ObjectiveTo investigate the efficacy and safety of Babaodan Capsule （BBD） in the treatment of patients with chronic hepatitis B virus （HBV） infection with damp-heat in the liver and gallbladder comorbid with gallbladder polyps. MethodsA randomized， double-blinded， placebo-controlled single-center trial was conducted among 120 patients with chronic HBV infection who were admitted to Beijing YouAn Hospital， Capital Medical University， from August 2020 to April 2023， and they were divided into treatment group （BBD） and control group （placebo）， with 60 patients in each group. The course of treatment was 24 weeks， and follow-up assessments were conducted every 4 weeks. The primary outcome measures were the number and maximum diameter of gallbladder polyps （assessed by ultrasound）， and the secondary outcome measures included traditional Chinese medicine （TCM） syndrome score， blood lipid levels， and liver function parameters. The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups， and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups； the Wilcoxon rank-sum test was used for comparison of ranked data between two groups； the generalized estimating equation was used to analyze repeated measures data. ResultsAfter 8 weeks of treatment， the treatment group had a significantly smaller diameter of polyps and a significantly lower number of polyps than the control group （Z=-1.76 and -1.80， both P<0.05）， and after 24 weeks of treatment， the treatment group had a significantly higher polyp reduction rate than the control group （30.51% vs 10.91%， P<0.05）. The subgroup analysis showed that patients receiving combined antiviral therapy， male patients， patients with a diameter of polyps of <5 mm， and patients with multiple polyps tended to achieve significantly greater benefits. At week 8 of treatment， the treatment group had a significantly better TCM syndrome score than the control group （Z=-2.35， P<0.05）； after treatment， compared with the control group， the treatment group had a significantly greater increase in high-density lipoprotein （Z=-1.85， P<0.05） and significantly lower levels of alanine aminotransferase （Z=-2.06， P <0.05）， aspartate aminotransferase （Z=-2.13， P<0.05）， total bilirubin （Z=-2.12， P<0.05）， and direct bilirubin （Z=-3.09， P<0.05）. No serious adverse events were reported in either group. ConclusionBBD can effectively reduce the size of gallbladder polyps， improve TCM syndrome score， and reduce the level of bilirubin in patients with chronic HBV infection with damp-heat in the liver and gallbladder， with a favorable safety profile， and it may be more suitable for patients receiving combined antiviral therapy and specific subgroups （male patients， patients with a diameter of polyps of <5 mm， and patients with multiple polyps.

[Objective]To explore the correlation between general anesthesia and mild cognitive impairment in older adults so as to provide new ideas for early prevention and timely intervention of mild cognitive impairment(MCI).[Methods]Based on the baseline survey of the Hubei memory and aging cohort study(2018-2023),the participants completed a thorough neuropsychological assessment and physical examination,and self-reported a history of general anesthesia and surgery.The association of general anesthesia and MCI in the elderly was analyzed using the logistic regression model.In addition,the stratification and interaction analysis of anesthesia history,anesthesia number and physical intellectual exercise were conducted separately.[Results]A total of 5 069 older adults aged 65 and above were included in this study,including 3 692 city dwellers and 1 377 rural people,among whom were 2 584 women(51%).Out of the 1 472 participants with history of general anesthesia,249 people(17.4%)had MCI.After controlling for confounding factors,there was a 39.6%increased risk of MCI in older adults who underwent general anesthesia[OR=1.396,95%CI(1.169,1.668),P<0.001],suggesting that general anesthesia may be an independent influence on MCI.For the older adults who had one general anesthesia[OR=1.235,95%CI(1.001,1.523),P=0.049],two general anesthesia[OR=1.779,95%CI(1.292,2.450),P<0.001],and three OR more general anesthesia[OR=2.395,95%CI(1.589,3.610),P<0.001],their risks of MCI were increased by 23.5%,77.9%,and 139.5%,respectively.Compared with the older adults without a history of general anesthesia who did not exercise,the risk of developing MCI was significantly negatively correlated with the exercise group,cognitive exercise group,and combined exercise and cognitive exercise groups(all P<0.001).The risk of developing MCI in the exercise group was 60.2%of that in the no exercise group[OR=0.602,95%CI(0.456,0.795)],the risk in the cognitive exercise group was 42.4%of that in the no exercise group[OR=0.424,95%CI(0.294,0.613)],and the risk in the combined exercise and cognitive exercise group was 27.0%of that in the no exercise group[OR=0.270,95%CI(0.208,0.353)].In the older adults with a history of general anesthesia,compared with the no exercise group,the risk of developing MCI was significantly negatively correlated with the cognitive exercise group and the combined exercise and cognitive exercise group(all P<0.05).The risk of developing MCI in the cognitive exercise group was 47.7%of that in the no exercise group[OR=0.477,95%CI(0.256,0.892)],the risk in the combined exercise and cognitive exercise group was 34.5%of that in the no exercise group[OR=0.345,95%CI(0.220,0.540)],while the risk in the exercise-only group did not show a significant difference.[Conclusion]The risk of MCI increased significantly in older adults with a history of general anesthesia,and this risk increased with the times of anesthesia.Physical and mental exercise reduces the risk of MCI.it is recommended that older adults with a history of anesthesia incorporate physical and mental exercise into their daily lives to prevent mild cognitive impairment.

Objective:To explore the effect of persuasion system-based health intervention in orthodontic patients treated with clear aligners.Methods:From January 2022 to December 2023, convenience sampling was used to select patients treated with clear aligners at the Department of Orthodontics in Affiliated Stomatological Hospital of Nanjing Medical University as participants. Patients admitted from January to December 2022 were included in the control group ( n=60), and those admitted from January to December 2023 were included in the observation group ( n=59). The control group received health guidance based on the theory of knowledge, attitude, and practice. Based on the control group, the observation group added health intervention with the assistance of a persuasion system. After one year of intervention, the oral care self-efficacy, enamel demineralization, periodontal health index (gingival index, plaque index, sulcus bleeding index, probing depth), and restart rate of both groups were evaluated. Results:After the intervention, the scores of the Self-efficacy Scale for Self-care in the observation group were higher than those in the control group, and the difference was statistically significant [ (71.03±1.97) vs. (57.82±2.58), P<0.01]. The enamel demineralization rate, periodontal health index (plaque index, gingival index, sulcus bleeding index, probing depth) score, and restart rate in observation group were all lower than those in control group ( P<0.05) . Conclusions:Persuasion system system-based health intervention can improve the oral care self-efficacy of orthodontic patients treated with clear aligners, alleviate oral health issues during clear aligners, and reduce the restart rate of clear aligner patients.

Objective To investigate the association between dietary behavior and mild cognitive impairment(MCI)in older adults,and to further analyze the role of cardiometabolic comorbidities in this relationship.Methods A total of 6599 older adults were recruited from 3 communities and 48 villages in Dawu County between 2018 and 2023 as part of the Hubei Elderly Memory Cohort Study.Dietary behaviors were assessed using a food frequency questionnaire and a dietary behavior questionnaire.Latent class analysis was performed to categorize the participants into healthy eat-ing behavior(HEB),sub-healthy eating behavior(SHEB),and unhealthy eating behavior(UEB).Cardiovascular-metabolic diseases were diabetes,hypertension,coronary heart disease,and cere-brovascular disease,which all diagnosed by physicians.MCI was diagnosed by a team of clinical experts according to Peterson's criteria.Multivariable logistic regression model was used to ana-lyze the impact of cardiometabolic comorbidities on the association between dietary behavior and MCI.Results The morbidity rate of MCI was 24.3％,and that of HEB,SHEB and UEB was 16.6％,24.3％and 31.3％,respectively.The incidence of MCI was higher in the participants who were female,over ≥75 years old,unmarried,and lack physical exercise,SHEB and UEB groups,had low educational level,lived in rural areas,had no stable income,had abnormal BMI,and more types of cardiometabolic diseases(P＜0.05,P＜0.01).After adjusting for confounders,multivari-able logistic regression analysis indicated that both UEB(OR=1.220,95％CI:1.004-1.418,P=0.045)and SHEB(OR=1.592,95％CI:1.345-1.883,P=0.001)were positively correlated with MCI risk in older adults.Further stratified analysis by cardiometabolic comorbidities revealed that for the patients in the HEB group,those suffering from hypertension+diabetes+coronary heart disease had the highest risk for MCI(OR=4.220,95％CI:1.913-9.309,P=0.001),while for the SHEB group,the following comorbidities were significantly associated with increased MCI risk:hypertension+diabetes(OR=1.640,95％CI:1.157-2.322,P=0.005),hypertension+cerebro-vascular disease(OR=1.454,95％CI:1.041-2.031,P=0.028),hypertension+diabetes+cere-brovascular disease(OR=2.064,95％CI:1.246-3.419,P=0.005),and hypertension+diabetes+coronary heart disease+cerebrovascular disease(OR=1.974,95％CI:1.036-3.760,P=0.039).Conclusion Older adults with SHEB or UEB have a higher risk of developing MCI,and the pres-ence of cardiometabolic comorbidities further exacerbates this risk.

Objective To investigate the association between dietary behavior and mild cognitive impairment(MCI)in older adults,and to further analyze the role of cardiometabolic comorbidities in this relationship.Methods A total of 6599 older adults were recruited from 3 communities and 48 villages in Dawu County between 2018 and 2023 as part of the Hubei Elderly Memory Cohort Study.Dietary behaviors were assessed using a food frequency questionnaire and a dietary behavior questionnaire.Latent class analysis was performed to categorize the participants into healthy eat-ing behavior(HEB),sub-healthy eating behavior(SHEB),and unhealthy eating behavior(UEB).Cardiovascular-metabolic diseases were diabetes,hypertension,coronary heart disease,and cere-brovascular disease,which all diagnosed by physicians.MCI was diagnosed by a team of clinical experts according to Peterson's criteria.Multivariable logistic regression model was used to ana-lyze the impact of cardiometabolic comorbidities on the association between dietary behavior and MCI.Results The morbidity rate of MCI was 24.3％,and that of HEB,SHEB and UEB was 16.6％,24.3％and 31.3％,respectively.The incidence of MCI was higher in the participants who were female,over ≥75 years old,unmarried,and lack physical exercise,SHEB and UEB groups,had low educational level,lived in rural areas,had no stable income,had abnormal BMI,and more types of cardiometabolic diseases(P＜0.05,P＜0.01).After adjusting for confounders,multivari-able logistic regression analysis indicated that both UEB(OR=1.220,95％CI:1.004-1.418,P=0.045)and SHEB(OR=1.592,95％CI:1.345-1.883,P=0.001)were positively correlated with MCI risk in older adults.Further stratified analysis by cardiometabolic comorbidities revealed that for the patients in the HEB group,those suffering from hypertension+diabetes+coronary heart disease had the highest risk for MCI(OR=4.220,95％CI:1.913-9.309,P=0.001),while for the SHEB group,the following comorbidities were significantly associated with increased MCI risk:hypertension+diabetes(OR=1.640,95％CI:1.157-2.322,P=0.005),hypertension+cerebro-vascular disease(OR=1.454,95％CI:1.041-2.031,P=0.028),hypertension+diabetes+cere-brovascular disease(OR=2.064,95％CI:1.246-3.419,P=0.005),and hypertension+diabetes+coronary heart disease+cerebrovascular disease(OR=1.974,95％CI:1.036-3.760,P=0.039).Conclusion Older adults with SHEB or UEB have a higher risk of developing MCI,and the pres-ence of cardiometabolic comorbidities further exacerbates this risk.

Objective:To explore the effect of persuasion system-based health intervention in orthodontic patients treated with clear aligners.Methods:From January 2022 to December 2023, convenience sampling was used to select patients treated with clear aligners at the Department of Orthodontics in Affiliated Stomatological Hospital of Nanjing Medical University as participants. Patients admitted from January to December 2022 were included in the control group ( n=60), and those admitted from January to December 2023 were included in the observation group ( n=59). The control group received health guidance based on the theory of knowledge, attitude, and practice. Based on the control group, the observation group added health intervention with the assistance of a persuasion system. After one year of intervention, the oral care self-efficacy, enamel demineralization, periodontal health index (gingival index, plaque index, sulcus bleeding index, probing depth), and restart rate of both groups were evaluated. Results:After the intervention, the scores of the Self-efficacy Scale for Self-care in the observation group were higher than those in the control group, and the difference was statistically significant [ (71.03±1.97) vs. (57.82±2.58), P<0.01]. The enamel demineralization rate, periodontal health index (plaque index, gingival index, sulcus bleeding index, probing depth) score, and restart rate in observation group were all lower than those in control group ( P<0.05) . Conclusions:Persuasion system system-based health intervention can improve the oral care self-efficacy of orthodontic patients treated with clear aligners, alleviate oral health issues during clear aligners, and reduce the restart rate of clear aligner patients.

Objective:To investigate the effects of Wumei-Fangfeng drug on Treg/Th17 immune balance in allergic rhinitis(AR)mice via regulating MMP9 derived from mast cell exosomes.Methods:Potential targets of Wumei and Fangfeng were screened,and the intersection was taken from the targets and AR risk genes,subsequently GO analysis and protein-protein interaction analysis were performed to screen therapeutic targets.AR mice model were constructed,mast cells and exosomes were separate from femurs of mice.Wumei-Fangfeng drug and exosomes were used to treat mice.The behavioral scores of mice in each group were evaluated,mRNA expressions of Foxp3,RORγt were detected in nasal mucosa of mice.After knocking down of MMP9 in exosomes,the behavioral score,Foxp3 and RORγt mRNA expressions were observed in AR mice.Results:Bioinformatics results showed that Wumei-Fangfeng drug may act on AR by mast cell exosomes derived IL-1β and MMP9.Compared with normal mice,mRNA expression of Foxp3 in AR mice was decreased,while RORγt mRNA expression was increased,and MMP9 expression was increased(all P<0.05).Expression of Foxp3 mRNA was increased,and expressions of RORγt and MMP9 were decreased in AR mice treated with Wumei-Fangfeng drug,however,mast cell exosomes could further counteract the effects of Wumei-Fangfeng drug,and the effects of mast cell exosomes was weakened after MMP9 knockdown.Conclusion:Wumei-Fangfeng drug regulates the imbalance of Treg/Th17 in AR mice by inhibiting the exosomal MMP9 of bone marrow-derived mast cells.

The syndrome/pattern of defensive qi deficiency is a common basic syndrome of traditional Chinese medicine in clinical practice. However,there is a lack of standardized and operable diagnostic specifications in practical applications. Based on the previous literature,this study proposed the idea of starting from the elements of the syndrome,qualitative diagnostic criteria for the syndrome/pattern of defensive qi deficiency oriented to the entire region of the disease were constructed based on the two dimensions of " deficient defensive qi failing to consolidate the exterior" and " qi deficiency" and constructing a set of quantitative evaluation criteria as the supporting content for the diagnostic items. The core members of the research group attempted to formulate the draft standard,then reached a consensus through the Delphi method expert questionnaire consultation and the Nominal group technique,and finally evaluated the reliability and validity of the standard through clinical verification to provide ideas for the standardization and normalization of research on syndromes.

Trials within cohorts （TwiCs） are design methods derived from randomized controlled trials （RCTS）. They have been widely used in chronic disease areas such as tumors and cardiovascular diseases. The basis of the TwiCs design is a prospective cohort of specific diseases. When RCTS need to be implemented， some patients meeting the inclusion and exclusion criteria are randomly sampled from the cohort to receive "trial interventions"， while the remaining patients in the cohort who meet the inclusion and exclusion criteria continue to receive conventional treatment as control groups. By comparing the efficacy differences between the intervention measures of the trial group and the control group， the efficacy of intervention measures was evaluated. Within the cohort， the same process could be repeated to carry out multiple RCTS， so as to evaluate different intervention measures or compare the efficacy of different doses or timing of interventions. Compared with classical RCTS， TwiCs make it easier to recruit patients from the cohort and have higher external validity， providing a new research paradigm for improving the efficiency and applicability of RCTS in clinical practice. However， TwiCs may also face the challenge of poor compliance of patients in the cohort. Researchers need to take effective measures to control these patients in the design and operation of TwiCs. This article focused on the methodological key points during the implementation of TwiCs， including multi-stage informed consent （patients are informed of consent at three stages： entering the cohort， entering the trial group， and after the trial）， randomization procedures （only random sampling of patients from the cohort to receive "trial interventions"）， sample size calculation， and statistical analysis methods. The article also compared the differences between TwiCs and traditional RCTS and illustrated TwiCs research design and analysis with examples， so as to provide new research ideas and methods for clinical researchers.

Objective:To compare the differences in the prevalence of mild micro-hepatic encephalopathy (MHE) among patients with cirrhosis by using the psychometric hepatic encephalopathy score (PHES) and the Stroop smartphone application (Encephal App) test.Methods:This prospective, multi-center, real-world study was initiated by the National Clinical Medical Research Center for Infectious Diseases and the Portal Hypertension Alliance and registered with International ClinicalTrials.gov (NCT05140837). 354 cases of cirrhosis were enrolled in 19 hospitals across the country. PHES (including digital connection tests A and B, digital symbol tests, trajectory drawing tests, and serial management tests) and the Stroop test were conducted in all of them. PHES was differentiated using standard diagnostic criteria established by the two studies in China and South Korea. The Stroop test was evaluated based on the criteria of the research and development team. The impact of different diagnostic standards or methods on the incidence of MHE in patients with cirrhosis was analyzed. Data between groups were differentiated using the t-test, Mann-Whitney U test, and χ2 test. A kappa test was used to compare the consistency between groups. Results:After PHES, the prevalence of MHE among 354 cases of cirrhosis was 78.53% and 15.25%, respectively, based on Chinese research standards and Korean research normal value standards. However, the prevalence of MHE was 56.78% based on the Stroop test, and the differences in pairwise comparisons among the three groups were statistically significant (kappa = -0.064, P < 0.001). Stratified analysis revealed that the MHE prevalence in three groups of patients with Child-Pugh classes A, B, and C was 74.14%, 83.33%, and 88.24%, respectively, according to the normal value standards of Chinese researchers, while the MHE prevalence rates in three groups of patients with Child-Pugh classes A, B, and C were 8.29%, 23.53%, and 38.24%, respectively, according to the normal value standards of Korean researchers. Furthermore, the prevalence rates of MHE in the three groups of patients with Child-Pugh grades A, B, and C were 52.68%, 58.82%, and 73.53%, respectively, according to the Stroop test standard. However, among the results of each diagnostic standard, the prevalence of MHE showed an increasing trend with an increasing Child-Pugh grade. Further comparison demonstrated that the scores obtained by the number connection test A and the number symbol test were consistent according to the normal value standards of the two studies in China and South Korea ( Z = -0.982, -1.702; P = 0.326, 0.089), while the other three sub-tests had significant differences ( P < 0.001). Conclusion:The prevalence rate of MHE in the cirrhotic population is high, but the prevalence of MHE obtained by using different diagnostic criteria or methods varies greatly. Therefore, in line with the current changes in demographics and disease spectrum, it is necessary to enroll a larger sample size of a healthy population as a control. Moreover, the establishment of more reliable diagnostic scoring criteria will serve as a basis for obtaining accurate MHE incidence and formulating diagnosis and treatment strategies in cirrhotic populations.