Objective:To explore the interaction of IL-2,IL-6 factors and intestinal flora disorder in patients with rheumatoid arthritis complicated with interstitial lung disease(RA-ILD).Methods:A total of 100 RA patients diagnosed at Shijiazhuang People's Hospital from June 2021 to June 2022 were enrolled and divided into the RA-ILD group(with ILD,n=27)and RA-noILD group(with-out ILD,n=73)according to the results of pulmonary CT and clinical manifestations.Fecal samples were collected from all partici-pants,and intestinal flora levels were cultured and analyzed.Bacterial DNA was extracted from fecal samples,and the 16S rDNA gene was amplified by PCR to generate DGGE profiles of gut microbiota.The Shannon-Wiener index,evenness,and richness of intestinal bacteria were calculated.Cluster analysis was performed to compare structural differences in gut microbiota between the groups.Demo-graphic characteristics,clinical symptoms,laboratory parameters,and intestinal flora-related indicators were compared between the groups.Multivariate Logistic regression analysis was conducted to identify independent risk factors for ILD development in RA pa-tients.Spearman correlation analysis was used to evaluate relationships between serum IL-2,IL-6 levels and gut microbiota parame-ters.Cox proportional hazards regression analysis was performed to determine independent factors influencing disease progression in RA-ILD patients.Results:Smoking,age≥53.77 years old,anti-CCP antibody≥334.60 RU/ml,IL-6≥199.47 ng/ml,IL-2<3.10 ng/ml,richness<18.39,Shannon-Wiener index<2.88,Bifidobacterium<7.27 CFU/g,Bacteroides fragilis<7.75 CFU/g,Hmax<3.14 and flora uniformity<0.92 were independent factors affecting the occurrence of ILD in patients with RA.In patients with RA-ILD,serum IL-6 level was negatively correlated with richness,Shannon-Wiener index,Hmax and flora evenness,while serum IL-2 level was positively correlated with richness,Shannon-Wiener index,Hmax and flora evenness.Smoking,age,anti-CCP antibody,IL-6,IL-2,richness,Shannon-Wiener index,Bifidobacterium,Bacteroides fragilis,Hmax and flora uniformity were independent factors affecting the outcome of RA-ILD patients(P<0.05).Conclusion:Smoking,age,anti-CCP antibody,IL-6,IL-2,richness,Shannon-Wiener index,Bifido-bacterium,Bacteroides fragilis,Hmax and flora uniformity have significant diagnostic and prognostic value for RA-ILD.The changes of intestinal microbial community in patients with RA-ILD and the changes in the number and structure of intestinal bacteria may be one of the important factors of RA patients complicated with ILD.

OBJECTIVE To evaluate the differences between the sampling methods of peristaltic pump+membrane filtration and rinsing for monitoring the cleaning and disinfection effectiveness of flexible endoscopes,and to pro-vide a reference for selecting an efficient sampling method for monitoring the cleaning and disinfection effectiveness of flexible endoscopes.METHODS A total of 305 cases of monitoring data on the cleaning and disinfection of flexi-ble endoscopes from People's Hospital of Rizhao in Shandong Province from Jan.2021 to Dec.2024 were selected.The results of 93 cases sampled by rinsing from Jan.2021 to Dec.2022 were compared with those of 212 cases sampled by peristaltic pump+membrane filtration from Jan.2023 to Dec.2024.The monitoring capabilities of different sampling methods for flexible endoscopes after cleaning and disinfection were evaluated,and the con-sumable costs of different sampling methods were also calculated.RESULTS The detection rate of pathogenic bac-teria after biological monitoring of the peristaltic pump+membrane filtration sampling method was 25.94％(55/212),which was higher than that of the rinsing sampling method(8.60％,8/93)(P＜0.05).There was no sta-tistically significant difference in the sampling qualification rate between the two methods(P=0.075).There was no statistically significant difference in the qualification rate between manual and mechanical cleaning and dis-infection methods under the same sampling method.However,there was a statistically significant difference in the detection rate of pathogenic bacteria between manual cleaning and disinfection(36.21％)and mechanical cleaning and disinfection(22.08％)under the peristaltic pump+membrane filtration sampling method(P=0.036).The detection rate of pathogenic bacteria of the peristaltic pump+membrane filtration sampling method was higher than that of the rinsing sampling method for both cleaning and disinfection methods(P＜0.05).The consumable cost per endoscope of the peristaltic pump+membrane filtration sampling method was(84.90±2.91)yuan,which was higher than that of the rinsing sampling method(32.24±4.73)yuan(P＜0.001).CONCLUSION Al-though the peristaltic pump+membrane filtration sampling method has higher consumable costs,it can effec-tively improve the detection rate of pathogenic bacteria and enhance the sensitivity of biological monitoring of cleaning and disinfection.

OBJECTIVE To evaluate the differences between the sampling methods of peristaltic pump+membrane filtration and rinsing for monitoring the cleaning and disinfection effectiveness of flexible endoscopes,and to pro-vide a reference for selecting an efficient sampling method for monitoring the cleaning and disinfection effectiveness of flexible endoscopes.METHODS A total of 305 cases of monitoring data on the cleaning and disinfection of flexi-ble endoscopes from People's Hospital of Rizhao in Shandong Province from Jan.2021 to Dec.2024 were selected.The results of 93 cases sampled by rinsing from Jan.2021 to Dec.2022 were compared with those of 212 cases sampled by peristaltic pump+membrane filtration from Jan.2023 to Dec.2024.The monitoring capabilities of different sampling methods for flexible endoscopes after cleaning and disinfection were evaluated,and the con-sumable costs of different sampling methods were also calculated.RESULTS The detection rate of pathogenic bac-teria after biological monitoring of the peristaltic pump+membrane filtration sampling method was 25.94％(55/212),which was higher than that of the rinsing sampling method(8.60％,8/93)(P＜0.05).There was no sta-tistically significant difference in the sampling qualification rate between the two methods(P=0.075).There was no statistically significant difference in the qualification rate between manual and mechanical cleaning and dis-infection methods under the same sampling method.However,there was a statistically significant difference in the detection rate of pathogenic bacteria between manual cleaning and disinfection(36.21％)and mechanical cleaning and disinfection(22.08％)under the peristaltic pump+membrane filtration sampling method(P=0.036).The detection rate of pathogenic bacteria of the peristaltic pump+membrane filtration sampling method was higher than that of the rinsing sampling method for both cleaning and disinfection methods(P＜0.05).The consumable cost per endoscope of the peristaltic pump+membrane filtration sampling method was(84.90±2.91)yuan,which was higher than that of the rinsing sampling method(32.24±4.73)yuan(P＜0.001).CONCLUSION Al-though the peristaltic pump+membrane filtration sampling method has higher consumable costs,it can effec-tively improve the detection rate of pathogenic bacteria and enhance the sensitivity of biological monitoring of cleaning and disinfection.

Objective:To explore the interaction of IL-2,IL-6 factors and intestinal flora disorder in patients with rheumatoid arthritis complicated with interstitial lung disease(RA-ILD).Methods:A total of 100 RA patients diagnosed at Shijiazhuang People's Hospital from June 2021 to June 2022 were enrolled and divided into the RA-ILD group(with ILD,n=27)and RA-noILD group(with-out ILD,n=73)according to the results of pulmonary CT and clinical manifestations.Fecal samples were collected from all partici-pants,and intestinal flora levels were cultured and analyzed.Bacterial DNA was extracted from fecal samples,and the 16S rDNA gene was amplified by PCR to generate DGGE profiles of gut microbiota.The Shannon-Wiener index,evenness,and richness of intestinal bacteria were calculated.Cluster analysis was performed to compare structural differences in gut microbiota between the groups.Demo-graphic characteristics,clinical symptoms,laboratory parameters,and intestinal flora-related indicators were compared between the groups.Multivariate Logistic regression analysis was conducted to identify independent risk factors for ILD development in RA pa-tients.Spearman correlation analysis was used to evaluate relationships between serum IL-2,IL-6 levels and gut microbiota parame-ters.Cox proportional hazards regression analysis was performed to determine independent factors influencing disease progression in RA-ILD patients.Results:Smoking,age≥53.77 years old,anti-CCP antibody≥334.60 RU/ml,IL-6≥199.47 ng/ml,IL-2<3.10 ng/ml,richness<18.39,Shannon-Wiener index<2.88,Bifidobacterium<7.27 CFU/g,Bacteroides fragilis<7.75 CFU/g,Hmax<3.14 and flora uniformity<0.92 were independent factors affecting the occurrence of ILD in patients with RA.In patients with RA-ILD,serum IL-6 level was negatively correlated with richness,Shannon-Wiener index,Hmax and flora evenness,while serum IL-2 level was positively correlated with richness,Shannon-Wiener index,Hmax and flora evenness.Smoking,age,anti-CCP antibody,IL-6,IL-2,richness,Shannon-Wiener index,Bifidobacterium,Bacteroides fragilis,Hmax and flora uniformity were independent factors affecting the outcome of RA-ILD patients(P<0.05).Conclusion:Smoking,age,anti-CCP antibody,IL-6,IL-2,richness,Shannon-Wiener index,Bifido-bacterium,Bacteroides fragilis,Hmax and flora uniformity have significant diagnostic and prognostic value for RA-ILD.The changes of intestinal microbial community in patients with RA-ILD and the changes in the number and structure of intestinal bacteria may be one of the important factors of RA patients complicated with ILD.

Purpose/Significance To introduce the knowledge graph technology in the field of electronic information into the study of traditional Chinese medicine(TCM)terminology,and to demonstrate the dialectical relationship between the therapeutic effects of TCM and its nature,flavor,meridians and TCM diseases in a vivid way.Method/Process The top-down ontology construction method is adopted to build the top-level structure of TCM ontology on the Protégé platform.Taking the 2020 edition of the Chinese Pharmacopoeia as the data source,the TCM information in the pharmacopoeia is split and extracted,and the information of each axis is sorted,disambiguated and nor-malized.With the help of the Protégé platform,entities and relationships are created,and the TCM triple data is output in RDF data for-mat.Finally,the Neo4j graph database is used to store and display the RDF data to form a systematic TCM knowledge graph.Result/Con-clusion It mainly realizes the construction of the knowledge graph of TCM in the pharmacopoeia,and fully reveals the complex knowledge system structure in the field of TCM through data statistical analysis,knowledge measurement and drawing of visual graphics.

Objective:To explore characteristics of intestinal flora in patients with rheumatoid arthritis complicated with inter-stitial lung disease(RA-ILD),to analyze its influencing factors,and to explore improvement of intestinal flora in patients with RA-ILD by different treatment methods.Methods:A total of 100 patients with RA-ILD who visited Shijiazhuang People's Hospital from June 2021 to June 2022 were selected as research objects,and 100 healthy patients in Shijiazhuang People's Hospital during same pe-riod were selected as healthy group.High throughput sequencing was performed on intestinal flora of two groups,OTU flora abundance and α-Diversity,β-diversity,flora distribution and LEfSe difference were analyzed.Another 100 patients with RA-ILD were randomly divided into group A(n=50)and group B(n=50).Group A was treated with leflunomide+nidanib or pifenidone,and group B was treated with leflunomide+nidanib or pifenidone+bifidobacterium triad.Improvement of intestinal flora in two groups after treatment was analyzed.Correlation analysis was used to determine correlation between changes of intestinal flora and clinical characteristics and indicators in RA-ILD patients.Results:OTU flora abundance,α-diversity and β-diversity in RA-ILD patients were lower than that of healthy people.Abundance of Intestinibacter in RA-ILD group was higher than that in healthy group,and abundance of Lactobacillus,Escherichia coli,Klebsiella,Candidatus saccharimonas,Odoribacter and Enterococcus in RA-ILD group were lower than that in healthy group.After treatment,flora structure of group A and group B was improved.Group B was closer to healthy population,and cu-rative effect was significantly better than that of group A.Integinibacter bacteria level was positively correlated with age,RA course,DAS28,CRP,RF and KL-6(P<0.05),and negatively correlated with DLCO(P<0.05).Lactobacillus level was negatively correlated with course of RA,DAS28,CRP,RF,IL-6(P<0.05),and positively correlated with VC(P<0.05);Shigella coli level was negtively correlatied with RA course,ILD course,DAS28,ESR,RF,TNF-α(P<0.05).Klebsiella level was positively correlated with VC and DLCO(P<0.05);Bacterial level of Candida saccharimonas was negatively correlated with DAS28,ESR,CRP,RF,IL-6,TNF-α(P<0.05)and positive correlated with DLCO(P<0.05);Odoribacter bacteria level was negatively correlated with DAS28,CRP,RF,IL-6 and KL-6(P<0.05),and positively correlated with VC(P<0.05);Enterococcus level was negatively correlated with course of RA,ILD,DAS28,ESR,RF and KL-6(P<0.05),while positively correlated with DLCO(P<0.05).Conclusion:Intestinal microflora abundance of RA-ILD patients is significantly lower than that of healthy people,and there aree significant differences in some microflora,which are closely related to clinical characteristics and indicators.Using of bifidobacterium triad in clinical treatment is helpful to improve intestinal flora of RA-ILD patients.

Objectives:To observe the incidence of residual shunt post patent foramen ovale(PFO)closure and the effect of PFO closure in these migraine patients at one year after PFO. Methods:This retrospective study included patients who underwent PFO closure for migraine in the Second Affiliated Hospital Zhejiang University School of Medicine from January 2019 to June 2022,patients were divided into the grade 0 shunt group(n=67),the grade Ⅰ shunt group(n=10),the grade Ⅱ shunt group(n=13)and the grade Ⅲ shunt group(n=16)according to the results of contrast transthoracic echocardiography(cTTE)at 1 year after PFO closure.The incidence of postoperative migraine attacks among different groups of patients were compared.The risk factors of residual shunt after PFO closure were explored. Results:The mean age of enrolled 106 patients with migraine was(35.80±11.70)years,of which 83 patients(78.30%)were female.One year after PFO closure,the migraine attack and rating scale were significantly decreased compared to baseline in the grade 0 shunt group,in the grade Ⅰ shunt group and in the grade Ⅱ shunt group(all P<0.05),but not in the grade Ⅲ shunt group(P>0.05).The rate of significant and complete migraine was significantly higher in the grade 0 shunt group(58.21%),in the gradeⅠ shunt group(60.00%),in the grade Ⅱ shunt group(69.23%)as compared to the grade Ⅲ shunt group(18.75%,P=0.02)at one year after PFO.The rate of grade 0 shunt after PFO closure in patients with the microvesicles appearing in≥6 cardiac cycles in resting state before operation was significantly lower than in patients with the microvesicles appearing within 6 cardiac cycles and no microvesicles in resting state(24.00%vs.83.87%vs.70.00%,P=0.04).Logistic multivariate regression analysis showed that patients with microvesicles appearing beyond 6 cardiac cycles in resting state were more likely to have residual shunts in postoperative cTTE compared to the patients with negative cTTE and microvesicles appearing within 6 cardiac cycles in the cTTE in resting state before operation(OR=0.06,95%CI:0.02-0.23,P<0.01;OR=0.014,95%CI:0.05-0.41,P<0.01). Conclusions:Migraine patients who underwent PFO closure and with grade 0 to grade Ⅱ residual shunt at one year after PFO are most likely to have significant remission of migraine,while the incidence of migraine remission is low in patients with grade Ⅲresidual shunt.The incidence of residual shunt after PFO closure is higher in patients with the microvesicles appearing in 6 cardiac cycles in resting state in the cTTE before operation than in patients with the microvesicles appearing within 6 cardiac cycles and no microvesicles.

Objective To understand the current situation of quality management and implementation of risk-based quality management in clinical trial institutions.Methods In the form of questionnaires,Questionnaire Star was used to create the questionnaire,which was sent to clinical trial organisations in all provinces and cities to fill in through emails and institutional WeChat groups.Results The questionnaire results from 123 clinical trial institutions from 25 provinces were included for analysis.The quality management status was as follows:104(84.6%)institutions of the main quality management mode were the internal quality control by GCP department.On average,each institution had 3、4 full-time staff for quality management,with an average of 1 full-time staff to manage 16.8 projects and 10.9 specialties.In the last three years,65(52.8%)institutions conducted training for researchers 2-3 times/year.Ninety-five(77.2%)institutions had established a clinical trial funding allocation system.Forty-nine(39.2%)institutions had established GCP informatization management system and 44(35.2%)institutions had established risk-based quality management model.In the case of coordination between the clinical trial institution and the sponsor,47(41.2%)institutions did not not aware of the sponsor's/CRO's quality management plan in their collaboration with the sponsor.Conclusion The surveyed institutions have weaknesses,such as insufficient dedicated personnel for quality management,low utilization rate of GCP information systems.The collaborative capacity between clinical trial institutions and sponsors needs to be improved,and the implementation rate of risk-based quality management is also low.

Electronic data management has the advantages of saving cost and research time and improving the data quality, which has gradually been the mainstream form of clinical data collection and management. It is important to improve the quality of Traditional Chinese Medicine (TCM) clinical researches. This paper introduces the function, general style, developing principles and processes, management and training of Standard Operating Procedure (SOP) for electronic clinical data management. The characteristics and difficulties of electronic data management of TCM clinical researches are discussed and suggested solutions are proposed in the end.

Objective:To explore the relationship of risk factors and clinical features to assessments of children with cerebral palsy (CP ) using a magnetic resonance imaging classification system (MRICS).Methods:Medical records of CP patients under 18 years old were reviewed retrospectively. Data including high-risk factors, cranial MRI results and clinical characteristics were collected. The cranial MRI results were classified according to the MRICS.Results:Of 1357 patients studied, 1112 (82%) had received cranial MRI scans. Among them, 962 (86.5%) showed MRI-identified brain abnormalities, 489 in the periventricular white matter. Subjects with different weeks of gestation, birth weights, delivery times, neonatal hypoxic-ischemic encephalopathy, and neonatal cerebral hemorrhage had significantly different MRI classifications according to the system. Premature birth, low birth weight and multiple births correlated with the incidence of white matter brain injury. Only 4 of the subjects with neonatal cerebral hemorrhage were classified as having normal brain structures using the MRICS. However, gender, birth method, and pathological jaundice had no significant relationship with MRICS ratings. Significant differences in MRICS classifications were observed between patients with different CP subtypes, gross motor function scores, as well as with or without epilepsy, speech or language impairment. But degrees of mental retardation were not significantly related with MRICS classifications.Conclusion:MRICS classifications relate closely with risk factors and the clinical characteristics of CP patients. The system can play an important role in finding pathogenesis and predicting clinical outcomes. It is worthy of applying and promoting in the clinic.