Objective To investigate the governance requirements for real world data(RWD)in China's medical standards and specifications,summarize key technical aspects of data governance,and provide refer-ences for RWD governance-related research.Methods Computerized searches were conducted in CNKI,Wan-fang Data,VIP,and SinoMed,as well as the official websites of 29 national medical societies and the National Standard Information Public Service Platform,covering all records from inception to December 12,2023.A data extraction form was developed,and the included standards and specifications were categorized according to the first six RWD governance processes outlined in the Guidelines for Real World Data Used to Generate Real-World Evidence(Trial)issued by the National Medical Products Administration:data security,data extraction,data cleaning,data transformation,data transmission and storage,and quality control.Relevant content on data governance was systematically summarized and comparatively analyzed.Results A total of 32 standards and specifications were included,comprising 15 foundational medical data standards and 17 data gov-ernance technical specifications.Among these,6 addressed data security,6 covered data extraction,5 focused on data cleaning,5 involved data transformation,6 pertained to data transmission and storage,and 4 discussed quality control.Foundational medical data standards included data description elements,terminology,and format standards,broadly covering essential data elements and meeting basic standardization needs.Data gov-ernance technical specifications primarily provided general guidelines for medical data governance,emphasizing requirements and recommendations.While requirements for data security and extraction were relatively well-de-fined,technical guidance on data transformation and quality control remained limited,and implementation pathways for data cleaning,transmission,and storage were insufficiently detailed.Conclusions As real-world evidence plays an increasingly critical role in healthcare decision-making,China's medical standards and speci-fications have established a preliminary governance framework for RWD.However,technical details and practi-cal implementation of RWD governance still require further refinement.

Objective To investigate the association of urinary phthalate metabolites with 4 high-density lipoprotein-cholesterol(HDL-C)-related inflammatory indicators[lymphocyte/HDL-C ratio(LHR),monocyte/HDL-C ratio(MHR),neutrophil/HDL-C ratio(NHR),and platelet/HDL-C ratio(PHR)],and to explain their possible biological mechanisms.Methods The 4 573 adult participants from the National Health and Nutrition Examination Survey(NHANES)were subjected,and then generalized linear regression(GLM),restricted cubic spline(RCS),and weighted quantile sum(WQS)regressions were performed to explore the potential associations of phthalates mono-exposures and mixed exposures,respectively,with the HDL-C-related inflammation metrics.Results Nine urinary phthalate metabolites were significantly positively associated with at least 1 inflammatory marker,while 1 metabolite(MEP)showed a negative association with an inflammatory indicator(LHR).Some exposure metabolites showed a nonlinear association with outcome inflammatory indicators.WQS regression revealed varying weight contributions of individual metabolite to each inflammatory outcome.Subgroup analyses indicated differential association effects of phthalates with HDL-C-related inflammatory metrics across gender,age,and BMI populations.Conclusion There are associations between phthalate exposure and HDL-C-related inflammation indicators,but further studies are needed to reveal the underlying mechanisms.

Objective To investigate the governance requirements for real world data(RWD)in China's medical standards and specifications,summarize key technical aspects of data governance,and provide refer-ences for RWD governance-related research.Methods Computerized searches were conducted in CNKI,Wan-fang Data,VIP,and SinoMed,as well as the official websites of 29 national medical societies and the National Standard Information Public Service Platform,covering all records from inception to December 12,2023.A data extraction form was developed,and the included standards and specifications were categorized according to the first six RWD governance processes outlined in the Guidelines for Real World Data Used to Generate Real-World Evidence(Trial)issued by the National Medical Products Administration:data security,data extraction,data cleaning,data transformation,data transmission and storage,and quality control.Relevant content on data governance was systematically summarized and comparatively analyzed.Results A total of 32 standards and specifications were included,comprising 15 foundational medical data standards and 17 data gov-ernance technical specifications.Among these,6 addressed data security,6 covered data extraction,5 focused on data cleaning,5 involved data transformation,6 pertained to data transmission and storage,and 4 discussed quality control.Foundational medical data standards included data description elements,terminology,and format standards,broadly covering essential data elements and meeting basic standardization needs.Data gov-ernance technical specifications primarily provided general guidelines for medical data governance,emphasizing requirements and recommendations.While requirements for data security and extraction were relatively well-de-fined,technical guidance on data transformation and quality control remained limited,and implementation pathways for data cleaning,transmission,and storage were insufficiently detailed.Conclusions As real-world evidence plays an increasingly critical role in healthcare decision-making,China's medical standards and speci-fications have established a preliminary governance framework for RWD.However,technical details and practi-cal implementation of RWD governance still require further refinement.

【Objective】 To compare the clinical features of Omicron and Delta cases, so as to provide scientific basis for the prevention and treatment of COVID-19. 【Methods】 The case-control study method was used to retrospectively analyze the clinical data of the Omicron cases admitted to the designated hospital for the treatment of COVID-19 in Xi’an from December 2021 to January 2022. and the Delta cases admitted during the same period were used as the control group. The demographic data, epidemiological history, vaccination status, clinical characteristics, laboratory tests, nucleic acid and antibody levels, and outcomes of patients in the two groups were collected and compared. 【Results】 A total of 21 patients were included in the study, 5 were Omicron patients and 16 were Delta cases. The mean age of the patients in the two groups were (38.20±15.07) and (37.69±10.39) years, respectively.The time interval between the last vaccination and the diagnosis was (145.40±77.92) days and (159.00±99.74) days, respectively. For the initial symptoms, the patients with Omicron were mainly characterized by throat discomfort (3, 60%), cough and sputum (2, 40%), and the patients with Delta were mainly characterized by throat discomfort (5, 31.25%), fatigue (5, 31.25%), cough and sputum (4, 25%). On admission, laboratory tests showed that 60% of Omicron patients had low lymphocytes and elevated erythrocyte sedimentation rate, and 50% of patients in the delta group had elevated hemoglobin. The Ct values of ORFlab gene, N gene and E gene with Omicron were lower than those with Delta. And the difference of E gene between the two groups was statistically significant (t=-2.711, P=0.024). IgG antibody levels increased in both groups.The time for nucleic acid to turn negative with Omicron was (28.20±5.89) days, and it was (18.50±7.73) days with Delta, and the difference between the groups was statistically significant (t=2.565, P=0.019). The length of hospitalization with Omicron was (30.60±4.88) days, and that with Delta was (22.13±7.81) days, and the difference was statistically significant (t=2.270, P=0.035). 【Conclusions】 The initial symptoms of Omicron patients are mainly throat discomfort, cough and sputum. The clinical manifestations are generally mild. The nucleic acid test Ct value is lower. The time for nucleic acid to turn negative and the time for hospitalization are longer, and the potential infectiousness is stronger. Those eligible for vaccination should complete the full course of vaccination and booster vaccination as soon as possible. At the same time, the management of "early detection, early reporting, early isolation, and early treatment" should be implemented.

Objective To investigate the Mycobacterium tuberculosis infection status and Clinical Characteristics in Yongchuan District, Chongqing by Tuberculosis Protein Chip.Methods Compared the conventional method to detect Mycobacterium tuberculosis in infectious department outpatient of Yongchuan Hospital , Chongqing Medical University from July 2014 to June 2015.Tuberculosis protein chip was selected to detect the Mycobacterium tuberculosis infection in Yongchuan area.Chi-square Test was applied to analyze the results.Results The positive rate of Tuberculosis Protein Chip, T-SPOT.BT, DNA Chip, Golden immnnochromatog-raphy, Acid-fast staining were 81.5%, 90.7%, 89.5%, 63.5% and 38.3%respectively on 162 cases of Pulmonary tuberculosis.The five methods were considered significant difference on the diagnosis of Pulmonary tuberculosis ( P<0.05 ).The positive rate of Tuberculosis Protein Chip, T-SPOT, Golden immnnochromatog-raphy were 90.6%,T-SPOT 94.3%and 47.2% respectively on 53 cases of extrapulmonary tuberculosis, it was a significant difference with the three methods(P<0.05),but there was no significant difference with Tuberculosis Protein Chip and T-SPOT.BT ( P>0.05 ).The highest positive rates of anti-LAM was 94%.Conclusion The results of Tuberculosis protein chip are reliable on pulmonary tuberculosis and extrapulmonary tuberculosis diagnosis.