hypertension and proportion of coronary heart disease(P＞0.05).Compared with the non-hypoproteinemia group,the hypoproteinemia group had longer hospital stays and higher levels of C-reactive protein,neutrophil/albumin ratio(NAR),neutrophil to lymphocyte ratio(NLR),platelet-lymphocyte ratio(PLR),and systemic immunoinflammatory index(SII).The prognostic nutritional index(PNI),body mass index(BMI),hemoglo-bin and total protein levels were lower,and the difference was statistically significant(P＜0.05).Body weight,BMI,hemoglobin,total protein,PNI and AECOPD patients with hypoproteinemia were negatively cor-related(P＜0.05),while age,length of hospital stay,C-reactive protein,NAR,NLR,PLR,SII and AECOPD patients with hypoproteinemia were positively correlated(P＜0.05).Binary logistic regression analysis showed that PNI,SII and NLR were the influencing factors of hypoproteinemia in AECOPD patients.Conclusion In clinical practice,attention should be paid to and timely correction of hypoproteinemia in pa-tients with AECOPD,improvement of inflammatory indicators and nutritional status of patients,and preven-tion of acute exacerbation.

The paper reported a patient under maintained hemodialysis for 11 years, with a large mass appeared in the right thigh after local injury. The mass was clinically considered as tumoral calcinosis combined with clinical, imaging and pathological findings. Several treatments such as enhancing dialysis adequacy, low calcium dialysate, calcimimetic agent, non-calcium- phosphorus binding agents, parathyroidectomy and intravenous infusion of sodium thiosulfate could not vanish the mass. Finally, the lump was surgically removed. The treatment of tumoral calcinosis in the hemodialysis patient can provide a instruction for similar situations in clinical practice.

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.

From the perspective of medical institutions, this paper sorted out the contents of Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human regarding "exemption from ethical review". At the same time, combined with domestic and foreign regulations, this paper deeply considered and analyzed the applicable premise and special circumstances of the provisions from the implementation level, and then put forward suggestions from the perspective of practical operation of medical institutions, with a view to providing some practical guidance and reference for ethical practitioners of medical institutions.

From the perspective of medical institutions, this paper sorted out the background of the promulgation and important changes of Measures for Ethical Review of Life Science and Medical Research Involving Humans, and summarized the changes that may significantly affect the ethical review of medical institutions. It involved terminology changes and expansion of the scope of ethic review, clarification of the responsibilities and independence of the ethics committee, the refinement of the ethical review process, the emphasis on the protection of personal information and the rights and interests of subjects, and first proposal to exempt from ethical review. In addition, based on the concept of strengthening the ethical governance of science and technology in the new version of regulations, this paper shared the consideration on the governance of ethical review within medical institutions, including safeguarding the dignity and rights of subject, clarifying the role and position of ethical review, exempting the implementation of ethical review, and managing entrusted ethical review. With a view to providing a certain reference for the ethics practitioners and researchers in various medical institutions.

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.