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 analyze the distribution and drug resistance of pathogens of bacterial bloodstream infection in patients with hematological diseases in the Department of Hematology of Tianjin Medical University General Hospital, and to provide etiological data for clinical empirical anti-infection treatment.Methods:A retrospective analysis was conducted on the general clinical information, pathogenic bacteria and drug susceptibility test results of patients with hematological diseases diagnosed with bacterial bloodstream infection by menstrual blood culture in our center from January 2016 to December 2022.Results:Patients included 498 inpatients, with a total of 639 bacterial strains. Among the patients, 86.9% patients had malignancies, and 76.7% had agranulocytosis. Symptoms of concurrent infections, including those of the respiratory tract, oral mucosa, skin and soft tissues, and abdominal sources were observed in 68.3% patients. Gram-negative bacteria (G -) accounted for 79.0% of the isolated bacteria, and gram-positive bacteria (G +) accounted for 21.0%. The top five isolated pathogens were Klebsiella pneumoniae (22.5%), Escherichia coli (20.8%), Pseudomonas aeruginosa (15.0%), Enterococcus faecium (5.5%), and Stenotrophomonas maltophilum (5.0%). Escherichia coli exhibited a decreasing trend of resistance to quinolones, cephalosporins, and carbapenems. Klebsiella pneumoniae exhibited increasing rates of resistance to quinolones and cephalosporins between 2016 and 2018, but the rated decreased after 2019. The resistance rate to carbapenems exhibited by Pseudomonas aeruginosa was approximately 20%. Carbapenem-resistant strains of Pseudomonas aeruginosa strains were first detected in 2017, with a peak resistance rate of 35.7%, detected in 2019. A 60.0% resistance rate to methicillin was observed in methicillin-resistant coagulase-negative staphylococci (MRCNS), and one case of linezolid-resistant MRCNS was detected. Conclusions:Pathogenic bacteria of bacterial bloodstream infections were widely distributed in our center, and precautions are warranted against carbapenem resistant P. aeruginosa and Klebsiella pneumoniae.

AIM:To compare the recovery of psy-chomotor function after intravenous anesthesia with remazolam or propofol compound alfentanil in patients undergoing painless gastrointestinal en-doscopy.METHODS:78 patients undergoing pain-less gastrointestinal endoscopy were randomly di-vided into group RA and group PA.Remiazolam or propofol combined with alfentanil were given intra-venously in group RA or group PA.The blood pres-sure,heart rate,respiratory rate and saturation of puls oxygen were recorded before procdure(T1),during checking(T2),awaking from anaesthesia(T3)and at discharging from PACU(T4).Psychomo-tor function,as measured by the Trieger's dot test(TDT)and digit symbol substitution test(DSST),were evaluated before anesthesia(T1),at discharg-ing from PACU(T4),1 h(T5)and 2 h(T6)after checking.RESULTS:From assessment of the TDT,number of dots missed(NDM),maximum distance of dots missed(MDDM)and average distance of dots missed(ADDM)at T4,T5 were significantly lower than those at T1 in two groups.The comple-tion rates and accuracy rates of DSST at T4,T5 were significantly lower than those at T1.Results of TDT and DSST at T6 were not significantly differ-ent to those at T1.The results of NDT,MDDM and ADDM at T4,T5 in group RA were significantly low-er than those in group PA.The completion rates and accuracy rates of DSST at T4,T5 in group RA increased significantly compared with group PA.Compared to group PA,the incidence of hypoten-sion was significantly lower in group RA.There was no significant difference in the incidence of respira-tory depression between the two groups.CONCLU-SION:Psychomotor function was fully recovered 2 h after surgery when remazolam compound alfent-anil was used for painless gastrointestinal endosco-py.Compared with propofol,psychomotor function recovery in the remazolam group was faster and there were fewer adverse effects after surgery in group RA.

Background/Aims: Low educational attainment is a well-established risk factor for nonalcoholic fatty liver disease (NAFLD) in developed areas. However, the association between educational attainment and the risk of NAFLD is less clear in China. Methods: A cross-sectional study including over 200,000 Chinese adults across mainland China was conducted. Information on education level and lifestyle factors were obtained through standard questionnaires, while NAFLD and advanced fibrosis were diagnosed using validated formulas. Outcomes included the risk of NAFLD in the general population and high probability of fibrosis among patients with NAFLD. Logistic regression analysis was employed to estimate the risk of NAFLD and fibrosis across education levels. A causal mediation model was used to explore the potential mediators. Results: Comparing with those receiving primary school education, the multi-adjusted odds ratios (95% confidence intervals) for NAFLD were 1.28 (1.16 to 1.41) for men and 0.94 (0.89 to 0.99) for women with college education after accounting for body mass index. When considering waist circumference, the odds ratios (95% CIs) were 0.94 (0.86 to 1.04) for men and 0.88 (0.80 to 0.97) for women, respectively. The proportions mediated by general and central obesity were 51.00% and 68.04% for men, while for women the proportions were 48.58% and 32.58%, respectively. Furthermore, NAFLD patients with lower educational attainment showed an incremental increased risk of advanced fibrosis in both genders. Conclusions In China, a low education level was associated with a higher risk of prevalent NAFLD in women, as well as high probability of fibrosis in both genders.

ObjectiveTo construct rehabilitation competency framework (RCF) of the speciality of education and rehabilitation (SER-RCF) based on World Health Organization RCF, to innovate the curriculum system. MethodsThe competency for undergraduate level professionals in the speciality of education and rehabilitation were analyzed to develop curriculum using RCF theory and methodology. ResultsTalent training was a kind of competency-based and outcome-based education. SER-RCF integrated the competencies and activities in the areas of professionalism, practice, learning and development, management and leadership, and research required for professional work in education and rehabilitation around core values and beliefs. It also designed the training objectives of the speciality of education and rehabilitation: to be ethical and correct, to be physically and mentally healthy, to have a solid foundation, to be sustainable, to be co-operative and enjoyable, and to be reflective and enquiring. SER-RCF played a central role in developing the curriculum system of rehabilitation, education and psychology, and practice. ConclusionReshaping the undergraduate level curriculum system of education and rehabilitation based on RCF is not only the implementation of the construction concept of new medicine and new liberal arts, but also can effectively connect with the international standard of rehabilitation higher education.

OBJECTIVE: To analyze the early effectiveness of unilateral biportal endoscopy (UBE) laminectomy in the treatment of two-level lumbar spinal stenosis (LSS). METHODS: The clinical data of 98 patients with two-level LSS treated with UBE between September 2020 and December 2021 were retrospectively analyzed. There were 53 males and 45 females with an average age of 59.9 years (range, 32-79 years). Among them, there were 56 cases of mixed spinal stenosis, 23 cases of central spinal canal stenosis, and 19 cases of nerve root canal stenosis. The duration of symptoms was 1.5- 10 years, with an average of 5.4 years. The operative segments were L _{2, 3} and L _{3, 4} in 2 cases, L _{3, 4} and L _{4, 5} in 29 cases, L _{4, 5} and L _5, S ₁ in 67 cases. All patients had different degrees of low back pain, among of which 76 cases were with unilateral lower extremity symptoms and 22 cases were with bilateral lower extremity symptoms. There were 29 cases of bilateral decompression in both segments, 63 cases of unilateral decompression in both segments, and 6 cases of unilateral decompression and bilateral decompression of each segment. The operation time, intraoperative blood loss, total incision length, hospitalization stay, ambulation time, and related complications were recorded. Visual analogue scale (VAS) score was used to assess the low back and leg pain before operation and at 3 days, 3 months after operation, and at last follow-up. The Oswestry disability index (ODI) was used to evaluate the functional recovery of lumbar spine before operation and at 3 months and last follow-up after operation. Modified MacNab criteria was used to evaluate clinical outcomes at last follow-up. Imaging examinations were performed before and after operation to measure the preservation rate of articular process, modified Pfirrmann scale, disc height (DH), lumbar lordosis angle (LLA), and cross-sectional area of the canal (CAC), and the CAC improvement rate was calculated. RESULTS: All patients underwent surgery successfully. The operation time was (106.7±25.1) minutes, the intraoperative blood loss was (67.7±14.2) mL, and the total incision length was (3.2±0.4) cm. The hospitalization stay was 8 (7, 9) days, and the ambulation time was 3 (3, 4) days. All the wounds healed by first intention. Dural tear occurred in 1 case during operation, and mild headache occurred in 1 case after operation. All patients were followed up 13-28 months with an average of 19.3 months, and there was no recurrence or reoperation during the follow-up. At last follow-up, the preservation rate of articular process was 84.7%±7.3%. The modified Pfirrmann scale and DH were significantly different from those before operation ( P<0.05), while the LLA was not significantly different from that before operation ( P=0.050). The CAC significantly improved ( P<0.05), and the CAC improvement rate was 108.1%±17.8%. The VAS scores of low back pain and leg pain and ODI at each time point after operation significantly improved when compared with those before operation, and the differences between each time points were significant ( P<0.05). According to the modified MacNab criteria, 63 cases were excellent, 25 cases were good, and 10 cases were fair, with an excellent and good rate of 89.8%. CONCLUSION UBE laminectomy is a safe and effective technique with little trauma and fast recovery for two-level LSS and the early effectiveness is satisfactory.
Male ; Female ; Humans ; Middle Aged ; Laminectomy ; Spinal Stenosis/surgery* ; Constriction, Pathologic/surgery* ; Low Back Pain ; Retrospective Studies ; Blood Loss, Surgical ; Endoscopy ; Lumbar Vertebrae/surgery* ; Spinal Fusion/methods* ; Decompression, Surgical ; Surgical Wound/surgery* ; Treatment Outcome

Objective:To compare results of four glycosylated hemoglobin A1c (HbA1c) detection methods and to evaluate the uncertainty of HbA1C results in clinical laboratory, and to provide method for clinical laboratory on the evaluation of uncertainty.Methods:According to the four uncertainty evaluation methods, which were recommended by "CNAS-TRL-001, the evaluation and expression of measurement uncertainty in medical laboratory", the relative and absolute uncertainty of low, medium and high HbA1c in 33 clinical laboratories measured in 2019 and 35 clinical laboratories measured in 2020 was evaluated by more than 6 months of internal quality control (IQC) data, trueness verification and external quality assessment (EQA) data. The four uncertainty evaluation methods were: IQC data and trueness verification data (method 1), only trueness verification data (method 2), IQC and EQA data (method 3) and only EQA data (method 4). The related statistical methods used in this analysis were Friedman and Wilcoxon signed rank test.Results:For method 1, the median range of relative and absolute uncertainty of low, medium and high HbA1c detection in 2019 and 2020 ranged from 4.21% to 9.24% and from 0.27% to 0.64%, respectively. Compared to method 1, the relative and absolute uncertainties obtained by method 2 were smaller, and the differences were statistically significant ( P<0.016 7, P<0.05). Compared to method 1, the relative uncertainties obtained by method 3 and method 4 were smaller, except for the high concentration of HbA1c level in 2020. Among the 6 pairs of comparisons (low, medium and high HbA1c in 2019 and 2020), there were 3 pairs (high HbA1c in 2019, low and medium HbA1c in 2020) and 2 pairs (low and high HbA1c in 2020) of differences with statistical significance (all P<0.016 7). Conclusion:The uncertainty evaluation of HbA1c detection in clinical laboratory should be evaluated based on IQC and trueness verification data.

Objective To investigate visual impairment students' quality of life and its influencing factors in Braille learning class at Quanzhou Special School. Methods November, 2020, 52 students (aged seven to 26) with the best corrected distance visual acuity of the better eye above 0.02 were investigated with near visual acuity, contrast sensitivity and Chinese-version Low Vision Quality of Life Questionnaire (CLVQOL). The subjects were divided into second grade blindness group, first grade low vision group and second grade low vision group according to the best corrected distance visual acuity of the better eye. Results There were significant differences in distance visual acuity (Z = 45.671, P < 0.001), near visual acuity (Z = 24.972, P < 0.001), and contrast sensitivity (CS) ( Z = 13.285, P = 0.001) among three groups. There was a correlation between near visual acuity and distance visual acuity (r = 0.74, P < 0.001), CS to distance visual acuity (r = -0.58, P < 0.001) and near visual acuity (r = -0.57, P < 0.001), score of CLVQOL and CS (r = 0.44, P < 0.001). There were significant differences in the total score (Z = 10.145, P = 0.006), distance visual acuity subscale (Z = 13.586, P = 0.001), psychological adjustment subscale (Z = 7.824, P = 0.020), reading and fine work subscale (Z = 7.923, P = 0.019) of CLVQOL among the three groups. Conclusion Quality of life is different with the visual impairment for students in special school, especially the distance visual acuity, psychological adjustment and fine reading. CS correlates to the quality of life of visually impaired students, which needs to be a part of evaluation of visual function.

Bacillus spp. are probiotics and can secrete a variety of natural antimicrobiol active substances, of which lipopeptides are an important class. Up to now, about 90 lipopeptides have been identified, and most of them are cyclic lipopeptides. surfactin, iturin, fengycin, bacillomycin and polymyxins are widely studied, and the first three have huge potential for application due to their properties of surfactants and anti-fungal, anti-bacterial, anti-viral, anti-tumor and anti-inflammatory functions. In this paper, the research progress in the structure, function, synthesis regulation, separation, purification and production of surfactin, iturin and fengycin was reviewed. Synthetic biology is a vital means to increase the yield of lipopeptides, and in the future, lipopeptides can be used in crop cultivation, animal farming, food, medicine and petroleum industries as well as environmental protection. Future research should be strengthened on the discovery of new lipopeptides, synthesis of high-activity lipopeptides, economical production of lipopeptides on a large scale and their safety evaluation.
Anti-Bacterial Agents ; Anti-Infective Agents/pharmacology* ; Bacillus ; Bacillus subtilis ; Lipopeptides/pharmacology* ; Peptides, Cyclic/pharmacology*