The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.

The Chinese Pharmacopoeia 2025 Edition is about to be officially released.Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission,has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ.General chapter 0237,integrating the cutting-edge concepts from WHO's related guidelines and the practical experience of biological reference standards both domestically,has revised the names of this chapter,updated and improved the technical requirements for candidate reference materials,collabo-rative calibration and value assignment,as well as stability research and monitoring.It also newly proposes the cal-culation of uncertainty of biological reference materials and emphasizes to pay attention to commutability.The im-plementation of general chapter 0237 will play a guiding role in improving the research and application level of bio-logical reference materials in China.This article,by interpreting the revised content of general chapter 0237,aims to provide a reference for the researchers of biological reference materials.

OBJECTIVE To explore the risk factors for central line-associated bloodstream infection(CLABSI)in the maintenance hemodialysis(MHD)patients based on the informatization surveillance system and establish and verify the risk prediction model so as to provide bases for early identification and prevention of CLABSI.METHODS A total of 300 MHD patients who were treated in hemodialysis center of the Affiliated Hospital of Xuzhou Medical University from Jan.2020 to Dec.2023 were recruited as the research subjects and were randomly divided into the training set group with 210 cases and the validation set group with 90 cases in a 7∶3 ratio.The risk factors for the CLABSI were analyzed,the prediction model was established and verified.The performance of the model was evaluated by the area under the curve(AUC)of receiver operating characteristic(ROC)curves and Hosmer-Lemeshow goodness of fit test.RESULTS Among the 300 MHD patients who were treated with central venous catheters,32 were diagnosed with CLABSI,and the incidence was 0.65 per 1,000 catheter days.Multivari-ate analysis showed that catheter indwelling time,repeated catheterization,previous history of catheter-related in-fection and diabetes mellitus were the risk factors for the CLABSI in the MHD patients(P＜0.05).The model based on the logistic regression equation was established as follows:logit(P)=-5.661+0.024 × catheter in-dwelling duration(week)+2.037 × repeated catheterization+1.546 × previous history of catheter-related infec-tion+3.391× diabetes mellitus.ROC curve analysis showed that the AUC of the training set was 0.916(95％CI:0.837 to 0.994),with the sensitivity 87.00％,the specificity 86.63％,Youden index 0.736;the AUC of the vali-dation set was 0.797(95％CI:0.632 to 0.962),with the sensitivity 77.78％,the specificity 82.72％,the Youden index 0.605.The model showed excellent discrimination and calibration degree.CONCLUSION The logistic regres-sion equation that is established based on the 4 risk factors,catheter indwelling duration,repeated catheterization,previous history of catheter-related infection and diabetes mellitus,shows remarkable predictive efficiency,and it can provide evidence for clinical screening and prevention of CLABSI.

Objective To construct a knowledge graph of healthcare-associated infection(HAI)prevention and control course,and evaluate its usability.Methods Based on the constructivist learning theory and the analyze-de-sign-develop-implement-evaluate(ADDIE)model,knowledge from various sources such as books,guidelines,and literature related to HAI prevention and control were integrated.The knowledge graph of HAI prevention and con-trol course were designed and constructed with the support of knowledge graph technology in Chaoxing Fanya plat-form.Thirty medical students were selected by convenience sampling method to try out the course knowledge graph.System usability scale and usage effect questionnaire were filled out to evaluate the usability of the knowledge graph.Results The knowledge graph of HAI prevention and control course contained 379 knowledge points asso-ciated with 520 test questions and 56 learning resources.After testing,the total score([70.50±12.20]points)was obtained for the usability of the knowledge graph.Among the four dimensions of the usage effect agreement ques-tionnaire,satisfaction,learning attitude,learning ability,and learning resource support accounted for 93.33％-96.67％,90.00％,93.33％-96.67％,and 83.33％-90.00％,respectively,with a high overall satisfaction rate.Conclusion The knowledge graph of HAI prevention and control course has good usability,which can realize students'personalized independent learning and improve their learning efficiency.

Objective To construct a clinical-radiological nomo-gram model for severe mycoplasma pneumoniae pneumonia coinfec-tion with other pathogens(Co-SMPP)in children.Methods The clinical and radiological data of children with severe mycoplasma pneumoniae pneumonia(SMPP)who underwent nucleic acid testing or bronchoalveolar lavage(BAL)were analyzed retrospectively.The data analysis were performed by using SPSS 27.0 software.The group comparison between simple SMPP and Co-SMPP children was conducted by using t-tests,Mann-Whitney U tests,or chi-square tests.Nomogram analysis was performed by using R software and rms packages.The predictive performance of the model was evaluated by using the receiver operating characteristic(ROC)curve.Results A total of 194 SMPP children were included in the study,including 136 cases(70.1％)with simple SMPP,58 cases(29.9％)with Co-SMPP.The fibrinogen and albumin levels were lower in Co-SMPP children[(3.53±0.85)g/L,41.00(39.03,43.68)g/L]than in simple SMPP children[(3.79±0.80)g/L,42.80(41.00,44.40)g/L],with P values of 0.047 and 0.036,respec-tively.The probability of bronchial stenosis and grid shadow were higher in Co-SMPP children than in simple SMPP children,and there were significant differences between the two groups(P＜0.001,P=0.010).The odds ratio of bronchial stenosis in predicting Co-SMPP children was 14.085.The clinical-radiological nomogram model had an area under the curve(AUC)of 0.840,with sensi-tivity and specificity of 0.756 and 0.848,respectively.Conclusion The nomogram model based on clinical-radiological features can effectively predict Co-SMPP.

Objective To explore the current situation of healthcare-associated infection(HAI)in patients in emergency rescue room and observation room,and analyze the causes.Methods Targeted surveillance was per-formed on patients in emergency rescue room and observation room of a tertiary first-class hospital in Xuzhou City from January 1 to December 31,2023 using prospective survey method.HAI,antimicrobial use,as well as invasive procedures and related infection rates were analyzed.Results The incidence of HAI in 540 patients was 0.19％(n=1),and the daily incidence of HAI was 0.54‰(1/1 841).The utilization rates of invasive ventilators,central ve-nous catheters,and indwelling urinary catheters were 6.79％(125/1 841),1.09％(20/1 841),and 2.93％(54/1 841),respectively.The incidences of ventilator-associated pneumonia,central line-associated bloodstream infec-tion,and catheter-associated urinary tract infection were 8.00‰(1/125),0(0/20),and 0(0/54),respectively.Pathogen detection rate before antimicrobial treatment was 99.22％(382/385).Conclusion The incidence of HAI in patients in emergency rescue room and observation room is low,the retention time of patients in rescue room is short,and pathogen detection of specimens before antimicrobial treatment is high.Patients in emergency rescue room and observation room are at high risk of HAI.It is necessary to carry out targeted surveillance on HAI to re-duce its incidence.

Objective To understand the application of healthcare-associated infection(HAI)quality control indi-cators and current status of HAI management in primary medical institutions in Jiangsu Province,and provide refe-rence and basis for primary medical institutions to improve HAI management quality and for health administrative departments to formulate HAI management relevant policies.Methods Data on HAI quality control indicators co-llected by Jiangsu Provincial Primary Healthcare Professional Quality Control Center from the first batch of 62 pri-mary sentinel medical institutions in the province were analyzed.Results of on-site inspections and assessments of 20 institutions were summarized and analyzed.Results From July 2023 to May 2024,a total of 145 814 inpatients were monitored,219 patients had 220 episodes of HAI.The incidence and case incidence of HAI were both 0.15％,and the main HAI site was upper respiratory tract(40.45％).The compliance rate and correct rate of hand hygiene were 81.34％(14.29％-100％)and 87.90％(18.46％-100％),respectively.The removal rate of surface pollu-tant from environmental objects was 77.24％(20.00％-100％),and the qualified rate of cleaning of device,appli-ances,and articles was 98.76％(10.00％-100％).The monitoring data records of quality control indicators in most primary healthcare institutions during on-site inspections didn't match the monthly data reported to the Jiangsu Provincial Primary Healthcare Professional Quality Control Center.Most healthcare workers in primary healthcare institutions lacked sufficient awareness and knowledge in infection prevention and control.Multiple HAI-related safety hazards existed in key departments of most primary medical institutions.Conclusion After nearly a year of continuous monitoring on HAI,the primary sentinel medical institutions have established their own data on the inci-dence of HAI.The compliance rate and correct rate of hand hygiene,as well as the removal rate of surface pollu-tants from environmental objects are still relatively low in some medical medical institutions,and there is much room for improvement.There is still a significant gap in terms of HAI prevention and control in some primary medical in-stitutions when referring to the standards.

Objective:To explore the clinical features and risk factors for pediatric severe Mycoplasma pneumoniae pneumonia (SMPP) complicated with pulmonary embolism. Methods:SMPP patients admitted to Department of Pediatrics, Jiaxing First Hospital and Pediatric Intensive Care Unit, Shanghai Children′s Hospital from December 2019 to December 2023 were included in this retrospective case-control study.According to whether they were complicated with pulmonary embolism, SMPP patients were divided into a pulmonary embolism group and a non-pulmonary embolism group.Clinical characteristics of the two groups, including general data, laboratory examination and imaging data were compared and analyzed.The t-test and Mann-Whitney rank-sum test were used to compare the measurement data, and the χ2 test was used to compare the count data.The risk factors of SMPP patients developing pulmonary embolism were analyzed by the univariate method. Results:There were 10 out of 62 SMPP children developing pulmonary embolism, showing an incidence of 16.13%.In the pulmonary embolism group, there were 5 boys and 5 girls, with a median age of 7.50 (5.75, 9.25) years.There were 52 children in the non-pulmonary embolism group, including 29 boys and 23 girls, with a median age of 6.50(5.00, 8.00)years.The hospitalization time, body temperature, total white blood cell count, neutrophil count, C-reactive protein levels, lactate dehydrogenase levels, prothrombin time, activated partial thromboplastin time, D-dimer (D-D) levels, fibrinogen degradation product levels, pleural effusion and atelectasis rates in the pulmonary embolism group were significantly higher than those in the non-pulmonary embolism group (all P<0.05). Fibrinogen levels in the pulmonary embolism group were significantly lower than those in the non-pulmonary embolism group ( P<0.05). Univariate Logistic regression analysis showed that the D-D level was a risk factor for SMPP patient developing pulmonary embolism.The receiver operating characteristic curve analysis revealed that the D-D level had the largest area under the curve for predicting pulmonary embolism of 0.990(95% CI: 0.972-1.000, P<0.001), with a sensitivity of 100%, a specificity of 92%, and a cut-off value of 4.63 mg/L. Conclusions:SMPP children complicated with pulmonary embolism are prone to high inflammation and impaired coagulation function.The increase of D-D levels is a risk factor for the development of pulmonary embolism in SMPP.

Objective To construct a knowledge graph of healthcare-associated infection(HAI)prevention and control course,and evaluate its usability.Methods Based on the constructivist learning theory and the analyze-de-sign-develop-implement-evaluate(ADDIE)model,knowledge from various sources such as books,guidelines,and literature related to HAI prevention and control were integrated.The knowledge graph of HAI prevention and con-trol course were designed and constructed with the support of knowledge graph technology in Chaoxing Fanya plat-form.Thirty medical students were selected by convenience sampling method to try out the course knowledge graph.System usability scale and usage effect questionnaire were filled out to evaluate the usability of the knowledge graph.Results The knowledge graph of HAI prevention and control course contained 379 knowledge points asso-ciated with 520 test questions and 56 learning resources.After testing,the total score([70.50±12.20]points)was obtained for the usability of the knowledge graph.Among the four dimensions of the usage effect agreement ques-tionnaire,satisfaction,learning attitude,learning ability,and learning resource support accounted for 93.33％-96.67％,90.00％,93.33％-96.67％,and 83.33％-90.00％,respectively,with a high overall satisfaction rate.Conclusion The knowledge graph of HAI prevention and control course has good usability,which can realize students'personalized independent learning and improve their learning efficiency.

Objective To explore the current situation of healthcare-associated infection(HAI)in patients in emergency rescue room and observation room,and analyze the causes.Methods Targeted surveillance was per-formed on patients in emergency rescue room and observation room of a tertiary first-class hospital in Xuzhou City from January 1 to December 31,2023 using prospective survey method.HAI,antimicrobial use,as well as invasive procedures and related infection rates were analyzed.Results The incidence of HAI in 540 patients was 0.19％(n=1),and the daily incidence of HAI was 0.54‰(1/1 841).The utilization rates of invasive ventilators,central ve-nous catheters,and indwelling urinary catheters were 6.79％(125/1 841),1.09％(20/1 841),and 2.93％(54/1 841),respectively.The incidences of ventilator-associated pneumonia,central line-associated bloodstream infec-tion,and catheter-associated urinary tract infection were 8.00‰(1/125),0(0/20),and 0(0/54),respectively.Pathogen detection rate before antimicrobial treatment was 99.22％(382/385).Conclusion The incidence of HAI in patients in emergency rescue room and observation room is low,the retention time of patients in rescue room is short,and pathogen detection of specimens before antimicrobial treatment is high.Patients in emergency rescue room and observation room are at high risk of HAI.It is necessary to carry out targeted surveillance on HAI to re-duce its incidence.