ObjectiveTo investigate the correlation of the serum levels of aminotransferases and their ratios with liver inflammation activity in pediatric chronic hepatitis B （pCHB） patients， and to provide a basis for selecting the dominant population for treatment. MethodsThis study was conducted among 1 267 pCHB patients who were admitted to The Fifth Medical Center of Chinese PLA General Hospital from January 2010 to August 2022 and these patients did not receive antiviral therapy. The patients were analyzed in terms of demographic features， blood routine， blood biochemistry， HBV serological markers， and liver biopsy data. According to liver inflammation activity based on liver biopsy， the patients were divided into no or mild inflammation activity （G0‍ ‍—‍ ‍G1） group and significant inflammation activity （G2‍ ‍—‍ ‍G4） group. The serum levels of aminotransferases and their ratios were compared between groups， and their correlation with liver inflammation activity in pCHB patients was analyzed. Additionally， the patients were stratified by the age， and the relationship between serum aminotransferase levels and liver inflammation activity was analyzed in each age group. For comparison of continuous data between two groups， the independent samples t-test was used when the data were normally distributed， while the Mann-Whitney U test was used when the data were not normally distributed； the chi-square test was employed for comparison of categorical data between two groups. A Spearman’s correlation analysis was performed for correlation assessment. ResultsAmong the 1 267 pCHB patients， there were 468 （36.9%） in the G0‍ ‍—‍ ‍G1 group and 799 （63.1%） in the G2‍ ‍—‍ ‍G4 group， and there were significant differences between the two groups in the levels of aspartate aminotransferase （AST）， alanine aminotransferase （ALT）， AST/ALT ratio， gamma-glutamyl transpeptidase （GGT）， total bilirubin， direct bilirubin， HBeAg quantification， low-density lipoprotein， and platelet count （PLT） （all P<0.05）. The correlation analysis showed that liver inflammation activity was negatively correlated with PLT and low-density lipoprotein （both P<0.05） and was positively correlated with GGT， total bilirubin， direct bilirubin， and HBeAg titer （all P<0.05）， while it was not significantly correlated with ALT， AST， and AST/ALT ratio （all P>0.05）. In the 0‍ ‍—‍ ‍12 years group， the 13‍ ‍—‍ ‍18 years male group， and the 13‍ ‍—‍ ‍18 years female group， liver inflammation activity aggravated with the increases in the serum levels of ALT and AST， and there were significant differences between groups （all P<0.05）. In the 0‍ ‍—‍ ‍12 years group， there was a significant difference in significant liver inflammation activity between the AST/ALT ratio >1 group and the AST/ALT ratio ≤1 group （P<0.001）. Among the 1 267 patients， 447 （35.28%） had an ALT level of <2×upper limit of normal （ULN）， among whom 196 （43.85%） had G≥2 liver inflammation， accounting for 15.47% of all children enrolled. ConclusionLiver inflammation activity is not significantly correlated with ALT， AST， and AST/ALT ratio in pCHB patients， suggesting that the serum levels of aminotransferases cannot truly reflect liver inflammation activity in pCHB patients with an aminotransferase level of <2×ULN. In clinical practice， liver biopsy should be performed for children with an aminotransferase level of <2×ULN to clarify whether antiviral therapy should be performed.

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BackgroundThe adolescent mood disorders become more prevalent， imposing progressively greater perceived and actual caregiving burdens on caregivers， while the current health education resources， delivery formats and training programs remain insufficient in addressing their needs. ObjectiveTo evaluate the effect of structured health education on the caregiver burden associated with adolescent mood disorders， thereby informing evidence-based strategies for alleviating the burden. MethodsA total of 195 caregivers of adolescent inpatients with mood disorders admitted to a tertiary general hospital in Mianyang from June 1， 2020 to July 31， 2022 were consecutively enrolled and randomly assigned to either the research group （n=99） or the control group （n=96） using random number table method. Both groups received routine health education. In addition， the research group participated in a structured health education program comprising three modules covering disease knowledge， medication management， coping with family stress， and guidance for daily living. Upon admission， baseline information regarding both caregivers and adolescent inpatients was collected though a self-administered questionnaire. Caregiver Strain Index （CSI） was administered to assess caregiver burden at admission， discharge， and 1， 3 and 6 months post-discharge. A self-designed health education feedback questionnaire was administered on the day of discharge to evaluate caregivers' feedback on the health education. At 6 months post-discharge， data on any hospital readmission were collected. ResultsUltimately， 85 caregivers （85.86%） in the research group and 84 caregivers （87.50%） in the control group completed the study. Generalized estimating equation analysis revealed significant time effects and group-by-time interaction effects on CSI scores between the two groups （Wald χ²=790.347， 10.047， P<0.05 or 0.01）. There was no statistically significant difference between the two groups in terms of access to disease information， trust preference and core information needs （P>0.05）. Additionally， caregivers in the research group reported significantly better understanding of the disease-related knowledge and higher ratings on the effectiveness of health education when compared to the control group， with statistically significant differences （P<0.01）. ConclusionIn contrast to routine health education， structured health education may help alleviate caregiving burden among caregivers of adolescents with mood disorders.［Funded by Sichuan Medical Association Project （number， Q190004）］

The food effect(FE)on drug absorption is an important part of clinical pharmacological studies of new drugs.The caloric ratios for each component of a high-fat meal are specified in the"Technical Guidelines for Food Bioavailability and Postprandial Bioequivalence Studies"approved by the US Food and Drug Administration(FDA)and the"Technical Guidelines for Food Effect Studies in New Drug Development"approved by the National Medical Products Administration.However,the recipes for high-fat meals vary among clinical research centers,showing their advantages and disadvantages.Thus,we present a modified version of high-fat meal recipes with easy-to-quantify calories,which is a combination of Western and Chinese flavors,easy to prepare,and meets Chinese tastes.The center satisfaction surveys showed that our modified version of the high-fat meal recipe greatly improved subject satisfaction and compliance,thus better safeguarding the quality of the trial.

Objective To compare the bioavailability and bioequivalence of pivastatin calcium dispersive tablets in healthy Chinese subjects.Methods A single dose of pitavastatin calcium(2 mg)was orally administered to the test preparation or reference preparation under fasting and postprandial conditions,respectively.The plasma concentrations of pitavastatin calcium were measured at different time points before and after administration by high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS).The bioequivalence of the two formulations was evaluated.Results Subjects received pitavastatin calcium test preparation and reference preparation in fasting condition,the Cmax were(47.79±23.99)and(46.03±21.82)ng·L-1;AUC0_,were(96.56±42.64)and(97.96±35.40)ng·h·L-1;AUC0_∞ were(102.09±43.01)and(103.46±35.62)ng·h·L-1,respectively.The 90％confidence intervals of the geometric mean ratios of Cmax,AUC0_t and AUC0-∞ of pitavastin-calcium test formulation and reference formulation were 96.28％-111.16％,94.46％-101.19％and 94.77％-101.31％,respectively.Subjects received pitavastatin calcium test preparation and reference preparation in fasting condition,the Cmax were(27.32±10.68)and(28.58±11.39)ng·L-1;AUC0_t were(82.76±27.58)and(84.06±29.12)ng·h·L-1;AUC0_∞ were(87.88±26.93)and(89.29±29.18)ng·h·L-1,respectively.The 90％confidence intervals of the geometric mean ratios of Cmax,AUC0_t and AUC0_∞ of the test formulation and the reference formulation of pitavastatin calcium were 87.39％-102.10％,94.62％-101.34％and 94.88％-101.47％,respectively.All of them were within the bioequivalence range of 80.00％to 125.00％.Conclusion Two pivastatin calcium dispersion tablets were bioequivalent and safe in healthy Chinese adult subjects.

Objective To elucidate utilization patterns,cost and safety of Bruton's tyrosine kinase inhibitors(BTKi)in the real world.Methods A retrospective cohort was designed and constructed using real-world BTKi data from a single lymphoma center.Descriptive analysis was performed to describe the demographic and clinical characteristics of the population.Medicine utilization and cost were quantified by defined daily doses(DDDs)and defined daily dose cost(DDDc),respectively.A generalized estimating equation(GEE)was used to explore the potential influencing factors of platelet aggregation rate(PAR).Results The study cohort included 193 patients[median age,65 years;77(39.90％)women],most of whom received ibrutinib(n=109,56.48％),and 77.20％patients combined BTKi with chemotherapy or targeted therapy.The implementation of national negotiation policy had a large impact on medicine utilization and cost.The DDDs difference between the two BTKis was reduced from 18.55 to 1.41 times.The DDDc for ibrutinib decreased from 1 619.99 Yuan to 567.00 Yuan,and that for zanubrutinib from 706.25 Yuan to 340.00 Yuan was already lower than ibrutinib.Interruptions were more readily observed in patients treated with ibrutinib,and hematological toxicity was the main adverse drug event(ADE)leading to treatment interruption.Besides,the GEE model showed that combining BTKi with antiplatelet medication significantly decreases the PAR[β=-34.35％,95％confidence interval(CI):-41.60％--27.11％,P＜0.001].Compared to zanubrutinib,ibrutinib also notably reduces the PAR(β=-12.38％,95％CI:-24.50％--0.27％,P＜0.05).Conclusion After the implementation of national negotiation policy,there is no significant difference in the clinical preference for two BTKis.Compared with ibrutinib,zanubrutinib showed an advantage in terms of economic profile,treatment interruptions caused by ADE,and the effect on PAR.

Objective To observe the therapeutic effects and mechanisms of Guanyuan Mingmen Sequential Acupuncture on rats with premature ovarian insufficiency(POI)model.Methods Female SD rats were divided into the blank group,the model group,the protein kinase A(PKA)inhibitor(H89)+acupuncture group,and the acupuncture group,with 12 rats in each group.Except for the blank group,the POI model was prepared by gavage with Tripterygium Glycosides Tablets in the other three groups of rats.After the model was successfully established,the blank group and the model group were bundled once a day;in the acupuncture group,Guanyuan(RN4)point was taken during the intermotility period,and in the pre-motility period,Mingmen(DU4)point was taken;in the H89+acupuncture group,the intervention was performed in accordance with the acupuncture protocol of the acupuncture group,and H89 was injected intraperitoneally for 30 minutes prior to each acupuncture session.Continuous intervention was performed for 20 days.Samples were taken from each group of rats in the first estrus period and in proestrus period after intervention.Enzyme-linked immunosorbent assay(ELISA)was used to measure the levels of follicle stimulating hormone(FSH)and estradiol(E2)during the estrous phase,Western Blot was used to measure the protein expressions of follicle stimulating hormone receptor(FSHR)and aromatase P450(P450arom)during the estrous phase,and the activity of granulocytes during the estrous phase and the proestrus phase were measured using the cell-counting kit 8(CCK-8)method.The immunohistochemistry method was used to detect the protein expression of pre-motility proliferating cell nuclear antigen(PCNA).Results(1)Compared with the blank group,the serum FSH level of the model group and H89+acupuncture group was significantly increased(P＜0.01),and the E2 level was significantly decreased(P＜0.001);there was no difference between the FSH level of the H89+acupuncture group and that of the model group(P＞0.05),and the E2 level of the H89+acupuncture group was lower than that of the model group(P＜0.05);the FSH level of the acupuncture group was lower than that of the model group and that of the H89+acupuncture group(P＜0.05),had no difference with the blank group(P＞0.05),E2 level was significantly higher than the model group and H89+ acupuncture group(P＜0.01),still being lower than the blank group(P＜0.05).(2)The protein expressions of FSHR and P450arom in the model group and H89 + acupuncture group was lower than those in the blank group;the protein expression of FSHR in the H89 + acupuncture group was not different from that in the model group(P＞0.05),while the protein expression level of P450arom was lower than that in the model group(P＜0.05);the protein expression levels of FSHR and P450arom in the acupuncture group were higher than those in the model group and H89 + acupuncture group,but still lower than those in the blank group(P＜0.05).(3)Both GCs activity and average optical density value of PCNA in the model group and H89+acupuncture group were lower than the blank group(P＜0.05);both GCs activity and average optical density value of PCNA in the H89+acupuncture group were lower than the model group(P＜0.05);the activity of GCs and average optical density value of PCNA of the acupuncture group were significantly higher than that of the model group and H89+acupuncture group(P＜0.05 or P＜0.01).Conclusion Guanyuan Mingmen Sequential Acupuncture can regulate sex hormone levels,increase GCs activity and promote GCs cell proliferation by up-regulating protein expressions of follicle stimulating hormone receptor(FSHR)/cyclic adenosine monophosphate(cAMP)/protein kinase A(PKA)pathway FSHR,P450arom,thus improving POI.

Objective To explore the relationship and internal path between activities of daily living(ADL),sleep quality and mental health of community elderly people in Shanghai.Methods A questionnaire survey was conducted among community residents aged 60 years and older seeing doctors in community health care center of five streets in Shanghai during Sept to Dec,2021 using convenience sampling.Activities of Daily Living(ADL),Pittsburgh Sleep Quality Index(PSQI)and 10-item Kessler Psychological Distress Scale(K10)were adopted in the survey.Single factor analysis,correlation analysis and multiple linear regression were used to analyze the data.The effect relationship between the variables was tested using Bootstrap's mediated effects test.Results A total of 1 864 participants were included in the study.The average score was 15.53±4.47 for ADL,5.60±3.71 for PSQI and 15.50±6.28 for K10.The rate of ADL impairment,poor sleep quality,poor and very poor mental health of the elderly were 23.6%,27.3%,11.9%and 4.9%,respectively.ADL and sleep quality were all positively correlated with mental health(r=0.321,P＜0.001;r=0.466,P＜0.001);ADL was positively correlated with sleep quality(r=0.294,P＜0.001).Multiple linear results of factors influencing mental health showed that ADL(β= 0.457,95%CI:0.341-0.573),sleep quality(β =0.667,95%CI:0.598-0.737)and mental health were positively correlated(P＜0.001).Sleep quality partially mediated the relationship between ADL and mental health(95%CI:0.078-0.124)with an effect size of 33.0%.Conclusion Sleep quality is a mediator between ADL and mental health among community elderly people.Improving ADL and sleep quality may improve mental health in the population.

Objective To investigate the risk factors for postoperative pulmonary embolism in patients with spontaneous cerebral hemorrhage,and construct and verify the nomogram model.Methods A retrospective cohort study was conducted on 558 patients admitted in the First Affiliated Hospital of Chongqing Medical University and the Three Gorges Hospital Affiliated to Chongqing University.And 393 of them who hospitalized from January 2015 to January 2021 were assigned into a modeling group,and the other 165 patients from February 2021 to January 2023 into a validation group.Univariate and multivariate stepwise logistic regression analyses were used to screen out the risk factors associated with pulmonary embolism after spontaneous cerebral hemorrhage surgery.Then a nomogram model was build based on these factors and verified.Results Based on age,blood loss,Glasgow coma scale(GCS)score,surgical treatments,levels of fibrin degradation products,D-dimer and hemoglobin,plasma osmolality,and deep vein thrombosis,a risk model of pulmonary embolism was built.Receiver operating characteristic(ROC)curve analysis showed the model had good discriminability for the presence of pulmonary embolism,and the area under the curve(AUC)value was 0.908.Hosmer-Lemeshow goodness-fit test indicated that the model had a good fit to the verification set(Chi-square=14.805,df=8,P=0.063),the correction curve was close to the ideal curve,and the prediction probability of the model was close to the actual occurrence probability,suggesting the model having good accuracy.Decision curve analysis revealed that the established nomogram model can get benefits under a large range of threshold probabilities.Conclusion We develop a prediction model for postoperative pulmonary embolism in patients with spontaneous cerebral hemorrhage after surgical treatment,which shows good prediction performance in both the training and validation groups,and can be used for accurate,prompt and quick identification for the occurrence of pulmonary embolism in clinical practice.

Objective:To explore the role of mechanical hemodynamic support (MHS) in mapping and catheter ablation of patients with hemodynamically unstable ventricular tachycardia (VT), report single-center experience in a cohort of consecutive patients receiving VT ablation during MHS therapy, and provide evidence-based medical evidence for clinical practice.Methods:This was a retrospective cohort study. Patients with hemodynamically unstable VT who underwent catheter ablation with MHS at Beijing Anzhen Hospital, Capital Medical University between August 2021 and December 2023 were included. Patients were divided into rescue group and preventive group according to the purpose of treatment. Their demographic data, periprocedural details, and clinical outcomes were collected and analyzed.Results:A total of 15 patients with hemodynamically unstable VT were included (8 patients in the rescue group and 7 patients in the preventive group). The acute procedure was successful in all patients. One patient in the rescue group had surgical left ventricular assist device (LVAD) implantation, remaining 14 patients received extracorporeal membrane oxygenation (ECMO) for circulation support. ECMO decannulation was performed in 12 patients due to clinical and hemodynamic stability, of which 6 patients were decannulation immediately after surgery and the remaining patients were decannulation at 2.0 (2.5) d after surgery. Two patients in the rescue group died during the index admission due to refractory heart failure and cerebral hemorrhage. During a median follow-up of 30 d (1 d to 12 months), one patient with LVAD had one episode of ventricular fibrillation at 6 months after discharge, and no further episodes of ventricular fibrillation and/or VT occurred after treatment with antiarrhythmic drugs. No malignant ventricular arrhythmia occurred in the remaining 12 patients who were followed up.Conclusions:MHS contributes to the successful completion of mapping and catheter ablation in patients with hemodynamically unstable VT, providing desirable hemodynamic status for emergency and elective conditions.