In September 2023， the Measures for Scientific and Technological Ethics Review （Trial Implementation） was issued， revising the provisions related to the simplified procedure for ethical review in Chapter 3， Section 3. This revision of these provisions provides systematic guarantees for further optimizing ethical review work， ensuring that ethical review procedure is well-regulated， and improving scientific research efficiency. The “simplified procedure” does not mean reducing the quality and requirements of the review. Instead， based on always following internationally recognized ethical standards and emphasizing not violating national laws and regulations， improving the efficiency of ethical review and subsequent research work， and promoting the development of life sciences and medical research involving humans. In practical work， it introduces numerous new opportunities and challenges for the improvement of ethics review ability， such as new tests on the judgment and decision-making power of ethics committees， how to ensure the reliability and controllability of the conditions related to the simplified review procedure， and how to determine the basic conditions for adopting the simplified review procedure for review. Therefore， to actively respond to the challenges and possible risks brought by the simplified procedure review， efforts should be made to achieve three “unifications”， including the unification of researchers’ moral autonomy and the heteronomy of supervision implemented by relevant departments； the unification of the standard formulation of the simplified procedure review and the review work in practice； and the unification of ethical responsibility and legal responsibility.

Objective:To explore the current situation and influencing factors of quality of life of septic patients in intensive care unit (ICU) after discharge, and to provide theoretical basis for clinical early psychological intervention and continuity of care.Methods:A prospective observational study was conducted. The septic patients who were hospitalized in the department of critical care medicine of the Affiliated Hospital of Jining Medical University and discharged with improvement from January 1 to December 31, 2022 were selected as the research objects. The demographic information, basic diseases, infection site, vital signs at ICU admission, severity scores of the condition within 24 hours after ICU admission, various biochemical indexes, treatment process, and prognostic indexes of all the patients were recorded. All patients were assessed by questionnaire at 3 months of discharge using the 36-item short-form health survey scale (SF-36 scale), the activities of daily living scale (ADL scale), and the Montreal cognitive assessment scale (MoCA scale). Multiple linear regression was used to analyze the factors influencing the quality of life of septic patients after discharge from the hospital.Results:A total of 200 septic patients were discharged with improvement and followed up at 3 months of discharge, of which 150 completed the questionnaire. Of the 150 patients, 57 had sepsis and 93 had septic shock. The total SF-36 scale score of septic patients at 3 months of discharge was 81.4±23.0, and the scores of dimensions were, in descending order, role-emotional (83.4±23.0), mental health (82.9±23.6), bodily pain (82.8±23.3), vitality (81.6±23.2), physical function (81.4±23.5), general health (81.1±23.3), role-physical (79.5±27.0), and social function (78.8±25.2). There was no statistically significant difference in the total SF-36 scale score between the patients with sepsis and septic shock (82.6±22.0 vs. 80.7±23.6, P > 0.05). Incorporating the statistically significant indicators from linear univariate analysis into multiple linear regression analysis, and the results showed that the factors influencing the quality of life of septic patients at 3 months after discharge included ADL scale score at 3 months after discharge [ β= 0.741, 95% confidence interval (95% CI) was 0.606 to 0.791, P < 0.001], length of ICU stay ( β= -0.209, 95% CI was -0.733 to -0.208, P = 0.001), duration of mechanical ventilation ( β= 0.147, 95% CI was 0.122 to 0.978, P = 0.012), total dosage of norepinephrine ( β= -0.111, 95% CI was -0.044 to -0.002, P = 0.028), mean arterial pressure (MAP) at ICU admission ( β= -0.102, 95% CI was -0.203 to -0.007, P = 0.036) and body weight ( β= 0.097, 95% CI was 0.005 to 0.345, P = 0.044). Conclusions:The quality of life of patients with sepsis at 3 months after discharge is at a moderately high level. The influencing factors of the quality of life of patients with sepsis at 3 months after discharge include the ADL scale score at 3 months after discharge, the length of ICU stay, the duration of mechanical ventilation, the total dosage of norepinephrine, MAP at ICU admission and body weight, and healthcare professionals should enhance the treatment and care of the patients during their hospitalization based on the above influencing factors, and pay attention to early psychological intervention and continued care for such patients.

Objective To investigate the impact of SARS-CoV-2 infection on male semen quality through meta-analysis and retrospec-tive study.Methods Literature retrieval was conducted in PubMed,CNKI,Wanfang Database and CBM database.Meta-analysis was performed using Stata 15.0.The male patients meeting the inclusion criteria from our hospital were enrolled as study subjects.General demographic data and semen parameters were collected.Single factor analysis of variance and graphing of semen parameters were con-ducted using GraphPad Prism 9.5.1.The test level was set at 0.05.Results A total of 9 studies involving 267 patients were included in the meta-analysis.There were no significant differences in sperm concentration and survival rate before and after SARS-CoV-2 infec-tion(P＞0.05).Semen volume and percentage of normal morphology significantly increased during 1-3 months after infection(P=0.005,P=0.010),with semen volume recovering to pre-infection level＞3 months later(P＞0.05).Sperm motility and progressive mo-tility increased＞3 months after infection(P=0.046,P=0.045),recovering to pre-infection levels(P=0.099,P=0.098).Sperm DNA fragmentation index may be temporarily elevated within 3 months after infection but gradually decreased＞3 months later.In the retrospective study of 8 cases,there were no statistical differences in semen parameters at different stages compared with pre-infection(P＞0.05),but semen parameters showed a negative trend during＜1 month after infection and recovered to pre-infection levels＞3 months later.Conclusion The results of this laboratory study are basically consistent with the meta-analysis.SARS-CoV-2 infection in males only caused short-term negative effects on sperm morphology,vitality and DNA integrity,but generally recovered to pre-infection levels＞3 months after infection.Due to the limitations of study subjects and sample size,the impact of SARS-CoV-2 infection on male semen quality needs to be further confirmed by long-term large-scale prospective studies.

Objective To investigate the genetic characteristics and recombination of human-infected sapoviruses(SaVs)worldwide using bioinformatics.Methods The complete genome sequences of SaVs were downloaded from the National Center for Biotechnology Information(NCBI)while high-quality complete genomes were retained for analysis.Molecular phylogenetic trees of SaVs were constructed to analyze their genetic characteristics,followed by recombination analysis of human-infected SaV strains genetype Ⅰ,Ⅱ,Ⅳ,and V(G Ⅰ,G Ⅱ,GⅣ,and GⅤ)with recombination analysis software.Results SaVs exhibited substantial genetic diversity worldwide and infected a wide range of hosts.Human-associated SaVs included G Ⅰ,G Ⅱ,GⅣ,and GⅤ,with GⅤ shared between human and swine hosts.Genetype recombination analysis of SaVs revealed a high frequency of recombination in SaV G Ⅱ strains that involved diverse hosts in the field of SaV G V strains.Recombination breakpoints of the virus were concentrated in the major viral proteins 1(VP1)and minor viral proteins 2(VP2).Conclusion Based on systematic analysis of the genetic characteristics of human-infected SaVs,the genotype distribution and prevalence of SaVs are investigated,the recombination patterns of SaV revealed,and its genetic dynamics highlighted.These findings can offer insights into epidemiological trends of viruses and help devise effective prevention and control strategies.

BACKGROUND: Immunotherapies such as adoptive immune cell infusion and immune-modulating agents are widely used for cancer treatment, and the concomitant symptoms, including cytokine release syndrome (CRS) or immune-related adverse events (irAEs), are frequently reported. However, clinical manifestations induced by mismatched donor granulocyte colony-stimulating factor mobilized peripheral blood mononuclear cell (GPBMC) infusion in patients receiving microtransplant (MST) have not yet been well depicted. METHODS: We analyzed 88 cycles of mismatched GPBMC infusion in patients with acute myeloid leukemia receiving MST and 54 cycles of chemotherapy without GPBMC infusion as a comparison. Clinical symptoms and their correlation with clinical features, laboratory findings, and clinical response were explored. RESULTS: Fever (58.0% [51/88]) and chills (43.2% [38/88]) were the significant early-onset symptoms after GPBMC infusion. Patients possessing less human leukocyte antigen-matching loci with the donor or those with unrelated donors experienced more chills (3 [2-5] loci vs. 5 [3-5] loci, P  = 0.043 and 66.7% [12/18] vs. 37.1% [26/70], P  = 0.024). On the other hand, those with decreased CD4 + /CD8 + T-cell ratio developed more fever (0.8 [0.7-1.2] vs. 1.4 [1.1-2.2], P  = 0.007). Multivariable analysis demonstrated that younger patients experienced more fever (odds ratio [OR] = 0.963, 95% confidence interval [CI]: 0.932-0.995, P  = 0.022), while patients with younger donors experienced more chills (OR = 0.915, 95% CI: 0.859-0.975, P  = 0.006). Elevated ultra-sensitive C-reactive protein levels in the absence of cytokine storm were observed following GPBMC infusion, which indicated mild and transient inflammatory response. Although no predictive value of infusion-related syndrome to leukemia burden change was found, the proportion of host pre-treatment activated T cells was positively correlated with leukemia control. CONCLUSIONS Mismatched GPBMC infusion in MST induced unique infusion-related symptoms and laboratory changes, which were associated with donor- or recipient-derived risk factors, with less safety and tolerance concerns than reported CRS or irAEs.
Humans ; Leukocytes, Mononuclear ; Hematopoietic Stem Cell Transplantation/adverse effects* ; Leukemia, Myeloid, Acute/therapy* ; Unrelated Donors ; Granulocyte Colony-Stimulating Factor ; Graft vs Host Disease

Objective:To construct the competence evaluation index system for disaster medical emergency rescue medical and nursing staff in northwest Sichuan, so as to provide reference for the establishment of high-quality, high-combat effectiveness and well-trained disaster medical emergency rescue team that conformed to the characteristics of disaster in northwest Sichuan.Methods:From February 2021 to January 2022, the competence evaluation index system for disaster medical emergency rescue personnel in northwest Sichuan was initially developed by means of literature analysis, semi-structured interview and expert consultation. Delphi method was used to conduct two rounds of consultation for 15 experts to verify the evaluation index system. Analytic hierarchy process and average distribution method of expert importance assignment were used to analyze the weight of each index.Results:In the two rounds of consultation, the positive coefficient of experts was 100.0% (15/15) , the authority coefficient of experts was 0.86 and 0.89, the coefficient of variation was 0.19 and 0.18, and the Kendall coordination coefficient was 0.223 and 0.525 respectively. The competence evaluation index system for disaster medical emergency rescue personnel in northwest Sichuan consisted of 4 first-level indicators, 14 second-level indicators and 79 third-level indicators.Conclusions:The competence evaluation index system constructed by Delphi method has high reliability, which provides a basis for the selection, training and assessment of emergency rescue personnel, and is of great significance for improving the emergency rescue capability of disaster medicine in northwest Sichuan.

Objective: To investigate the prevalence of anemia among students aged 6-15 years old participated in the Nutrition Improvement Program for Rural Compulsory Education Program in 2012-2021 in Hunan Province, and to explore associated factors. Methods: A cluster random sampling method was used. The survey was conducted among compulsory education students who came from counties in Hunan Province where nutrition improvement plan and key surveillance were carried out. Height and weight were measured, hemoglobin, dietary habits and health knowledge were collected. Results: Since the implementation of nutrition improvement plan in 2012, the anemia rate decreased from 12.8% to 9.3%, the average hemoglobin content decreased from 133.9 g/L to 130.0 g/L. The proportion of students eating meat every day increased from 20.4% to 47.3%. Students eating three or more servings of table tennis ball size of meal increased from 21.4% to 47.3%. The proportion of students eating more than three kinds of vegetables per day was 39.1% in 2016 and 32.6% in 2019, and less than 30% in other years. The proportion of students eating three or more servings of table tennis ball size of vegetables increased from 19.5% to 39.6%, and the proportion of students eating snack less than once a day increased from 13.1% to 76.9%. The proportion of students drinking beverages less than once a day increased from 36.5% to 90.7%. Girls, older than 12 years, not eating meat every day, and who eat less than 1 serving of table tennis ball size of meat, eat less than 3 servings of table tennis ball size of vegetables and fruit at one time, and who eat less than 3 kinds of vegetables every day, and those who grow slowly had higher risk of anemia. Potential factors of anemia in students varied by survey year. Conclusion The implementation of the compulsory education has improved the nutritional status of compulsory education students in rural areas of Hunan Province, but anemia still occurs. Potential factors associated with childhood anemia are changing. Child health literacy education should adapt to the changing social and economic enviornment, as well as lifestyles. Targeted and appropriate nutritional education and intervention are greatly needed.

Traditional Chinese Medicine (TCM) products could be registered as natural health products (NHPs) in Canada. Its registration process could be mainly divided into simple-application, traditional-application and non-traditional application. By analyzingi the TCM registration evidence system and its safety, effectiveness and quality required by different registration categories in Canada, we found that "simple-application" procesure needs to submit evidence based on the parameters of a component in the monograph. As for "traditional application", TCM products need to be used at least 50 years with, traditional material or Pharmacopoeia can be used as evidence; As for non-traditional application, TCM products need to provide evidence according to the disease risk level, and most of them need to provide scientific experiment evidence. Therefore, from the experience of TCM registration evidence system in Canada, the registration of TCM products should pay attention to improve the its classification method, refining its evidence requirements and data types, promoting the formulation of monograph of TCM, realizing the scientific evaluation and rapid review of classic famous prescriptions, and promoting the inheritance and innovative development of TCM in China.

Objective:To explore the value of lactic acid (Lac), procalcitonin (PCT), sequential organ failure assessment (SOFA) score and acute physiology and chronic health evaluationⅡ (APACHEⅡ) score in assessing the severity and predicting the prognosis in sepsis shock.Methods:A retrospectively study was conducted. Patients with septic shock hospitalized in the department of critical care medicine of the Affiliated Hospital of Jining Medical University from April 2015 to June 2019 were enrrolled. The patient's gender, age, body mass index (BMI), infection site, organ dysfunction status; Lac, PCT, C-reactive protein (CRP), heart rate and body temperature immediately after admission to the intensive care unit (ICU); APACHEⅡ and SOFA scores within 24 hours, and 28-day prognosis were collected. According to the 28-day prognosis, the patients with septic shock were divided into the survival group and the death group, and the differences in the indicators between the groups were compared. Multivariate Logistic regression analysis was used to screen the risk factors of 28-day death in patients with septic shock; receiver operating characteristic curve (ROC curve) was used to analyze the value of Lac, PCT, SOFA, APACHEⅡ, and age in predicting the 28-day prognosis of patients with septic shock.Results:A total of 303 septic shock patients were enrolled, of which 124 cases survived and 179 died on the 28th day, and the 28-day mortality was 59.08%. ① Compared with the survival group, patients in the death group were older (years old: 66.58±15.22 vs. 61.15±15.68), APACHEⅡ, SOFA, proportion of lung infections, Lac increased [APACHEⅡ score: 22.79±7.62 vs. 17.98±6.88, SOFA score: 9.42±3.51 vs. 5.65±1.59, proportion of lung infections: 53.63% (96/179) vs. 39.52% (49/124), Lac (mmol/L): 5.10±3.72 vs. 3.71±2.56], oxygenation index (PaO 2/FiO 2) and ICU body temperature decreased [PaO 2/FiO 2 (mmHg, 1 mmHg = 0.133 kPa): 198.94±80.15 vs. 220.68±72.06, ICU body temperature (℃): 37.47±1.08 vs. 37.80±1.14], and the differences were statistically significant (all P < 0.05).②Multivariate Logistic regression analysis results: after adjusted for potential confounding factors, APACHEⅡ, PCT, Lac, age and SOFA were independent risk factors for death in patients with septic shock [APACHEⅡ: odds ratio ( OR) =1.05, 95% confidence interval (95% CI) was 1.01-1.10, P = 0.039; PCT: OR = 0.99, 95% CI was 0.98-1.00, P =0.012; Lac: OR = 1.23, 95% CI was 1.08-1.40, P = 0.002; age: OR = 1.03, 95% CI was 1.01-1.05, P =0.009; SOFA score: OR =1.88, 95% CI was 1.59-2.22, P < 0.001]. ③ROC curve analysis showed that APACHEⅡ, Lac, age and SOFA could predict the prognosis of patients with septic shock [APACHEⅡ: the area under the ROC curve (AUC) = 0.682 4, 95% CI was 0.621 7-0.743 1, P = 0.000; when the best cut-off value was 18.500, its sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio were 72.63%, 54.84%, 69.89%, 58.12%, 1.608 1 and 0.499 2, respectively. Lac: AUC = 0.604 5, 95% CI was 0.540 8-0.668 2, P = 0.002; when the best cut-off value was 3.550 mmol/L, the sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio were 50.84%, 73.39%, 73.39%, 50.94%, 1.910 3 and 0.669 9, respectively. Age: AUC = 0.599 1, 95% CI was 0.535 4-0.662 7, P = 0.003; when the best cut-off value was 72.500 years old, the sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio were 42.46%, 75.00%, 71.03%, 47.45%, 1.698 3 and 0.767 2, respectively. SOFA: AUC =0.822 3, 95% CI was 0.776 7-0.867 9, P = 0.000; when the best cut-off value was 7.500, its sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio were 68.72%, 87.90%, 89.13%, 66.06%, 5.680 4, 0.355 9 respectively]. The combined prediction had a good sensitivity (72.63%) and specificity (84.86%), and AUC (0.876 5) was higher than that of a single variable, suggested that the multivariate combination was more accurate in predicting the short-term outcome of septic shock. Conclusion:Lac, PCT, SOFA score, APACHEⅡ score and age were independent risk factors for death in patients with septic shock, and the accuracy of Lac, SOFA score, APACHEⅡ score and age in predicting short-term prognosis of septic shock was better than that of single variable, and the diagnostic value was higher.

Objective To study the seropositive ratio of the antibody to aquporin 4 (AQP4-IgG) and myelin oligodendrocytes glycoprotein antibody(MOG-IgG)in patients with autoimmune-associated central nervous system (CNS) diseases. Meanwhile, epidemiology and clinical manifestation and diagnosis,laboratory examination and magnetic resonance imaging(MRI)of AQP4-IgG seropositive and MOG-IgG seropositive patients are described. Methods 2068 patients serum samples were collected and enrolled in the multi-center research. The methodology of cell-mediated immunofluorescence staining was used to detect serum AQP4-IgG and MOG-IgG. Clinic medical records were collected and characteristics of epidemiology and manifestation were compared. Results 681 patients were AQP4-IgG seropositive and 110 patients were MOG-IgG seropositive. The female/male ratio and age of onset of patients with AQP4-IgG seropositive(616 female and 65 male,female:male=9.50:1.00;Age of onset=41.7±14.9)were significantly higher than that of patients with MOG-IgG (57 female and 53 male, female:male=1.08:1.00, P<0.0001; Age of onset=27.0 ±17.7, P<0.0001). The optic neuritis was significantly higher in patients with AQP4-IgG seropositive and patients with MOG-IgG seropositive (38.4% vs.53.5%, P<0.05).Among patients with AQP4-IgG seropositive, 42.14% conformed the diagnostic criteria of neuromyelitis optica (NMO),which was higher than that of patients with MOG-IgG seropositive (13.64%, P<0.0001). Laboratory examination showed that there was no significant difference in cerebrospinal fluid protein levels between patients with AQP4-IgG seropositive and those with MOG-IgG seropositive.MRI imaging suggested that AQP4-IgG positive patients were more common in cervical thoracic spinal cord lesions, while MOG-IgG positive patients were more involved in thoracolumbar spinal cord. The study also found that these two groups of patients could be comorbid with other autoimmune antibodies. Conclusions This multi-center research has revealed that patients with AQP4-IgG seropositive and those with MOG-IgG seropositive display differences in epidemiology,clinic manifestations and diagnosis,laboratory examination and MRI imaging. AQP4-IgG and MOG IgG auto-antibody detection are necessary for clinic diagnosis and differential diagnosis.