1.Mechanism of Buzhong Yiqitang in Ameliorating Thyroiditis Damage in AIT Mice by Modulating TLR4/NF-κB/AIM2 Signaling Pathway
Zhuo ZHAO ; Zhe JIN ; Zhengzheng LI ; Xuanlin GUO ; Jiayun LI ; Tongran GAO ; Pin LI ; Zhimin WANG ; Yuanping YIN ; Ziyu LIU ; Xiao YANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):1-9
		                        		
		                        			
		                        			ObjectiveTo explore the mechanism of Buzhong Yiqitang in ameliorating inflammatory injury in autoimmune thyroiditis (AIT) mice based on the Toll-like receptor 4(TLR4)/nuclear transcription factor-kappa B(NF-κB)/absent in melanoma 2(AIM2)inflammasome signaling pathway. MethodThe 120 genetically susceptible 8-week-old NOD.H-2h4 mice were selected and randomly divided into control group, model group, low, medium and high dose groups of Buzhong Yiqitang (4.78, 9.56, 19.12 g·kg-1), and western medicine group (selenium yeast tablets, 3.033×10-5 g·kg-1). The AIT model mice in each group drank ad libitum 0.05% sodium iodide aqueous solution for 8 weeks to establish the AIT model, and the control group drank ad libitum distilled water. Eight weeks later, the mice in each dosing group were divided into groups and gavage. The swelling of thyroid tissue was observed with the naked eye, and the weight of spleen was weighed. The content of serum inflammatory factors interleukin-1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) was measured by enzyme-linked immunosorbent assay (ELISA), and Real-time PCR was used to detect the expression of HMGB1, TLR4, AIM2, NF-κB p65,apoptosis-associated speck-like protein(ASC),cysteinyl aspartate-specific protease-1(Caspase-1), IL-1β mRNA. Western blot was used to detect the expression of high motility group protein 1 (HMGB1), TLR4, AIM2, NF-κB p65, phosphorylation(p)-NF-κB p65, ASC, Caspase-1, and IL-1β proteins in thyroid tissue, and immunofluorescence staining was used to observe the protein expression of HMGB1, AIM2, and NF-κB p65 in thyroid tissue of mice. ResultCompared with the control group, the thyroid tissue of mice in the model group was significantly swollen, the spleen quality was significantly increased, and the expression of HMGB1, TLR4, NF-κB p65, AIM2, ASC, Caspase-1, IL-1β in thyroid tissue was significantly increased (P<0.01). Compared with the model group, the swelling of thyroid tissue in mice in each dose group of Buzhong Yiqitang was improved, the quality of spleen was significantly reduced, and the expression of HMGB1, TLR4, AIM2, NF-κB p65, p-NF-κB p65, ASC, Caspase-1, IL-1β in thyroid tissue was significantly reduced (P<0.05, P<0.01). ConclusionBuzhong Yiqitang can effectively improve the inflammatory injury of AIT, and regulating the abnormal activation of the TLR4/NF-κB/AIM2 inflammasome signal pathway may be one of its intervention mechanisms. 
		                        		
		                        		
		                        		
		                        	
2.Further Discussion on Legal Points in Ethical Review of Research Participants’ Informed Consent
Chinese Medical Ethics 2023;36(3):240-248
		                        		
		                        			
		                        			The protection of research participants’ rights and interests is mainly guaranteed through the informed consent system and the ethical review of the Ethics Committee. In practice, some sponsors or researchers misused or mixed legal terms when writing the informed consent forms. More importantly, during the implementation of informed consent by researchers, the phenomenon that insufficient and incomplete notification, and derogation of research participants’ specific rights and interests occurred. This not only affected the scientific nature of the research, but also violated the original intention of clinical trials or medical researchers, and did not fully respect the human dignity and value of research participants. It was urgent for the ethics committee to correct it during the ethical review, and urge the researchers or sponsors to correct and improve it in a timely manner.
		                        		
		                        		
		                        		
		                        	
3.Distribution characteristics of traditional Chinese medicine syndromes in 4 367 adult influenza patients: a Meta-analysis
Siyuan LEI ; Xuanlin LI ; Zhenzhen FENG ; Liu CHUN ; Jiansheng LI
Chinese Critical Care Medicine 2023;35(1):23-27
		                        		
		                        			
		                        			Objective:To systematically evaluate the distribution characteristics of traditional Chinese medicine (TCM) syndromes in adult influenza patients and to provide a basis for the TCM syndrome differentiation of influenza.Methods:The CNKI, CBM, Wanfang, VIP, PubMed, Embase, Cochrane Library databases were searched to collect cross -sectional studies on the distribution pattern of TCM syndromes in adult patients with influenza. The risk of bias assessment tool for cross -sectional studies developed by the Joanna Briggs Institute (JBI) evidence -based health care center was used to evaluate the literature quality, and the Stata 15.1 software was used to conduct a Meta -analysis of the pooled effect sizes of the included studies. Results:A total of 11 studies with 4 367 influenza patients were included. Quality assessment results of JBI showed that the risk bias was higher in the sample size calculation, and the description of sampling modalities and response rate was unclear. There were 17 influenza syndromes after specification, and a single group rate Meta -analysis was performed of the syndromes with ≥ 50 incident cases showed that there were 9 syndromes with an incidence ≥ 10% and statistical significance, the top 5 syndromes were syndrome of wind and heat invading the defense [ n = 1 583, RATE = 34.3%, 95% confidence interval (95% CI) was 22.2%-46.3%], syndrome of exterior cold and interior heat ( n = 1 122, RATE = 36.1%, 95% CI was 21.2%-51.1%), syndrome of wind -cold fettering the exterior ( n = 860, RATE = 19.4%, 95% CI was 10.7%-28.0%), syndrome of heat and toxin in the lung ( n = 217, RATE = 17.1%, 95% CI was 9.1%-25.0%), and syndrome of disease involving both defense phase and qi phase ( n = 184, RATE = 38.8%, 95% CI was 14.2%-63.5%). The results of the subgroup analysis in different geographical regions showed that the frequency of distribution of syndrome of wind and heat invading the defense and heat and toxin in the lung was higher in the South (RATE: 36.5%, 18.6%) than in the North (RATE: 30.9%, 15.4%), and the frequency of distribution of syndrome of wind -cold fettering the exterior and exterior cold and interior heat in the North (RATE: 23.8%, 40.1%) was higher than that in the South (RATE: 15.7%, 32.3%). Conclusions:There are 9 common TCM syndromes of influenza, including wind and heat invading the defense syndrome, exterior cold and interior heat syndrome, wind -cold fettering the exterior syndrome, heat and toxin in the lung syndrome, disease involving both defense phase and qi phase syndrome, wind and heat complicated by dampnessinvading the surface syndrome, wind and cold complicated by dampnessinvading the surface syndrome, defense phase syndrome and dampness and heatinvading the surface syndrome, which can provide a reference for the TCM syndrome differentiation and treatment of influenza.
		                        		
		                        		
		                        		
		                        	
4.Legal Points in Ethical Review of Subjects’ Informed Consent
Chinese Medical Ethics 2022;35(11):1188-1195
		                        		
		                        			
		                        			Subjects’ informed consent are needed in biomedical research, which has been confirmed by the Civil Code of the People’s Republic of China, Law of the People’s Republic of China on the Promotion of Basic Medical and Health Care, and Law on Doctors of the People’s Republic of China. Due to the professionalism and complexity of the law, researchers often have deficiencies in the use of legal terms, the fulfillment of disclosure obligations and the protection of subjects’ rights and interests when writing informed consent forms. When the ethics committee conducts ethical review on the informed consent form of the subjects, there are some problems such as lack of objective ability or insufficient subjective attention to the above shortcomings of the researchers. By combing the legal points, this paper summarized the correction scheme to provide reference for ethical review.
		                        		
		                        		
		                        		
		                        	
5.Evaluation of the efficacy and safety of human coagulation factor Ⅷ in the treatment of hemophilia A patients
Ruyi CHEN ; Yan WU ; Yiyun LIU ; Mingxia HOU ; Qingshuang SONG ; Xuanlin ZHONG ; Xueyun WANG ; Wenjie XIE ; Caiping GUO ; Zhan ZHANG ; Yunjia ZHANG
Chinese Journal of Blood Transfusion 2022;35(12):1220-1225
		                        		
		                        			
		                        			【Objective】 To evaluate the efficacy and safety of human coagulation factor Ⅷ developed by Shenzhen Weiguang Biological products Co, Ltd in the treatment of patients with hemophilia A. 【Methods】 A prospective, multi-center, open, single-group clinical study was conducted. A total of 65 subjects with hemophilia A were enrolled, and human coagulation factor Ⅷ(FⅧ) was injected according to the patients’ bleeding severity. The improvement score of bleeding symptoms and signs after the first infusion of the first bleeding event and the transfusion efficiency of FⅧ activity at 10 min and 1 hour after infusion were taken as the main efficacy indexes. The improvement scores of bleeding symptoms and signs after the first infusion and the increase of FⅧ activity at 10 min and 1 hour after infusion were the secondary efficacy indexes. 【Results】 The 65 subjects were enrolled in safety analysis set (SS) and full analysis set (FAS), and 58 of them were enrolled in protocol analysis set (PPS). Ten minutes and one hour after the first infusion, the level of factor Ⅷ activity in the subjects increased significantly, and the FⅧ activity increased by 100% or more in more than 79% of the subjects. The average infusion efficiency of FⅧ activity in all subjects was more than 100%. In 70% of the subjects, the pain was relieved rapidly and /or the bleeding symptoms were significantly improved 8 hours after each bleeding infusion, and the improvement rate of bleeding symptoms and signs reached 100% 72 hours after infusion. 【Conclusion】 After infusion of human coagulation factor Ⅷ, the activity level of factor Ⅷ in patients with hemophilia A significantly increased. The infusion efficiency can reach a optimal level, and the bleeding symptoms can be significantly improved.
		                        		
		                        		
		                        		
		                        	
6.A multicenter phase Ⅲ clinical study of human prothrombin complex concentrate in treatment of hemophilia B
Wei ZHANG ; Yirun LIU ; Yan WU ; Xuanlin ZHONG ; Qingshuang SONG ; Shitao CHEN ; Xueyun WANG ; Caiping GUO ; Zhan ZHANG ; Yunjia ZHANG
Chinese Journal of Blood Transfusion 2022;35(9):915-919
		                        		
		                        			
		                        			【Objective】 To evaluate the clinical efficacy and safety of one kind of human prothrombin complex concentrate in treatment of patients with hemophilia B. 【Methods】 The clinical data of 36 patients with hemophilia B treated with human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co. Ltd. from May 2018 to April 2019 were retrospectively analyzed, and its clinical efficacy and safety were analyzed. 【Results】 A total of 35 subjects entered the full analysis set (FAS)and safety set (SS), 33 subjects entered the per protocol Set (PPS). Thirty minutes after the first infusion of FAS subjects, the activity of coagulation factor Ⅸ increased from (3.93±0.975) IU/dL to (25.61±9.337) IU/dL, and the infusion efficiency was (96.43±22.007)%. The increased value of coagulation factor Ⅱ activity was (73.25±14.874) IU/dL. The activity of coagulation factor Ⅶ was (42.79±16.847) IU/dL. The increased value of coagulation factor Ⅹ activity was (65.29±17.042) IU/dL. The increased value of coagulation factor Ⅸ activity was (21.68±9.434%) IU/dL. Twenty-four hours after the first infusion of FAS subjects, the improvement of bleeding symptoms and signs was excellent in 21 cases (60%), improved in 14 cases (40.0%), and the effective rate was 100%. The incidence of adverse reactions was 2.9%(1/35), and there was no antibody to human coagulation factor Ⅸ and new virus infection. 【Conclusion】 Infusion of human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co. Ltd. in the treatment of hemophilia B has significant clinical efficacy and good safety.
		                        		
		                        		
		                        		
		                        	
7.Meta-analysis of single-group rate of the distribution of traditional Chinese medicine syndromes in 2 139 patients with coronavirus disease 2019
Xuanlin LI ; Wenrui LIU ; Wenqing HE ; Yang XIE ; Jiansheng LI
Chinese Critical Care Medicine 2020;32(6):664-670
		                        		
		                        			
		                        			Objective:To systematically evaluate the incidence of coronavirus disease 2019 (COVID-19) syndrome in traditional Chinese medicine (TCM), and to provide a basis for the standard of COVID-19 syndrome differentiation.Methods:CNKI, China Medical Journal Network, PubMed and Embase databases were searched by computer, and TCM syndrome data of COVID-19 cross-sectional surveys and case series were collected from the establishment of the database to March 31st in 2020. Two researchers independently screened the literature, extracted relevant data such as TCM syndromes, and evaluated the quality of the literature according to the quality assessment tool recommended by the JBI Evidence-Based Health Care Center. Stata 14.0 software was used to perform a single-group Meta-analysis of TCM syndromes.Results:Thirteen cross-sectional studies and 5 case series studies were included, with a total of 2 139 patients. The analysis of the cross-sectional studies showed that the risk bias was higher in the identification, control and accuracy of the confounding factors, and the description of the reliability and validity of the outcome indicators was unclear. The analysis of the case series studies showed that the overall risk bias was small, but there was a lack of a comprehensive description of the assessment when selecting patients. A total of 33 TCM syndromes of COVID-19 were sorted out by combining the TCM syndromes with the same disease position and pathogenic syndrome in the included 18 literatures, and there were 10 types of TCM syndromes of which the number of occurrences was ≥50, the incidence rate was ≥10%, and had statistical significance [indicated that 95% confidence interval (95% CI) didn't cross the meaningless line 0], including cold dampness syndrome (469 cases, incidence rate was 28.2%, 95% CI was 5.9%-50.6%), damp heat syndrome (247 cases, incidence rate was 32.1%, 95% CI was 10.7%-53.6%), epidemic closed lung syndrome (228 cases, incidence rate was 28.9%, 95% CI was 12.5%-45.2%), pulmonary and spleen Qi deficiency syndrome (202 cases, incidence rate was 22.1%, 95% CI was 9.5%-34.7%), dampness stagnation lung syndrome (180 cases, incidence rate was 41.2%, 95% CI was 18.4%-64.1%), dampness obstructing lung and spleen syndrome (81 cases, incidence rate was 56.3%, 95% CI was 48.1%-64.4%), evil heat syndrome lung syndrome (76 cases, incidence rate was 31.1%, 95% CI was 25.3%-36.9%), dampness-blocking lung and stomach syndrome (70 cases, incidence rate was 13.4%, 95% CI was 10.4%-16.3%), heat poisoning lung closure syndrome (55 cases, incidence rate was 16.9%, 95% CI was 8.3%-25.5%), and Qi-Yin deficiency syndrome (53 cases, incidence rate was 13.7%, 95% CI was 2.7%-24.8%). Subgroup analysis showed that there were 6 types of TCM syndromes that met the above conditions in cross-sectional studies, namely cold and damp lung syndrome (200 cases, incidence rate was 20.9%, 95% CI was 12.6%-29.2%), damp heat syndrome (221 cases, incidence rate was 41.8%, 95% CI was 9.4%-74.2%), dampness-disease lung syndrome (120 cases, incidence rate was 41.4%, 95% CI was 8.6%-74.3%), lung and spleen Qi deficiency syndrome (115 cases, incidence rate was 19.2%, 95% CI was 6.8%-31.7%), heat-fever lung syndrome (76 cases, incidence rate was 31.1%, 95% CI was 25.3%-36.9%) and Qi-Yin deficiency syndrome (53 cases, incidence rate was 13.7%, 95% CI was 2.7%-24.8%). There were 3 kinds of TCM syndromes in case series studies, which were virus closed lung syndrome (133 cases, incidence rate was 44.0%, 95% CI was 24.5%-63.4%), lung and spleen Qi deficiency syndrome (87 cases, incidence rate was 38.7%, 95% CI was 32.3%-45.0%), and dampness and depression lung syndrome (60 cases, incidence rate was 40.6%, 95% CI was 29.3%-52.0%). Conclusions:The TCM syndromes of COVID-19 syndrome were widely distributed and complex. The main TCM syndromes were cold dampness syndrome, damp heat syndrome, epidemic closed lung syndrome, pulmonary and spleen Qi deficiency syndrome, dampness stagnation lung syndrome, dampness obstructing lung and spleen syndrome, evil heat syndrome lung syndrome, dampness-blocking lung and stomach syndrome, heat poisoning lung closure syndrome, Qi-Yin deficiency syndrome, which can provide reference for the standard of TCM syndrome differentiation of COVID-19.
		                        		
		                        		
		                        		
		                        	
8.Legal and Ethical Issues on Unrelated Living Organ Cross-Transplantation
Chinese Medical Ethics 2017;30(10):1201-1205
		                        		
		                        			
		                        			Unrelated living organ cross -transplantation has rich connotation and complex constructs .Revie-wing on the legislative attitudes of countries and regions around the world , there are three types including absolute prohibition , strict limit and explicit permission .From the perspectives of law , ethics and practice in our country , unrelated living organ cross-transplantation has had a legitimate basis .In the future, our country should recognize unrelated living organ cross -transplantation by legislation .In addition, it should strictly limit its applicable condi-tions and procedures , further to improve the distribution and sharing system of organ transplantation and explore the establishment of appropriate compensation systems for organ donors .
		                        		
		                        		
		                        		
		                        	
9.Research on Telemedicine and Its Legal Regulation
Chinese Medical Ethics 2017;30(11):1317-1321
		                        		
		                        			
		                        			At present,domestic and foreign have not yet formed a unified understanding of telemedicine.The distribution of medical resources in our country is not balanced,the grassroots or remote areas are lack of medical resources,especially high quality human resources,thus our country has the inner demand of developing on telemedicine.Due to the lagging of legislation and policy,telemedicine puts forward many legal and ethical challenges on the practicing qualification of physicians,the practicing registration of physicians,the protection of the rights of patients' informed consent and privacy,and so on.We should carefully distinguish the behavior of health counseling or diagnoses & treatment in telemedicine,in order to clarify the legal relationships among of the invitational medical institution,invitee medical institution,and patient,it will be the basis of bearing of legal liability.
		                        		
		                        		
		                        		
		                        	
10.Effects of inflammatory markers on the level of reactive oxygen species and mitochondria DNA copy numbers in granulosa cells of patients without PCOS
Xuanlin ZHANG ; Yi LI ; Li LIU ; Wenjing ZHANG ; Xiangtong MENG ; Fengqin XU
Tianjin Medical Journal 2016;44(9):1099-1101
		                        		
		                        			
		                        			Objective To study the effect of inflammatory markers on the level of reactive oxygen species (ROS) and mitochondrial DNA (mtDNA) copy numbers in granulosa cells of patients without polycystic ovary syndrome (PCOS). Methods Fifty patients without PCOS treated with in vitro fertilization and embryo transfer (IVF-ET) were selected in this study. The granulosa cells were extracted and cultured in vitro. Cells were randomly divided into treatment group and control group. The 5 nmol/L interleukin (IL)-1, IL-6 and tumor necrosis factor (TNF)-αwere given to treatment group, and same amount of inflammatory diluted solution was added to control group. The levels of ROS and copy numbers of mtDNA were compared between two groups. Results The ROS levels and mtDNA copy number of granulosa cells were significantly higher in IL-1, IL-6 and TNF-αtreatment groups than those of control group (P<0.05). Conclusion Inflammatory markers of IL-1, IL-6 and TNF-αincrease the level of ROS and damage mtDNA in granulosa cells.
		                        		
		                        		
		                        		
		                        	
            
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