1.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
		                        		
		                        			
		                        			Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
		                        		
		                        		
		                        		
		                        	
2.Multicenter evaluation of the diagnostic efficacy of jaundice color card for neonatal hyperbilirubinemia
Guochang XUE ; Huali ZHANG ; Xuexing DING ; Fu XIONG ; Yanhong LIU ; Hui PENG ; Changlin WANG ; Yi ZHAO ; Huili YAN ; Mingxing REN ; Chaoying MA ; Hanming LU ; Yanli LI ; Ruifeng MENG ; Lingjun XIE ; Na CHEN ; Xiufang CHENG ; Jiaojiao WANG ; Xiaohong XIN ; Ruifen WANG ; Qi JIANG ; Yong ZHANG ; Guijuan LIANG ; Yuanzheng LI ; Jianing KANG ; Huimin ZHANG ; Yinying ZHANG ; Yuan YUAN ; Yawen LI ; Yinglin SU ; Junping LIU ; Shengjie DUAN ; Qingsheng LIU ; Jing WEI
Chinese Journal of Pediatrics 2024;62(6):535-541
		                        		
		                        			
		                        			Objective:To evaluate the diagnostic efficacy and practicality of the Jaundice color card (JCard) as a screening tool for neonatal jaundice.Methods:Following the standards for reporting of diagnostic accuracy studies (STARD) statement, a multicenter prospective study was conducted in 9 hospitals in China from October 2019 to September 2021. A total of 845 newborns who were admitted to the hospital or outpatient department for liver function testing due to their own diseases. The inclusion criteria were a gestational age of ≥35 weeks, a birth weight of ≥2 000 g, and an age of ≤28 days. The neonate′s parents used the JCard to measure jaundice at the neonate′s cheek. Within 2 hours of the JCard measurement, transcutaneous bilirubin (TcB) was measured with a JH20-1B device and total serum bilirubin (TSB) was detected. The Pearson′s correlation analysis, Bland-Altman plots and the receiver operating characteristic (ROC) curve were used for statistic analysis.Results:Out of the 854 newborns, 445 were male and 409 were female; 46 were born at 35-36 weeks of gestational age and 808 were born at ≥37 weeks of gestational age. Additionally, 432 cases were aged 0-3 days, 236 cases were aged 4-7 days, and 186 cases were aged 8-28 days. The TSB level was (227.4±89.6) μmol/L, with a range of 23.7-717.0 μmol/L. The JCard level was (221.4±77.0) μmol/L and the TcB level was (252.5±76.0) μmol/L. Both the JCard and TcB values showed good correlation ( r=0.77 and 0.80, respectively) and agreements (96.0% (820/854) and 95.2% (813/854) of samples fell within the 95% limits of agreement, respectively) with TSB. The JCard value of 12 had a sensitivity of 0.93 and specificity of 0.75 for identifying a TSB ≥205.2?μmol/L, and a sensitivity of 1.00 and specificity of 0.35 for identifying a TSB ≥342.0?μmol/L. The TcB value of 205.2?μmol/L had a sensitivity of 0.97 and specificity of 0.60 for identifying TSB levels of 205.2 μmol/L, and a sensitivity of 1.00 and specificity of 0.26 for identifying TSB levels of 342.0 μmol/L. The areas under the ROC curve (AUC) of JCard for identifying TSB levels of 153.9, 205.2, 256.5, and 342.0 μmol/L were 0.96, 0.92, 0.83, and 0.83, respectively. The AUC of TcB were 0.94, 0.91, 0.86, and 0.87, respectively. There were both no significant differences between the AUC of JCard and TcB in identifying TSB levels of 153.9 and 205.2 μmol/L (both P>0.05). However, the AUC of JCard were both lower than those of TcB in identifying TSB levels of 256.5 and 342.0 μmol/L (both P<0.05). Conclusions:JCard can be used to classify different levels of bilirubin, but its diagnostic efficacy decreases with increasing bilirubin levels. When TSB level are ≤205.2 μmol/L, its diagnostic efficacy is equivalent to that of the JH20-1B. To prevent the misdiagnosis of severe jaundice, it is recommended that parents use a low JCard score, such as 12, to identify severe hyperbilirubinemia (TSB ≥342.0 μmol/L).
		                        		
		                        		
		                        		
		                        	
3.Determination of Selenium in Organic Matrices Using Hydride Generation Atomic Fluorescence Spectrometry Combined with Online Oxygen Combustion
Yuan-Yuan MA ; Xiao-Hui HU ; Yong-Yu DING ; Xiang-Dong GAO ; Tai-Cheng DUAN
Chinese Journal of Analytical Chemistry 2024;52(10):1602-1608
		                        		
		                        			
		                        			An online sample decomposition and detection method for high-throughput determination of Se content in organic samples was established based on oxygen combustion combined with hydride generation atomic fluorescence spectrometry.The sole product of Se in oxygen combustion,SeO2,was quantitatively captured on the walls of the combustion flask in an open system.It was then eluted online and reacted in situ with 10%(V/V)HC1 carrier solution and 2%(m/V)NaBH4 reductant solution within the combustion flask.After optimization,for a maximum sample processing amount of 0.2 g,the sample analysis throughput was 20 sample/h.The detection limit(LOD,3SD)for Se reached 0.012 mg/kg,and the relative standard deviations for parallel determinations(RSDs,n=6)was 1.7%.The analytical results of certified reference materials,scallop(GBW10024)and chicken(GBW10018),were consistent with the certified values,and the analytical results of real samples were in good agreement with those obtained by traditional wet digestion.
		                        		
		                        		
		                        		
		                        	
4.Advances in the multi-omics research on nonalcoholic fatty liver disease
Mingxiu DUAN ; Xinli CHEN ; Weiyu CHANG ; Yuan YANG ; Shiqi YANG ; Hui WU
Journal of Clinical Hepatology 2024;40(6):1240-1247
		                        		
		                        			
		                        			The prevalence rate of nonalcoholic fatty liver disease(NAFLD)reaches up to 30%around the world,and the disease has a serious impact on human health and constitutes a public health burden.Due to difficulties in the diagnosis and monitoring of NAFLD,it is important to identify potential drug targets and biomarkers,and multi-omics techniques hold great promise in the search for early diagnostic markers,therapeutic targets,and outcome and prognostic assessment of NAFLD.This article reviews the research advances in multi-omics techniques in the field of NAFLD in recent years,in order to provide a richer theoretical basis and new strategies for the prevention and treatment of NAFLD.
		                        		
		                        		
		                        		
		                        	
5.Diagnostic Methods of Global Developmental Delay Caused by 10q24.3 Heterozygous Loss: A Case Discussion
Yuan-hui DUAN ; Jie CAO ; Yue-xu OU ; Jie-ling LI
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(2):348-353
		                        		
		                        			
		                        			ObjectiveTo discuss the diagnostic methods of global developmental delay caused by 10q24.3 heterozygous loss. MethodsA retrospective analysis was conducted on the clinical data of one child with global developmental delay, and the results of low depth whole-genome copy number variation sequencing (CNVseq) and family whole exome sequencing (WES) of the child and his parents. ResultsThe patient was a 10-month-old male with developmental retardation in four areas, with some special features (ocular hypertelorism, strabismus, flat nose bridge, protruding forehead, cleft palate, high palatal arch, etc.) and hypotonia of limbs. The CNVseq and WES test showed that the patient had new 10q24.3 heterozygosis loss. Because this region contains the gene SUFU associated with basal cell nevus syndrome and the gene CNNM2 associated with hypomagnesemia, seizures, and mental retardation, and the gene TRIM8 associated of Focal segmental glomerulosclerosis with neurodevelopmental syndrome, we speculated that the cause of the disease in the child was highly related to the heterozygosity deletion of SUFU gene and CNNM2 gene and TRIM8 gene. ConclusionGenetic testing should be improved as soon as possible for children with global developmental delay and special facial manifestations, so as to make clear diagnosis and to judge prognosis. 
		                        		
		                        		
		                        		
		                        	
6.Application of mixture analysis methods in association between metals mixture exposure and DNA oxidative damage.
Yan Hua WANG ; Hui Ge YUAN ; Li Ya ZHANG ; Yang LIN ; Ting WANG ; Huan XU ; Xing ZHAO ; Hua Wei DUAN
Chinese Journal of Preventive Medicine 2023;57(7):1026-1031
		                        		
		                        			
		                        			Objectives: To study the association between metals mixture exposure and DNA oxidative damage using mixture analysis methods, and to explore the most significant exposure factors that cause DNA oxidative damage. Methods: Workers from steel enterprises were recruited in Shandong Province. Urinary metals were measured by using the inductively coupled plasma mass spectrometry method. The level of urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) was determined by using the ultra-high performance liquid chromatography-mass spectrometry method. Bayesian kernel machine regression (BKMR), elastic net regression and quantile g-computation regression were used to analyze the association between urinary metals and urinary 8-OHdG. Results: A total of 768 subjects aged (36.15±7.40) years old were included in the study. BKMR, elastic net regression and quantile g-computation all revealed an overall positive association between the mixture concentration and increased urinary 8-OHdG. The quantile g-computation results showed that with a 25% increase in metal mixtures, the urinary 8-OHdG level increased by 77.60%. The elastic net regression showed that with a 25% increase in exposure risk score, the urinary 8-OHdG level increased by 26%. The BKMR summarized the contribution of individual exposures to the response, and selenium, zinc, and nickel were significant contributors to the urinary 8-OHdG elevation. Conclusion: Exposure to mixed metals causes elevated levels of DNA oxidative damage, and selenium, zinc, and nickel are significant exposure factors.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Nickel/toxicity*
		                        			;
		                        		
		                        			Selenium
		                        			;
		                        		
		                        			Bayes Theorem
		                        			;
		                        		
		                        			Metals/toxicity*
		                        			;
		                        		
		                        			8-Hydroxy-2'-Deoxyguanosine
		                        			;
		                        		
		                        			Oxidative Stress/physiology*
		                        			;
		                        		
		                        			Zinc
		                        			;
		                        		
		                        			DNA Damage
		                        			
		                        		
		                        	
7.Interpretation of the essential updates in guidelines for the prevention and treatment of chronic hepatitis B (Version 2022).
Hong YOU ; Ya Meng SUN ; Meng Yang ZHANG ; Yue Min NAN ; Xiao Yuan XU ; Tai Sheng LI ; Gui Qiang WANG ; Jin Lin HOU ; Zhongping DUAN ; Lai WEI ; Fu Sheng WANG ; Ji Dong JIA ; Hui ZHUANG
Chinese Journal of Hepatology 2023;31(4):385-388
		                        		
		                        			
		                        			Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association update the guidelines for the prevention and treatment of chronic hepatitis B (version 2022) in 2022. The latest guidelines recommend more extensive screening and more active antiviral treating for hepatitis B virus infection. This article interprets the essential updates in the guidelines to help deepen understanding and better guide the clinical practice.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Hepatitis B, Chronic/drug therapy*
		                        			;
		                        		
		                        			Hepatitis B/drug therapy*
		                        			;
		                        		
		                        			Hepatitis B virus
		                        			;
		                        		
		                        			Antiviral Agents/therapeutic use*
		                        			;
		                        		
		                        			Gastroenterology
		                        			
		                        		
		                        	
8.Ten-year changes in clinical characteristics and antiviral treatment patterns of chronic hepatitis B in China: a CR-HepB-based real-world study.
Xiao Qian XU ; Hao WANG ; Shan SHAN ; Hong YOU ; Yue Min NAN ; Xiao Yuan XU ; Zhong Ping DUAN ; Lai WEI ; Jin Lin HOU ; Hui ZHUANG ; Ji Dong JIA ; Yuan Yuan KONG
Chinese Journal of Hepatology 2023;31(7):698-704
		                        		
		                        			
		                        			Objective: To understand ten-year changes in clinical characteristics and antiviral treatment patterns of chronic hepatitis B in China. Methods: Patients with chronic HBV infection:demographic, virologic, hematologic, blood biochemistry, and antiviral treatment data were extracted from the China Registry of Hepatitis B (CR-HepB) database between 2012 and 2022 for descriptive statistics and change trend analysis. Multiple group comparisons were conducted using the Kruskal Wallis H test, while counting data was compared between groups using χ (2) test. Results: A total of 180 012 patients with chronic HBV infection were included, with a median age of 40 years old, and a male proportion accounting for 60.2%. The HBeAg positive rate was 43.3%. Over time, the median age of new patients each year increased from 39 to 47 years, while the HBeAg positive rate decreased from 51.3% to 32.8%. The initial diagnosis of patients was mainly CHB (71.4%), followed by hepatitis B cirrhosis (11.8%), inactive HBsAg carrier status (10.6%), and chronic HBV carrier status (6.2%). Among the newly registered patients every year from 2012 to 2022, the proportion of hepatitis B cirrhosis remained stable, but after 2019, the proportion of CHB increased and the proportion of other diagnoses decreased. The proportion of patients with cirrhosis increased with age in different age groups, with 3.5%, 19.3%, and 30.4% in the < 40, 40-69, and≥70 age groups, respectively. The proportion of women in patients with cirrhosis also increased with age, from 16.1% in those < 30 years old to 44.3% in those≥80 years old. From 2012 to 2022, the proportion of patients receiving first-line nucleos(t)ide analog antiviral treatment increased year by year, from 51.0% in 2012-2013 to 99.8% in 2022. Conclusion: The CR-HepB registration data reflect the changes in clinical characteristics and antiviral treatment patterns in patients with chronic HBV infection in China over the past ten years and can thus provide a reference to promote hepatitis B diagnosis and treatment practice, as well as scientific research.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Aged, 80 and over
		                        			;
		                        		
		                        			Antiviral Agents/therapeutic use*
		                        			;
		                        		
		                        			Hepatitis B, Chronic/epidemiology*
		                        			;
		                        		
		                        			Hepatitis B e Antigens
		                        			;
		                        		
		                        			Hepatitis B/drug therapy*
		                        			;
		                        		
		                        			Hepatitis B Surface Antigens
		                        			;
		                        		
		                        			Hepatitis A
		                        			;
		                        		
		                        			Liver Cirrhosis/drug therapy*
		                        			;
		                        		
		                        			China/epidemiology*
		                        			;
		                        		
		                        			Registries
		                        			;
		                        		
		                        			Hepatitis B virus/genetics*
		                        			;
		                        		
		                        			DNA, Viral
		                        			
		                        		
		                        	
9.On-Site Assessment of a Cryogenic Disinfectant for the Alpine Environment and Outer Packaging of Frozen Items.
Jin SHEN ; Bin YANG ; Jia Qing XIAO ; Lu Yao LI ; Hui Hui SUN ; Hong Yang DUAN ; Wei ZHANG ; Chen LIANG ; Lu CHEN ; Li LI ; Yan Yan CHEN ; Yuan LYU ; Song TANG ; Jiao WANG ; Liu Bo ZHANG ; Lin WANG
Biomedical and Environmental Sciences 2023;36(2):174-184
		                        		
		                        			OBJECTIVE:
		                        			To study the effectiveness and feasibility of cryogenic disinfectants in different cold scenarios and analyze the key points of on-site cryogenic disinfection.
		                        		
		                        			METHODS:
		                        			Qingdao and Suifenhe were selected as application sites for the manual or mechanical spraying of cryogenic disinfectants. The same amount of disinfectant (3,000 mg/L) was applied on cold chain food packaging, cold chain containers, transport vehicles, alpine environments, and article surfaces. The killing log value of the cryogenic disinfectant against the indicator microorganisms ( Staphylococcus aureus and Escherichia coli) was used to evaluate the on-site disinfection effect.
		                        		
		                        			RESULTS:
		                        			When using 3,000 mg/L with an action time of 10 min on the ground in alpine regions, the surface of frozen items, cold-chain containers, and cold chain food packaging in supermarkets, all external surfaces were successfully disinfected, with a pass rate of 100%. The disinfection pass rates for cold chain food packaging and cold chain transport vehicles of centralized supervised warehouses and food processing enterprises were 12.5% (15/120), 81.67% (49/60), and 93.33% (14/15), respectively; yet, the surfaces were not fully sprayed.
		                        		
		                        			CONCLUSION
		                        			Cryogenic disinfectants are effective in disinfecting alpine environments and the outer packaging of frozen items. The application of cryogenic disinfectants should be regulated to ensure that they cover all surfaces of the disinfected object, thus ensuring effective cryogenic disinfection.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Disinfectants/pharmacology*
		                        			;
		                        		
		                        			Disinfection
		                        			;
		                        		
		                        			Escherichia coli
		                        			;
		                        		
		                        			Staphylococcal Infections
		                        			;
		                        		
		                        			Staphylococcus aureus
		                        			
		                        		
		                        	
10.Serum Uric Acid Level and Its Influencing Factors in Patients with Diabetes Insipidus.
Shi-Han WANG ; Hui-Juan ZHU ; Lian DUAN ; Fan PING ; Xi WANG ; Yue CHI ; Tao YUAN
Acta Academiae Medicinae Sinicae 2023;45(1):44-49
		                        		
		                        			
		                        			Objective To investigate the level of serum uric acid in patients with diabetes insipidus (DI),summarize the clinical characteristics of central diabetes insipidus (CDI) patients with hyperuricemia (HUA),and analyze the factors affecting the level of serum uric acid in the patients with CDI. Methods The clinical data of DI patients admitted to Peking Union Medical College Hospital from 2018 to 2021 were retrospectively analyzed.The patients were assigned into a child and adolescent group (≤ 18 years old) and an adult group (>18 years old) according to their ages.The demographic and biochemical data between two groups of patients with and without HUA were compared.Spearman correlation analysis and multiple linear regression analysis were performed to analyze the correlations between serum uric acid level and other factors. Results Among the 420 DI patients,411 patients had CDI (97.9%),including 189 patients with HUA (46.0%).Thirteen (6.9%) out of the 189 CDI patients with HUA presented the disappearance of thirst.The prevalence of HUA in children and adolescents was higher than that in adults (χ2=4.193,P=0.041).The level of serum uric acid in the CDI patients with HUA and disappearance of thirst was higher than those without disappearance of thirst (U=2.593,P=0.010).The multiple linear regression predicted serum creatinine (β=0.472,95%CI=2.451-4.381,P<0.001) and body mass index (β=0.387,95%CI=6.18-12.874,P<0.001) as the independent risk factors of serum uric acid level increment in children and adolescents,while serum creatinine (β=0.361,95%CI=1.016-1.785,P<0.001),body mass index (β=0.208,95%CI=2.321-6.702,P<0.001),triglyceride (β=0.268,95%CI=12.936-28.840,P<0.001),and total cholesterol (β=0.129,95%CI=2.708-22.250,P=0.013) were the independent risk factors in adults. Conclusions The patients with CDI were more likely to have HUA,and the prevalence of HUA in children and adolescents was higher than that in adults.Body mass index,serum creatinine,triglyceride,total cholesterol,and disappearance of thirst were the risk factors for the increased level of serum uric acid in CDI patients.
		                        		
		                        		
		                        		
		                        			Adolescent
		                        			;
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Child
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Uric Acid
		                        			;
		                        		
		                        			Creatinine
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Diabetes Insipidus
		                        			;
		                        		
		                        			Hyperuricemia
		                        			;
		                        		
		                        			Triglycerides
		                        			;
		                        		
		                        			Cholesterol
		                        			;
		                        		
		                        			Diabetes Mellitus
		                        			
		                        		
		                        	
            
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