OBJECTIVE:To promote the supervision and management of clinical trial by institution. METHODS:The structure and function of clinical trial management system(CTMS)developed by our hospital and other enterprise together were analyzed to evaluate the application and operation result of CTMS. RESULTS & CONCLUSIONS:CTMS of our hospital is made up of foun-dation,efficiency and strategy. It is equipped with role allocation,information exchange and report,information warning,drug tracking,clinical trial process control,quality control of electronic record,electronic signature and integration and connection with other system,etc. Relevant operation procedure is established to promote standardization and institutionalization of CTMS. Due to the application of CTMS,the cooperation among departments become smoother,and management level have been enhanced in dai-ly management,pharmacy management,subjects and document administration. It also simplifies the work of researcher and reduc-es the human error by the autogeneration of trial records and tables with the system. Consequently,the monitor coveraged through-out all the trial process.

OBJECTIVE:To ensure the stability of electronic data capture(EDC)system in drug clinical trials and to improve the quality of drug clinical trials. METHODS:The quality control system for EDC system was established and introduced from the formulation of quality control process,establishment of data standard,trial project management,daily management,trial project design,system operation,system function,etc. RESULTS & CONCLUSIONS:Data standard have been achieved through estab-lishing EDC quality control system by our hospital based on attributable,legible,contemporaneous,original and accurate principle. The management of trial project and daily management are conducted through data registration,staff training,the formulation of da-ta management plan,fault emergency treatment,database backup;multiple verification of support data,data lock and export,trial report autogeneration and other functions have been realized by formulating related standard operation instruction,program file,op-eration manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foun-dation for further data mining.

Objective To develop a human Tim-3 specific monoclonal antibody and evaluate its biological activity and possible use in clinical diseases associated with dysregulated Tim-3 expression .Methods The BALB/c mice were immu-nized by conventional method, and positive clones were used to develop anti-human Tim-3 antibody, the binding and neutralization activities of which in vitro and in vivo were investigated.Results ①A monoclonal antibody (clone L3D) which could specifically bind to human Tim-3 protein in ELISA assay was obtained and the subtype of the monoclonal antibody was IgG2a .②Flow cytometry indicated that the monoclonal antibody could bind to Tim-3 expressed in human U937 cells.This antibody also showed a cross activity to mice′Tim-3.③The monoclonal antibody inhibited the apoptosis of THP1 cells induced by Gal-9, the ligand of Tim-3.④Injection of Tim-3 antibody exacerbated sepsis in mice as marked by the decreased survival rate and increased expression of pro-inflammatory cytokines .Conclusion An anti-human Tim-3 monoclonal antibody is successfully obtained.The excellent binding and neutralization activities of this antibody enable it to be widely used in clinical diseases associated with deregulated Tim-3 expression .

Objective To investigate risk factors of medication non-adherence in elderly patients with hypertension through Meta-analysis.Methods Literatures on medication non-adherence in elderly patients with hypertension were systematically reviewed across various databases,from inception to September 1st 2023,including CNKI,VIP,Wangfong Database,SinoMed,PubMed,Web of Science,Cochrane Library、EMbase.Meta-analysis was conducted using RevMan 5.4.Results A total of 19 articles were included,comprising a total of 18 220 patients in sample size.Meta analysis identified 10 risk factors,showed significant association(P<0.05)with:age[OR=1.36,95%CI=(1.00,1.86)],place of residence[OR=1.91,95%CI=(1.33,2.75)],method of payment for medical expenses[OR=1.60,95%CI=(1.38,1.86)],income level[OR=1.68,95%CI=(1.45,1.95)],occupational status[OR=1.79,95%CI=(1.37,2.36)],social support[OR=1.43,95%CI=(1.27,1.60)],comorbidity[CI=0.33,95%(0.19,0.58)],frequency of blood pressure measurement[CI=1.53,95%(1.14,2.05)],disease awareness[OR=1.70,95%CI=(1.44,2.00)]and dedication frequency[OR=1.44,95%CI=(1.16,1.79)].In addition,the number of influencing factors such as gender,marital status,depression,cognitive impairment,and complications was included in<3 articles,and only descriptive analysis was conducted.Conclusion Healthcare providers should focus on the identification and management of the risk factors associated with medication non-adherence in elderly patients with hypertension,therefore to reduce the incidence of medication non-adherence.

Objective To investigate the self-healing status of children with abnormal tongue root sounds at different age stages of 4 to 12 years old who have not received articulation training,and to provide correct guidance plans for patients.Methods Through retrospective analysis,114 cases of children diagnosed with functional dysar-thria and abnormal root of tongue in Kunming children's hospital from 2019 to 2020 who refused to do rehabilitation training but could receive long-term outpatient follow-up visit,were selected.The follow-up visit was conducted one year later to reevaluate the root of tongue of the children,and the relationship between the self-healing situation of the children's root of tongue and age and wrong form was statistically analyzed.Results Among the 114 children with abnormal root sound,35 cases(30.70％)healed by themselves.The self-healing rates of each age group were as follows:4～5 years old(45.24％),5～6 years old(27.08％),6～7 years old(14.29％),7～12 years old(10.00％).The self-healing rate of all age groups was significant(x2=8.254,P=0.041).There were 287 fre-quency of errors in 114 cases,among which the self-healing rate of consonant loss was the highest(41.46％),fol-lowed by consonant substitution(40.76％),and consonant distortion was the worst(16.67％).The overall differ-ence of the three error forms was statistically significant(x2=10.003,P=0.007).According to different root sounds,the self-healing rate of/h/sound was the highest(31/60.78％),followed by/k/sound(40,32.26％),and/g/sound was the worst(35,31.25％).There was significant difference among the three root sounds(x2=15.172,P＜0.001).There was no significant difference in the self-healing rate between male and female children(x2=1.311,P=0.252).Conclusion The rate of root sound healing in children with functional articulation disor-der was related to age,wrong form and wrong root sound,but not gender.