Objective:To standardize the management of Investigator-Initiated Trials(IITs) and improve the quality of research projects, this study takes a tertiary hospital in Beijing as an example to analyze the key risk points in the implementation process of IITs and proposes countermeasures based on the issues identified during the management process.Methods:The study analyzed the IITs conducted at in the hospital from 2022 to 2023, focusing on 4 aspects: project classification evaluation and management (risk management), project implementation quality (process management), collaboration and support conditions(contract review and execution), and participant protection (medical ethics). It examined the key points and difficulties in project process management to standardize the quality management of IITs.Results:The implementation process management of IITs in medical institutions was an essential component for standardized clinical research management and an effective means to ensure the scientific nature of clinical research and the quality of data.Conclusions:Medical institutions should establish an effective and feasible IIT quality management system to comprehensively enhance the quality of IIT project, aiming to produce high-quality clinical research outcomes.

Objective:To explore the symptoms of Ménière′s disease patients and their impact on quality of life.Methods:A cross-sectional study was conducted, consecutively enrolling patients of Ménière′s disease who visited the Otolaryngology Clinic at the Eye & ENT Hospital of Fudan University from October 2014 to December 2022. The Chinese version of the Ménière′s Disease Outcomes Questionnaire (MDOQ) and a Ménière′s disease-specific symptom checklist were utilized for assessment. SPSS 25.0 software was employed to perform multiple linear regression analysis to determine the impact of Ménière′s disease symptoms on patients′ quality of life.Results:A total of 790 patients with a definitive diagnosis of Ménière′s disease who met the inclusion and exclusion criteria were analyzed. The cohort comprised 418 males and 372 females, with a mean age of (54.8±13.1) years and a diagnosis duration ranging from 0 to 72 months, with a median of 3 months. The total score of the Chinese MDOQ was 61.0±12.0. The symptomatic presentations of the enrolled patients included hearing changes, tinnitus, aural fullness, drop attacks, vertigo episodes, visual instability, dizziness, and headache. Multiple linear regression analysis revealed that age, tinnitus, aural fullness, frequency of drop attacks, visual instability, dizziness, and headache were significant factors affecting the quality of life in Ménière′s disease patients ( F=145.50, P<0.05). Conclusions:The quality of life in Ménière′s disease patients requires improvement. Attention to the specific symptoms of Ménière′s disease and their impact on patients′ quality of life, along with targeted symptom interventions based on these findings, will be a focal point in future disease management.

Objective To explore the value of the corrected-size ratio(c-SR)value of intracranial volume computed tomography angiography(CTA)in predicting the risk of intracranial aneurysm rupture.Methods A total of 81 patients with aneurysms who had follow-up records were selected.Among them,39 patients with unruptured aneurysms and underwent regular follow-ups,while 9 patients with unruptured aneurysms opted for surgical intervention.Additionally,surgery was performed on 33 patients with ruptured aneu-rysms.Three-dimensional reconstruction of CTA was performed to obtain the morphological parameters of aneurysms.The initial size ratio(SR)value of aneurysm and the follow-up SR value or postoperative c-SR value were obtained.The changes in SR values of unruptured aneurysms were analyzed,the preoperative SR values and postoperative c-SR values of aneurysms were analyzed.Finally,the correla-tion between the intial SR value of unruptured aneurysms and the c-SR value of ruptured aneurysms was compared.Results No sig-nificant difference was observed between the initial SR value of unruptured aneurysms and the follow-up SR value(P>0.05).Simi-larly,no significant difference was noted between the preoperative SR value of unruptured aneurysms and the postoperative c-SR value(P>0.05).The preoperative SR value of ruptured aneurysms differed significantly from the postoperative c-SR value(P<0.05).There was a significant difference between the initial SR value of unruptured aneurysms and the postoperative c-SR value of ruptured aneurysms(P<0.05).The receiver operating characteristic(ROC)curve analysis was performed on the initial SR value of unrup-tured aneurysms and the postoperative c-SR value of ruptured aneurysms.The area under the curve(AUC)was 0.860 and the best cut-off value was 1.045.Conclusion Unruptured aneurysms remain stable for an extended period of time,exhibiting no significant change in morphological parameters.It can be concluded that surgical intervention does not affect the SR value of aneurysms.In the case of subarachnoid hemorrhage caused by ruptured aneurysms,the parent artery become thinner,then the preoperative SR value of ruptured aneurysms may be exaggerated,which results in the distortion of the preoperative SR value of ruptured aneurysms.However,the postoperative c-SR value is the true SR value before the rup-ture of aneurysms.

Objective To explore the value of the corrected-size ratio(c-SR)value of intracranial volume computed tomography angiography(CTA)in predicting the risk of intracranial aneurysm rupture.Methods A total of 81 patients with aneurysms who had follow-up records were selected.Among them,39 patients with unruptured aneurysms and underwent regular follow-ups,while 9 patients with unruptured aneurysms opted for surgical intervention.Additionally,surgery was performed on 33 patients with ruptured aneu-rysms.Three-dimensional reconstruction of CTA was performed to obtain the morphological parameters of aneurysms.The initial size ratio(SR)value of aneurysm and the follow-up SR value or postoperative c-SR value were obtained.The changes in SR values of unruptured aneurysms were analyzed,the preoperative SR values and postoperative c-SR values of aneurysms were analyzed.Finally,the correla-tion between the intial SR value of unruptured aneurysms and the c-SR value of ruptured aneurysms was compared.Results No sig-nificant difference was observed between the initial SR value of unruptured aneurysms and the follow-up SR value(P>0.05).Simi-larly,no significant difference was noted between the preoperative SR value of unruptured aneurysms and the postoperative c-SR value(P>0.05).The preoperative SR value of ruptured aneurysms differed significantly from the postoperative c-SR value(P<0.05).There was a significant difference between the initial SR value of unruptured aneurysms and the postoperative c-SR value of ruptured aneurysms(P<0.05).The receiver operating characteristic(ROC)curve analysis was performed on the initial SR value of unrup-tured aneurysms and the postoperative c-SR value of ruptured aneurysms.The area under the curve(AUC)was 0.860 and the best cut-off value was 1.045.Conclusion Unruptured aneurysms remain stable for an extended period of time,exhibiting no significant change in morphological parameters.It can be concluded that surgical intervention does not affect the SR value of aneurysms.In the case of subarachnoid hemorrhage caused by ruptured aneurysms,the parent artery become thinner,then the preoperative SR value of ruptured aneurysms may be exaggerated,which results in the distortion of the preoperative SR value of ruptured aneurysms.However,the postoperative c-SR value is the true SR value before the rup-ture of aneurysms.

Objective:To standardize the management of Investigator-Initiated Trials(IITs) and improve the quality of research projects, this study takes a tertiary hospital in Beijing as an example to analyze the key risk points in the implementation process of IITs and proposes countermeasures based on the issues identified during the management process.Methods:The study analyzed the IITs conducted at in the hospital from 2022 to 2023, focusing on 4 aspects: project classification evaluation and management (risk management), project implementation quality (process management), collaboration and support conditions(contract review and execution), and participant protection (medical ethics). It examined the key points and difficulties in project process management to standardize the quality management of IITs.Results:The implementation process management of IITs in medical institutions was an essential component for standardized clinical research management and an effective means to ensure the scientific nature of clinical research and the quality of data.Conclusions:Medical institutions should establish an effective and feasible IIT quality management system to comprehensively enhance the quality of IIT project, aiming to produce high-quality clinical research outcomes.

Objective:To explore the symptoms of Ménière′s disease patients and their impact on quality of life.Methods:A cross-sectional study was conducted, consecutively enrolling patients of Ménière′s disease who visited the Otolaryngology Clinic at the Eye & ENT Hospital of Fudan University from October 2014 to December 2022. The Chinese version of the Ménière′s Disease Outcomes Questionnaire (MDOQ) and a Ménière′s disease-specific symptom checklist were utilized for assessment. SPSS 25.0 software was employed to perform multiple linear regression analysis to determine the impact of Ménière′s disease symptoms on patients′ quality of life.Results:A total of 790 patients with a definitive diagnosis of Ménière′s disease who met the inclusion and exclusion criteria were analyzed. The cohort comprised 418 males and 372 females, with a mean age of (54.8±13.1) years and a diagnosis duration ranging from 0 to 72 months, with a median of 3 months. The total score of the Chinese MDOQ was 61.0±12.0. The symptomatic presentations of the enrolled patients included hearing changes, tinnitus, aural fullness, drop attacks, vertigo episodes, visual instability, dizziness, and headache. Multiple linear regression analysis revealed that age, tinnitus, aural fullness, frequency of drop attacks, visual instability, dizziness, and headache were significant factors affecting the quality of life in Ménière′s disease patients ( F=145.50, P<0.05). Conclusions:The quality of life in Ménière′s disease patients requires improvement. Attention to the specific symptoms of Ménière′s disease and their impact on patients′ quality of life, along with targeted symptom interventions based on these findings, will be a focal point in future disease management.

BACKGROUND:It has been found that vascular endothelial growth factor 165 and bone morphogenetic proteins interact with each other during hypoxia-reoxygenation and are involved in the repair process of osteoblast injury by regulating the activation of intracellular signaling pathways. OBJECTIVE:To further investigate the relationship between vascular endothelial growth factor 165/bone morphogenetic protein and hypoxic-reoxygenated osteoblast injury. METHODS:Osteoblasts were selected and the hypoxic-reoxygenated injury model was established.Vascular endothelial growth factor 165 and bone morphogenetic protein expressions at mRNA and protein levels were detected by real-time PCR and western blot before and after modeling.After modeling,osteoblasts were given different concentrations of vascular endothelial growth factor 165 and bone morphogenetic protein 2(10,20,40 ng/mL).Cell proliferation was detected by cell counting kit-8 method and apoptosis was detected by DAPI at 12,24,36,48,and 72 hours after treatment. RESULTS AND CONCLUSION:Compared with before modeling,the mRNA and protein expressions of vascular endothelial growth factor 165 and bone morphogenetic protein 2 in osteoblasts after modeling were significantly decreased(P＜0.05).The proliferation rate of osteoblasts was significantly increased with the increase of vascular endothelial growth factor 165 concentration(P＜0.05),while the apoptosis rate of osteoblasts decreased significantly with the increase of vascular endothelial growth factor 165 concentration(P＜0.05).The proliferation rate of osteoblast was significantly increased with the increase of bone morphogenetic protein 2 concentration(P＜0.05),while the apoptosis rate of osteoblast decreased significantly with the increase of bone morphogenetic protein 2 concentration(P＜0.05).To conclude,vascular endothelial growth factor 165 and bone morphogenetic protein are lowly expressed in hypoxic-reoxygenated osteoblast injury,and treatment with vascular endothelial growth factor 165 and bone morphogenetic protein can reduce the injury of hypoxic-reoxygenated osteoblast in a concentration-dependent manner,suggesting that vascular endothelial growth factor 165 and bone morphogenetic protein have a significant protective effect against the injury of hypoxic-reoxygenated osteoblasts.

Objectives:To discuss the inhibitory effect of Lactobacillus reuteri on the replication of rotavirus(RV)strain SA11 in vivo and in vitro,and to clarify its effect on the expression of related immune factors.Methods:For in vitro experiments,Lactobacillus reuteri was cultured and identified,and the standard curve and growth curve were plotted to screen the optimal time and concentration for Lactobacillus reuteri cultivation.The cells were infected with Lactobacillus reuteri at the concentrations of 5×108,10×108,50×108,100×108,200×108,and 500×108 CFU·mL-1,and the surival rates of Caco-2 cells were detected by trypan blue staining method.Various concentrations of Lactobacillus reuteri were co-incubated with RV in vitro and applied to the Caco-2 cells.The cells were divided into negative control group(NC group),positive control group(PC group),and 107,108,109,and 1010 CFU·mL-1 Lactobacillus reuteri groups.Immunofluorescence focus method was used to detect the viral titers in the Caco-2 cells after treated with Lactobacillus reuteri and real-time fluorescence quantitative PCR(RT-qPCR)method was used to detect the copy numbers of RV VP6 gene in the Caco-2 cells after treated with various concentrations of Lactobacillus reuteri.In in vivo experiments,25 litters of SPF suckling mice were divided into control group,RV group(infected with SA11 strain),Ab-NC group(treated with antibiotic to deplete gut microbiota),Ab-RV group(depleting gut microbiota and then infected with SA11 strain),and Ab-Lac-RV group(depleting gut microbiota,treated with Lactobacillus reuteri,and then infected with SA11 strain).The fecal samples were collected on days 2,4,6,8,and 10 gavage,colon tissue sample were collected on day 4 of and RT-qPCR method was used to detect the copy numbers of RV VP6 gene in feces and the mRNA expression levels of interleukin(IL)-1β,IL-8,IL-10,interferon-γ(IFN-γ),and tumor necrosis factor-α(TNF-α)in colon tissue of the suckling mice in vartious groups.Results:The Lactobacillus reuteri grew well,with round,smooth,and milky white convex colonies and neat edges.After Gram staining,the bacteria appeared purple,irregular,and square-shaped rods.16SrDNA sequencing showed 99%sequence homology,indicating successful activation of Lactobacillus reuteri.The number of live Lactobacillus reuteri was linearly related to the absorbance(A)value,and the standard curve for regression analysis was Y=0.437 5X+0.000 6,R2=0.999 4.During the 0-2 h cultivation period,the bacteria were at the logarithmic growth phase with slow growth;from 2-14 h,the bacteria grew rapidly and stabilized at 14-16 h,reaching the growth rate peak at 16 h,after which they entered the decline phase.Infection with Lactobacillus reuteri at concentrations of 5×108,10×108,50×108,100×108,and 200×108 CFU·mL-1 resulted in the survival rates of Caco-2 cells were all>90%,so these concentrations were selected for the further experiments.Compared with PC group,the copy numbers of RV VP6 gene in the Caco-2 cells in 5×108,10×108,50×108,100×108,and 200×108 CFU·mL-1 Lactobacillus reuteri groups were significantly decreased(P<0.01).Compared with PC group,the viral titers in the Caco-2 cells in 107,108,109,and 1010 CFU·mL-1 Lactobacillus reuteri groups were significantly decreased(P<0.01).Compared with control group,the numbers of gut microbiota colonies in Ab-NC,Ab-RV,and Ab-Lac-RV groups were significantly decreased,indicating successful depletion of gut microbiota in the suckling mice.On days 2 and 4 after gavage,the RV VP6 gene copy number in the feces in Ab-RV group was significantly lower than that in RV group(P<0.05).On days 4,6,8,and 10 after gavage,the RV VP6 gene copy number in the feces in Ab-Lac-RV group was significantly lower than that in Ab-RV group(P<0.05).Compared with control group,the expression levels of IL-1β,IL-10,IFN-γ,and TNF-α mRNA in colon tissue in Ab-RV and Ab-Lac-RV groups were significantly increased(P<0.05 or P<0.01),while the expression level of IL-8 mRNA was significantly decreased(P<0.05),and the expression level of IL-10 mRNA in colon tissue in Ab-LAC-RV group was significantly increased(P<0.01).Conclusion:Lactobacillus reuteri may inhibit the RV replication by upregulating the expressions of IL-1β,IL-10,IFN-γ,and TNF-α mRNA and downregulating the expression of IL-8 mRNA.

Objective:To construct and test the reliability and validity of an assessment scale for self-management of patients with dry eye, so as to help patients establish dry eye related health behaviors.Methods:Based on the knowledge attitude and practice theory, the initial scale was constructed on the basis of literature review and qualitative interview, and revised through Delphi expert consultation and expert argumentation. After the preliminary investigation, 211 dry eye patients treated in the dry eye nursing outpatient department of Beijing Tongren Hospital from August 2023 to January 2024 were selected by convenience sampling method for questionnaire investigation to test the reliability and validity of the scale.Results:Among 211 dry eye patients, there were 58 males and 153 females, aged (39.31 ± 12.81) years old. The scale of self-management of patients with dry eye included 27 items in 3 dimensions: knowledge, attitude and behavior. The authority coefficient of the two rounds of expert consultation was 0.86, and the Kendall coordination index increased from 0.175 to 0.223 (both P < 0.01). The cumulative variance contribution rates of the three dimensions were 41.843%, 54.219% and 44.273%, respectively. The Cronbach α coefficient of the scale was 0.787, and the Spearman-Brown coefficient was 0.641. Conclusions:The scale of self-management of patients with dry eye has good reliability and validity and can be used in the assessment of dry eye patients to provide a reference basis for targeted guidance and intervention.

Objective:To prepare a humanized monoclonal antibody against periostin and establish a stable cell line.Meth-ods:Based on anti-periostin mouse monoclonal antibody developed by our laboratory,total RNA was extracted,and variable region sequences were obtained by RT-PCR amplification of VH and VL genes.The mouse antibody CDR region was transplanted into the human antibody framework receptor region,and the gene was subcloned into the expression vector PATX-GS2,and stably transfected into CHO cells.Monoclonal cell lines were obtained by MSX pressure screening and limited dilution.Results:VH and VL genes were amplified by RT-PCR,and the sequence of the light and heavy chain variable region were determined.Antibody humanization were successfully stablished by CDR transplantation method a murine antibody to a human framework,and a eukaryotic expression plasmid was constructed,which was transfected into CHO cells for expression,and human anti-periostin antibody was successfully obtained.ELISA and Western blot results showed that the humanized antibody had good anti-periostin activities and binding affinity.Conclu-sion:In this study,anti-periostin humanized monoclonal antibody has been successfully prepared,which can specifically bind to peri-ostin proteins in vivo and have biological activity,providing scientific data for the precise treatment of retinal fibrosis,tissue and organ fibrosis,and malignant tumors.