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Objective:To explore the independent predictive factors of cirrhosis in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection, and establish a nomogram model based on clinical laboratory data and analyze the predictive value of this model.Methods:The laboratory data of 596 patients with HBeAg-negative chronic HBV infection and 677 patients with hepatitis B cirrhosis, who were hospitalized in the First Hospital of China Medical University from 2011 to 2021, were retrospectively analyzed. Patients were randomly divided into training group ( n=892) and validation group ( n=381) at the ratio of 7∶3. The independent predictive factors of cirrhosis were analyzed by univariate logistic regression, multiple collinearity test and multivariate logistic regression. The nomogram model was established and the prediction value of this model was evaluated. Results:According to multivariate logistic regression analysis, hepatitis B core antibody ( OR=1.492, 95% CI 1.316-1.706), glutamine transpeptidase ( OR=1.015, 95% CI 1.010-1.022), platelet ( OR=0.986, 95% CI 0.982-0.988) and albumin ( OR=0.853, 95% CI 0.824-0.882) were independent predictors of cirrhosis ( P<0.05), and the nomogram was established based on the four indicators. Receiver operating characteristic curves showed that area under the curve of the nomogram was 0.933 (95% CI 0.916-0.950), and that of the validation group was 0.931 (95% CI 0.905-0.956). The calibration curves indicated the nomogram model was highly consistent with the actual outcome. Decision curves and clinical impact curves confirmed that the model had high net benefit and good clinical application performance. Conclusions:Hepatitis B core antibody, glutamine transpeptidase, platelet and albumin are independent predictors of cirrhosis among patients with HBeAg-negative chronic HBV infection. The newly developed nomogram model based on these factors could be used to predict cirrhosis risk in these patients.
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OBJECTIVE To evaluate the bioequivalence of a single oral administration of two palbociclib preparations in healthy subjects under fasting and fed conditions. METHODS Twenty-four healthy subjects （fasting test） and twenty healthy subjects （fed test） were enrolled and divided into two groups. A single-center， open-label， single-dose， two-formulation， two- period， two-sequence and crossover trial was designed. The subjects in the two groups were given the test preparation （domestic Palbociclib capsules） or the reference preparation （original Palbociclib capsules） orally under fasting or fed conditions respectively followed by a 14-day washout period. The blood samples were collected at different time points before and after treatment. After pretreatment， the mass concentration of palbociclib in vivo was determined by high-performance liquid chromatography-tandem mass spectrometry with palbociclib-d8 as the internal standard. SAS V9.4 software was used to calculate the pharmacokinetic parameters and evaluate the bioequivalence. RESULTS Under fasting condition， the cmax of the test preparation and the reference preparation were （71.4±18.1） and （73.8±19.0） ng/mL； AUC0－t were （1 754±412） and （1 793±448） h·ng/mL； AUC0－∞ were （1 851±456） and （1 887±478） h·ng/mL， respectively. Under fed condition， the cmax of the test preparation and the reference preparation were （78.4±18.3） and （81.9±21.7） ng/mL； AUC0－t were （1 905±375） and （1 932±318） h·ng/mL； AUC0－∞ were （2 027±411） and （2 050±342） h·ng/mL， respectively. The 90%CI of the geometric mean ratio of the above parameters was within the acceptable range （80.00%-125.00%）. Under fasting and fed conditions， there were 20 and 16 adverse events in 9 and 8 subjects， respectively， but no serious adverse event was observed. CONCLUSIONS Under the fasting and fed conditions， the test preparation and the reference preparation of Pibociclib capsules are bioequivalent and have comparable safety.
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Objective:The risk factors for hepatocellular carcinoma (HCC) in hepatitis B virus (HBV)-positive cirrhosis patients were screened based on commonly used laboratory indexes for the purpose of establishing a predictive model and the prediction efficacy of established model was validated in a validation patient cohort.Methods:The clinical data of 661 male patients with HBV-positive cirrhosis (cirrhosis group) and 694 male patients with HBV-positive HCC admitted to the First Hospital of China Medical University from 2010 to 2020 were retrospectively analyzed, age and complete blood count,liver function index (aspartate transaminase/alanine transaminase,glutamine transpeptidase,total protein, prealbumin, total bile acid, total bilirubin,direct bilirubin,cholinesterase), HBV markers, alpha-fetoprotein (AFP), fibrinogen,calcium were compared between the two groups. Multivariate Logistic regression was used to analyze the independent risk factors of HCC. The prediction model of high risk HCC ( P<0.05) was constructed and validated by receiver operating characteristic (ROC) curve and calibration curve. Results:There was significant difference in complete blood count, liver function index, HBV core antibody, HBV core antibody IgM, alpha-fetoprotein, fibrinogen, calcium between the two groups ( P<0.05). Multivariate analysis showed that calcium ( OR=35.770,95% CI 13.39-99.304),HBV core antibody ( OR=0.878,95% CI 0.816-0.944), AFP ( OR=1.002, 95% CI 1.001-1.003), fibrinogen ( OR=1.369, 95% CI 1.202-1.564) were the independent risk factors for HCC ( P<0.05), and were used for the nomogram. The AUC of the nomogram was 0.750 (95% CI 0.720-0.781) and the AUC of the validation group was 0.752 (95% CI 0.705-0.798). Conclusions:Based on calcium, hepatitis B virus core antibody, AFP, fibrinogen, a nomogram of the HCC is established and verified by ROC curve, which could be used to predict the risk of HBV-positive HCC.
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Objective:To analyze the laboratory tests and clinical characteristics of patients with lupus anticoagulant-positive cerebral infarction.Methods:A retrospective analysis of 216 patients with cerebral infarction hospitalized in Beijing Tiantan Hospital from January 2016 to October 2021 was performed, and the patients were divided into LA-positive cerebral infarction group (168 cases) and LA-negative cerebral infarction group (48 cases) according to the detection of lupus anticoagulant (LA) in cerebral infarction patients, and the laboratory test data between the two groups were compared, and the risk factors related to cerebral infarction, including body mass index (BMI), smoking history, drinking history, hypertension, hyperlipidemia, diabetes history, were included for comparative analysis. LA was performed using the silica clotting time (SCT) method and the modified diluted russell viper venom time (dRVVT) method, respectively. The dRVVT method was used to detect LA. The LA-positive cerebral infarction group was divided into three subgroups according to the positive detection, namely, the dRVVT single-positive group (110 cases), the SCT single-positive group (40 cases) and the double-positive group (18 cases), and the comparison of laboratory indices between different subgroups was performed.The measurement data of normal distribution between the two groups were compared by independent sample t-test, and the mean between multiple groups was compared by ANOVA; The rank sum test was used to compare the median between the measurement data groups that did not conform to the normal distribution, and the χ 2 test was used to compare the counting data groups. Results:The levels of antithrombin Ⅲ and protein C of the LA-positive group ((102.85±14.39)% and (108.52±22.62)%) were all lower than those of the LA-negative group ((110.16±11.10)% and (116.34±18.14)%), the difference was statistically significant ( t values were 3.25, 2.20, P values were 0.001, 0.029, respectively). The levels of fibrinogen, homocysteine, high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate, white blood cells and neutrophil were (3.43(3.07,4.03) g/L), (17.92(14.07,23.71) μmol/L), (6.97(2.33,11.46) mg/L), (15.00(6.75,29.00) mm/h), (8.61(6.72,10.86)×10 9/L) and (5.81(4.39,7.91)×10 9/L), all were higher than those in the LA-negative group with values of (3.14(2.68, 3.62) g/L), (14.62(12.49, 18.41) μmol/L), (3.18(2.09,4.32) mg/L), (9.50(3.75,19.00) mm/h), (7.20(6.22,8.33)×10 9/L) and (4.47(4.02,5.57)×10 9/L), and the differences were statistically significant ( Z values were 2.77, 2.89, 3.32, 2.45, 3.15 and 3.76, P values were 0.006、0.004、0.001, 0.014, 0.002 and <0.001, respectively). There were no significant differences in age, gender, BMI, personal history, past medical history and other laboratory indicators between the two groups (all P>0.05). Comparison among different subgroups in LA positive group showed that D dimer and hs-CRP levels in double-positive group were 0.58(0.50,0.84) mg/L and 7.77(5.94,21.61) mg/L, higher than those in SCT single-positive group with values of 0.45(0.32,0.56) mg/L and 2.98(1.09,6.07) mg/L, and protein S level of double-positive group (97.36±25.45)% was lower than that in SCT single-positive group (114.85±22.74)%, the differences were statistically significant (all P<0.05). D dimer, prothrombin time, hs-CRP and neutrophil levels in dRVVT single-positive group were (0.58(0.50,0.84) mg/L), (11.40(11.10,12.10) s), (6.97(4.07,11.97) mg/L) and (5.83(4.51,8.27)×10 9/L), which were higher than those in SCT single-positive group with values of (0.45(0.32,0.56) mg/L), (11.15(10.70,11.43) s), (2.98(1.09,6.07) mg/L) and (5.08(3.92,6.07)×10 9/L), the difference was statistically significant (all P<0.05). Protein C and triglyceride levels were ((105.65±20.62)%) and (1.38(1.05, 1.75) mmol/L) in dRVVT single-positive group, which were lower than those in SCT single-positive group with values of ((117.05±20.86)% and 1.60(1.29,2.36) mmol/L), the differences were statistically significant (all P<0.05). Conclusion:There were significant differences between LA positive and LA negative cerebral infarction patients in laboratory examination. In LA positive cerebral infarction patients, the levels of fibrinogen, homocysteine, hs-CRP, white blood cells, neutrophil and erythrocyte sedimentation rate were higher, while the levels of anticoagulant protein antithrombin Ⅲ and protein C were lower. It is of great significance to pay close attention to the level and change of laboratory related risk factors in patients with LA positive cerebral infarction and give early intervention and treatment for the prevention of the occurrence and recurrence of cerebral infarction.
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To investigate if ginkgo biloba extract (Egb-761) can improve tardive dyskinesia (TD) symptoms through increasing the activity of plasma MnSOD. Methods We enrolled a total of 384 schizophrenia patients including 157 TD patients and 227 non-TD patients, as well as 280 normal subjects. The difference of MnSOD level in plasma among these groups were compared. TD patients were then randomly divided into two groups. The treatment group (n=77) and the placebo group (n=75) were treated with 240 mg of Egb-761 or placebo per day for 12 weeks, respectively. The abnormal involuntary movement scale (AIMS) and the positive and negative symptoms scale (PANSS) were used to evaluate the severity of the symptoms in baseline, the sixth week and the twelfth week after treatment. The level of MnSOD activity in plasma was also detected before and after the treatment. Results The level of MnSOD activity was lower in schizophrenia groups than in healthy control group (P＜0.01). In addition, the level of MnSOD activity was significantly lower in TD group than in non-TD group (P＜0.05). Repeated measures analysis of variance showed that group effect (F=4.00, P=0.05), time effect (F=32.17, P＜0.01) and interactive effect of group and time (F=39.04, P＜0.01) were significant in AIMS total score. The AIMS total score of treatment group was significantly lower than that of placebo group at 6-week and 12-week time points (all P＜0.01). Repeated measures analysis of variance showed that time effect (F=23.04, P＜0.01) and interactive effect of group and time (F=6.41, P＜0.05) were significant in the level of MnSOD activity. In addition, the level of MnSOD at baseline was significantly correlated with the reduction of AIMS total score during the treatment period (r=0.27, P=0.018). Conclusion Treatment of Egb-761 can improve symptoms of TD and activity of MnSOD.
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Pharmacogenomics is a discipline studying the influence of genetic differences on drug effectiveness .It promises to op-timize the effect of medicine and reduce side effects .It is one of the most effective ways to predict the drug reaction in human body by using pharmacogenomics , which can achieve the goal of precision medicine .With the rapid development of the genetical test technolo-gies, the in vitro individual genome testing projects with the properties of high throughput , and measurable and low cost are better to be applied in medical practice and guiding for making individualized medicine plan .The study elucidated the progress in single nucleotide polymorphism and its clinical application , and focused on the strategic effects of pharmacogenomics on individualized treatment and gene diversity for guiding medicine .
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OBJECTIVE:To evaluate the efficacy and safety of tiotropium bromide in the treatment of COPD patients and pro-vide evidence-based reference for the clinical treatment. METHODS:PubMed,EMBase,Medline,Cochrane Library,CJFD,Wan-Fang and VIP database were retrieved to collect the randomized controlled trial(RCT)of tiotropium bromide(test group)vs. place-bo(control group)in the treatment of COPD. The data was extracted and the quality was evaluated by Rev Man 5.0 software. RE-SULTS:A total of 19 studies were included,involving 16 318 patients. Meta-analysis shows that the FEV1[MD=0.13,95%CI (0.12,0.14),P<0.001],FVC[MD=0.20,95%CI(0.20,0.25),P<0.001] in test group were higher than control group,SGRQ score [MD=-2.94,95%CI(-3.38,-2.49),P<0.001] and COPD exacerbation rate[RR=0.83,95%CI(0.77,0.90),P<0.001] in test group were lower than those in control group ,but the dry mouth rate was higher than that of control group[RR=2.07,95%CI(1.34, 3.20),P<0.001],there were significant differences in 2 groups . CONCLUSIONS:Tiotropium bromide has good efficacy in the treatment of COPD. However,it may cause dry mouth. Due to the methodological limitations of included studies,it remians to be further verified by large-sample and high-quality RCT.
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Objective To examine the reliability and validity of the meaning in life questionnaire (MLQ) in Chinese sergeants.Methods Convenience sampling was applied to collect data from 574 sergeants.Part of the data randomly selected (n=278) was conducted exploratory factor analysis and the other (n=296) was used in confirmatory factor analysis.The satisfaction with life scale(SWLS),self-rating depression scale (SDS),and selfrating anxiety scale(SAS) were administered to test the criterion-related validity.Results (1) Exploratory factor analysis vertified a 2-factor model which consisted of presence of meaning (MLQ-P) and search for meaning (MLQ-S),and their cumulative contribution rate was 61.02％.The range of factor loading was between 0.62 and 0.85.Confirmatory factor analysis confirmed the hypothesized 2-factor model (x2 =32.82,GFI =0.97,AGFI =0.94,NFI =0.96,CFI =0.98,RMSEA =0.06).(2) The internal consistencies were good for the overall scale (Cronbach's alpha =0.79) and the subscales (Cronbach's alpha =0.80 and 0.78,respectively).(3) MLQ-P score was positively correlated with SWLS (r=0.21,P＜0.01),while negatively correlated with SDS and SAS(r=-0.50,-0.43).MLQ-S had positive correlation with MLQ-P(r=0.31,P＜0.01).(4)Scores of MLQ-p and MLQ-S in sergeants were higher than college students(t=38.13,P＜0.001,t=25.07,P＜0.001).Conclusion The Chinese version of MLQ is reliable and valid for application to Chinese sergeants.
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To realize the medical semantic annotation of mammogram, a semantic modeling approach for micro-calcifications in mammogram based on hierarchical Bayesian network (BN) was proposed. Firstly, support vector machines (SVM) were used to map low-level image feature into feature semantics, then high-level semantic was captured through fusing the feature semantics using BN. Finally semantic model was established. To validate the method, the model was applied to annotate the semantic information of mammograms. In this experiment, 142 images were chosen as training set and 50 images as testing set. The results showed that the accuracy of malignant samples was 81.48%, and that of benign samples was 73.91%.