1.Interpretation of Guidelines for Occupational Hazard Assessment and Control of Active Pharmaceutical Ingredient in the Pharmaceutical Industry (T/WSJD60—2024)
Ying TANG ; Jian CHEN ; Tao LI ; Huifang YAN ; Yongqing CHEN ; Yi XU ; Yong NING ; Man YU ; Chenyi TAO ; Xia ZHANG
Journal of Environmental and Occupational Medicine 2025;42(11):1381-1385
The Guidelines for Occupational Hazard Assessment and Control of Active Pharmaceutical Ingredient in the Pharmaceutical Industry (T/WSJD 60—2024) is the first guiding standard in the field of health in China that focuses on occupational health protection for active pharmaceutical ingredient (API). It covers the general principles, work procedures, assessment methods, and control strategies for API occupational hazard assessment, providing practical guidance and recommendations for pharmaceutical enterprises to eliminate or reduce occupational health risks associated with API, improve working environment, and enhance refined management practices. This article interpreted and analyzed the background of standard establishment, formulation process, fundamental basis, and main content, to provide scientific and comprehensive technical support for occupational health managers in the pharmaceutical industry to better apply this standard.
2.Expert consensus on prognostic evaluation of cochlear implantation in hereditary hearing loss.
Xinyu SHI ; Xianbao CAO ; Renjie CHAI ; Suijun CHEN ; Juan FENG ; Ningyu FENG ; Xia GAO ; Lulu GUO ; Yuhe LIU ; Ling LU ; Lingyun MEI ; Xiaoyun QIAN ; Dongdong REN ; Haibo SHI ; Duoduo TAO ; Qin WANG ; Zhaoyan WANG ; Shuo WANG ; Wei WANG ; Ming XIA ; Hao XIONG ; Baicheng XU ; Kai XU ; Lei XU ; Hua YANG ; Jun YANG ; Pingli YANG ; Wei YUAN ; Dingjun ZHA ; Chunming ZHANG ; Hongzheng ZHANG ; Juan ZHANG ; Tianhong ZHANG ; Wenqi ZUO ; Wenyan LI ; Yongyi YUAN ; Jie ZHANG ; Yu ZHAO ; Fang ZHENG ; Yu SUN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(9):798-808
Hearing loss is the most prevalent disabling disease. Cochlear implantation(CI) serves as the primary intervention for severe to profound hearing loss. This consensus systematically explores the value of genetic diagnosis in the pre-operative assessment and efficacy prognosis for CI. Drawing upon domestic and international research and clinical experience, it proposes an evidence-based medicine three-tiered prognostic classification system(Favorable, Marginal, Poor). The consensus focuses on common hereditary non-syndromic hearing loss(such as that caused by mutations in genes like GJB2, SLC26A4, OTOF, LOXHD1) and syndromic hereditary hearing loss(such as Jervell & Lange-Nielsen syndrome and Waardenburg syndrome), which are closely associated with congenital hearing loss, analyzing the impact of their pathological mechanisms on CI outcomes. The consensus provides recommendations based on multiple round of expert discussion and voting. It emphasizes that genetic diagnosis can optimize patient selection, predict prognosis, guide post-operative rehabilitation, offer stratified management strategies for patients with different genotypes, and advance the application of precision medicine in the field of CI.
Humans
;
Cochlear Implantation
;
Prognosis
;
Hearing Loss/surgery*
;
Consensus
;
Connexin 26
;
Mutation
;
Sulfate Transporters
;
Connexins/genetics*
3.Study on CD36 gene expression in megakaryocytic lineage derived from umbilical cord blood hematopoietic stem cells cultured in vitro
Fang XU ; Guangshu YU ; Xia LING ; Ji HE ; Xianguo XU
Chinese Journal of Blood Transfusion 2025;38(5):605-609
Objective: To elucidate the expression level and transcript structure of the CD36 gene in megakaryocytes cultured in vitro. Methods: Using umbilical cord blood CD34
hematopoietic stem cells as the starting point, megakaryocytic lineage cells were directionally cultured in vitro using different combinations of cytokines. Total cell RNA was extracted from cultures at 0 d, 7 d, and 12 d, and megakaryocyte RNA was extracted from CD41a-sorted cells after 14 d and 18 d of culture. RNA-NGS sequencing technology was used to analyze the RNA gene expression profiles across the five culture periods and further investigate CD36 gene expression. Results: The number of megakaryocytes generated in the TPO (100 ng/mL) group [(2.2±0.02)×10
/mL] was significantly higher than that in the other five groups. A total of 22 066 expressed genes were detected in the RNA of the five culture periods, and gene expression levels at each time point were correlated with the culture timeline. CD36 gene expression increased with culture time, with FPKM values for CD36 expression in the megakaryocytic lineage at 14 d and 18 d being 18.35 and 101.85, respectively, which were much lower than those for ITGA2B and ITGB3 genes but slightly higher than that for CD109 gene in the megakaryocytic lineage. The longest transcript of CD36 in the 18 d megakaryocytic lineage was 3.8 kb, encompassing all sequence of exons E3 to E14 and a partial sequence of E15. Conclusion: This is the first report on the expression level and transcript structure of the CD36 gene in megakaryocytes cultured in vitro, providing fundamental data for research on the expression and regulation of the CD36 gene in the megakaryocytic lineage.
4.Interpretation of the group standard of " Humanistic Caring Management Standards for Patients in the Operating Room"
Ruiying YU ; Xinyue MIAO ; Qingmin ZHANG ; Yilan LIU ; Shujie GUO ; Huiling LI ; Guo CHEN ; Chunlan ZHOU ; Ting LIU ; Shuhua DENG ; Hongzhen XIE ; Yu CHENG ; Yinglan LI ; Yanlan MA ; Xia XIN ; Yanjin LIU ; Yongyi CHEN ; Gendi LU ; Xiaoqin GAN ; Feng XU ; Zuwei XIA ; Li HE ; Qinqin CHEN ; Fukang ZHANG ; Songmei WU ; Yi LI ; Wenjuan ZHOU
Chinese Journal of Hospital Administration 2025;41(7):512-517
Humanistic caring for patients in the operating room refers to providing the whole process of caring medical services for patients in the operating room. In order to standardize humanistic caring services for patients in the operating room of medical institutions, improve the comprehensive service level of the operating room, and enhance the surgical experience of patients, the Chinese Association for Life Care released the group standard " Humanistic Caring Management Standards for Patients in the Operating Room" in December 2023. This article interpreted the basic requirements for humanistic caring of patients in the operating room, the environment and facilities for humanistic caring, the procedures and measures for humanistic caring, and the quality management framework, aiming to assist administrators and clinical practitioners across various levels of medical institutions in accurately understanding and effectively implementing the standard, and to provide essential textual reference and practical guidance for promoting the application of the standard.
5.Clinical characteristics and distribution and drug resistance of pathogenic bacteria in children with non-chronic osteomyelitis from a single center in Shanghai area between 2013 and 2023
Qiaoxin FANG ; Hui YU ; Yingzi YE ; Lijing YE ; Xia WU ; Jun XU ; Shuzhen HAN
Chinese Journal of Infectious Diseases 2025;43(1):7-13
Objective:To analyze the clinical characteristics, distribution of common pathogenic bacteria and drug resistance in children with non-chronic osteomyelitis, to provide a basis for empirical antimicrobial drug selection.Methods:This study was a retrospective analysis cohort study. Clinical data, pathogenic bacteria and drug sensitivity test results of 289 children aged 0 to 18 years with non-chronic osteomyelitis who were hospitalized in the Pediatrics Hospital of Fudan University from January 2013 to June 2023 were collected retrospectively. Statistical analyses were performed using chi-square test.Results:Of the 289 children, 188(65.1%) were male, with a male to female ratio of 1.86∶1, and the age was 3.00(0.66, 8.00) years. The age less than six years amounted 65.1% (188/289). The incidence was the highest from December to February of the following year, reaching 32.5%(94/289). The clinical manifestations were fever in 193 cases (66.8%), fever with localized pain in 47 cases (16.3%), and fever with localized swelling and fever with localized swelling and pain in 39 cases (13.5%) each. Single bone involvement was observed in 242(83.7%) cases, including 88(36.4%) femur, 47(19.4%) tibia, and 37(15.3%) humerus. Of the 130 pathogen-positive cases, 102(78.5%) were Staphylococcus aureus (SA) including 45(44.1%) methicillin-resistant Staphylococcus aureus (MRSA), 10(7.7%) were Pseudomonas aeruginosa, and 3(2.3%) each were Klebsiella pneumoniae and Staphylococcus mansoni. The rate of MRSA detection in SA fluctuated each year from 2013 to 2023, with the highest in 2017, when eight out of 13 SA cases were MRSA. The resistance rates of all SA to vancomycin, linezolid, moxifloxacin, ciprofloxacin, gentamicin, rifampicin, ceflorin, tigecycline, ticlosporin, fosfomycin, daptomycin, furotoxin, quinupristin/dalfopristin were all zero, and the differences in resistance rates of methicillin-susceptible Staphylococcus aureus (MSSA) and MRSA to cefazolin, cefuroxime, benzoxiline, ampicillin/sulbactam, and clindamycin were all statistically significant ( χ2=68.91, 68.91, 82.00, 68.91 and 9.20, respectively, all P<0.05). Intravenous anti-infective treatment was administered for 24(35, 47) days in 289 children with osteomyelitis, for a total duration of 42.00(35.00, 47.00) days. After treatment, 287 cases (99.3%) were discharged with improvement, while two cases (0.7%) died. One death was due to phagocytosis syndrome and septic shock, and the other death was due to septic shock and multiple organ dysfunction. Conclusions:Non-chronic osteomyelitis in children is most common in male children under six years old, and the most common sites are femur, tibia and humerus. The main clinical manifestations are fever, localized swelling and pain. SA was the most common causative agent. No SA strain resistant to vancomycin, linezolid, moxifloxacin, ciprofloxacin, gentamicin, rifampicin, ceflorin, tigecycline, ticlosporin, fosfomycin, daptomycin, furotoxin, quinupristin/dalfopristin is found.
6.Comparison of clinical manifestations,laboratory characteristics,and treatment outcomes of 258 patients with acute and chronic brucellosis
Xu ZHAO ; Ke-mei NIU ; Xia GAO ; Chun-xu SONG ; Yu FAN ; Qing-qing XU ; Zhong-rong LU ; Kun LI ; Feng GAO ; Mei-chun HAO ; Bing-zhi LIU ; Hai JIANG
Chinese Journal of Zoonoses 2025;41(6):660-667
To compare and analyze the clinical manifestations,laboratory characteristics,imaging findings,and treatment outcomes of patients with acute and chronic brucellosis,a retrospective analysis was conducted on 258 patients with brucellosis(202 in the acute group and 56 in the chronic group)hospitalized in Xinkang Hospital in Dalad Banner,Ordos City,Inner Mongolia Autonomous Region,from November 2023 to November 2024.General data,epidemiological characteristics,clinical presentations,laboratory test results,imaging findings,treatment outcomes,and prognosis were collected.The incidences of fever(51.5%vs 7.1%),fatigue(30.2%vs 12.5%),joint pain(42.9%vs 16.1%),and muscle pain(9.9%vs.1.8%)were significantly higher in the acute phase group(all P<0.05).The incidence of osteoarthritis complications was higher in the chronic brucellosis group(51.8%vs 8.9%,χ2=75.697,P<0.01).Univariate ANOVA analysisshowed that the Serum Agglutination Tests(SAT),alanine aminotransferase(ALT),aspartate aminotransferase(AST),total bilirubin(TBIL),creatinine(CRE),C-reactive protein(CRP),erythrocyte sedimentation rate(ESR),and bone destructionexhibited statistically significant differences between the acute and chronic phases of brucellosis(all P<0.05).Multivariate logistic regression analysis indicated that abnormal ALT(OR=14.18,95%CI:1.11-181.72;P=0.041)and bone destruction(OR=0.16,95%CI:0.04-0.63;P=0.009)were associated with chronic brucellosis.After treatment,all patients experienced have symptom relief in varying degrees,with 157 patients(60.9%)cured and 101 patients(39.1%)symptomatic improved(P<0.01).In conclusion,the incidences of fever,fatigue,and joint pain in patients during the acute phase is significantly higher than that those in patients during the chronic phase,while the incidence of osteoarthritis complications is higher in chronic phase patients.The incidences of abnormal SAT,ALT,AST,TBIL,CRE,CRP,and ESR,and bone destruction varies at different stages of brucellosis.Of those,abnormal ALT and bone destruction show a stronger association with,which can assist the clinical staging of brucellosis.
7.A prospective study of the effect of physical activity on mortality risk in patients with chronic obstructive pulmonary disease in Sichuan Province
Ying ZHANG ; Xiaofang CHEN ; Xiaofang CHEN ; Xia WU ; Xiaoyu CHANG ; Zhuo WANG ; Xu HAN ; Jun LYU ; Canqing YU ; Pei PEI ; Dianjianyi SUN ; Xianping WU
Chinese Journal of Epidemiology 2025;46(8):1347-1353
Objective:To investigate the effect of physical activity on mortality risk in patients with chronic obstructive pulmonary disease (COPD) in Sichuan Province.Methods:Based on baseline data from 2004 to 2008 from the China Kadoorie Biobank project site in Pengzhou City, Sichuan Province, a total of 8 501 COPD patients aged 30-79 years were enrolled and followed up for a long period to determine mortality outcomes. Quartiles were used to group physical activity levels. The Cox proportional hazards regression model was used to analyze the effect of physical activity level on mortality outcomes.Results:As of December 31, 2017, the cumulative follow-up of the participants totaled 85 600.58 person-years (mean follow-up duration: 10.07 years). During this period, a total of 2 000 deaths were recorded, yielding a cumulative mortality rate of 23.53%. Among these deaths, 665 were attributed to COPD, corresponding to a cumulative mortality rate of 7.82%; and 1 116 were attributed to cardiovascular and cerebrovascular disease (CVD), corresponding to a cumulative mortality rate of 13.13%. The Cox proportional hazards regression model analysis revealed that, after adjusting for confounding factors, total physical activity was associated with a reduced risk of mortality from COPD, CVD, and all causes in patients with COPD. Compared with the low-level group of total physical activity, the medium-high-level group had the lowest risk of COPD mortality, with an HR of 0.39 (95% CI: 0.30-0.49). The high-level group had the lowest risk of CVD death and all-cause death, with HRs of 0.46 (95% CI: 0.37-0.56) and 0.55 (95% CI: 0.48-0.64), respectively. The lowest risk of COPD death and CVD death was found in the medium-high level of work-based physical activity group, with HRs of 0.36 (95% CI: 0.28-0.46) and 0.43 (95% CI: 0.36-0.51), respectively; the risk of all-cause mortality was lowest in the medium-high and high-level groups, with HRs values of 0.53 (95% CI: 0.46-0.61) and 0.53 (95% CI: 0.45-0.61). The risk of COPD death was lowest in the high-level transportation physical activity group, with an HR of 0.66 (95% CI: 0.53-0.83), and the risk of CVD and all-cause death was lowest in the medium-high level group, with HRs of 0.63 (95% CI: 0.53-0.76) and 0.73 (95% CI: 0.64-0.84), respectively. The risk of COPD death and CVD death was the lowest in the high-level domestic physical activity group, with HRs of 0.66 (95% CI: 0.49-0.89) and 0.76 (95% CI: 0.61-0.95), respectively, and the risk of all-cause death was the lowest in the medium-high level group, with an HR of 0.82 (95% CI: 0.72-0.94). There is no statistical association between leisure physical activity and the risk of death from three types of diseases. Conclusions:Total physical activity, including work-based, transportation-based, and domestic physical activity, reduced the risk of COPD, CVD, and all-cause mortality in patients with COPD in Sichuan Province. The magnitude of mortality risk was influenced by the type and level of physical activity.
8.Feasibility and exploration of optimal communication models for robot-assisted urological telesurgery: a multicenter, single-arm, retrospective study
Ye WANG ; Taoping SHI ; Sheng TAI ; Sunyi YE ; Yubai ZHANG ; Bingzhang QIAO ; Chenfeng WANG ; Gen CHENG ; Zhi LI ; Qing AI ; Qingbo HUANG ; Baojun WANG ; Qing YUAN ; Junnan XU ; Guojun LIU ; Yu CHEN ; Wuyi ZHAO ; Jianle MAO ; Shiwei LI ; Shuo WANG ; Dan XIA ; Wanhai XU ; Chaozhao LIANG ; Hongzhao LI ; Xin MA ; Xu ZHANG
Chinese Journal of Urology 2025;46(5):331-336
Objective:To evaluate the efficacy and feasibility of a domestically developed robotic surgical system based on fiber-optic dedicated line communication in cross-regional urological telesurgery.Methods:This was multicenter,single-arm,retrospective case series study. The data of patients who underwent urological telesurgeries using the telesurgical system between January 2023 and December 2024 were analyzed. The cohort included 59 patients from seven hospitals across China. Among the patients,47 were male(79.7%)and 12 were female(20.3%),with a median age of 63.0(56.0,68.0)years and a body mass index of(24.7 ± 3.0)kg/m 2. Surgical procedures included 32 radical prostatectomies,24 partial nephrectomies,one radical nephrectomy,one adrenalectomy,and one ureteral reconstruction. The perioperative indicators,pathological results and postoperative complications were analyzed. The network monitoring data were collected,and the perioperative data of patients,remote system monitoring data and costs were compared between the two communication modes of optical transport network(OTN)and cloud-connect network(CCN). Results:All 59 remote surgeries were successfully completed,with a mean operative time of(138.0 ± 54.0)minutes,median intraoperative blood loss of 50.0(30.0,100.0)ml and a postoperative hospital stay of 5.0(4.0,6.0)days. No cases required reoperation,Clavien-Dindo grade ≥3 complications,or readmission. The geographical distance between the primary and remote surgical sites ranged from 450 to 2 800 km. Network monitoring revealed increased bidirectional latency with distance increasing:the shortest latency time(Hefei-Hangzhou,450 km)was(16.59 ± 0.80)ms,while the longest(Harbin-Hangzhou,2 200 km)latency time was(53.31 ± 0.31)ms. Average frame loss per procedure was 0?1.27 frames. The results of subgroup analysis comparing OTN and CCN communication modes showed no significant differences in operative time[(130.7 ± 70.5)minutes vs.(142.1 ± 42.9)minutes, P = 0.442],postoperative hospitalization[6.0(4.0,8.0)d vs. 5.0(4.0,6.0)d, P = 0.581],or readmission rates(0 vs. 0). However,CCN demonstrated significant cost advantages with 500 RMB per operation vs. 3 000 RMB per operation for OTN. Conclusions:Urological telesurgery using fiber-optic communication is feasible. The CCN mode,with its cost-effectiveness,excellent usability,and multi-point interconnection flexibility,is currently the preferred communication model for telesurgical applications.
9.Family socioeconomic status and children's reading fluency: the chain mediating role of family reading environment and children's living and learning styles.
Wen-Xin HU ; Lei ZHANG ; Cai WANG ; Zi-Yue WANG ; Jia-Min XU ; Jing-Yu WANG ; Jia ZHOU ; Wen-Min WANG ; Meng-Meng YAO ; Xia CHI
Chinese Journal of Contemporary Pediatrics 2025;27(4):451-457
OBJECTIVES:
To study the impact of family socioeconomic status on children's reading fluency and the chain mediation effect of family reading environment and children's living and learning styles in this relationship.
METHODS:
A total of 473 children from grades 2 to 6 in two primary schools in Nanjing were selected through stratified random sampling. The children's reading fluency was assessed, and a questionnaire was used to collect information on family socioeconomic status, family reading environment, and children's living and learning styles. The mediation model was established using the Process macro in SPSS, and the Bootstrap method was employed to test the significance of the mediation effects.
RESULTS:
Family socioeconomic status, family reading environment, and children's living and learning styles were significantly positively correlated with reading fluency (P<0.001). The family reading environment and children's living and learning styles mediated the relationship between family socioeconomic status and children's reading fluency. Specifically, the independent mediation effect of family reading environment accounted for 11.02% of the total effect, while the independent mediation effect of children's living and learning styles accounted for 10.79%. The chain mediation effect of family reading environment and children's living and learning styles accounted for 7.41% of the total effect.
CONCLUSIONS
Family socioeconomic status can affect children's reading fluency through three pathways: family reading environment, children's living and learning styles, and the chain mediation effect of family reading environment and children's living and learning styles.
Humans
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Child
;
Male
;
Female
;
Reading
;
Learning
;
Social Class
;
Family
10.Thiotepa-containing conditioning for allogeneic hematopoietic stem cell transplantation in children with inborn errors of immunity: a retrospective clinical analysis.
Xiao-Jun WU ; Xia-Wei HAN ; Kai-Mei WANG ; Shao-Fen LIN ; Li-Ping QUE ; Xin-Yu LI ; Dian-Dian LIU ; Jian-Pei FANG ; Ke HUANG ; Hong-Gui XU
Chinese Journal of Contemporary Pediatrics 2025;27(10):1240-1246
OBJECTIVES:
To evaluate the safety and efficacy of thiotepa (TT)-containing conditioning regimens for allogeneic hematopoietic stem cell transplantation (HSCT) in children with inborn errors of immunity (IEI).
METHODS:
Clinical data of 22 children with IEI who underwent HSCT were retrospectively reviewed. Survival after HSCT was estimated using the Kaplan-Meier method.
RESULTS:
Nine patients received a traditional conditioning regimen (fludarabine + busulfan + cyclophosphamide/etoposide) and underwent peripheral blood stem cell transplantation (PBSCT). Thirteen patients received a TT-containing modified conditioning regimen (TT + fludarabine + busulfan + cyclophosphamide), including seven PBSCT and six umbilical cord blood transplantation (UCBT) cases. Successful engraftment with complete donor chimerism was achieved in all patients. Acute graft-versus-host disease occurred in 12 patients (one with grade III and the remaining with grade I-II). Chronic graft-versus-host disease occurred in one patient. The incidence of EB viremia in UCBT patients was lower than that in PBSCT patients (P<0.05). Over a median follow-up of 36.0 months, one death occurred. The 3-year overall survival (OS) rate was 100% for the modified regimen and 88.9% ± 10.5% for the traditional regimen (P=0.229). When comparing transplantation types, the 3-year OS rates were 100% for UCBT and 93.8% ± 6.1% for PBSCT (P>0.05), and the 3-year event-free survival rates were 100% and 87.1% ± 8.6%, respectively (P>0.05).
CONCLUSIONS
TT-containing conditioning for allogeneic HSCT in children with IEI is safe and effective. Both UCBT and PBSCT may achieve high success rates.
Humans
;
Retrospective Studies
;
Transplantation Conditioning/methods*
;
Thiotepa/therapeutic use*
;
Hematopoietic Stem Cell Transplantation/adverse effects*
;
Male
;
Female
;
Child, Preschool
;
Infant
;
Child
;
Transplantation, Homologous
;
Graft vs Host Disease
;
Adolescent

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