1.Analysis of the dilemmas of the simplified ethical review procedure in practice
Benze HU ; Yuhong HUANG ; Xufang GU ; Weihua GUO ; Siyuan HU ; Yaqing YANG
Chinese Medical Ethics 2025;38(1):46-51
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.
2.Evaluation of colistin sulfate administration regimen based on PK/PD theory and Monte Carlo simulation
Yingchao MA ; Xia WU ; Yongjing WANG ; Jianjun GU ; Xiuling YANG
China Pharmacy 2025;36(4):459-463
OBJECTIVE To evaluate the therapeutic efficacy of 5 regimens of colistin sulfate for common Gram-negative bacilli infection based on pharmacokinetics (PK)/pharmacodynamics (PD) theory and Monte Carlo simulation. METHODS Minimal inhibitory concentration (MIC) data of colistin sulfate against Acinetobacter baumannii, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and Enterobacter cloacae in 2023 were collected from the China Antimicrobial Resistance Surveillance System. Monte Carlo simulation was conducted with the ratio of the area under the concentration-time curve from 0 to 24 hours in the unbound state to the MIC (fAUC0-24 h/MIC) ≥15 as the target value, the probabilities of target attainment (PTA) of 5 regimens of colistin sulfate to achieve the target ratio were obtained at different MIC; and the expected population PTA, specifically the cumulative fraction of response (CFR), for each regimen within a specific bacterial population was further calculated, to evaluate the therapeutic efficacy of the five colistin sulfate regimens. RESULTS When bacterial MIC≤0.5 µg/mL, PTA of all colistin sulfate regimens (500 000 IU, q12 h; 500 000 IU, q8 h; 750 000 IU, q12 h; 750 000 IU, q8 h; 1 000 000 IU, q12 h) were all more than 90%. When bacterial MIC=1 µg/mL, PTA for regimen (750 000 IU, q8 h) against A. baumannii, K. pneumoniae, P. aeruginosa, E. coli and E. cloacae, and for regimen (1 000 000 IU, q12 h) against the other four bacterial species (excluding P. aeruginosa) remained above 90%. When bacterial MIC≥2 µg/mL, PTA of 5 colistin sulfate regimens were all lower than 90%. For E. coli, the CFR of only colistin sulfate regimen (500 000 IU, q12 h) was less than 90%; for K. pneumoniae, the CFR of only colistin sulfate regimen (750 000 IU, q8 h and 1 000 000 IU, q12 h) was greater than 90%; for the other three bacteria, CFR of 5 regimens were all less than 90%. CONCLUSIONS When the MIC of Gram-negative bacteria is less than 0.5 µg/mL, colistin sulfate regimen with a routine dose can be selected for treatment. When MIC was 1 µg/mL, an increase in the dosing amount or frequency is required. The empirical treatment of the other four bacterial infections excluding E. coli requires the use of off-label doses.
3.Impact factor selection for non-fatal occupational injuries among manufacturing workers by LASSO regression
Yingheng XIAO ; Chunhua LU ; Juan QIAN ; Ying CHEN ; Yishuo GU ; Zeyun YANG ; Daozheng DING ; Liping LI ; Xiaojun ZHU
Journal of Environmental and Occupational Medicine 2025;42(2):133-139
Background As a pillar industry in China, the manufacturing sector has a high incidence of non-fatal occupational injuries. The factors influencing non-fatal occupational injuries in this industry are closely related at various levels, including individual, equipment, environment, and management, making the analysis of these influencing factors complex. Objective To identify influencing factors of non-fatal occupational injuries among manufacturing workers, providing a basis for targeted interventions and surveillance. Methods A total of
4.Distribution characteristics of self-reported diseases and occupational injuries among workers in manufacturing enterprises
Lin ZHANG ; Zhi’an LI ; Yishuo GU ; Juan QIAN ; Chunhua LU ; Jianjian QIAO ; Yong QIAN ; Zeyun YANG ; Xiaojun ZHU
Journal of Environmental and Occupational Medicine 2025;42(2):165-170
Background Diseases severely affect the efficiency of workers. Comorbidity refers to the coexistence of two or more chronic diseases or health problems in the same individual. Previous studies have primarily focused on occupational injuries caused by environmental exposures, while the analysis of the epidemiological characteristics of self-reported diseases and occupational injuries among manufacturing workers has been insufficient. Objective To analyze the distribution of self-reported diseases and occupational injuries among manufacturing workers, the strength of correlation between different diseases, and common disease combinations, and to preliminarily explore the relationship between self-reported diseases and occupational injuries. Methods A cross-sectional survey was conducted to investigate the occupational injuries of
5.Molecular characterization of Cronobacter sakazakii in patients with diarrhea in a hospital in Changping District, Beijing, 2019
Yang ZHANG ; Dongxun LI ; Weijun WANG ; Huancai NIU ; Tian GU ; Gaolin SHU
Shanghai Journal of Preventive Medicine 2025;37(1):29-33
ObjectiveTo understand the current status of Cronobacter sakazakii (Cronobacter spp.) infection and its molecular epidemiological characteristics among patients with diarrhea, so as to provide evidence for the prevention and control of diarrhea disease caused by infection with Cronobacter spp. in Changping District, Beijing. Methods760 stool samples were collected from the diarrhea patients in a sentinel hospital in 2019, for the detection of Cronobacter spp., Salmonella, diarrheogenic Escherichia coli (DEC), and Vibrio Parahaemolyticus. Meanwhile, drug sensitivity experiment and pulsed-field gel electrophoresis (PFGE) typing analysis were conducted on the Cronobacter spp. strains isolated. ResultsA total of 20 Cronobacter spp. strains (2.63%) were isolated, with a lower detection rate than that of Salmonella and Vibrio Parahaemolyticus (χ2=9.052, P=0.011). However, there were no statistically significant differences between the detection rates in Cronobacter spp. and DEC (χ2=1.076, P=0.300). Seasonal characterization analysis showed that Cronobacter spp. could be detected in spring (1.00%), summer (4.17%), autumn (3.00%) and winter (1.67%), and the differences were statistically significant (χ2=662.700, P<0.001). The PFGE analysis showed that 20 PFGE banding patterns were found in 20 Cronobacter spp. strains, with a similarity coefficient ranging from 56.30% to 90.09% and a diverse PFGE banding pattern. The drug sensitivity experiment results showed that 18 (90.00%) strains were resistant to cefazolin, and2 (10.00%) strains were intermediate. While, as for cefoxitin, 2 (10.00%) strains were resistant to it, and 5 (25.00%) strains were intermediate. All the 20 strains were 100.00% sensitive to the other 11 antibiotics. ConclusionIn the study, Cronobacter spp. is detected in all seasons through the year, with a high resistance rate to cefazolin, no multi-drug resistant bacteria appeared, and diverse PFGE banding patterns.
6.Efficacy and safety of endoscopic retrograde cholangiopancreatography combined with oral cholangiopancreatography in the treatment of duodenal papilla cholecystectomy
Liying TAO ; Hongguang WANG ; Qingmei GUO ; Xiang GUO ; Lianyu PIAO ; Muyu YANG ; Yong YU ; Libin RUAN ; Jianbin GU ; Si CHEN ; Yingting DU ; Xiuying GAI ; Sijie GUO
Journal of Clinical Hepatology 2025;41(3):513-517
ObjectiveTo investigate the feasibility and safety of endoscopic retrograde cholangiopancreatography (ERCP) combined with oral cholangiopancreatography in the treatment of major duodenal papilla gallbladder polyps. MethodsA retrospective analysis was performed for the clinical data of eight patients with choledocholithiasis and gallbladder polyps who underwent ERCP and combined with oral cholangiopancreatography for major duodenal papilla cholecystectomy in Center of Digestive Endoscopy, Jilin People’s Hospital, from May 2022 to June 2024, and related data were collected, including the success rate of surgery, the technical success rate of gallbladder polyp removal, the superselective method of cystic duct, the time of operation, the time of gallbladder polyp removal, and surgical complications. ResultsBoth the success rate of surgery and the technical success rate of gallbladder polyp removal reached 100%, and of all eight patients, three patients used guide wire to enter the gallbladder under direct view, while five patients received oral cholangiopancreatography to directly enter the gallbladder. The time of operation was 51.88±12.34 minutes, and the time of gallbladder polyp removal was 23.13±10.94 minutes. The diameter of gallbladder polyp was 2 — 8 mm, and pathological examination showed inflammatory polyps in three patients, adenomatous polyps in one patient, and cholesterol polyps in four patients. There were no complications during or after surgery. The patients were followed up for 2 — 27 months after surgery, and no recurrence of gallbladder polyp was observed. ConclusionOral cholangiopancreatography is technically safe and feasible in endoscopic major duodenal papilla cholecystectomy.
7.Introduction and enlightenment of the Recommendations and Expert Consensus for Plasm a and Platelet Transfusion Practice in Critically ill Children: from the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB)
Lu LU ; Jiaohui ZENG ; Hao TANG ; Lan GU ; Junhua ZHANG ; Zhi LIN ; Dan WANG ; Mingyi ZHAO ; Minghua YANG ; Rong HUANG ; Rong GUI
Chinese Journal of Blood Transfusion 2025;38(4):585-594
To guide transfusion practice in critically ill children who often need plasma and platelet transfusions, the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB) developed Recommendations and Expert Consensus for Plasma and Platelet Transfusion Practice in Critically Ill Children. This guideline addresses 53 recommendations related to plasma and platelet transfusion in critically ill children with 8 kinds of diseases, laboratory testing, selection/treatment of plasma and platelet components, and research priorities. This paper introduces the specific methods and results of the recommendation formation of the guideline.
8.Predictive value of NLR,PLR,LMR and PNI for clinical efficacy and prognosis of combined targeted therapy and immunotherapy for advanced HCC
LIU Quanyi1 ; YANG Yixin1 ; XU Lei2 ; GU Yun1 ; SHEN Lei3
Chinese Journal of Cancer Biotherapy 2025;32(3):309-315
[摘 要] 目的:探究中性粒细胞/淋巴细胞比值(NLR)、血小板/淋巴细胞比值(PLR)、淋巴细胞/单核细胞比值(LMR)及预后营养指数(PNI)对免疫检查点抑制剂(ICI)联合抗血管生成药物治疗晚期肝细胞癌(HCC)患者疗效及预后的预测价值。方法:收集2020年1月至2023年12月间在大理大学第一附属医院收治的使用ICI联合抗血管生成药物治疗的85例晚期HCC患者的一般临床资料、治疗前患者的NLR、PLR、LMR、PNI、临床疗效及预后。采用受试者工作特征(ROC)曲线计算NLR、PLR、LMR、PNI的最佳截断值,以此将患者分成高、低2组。使用Kaplan-Meier法绘制生存曲线,采用Cox比例风险回归模型进行单因素、多因素分析各指标对患者OS的影响。结果:低NLR组、低PLR组、高LMR组、高PNI组患者治疗有效率均分别高于高NLR组、高PLR组、低LMR组和低PNI组(均P < 0.05)。低NLR组、低PLR组患者OS率均分别显著高于高NLR组、高PLR组(均P < 0.05);高LMR组、高PNI组患者OS率均分别显著高于低LMR组和低PNI组(均P < 0.05)。NLR ≥ 1.94、男性、乙型肝炎病毒感染是晚期HCC患者预后的独立危险因素(均P < 0.05)。结论: NLR ≥ 1.94、男性、乙型肝炎病毒阳性是影响患者疗效、预后的危险因素,NLR ≥ 1.94评估晚期HCC患者免疫联合靶向的疗效及预后有一定的临床价值。
9.Expression of KCNN4 in pancreatic cancer tissues, its correlation with prognosis, and impact on pancreatic cancer cell proliferation
YANG Xuan ; CHEN Xinyuan ; RUAN Xiaoyu ; WU Qingru ; GU Yan
Chinese Journal of Cancer Biotherapy 2025;32(4):371-377
[摘 要] 目的:探究钾钙激活通道亚家族N成员4(KCNN4)在胰腺癌组织中的表达及其对胰腺癌进展的影响,解析KCNN4在胰腺癌临床诊断及预后判断中的作用。方法:利用GEPIA2数据分析平台,结合TCGA和GTEx数据库的数据分析KCNN4在胰腺癌组织中的表达水平及其与患者预后的关系。收集24例海军军医大学长海医院手术切除的胰腺癌患者的癌及癌旁组织标本,通过qPCR、WB法和免疫组化染色技术验证KCNN4在胰腺癌组织中的表达水平。利用shRNA敲低人胰腺癌细胞中BXPC3和PANC-1中KCNN4的表达,通过CCK-8和克隆形成实验检测细胞增殖与生长情况。利用小鼠胰腺癌KPC细胞构建胰腺癌原位成瘤模型,观察敲低KCNN4对胰腺原位成瘤的影响,统计小鼠生存期(OS)。结果:整合TCGA和GTEx数据库数据分析结果发现,KCNN4在胰腺癌组织中高表达(P < 0.05),且与患者OS和DFS缩短相关(均P < 0.05)。胰腺癌组织中KCNN4 mRNA和蛋白表达量均显著高于癌旁组织(均P < 0.01)。KCNN4敲低后,胰腺癌细胞生长速率显著减慢、克隆形成数量显著减少(均P < 0.01)。小鼠胰腺原位荷瘤实验结果表明,KCNN4敲低可抑制肿瘤细胞在胰腺原位的生长并延长小鼠OS。结论:KCNN4在胰腺癌组织中高表达,其能促进胰腺癌细胞增殖和胰腺癌进展,与患者预后密切相关,有望作为胰腺癌临床诊断及预后评估的靶点。
10.Correlation among picky eating levels in preschool children, parenting self-efficacy and parenting stress
YANG Jing, LIU Qian, YIN Xia, GU Ling, ZHU Jie
Chinese Journal of School Health 2025;46(5):681-684
Objective:
To explore the correlation among picky eating levels in preschool children, parental self-efficacy and parenting stress.
Methods:
A convenience sampling method was employed to conduct an electronic questionnaire survey among 459 children aged 3-6 years and their parents from five kindergartens in Urumqi in November 2023. The survey included a general information questionnaire, the Children s Eating Behavior Questionnaire (CEBQ), the Parenting Sense of Competence Scale (PSOC), and the Parenting Stress Index-Short Form (PSI-SF). The Mann-Whitney U-test was used for twogroup comparisons, and the Kruskal-Wallis H-test was applied for multi-group comparisons. Spearman correlation analysis was conducted to examine the relationships between children s picky eating levels and parenting selfefficacy as well as parenting stress.
Results:
The picky eating score of preschool children was 10.00 (4.00), and the parenting self-efficacy score was 58.00 (12.00), both indicating a moderate level. The parenting stress score was 75.00 (16.00), reflecting a moderately low level. Spearman correlation analysis showed that children s picky eating levels were negatively correlated with the total score of parenting self-efficacy ( r =-0.28) and positively correlated with the total score of parenting stress( r =0.25)( P <0.01).
Conclusions
Picky eating levels of preschool children are closely associated with parenting self-efficacy and parenting stress. Picky eating behaviors in children can be reduced by implementing various effective measures to enhance parenting self-efficacy and alleviate parenting stress.


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