Aim To compare the pharmacokinetics of pemirolast potassium tablets in healthy subjects in Chi-na under single fasting and postprandial conditions,and to evaluate the bioequivalence of the test prepara-tion(T)and the reference preparation(R).Methods A randomized,open-ended,single-dose,two-cycle,double-cross bioequivalence trial design was adopted,and 26 and 30 subjects were enrolled in the fasting group and the postprandial group,respectively,and 10 mg of the test preparation and the reference preparation were taken in the fasting or postprandial state each cy-cle,and venous blood was collected at the designed time points before and after the administration cycle.The concentration of pemirolast potassium in plasma was determined by LC-MS/MS method,and the phar-macokinetic parameters were calculated with PhoenixTM WinNonlin ?(8.3)software,and the bioequivalence analysis of the two preparations was performed.Re-sults The t1/2 of the test preparation and the reference preparation was(4.44±0.91)h and(4.49±0.93)h,respectively;the median tmax was(1.96±1.29)h and(2.18±1.25)h,respectively;the Cmax was(867.12±205.56)μg·L-1 and(863.35±172.03)μg·L-1,respectively;the AUC0-t was(5 513.23±1463.67)h·μg·L-1 and(5 661.32±1 628.65)h·μg·L-1,respectively;AUC0_∞ was(5 699.81±1477.68)h·μg·L-1 and(5 849.44±1 644.75)h·μg·L-1,respectively.The statistical results of the 90％confidence intervals of the main pharmacokinetic parameters Cmax,AUC0-t,and AUC0-∞ was 92.49％～107.53％,94.71％～100.67％and 95.28％～100.27％,respectively,all of which were within the range of 80.00％～125.00％,and the safety of the tested preparation and the reference preparation was good when taken orally on an empty stomach.The t1/2 of single oral administration after prandial administra-tion of the tested preparation and the reference prepara-tion was(4.46±0.78)and(4.51±0.84)h,respec-tively;the median tmax was(3.08±1.36)h and(3.28±1.28)h,respectively;the Cmax was(683.83±111.87)μg·L-1 and(689.77±110.24)μg·L-1,respectively;the AUC0-t was(5 695.99±1566.05)h·μg·L-1 and(5 773.60±1 551.04)h·μg·L-1,respectively;the AUC0-∞ was(5 914.06±1 551.86)h·μg·L-1 and(5 967.30±1552.89)h·μg·L-1,respectively.The 90％confi-dence interval of Cmax,AUC0-t,and AUC0-∞ was 93.56％～104.69％,96.43％～100.83％,and 97.29％～101.14％,respectively,which was in the range of 80.00％～125.00％,and the safety of the tested preparation and the reference preparation was good after meals.Conclusion In the state of fasting and postprandial single oral administration,the two kinds of pemirolast potassium tablets have good bio-equivalence.

Objective To explore the clinical efficacy of omacycline(OMC)in the treatment of diabetes mellitus complicated with community-acquired bacterial pneumonia(CABP).Methods Clinical data of T2DM patients with CABP admitted to The First Hospital of Jiaxing from August 2022 to July 2023 were divided into OMC group and non-OMC(NOMC)group according to wheter they received OMC treatment or not.The absorption of pulmonary lesions after treatment,changes in inflammatory indicators[white blood cell count(WBC),C-reactive protein(C-reactive protein,CRP),and anterior calcitonin(procalcitonin,PCT)],comprehensive index[hospitalization days,total hospitalization costs,blood glucose standard within 3 d and glucocorticoid use]and the occurrence of adverse reactions were analyzed and compared.Results A total of 100 diabetes mellitus patients with CABP were included in this study,including 36 cases in OMC group and 64 cases in NOMC group.The absorption of pulmonary inflammation in the OMC group was significantly higher than that in the NOMC group(P<0.05).Before treatment,there was no statistical difference in WBC,CRP and PCT between the two groups(P>0.05).After treatment,WBC,CRP,and PCT in both groups were significantly lower than those before treatment(P<0.05).Furthermore,WBC,CRP,PCT levels,hospital stay,total hospitalization costs and glucocorticoid use rate were significantly lower in the OMC group than in the NOMC group(P<0.05).The blood glucose compliance rate within 3 d in the OMC group was significantly higher than that in the NOMC group(P<0.05).None of the patients had serious complications during the treatment period.Conclusion OMC treatment of T2DM complicated with CABP is helpful for early disease control and rehabilitation,and reduces the treatment burden.

Objective:To investigate the guiding significance of monitoring of immune factors and T lymphocyte subsets in immunomodulatory treatment of sepsis.Methods:Eighty patients with sepsis admitted to Nangyang First People's Hospital from June 2022 to December 2023 were selected as sepsis group,and 80 healthy volunteers who underwent physical examination during the same period were selected as health group.Detection of immune factors[complement C3,IgA,IgG,IgM,IFN-γ,programmed cell death receptor-1(PD-1)]and T lymphocyte subsets(CD4+,CD8+,CD4+/CD8+)on the day of physical examination in healthy group,the day after sepsis group was enrolled,before treatment,and on day 1,3,and 7 after treatment,expressions of immune factors and T lymphocyte subsets were compared between the two groups.All 80 patients with sepsis received comprehensive treatment,during which thymosine-α1 was added for immunoconditioning treatment.Patients were divided into groups according to the improvement of their condition after immunoconditioning treatment[low-risk group(n=31),medium-risk group(n=34),high-risk group(n=15)]and disease outcome[survival group(n=55)and death group(n=25)].To analyze the efficacy of immune factors and T lymphocyte subsets in predicting the condition improvement and disease outcome of patients with sepsis after immune conditioning treatment.Results:Compared with healthy group,expression levels of immune factor complements C3,IgA,IgG,IgM and IFN-γ in sepsis group were decreased,relative expression level of PD-1 mRNA was increased,the values of CD4+T and CD4+T/CD8+T of T lymphocyte subsets were decreased,while CD8+T was increased(P<0.05).Compared with before treatment and 1 day after treatment,expression levels of complements C3,IgA,IgG,IgM,IFN-γ,CD4+T and CD4+T/CD8+T of T lymphocyte subsets were significantly increased in patients with sepsis after treatment on 3 and 7 days,while the relative expression level of PD-1 mRNA and CD8+T were significantly decreased(P<0.05).Condition of sepsis patients improved significantly after immune conditioning treatment,that is,proportion of low-risk patients increased,and proportion of medium-risk patients and high-risk patients decreased(Z=6.954,P<0.05).Levels of C3,IgA,IgG,IgM,IFN-γ,CD4+T and CD4+T/CD8+T in high-risk groups were significantly decreased,while PD-1 and CD8+T were significantly increased in low-risk and medium-risk groups(P<0.05).Levels of C3,IgA,IgG,IgM,IFN-γ,CD4+T and CD4+T/CD8+T in death group were significantly lower than those in survival group,while PD-1 and CD8+were significantly increased(P<0.05).ROC curve analysis showed that AUC of the combination of immune factors and T lymphocyte subsets to predict the improve-ment of the condition of sepsis patients after immune conditioning treatment was 0.923,the sensitivity was 89.90%,and the specificity was 82.31%.The efficacy of predicting the disease outcome of sepsis patients after immune conditioning treatment showed that the pre-dicted AUC was 0.965.The sensitivity was 95.60%and the specificity was 86.57%,which were obviously better than the single item.Conclusion:Sepsis patients have immune dysfunction related to immune factors and abnormal T lymphocyte subsets,immunomodu-latory therapy can help improve immune dysfunction,monitor immune factors upon admission,and levels of T lymphocyte subsets are helpful for early prediction of disease progression and prognosis in sepsis patients after immunomodulatory therapy.

Objective:To analyze the clinical characteristics of patients with Epstein-Barr virus(EBV)-associated hemophagocytic lymphohistiocytosis(HLH)with acute kidney injury(AKI).Methods:EBV-HLH patients who were hospitalized in our hospital from January 2014 to December 2020 were collected,and their clinical characteristics,treatment,concurrent acute kidney injury and prognosis were retrospectively analyzed.Results:In this study,the incidence of AKI complicated by EBV-HLH was 65.5％,and the 28-day mortality rate was 15.3％.Compared with non-AKI group,patients in the AKI group had higher levels of bilirubin,lactate dehydrogenase,creatinine,urea nitrogen,and β2-microglobulin(β2-MG),poorer coagulation,and lower soluble IL-2 receptor(sCD25).Patients in the AKI group had a higher proportion of chemotherapy,transplantation,mechanical ventilation,and the application of vasoactive medications,and were hospitalized for longer periods of time,with higher in-hospital mortality rates and 28-day mortality rates.Patients in the AKI group were analyzed in subgroups according to the Kidney Disease Improving Global Outcomes(KDIGO)classification,and the levels of leukocytes,bilirubin,albumin,creatinine,urea nitrogen,β2-MG,activated partial thromboplastin time(APTT),and prothrombin time activity(PTA)were more responsive to the severity of the patient's condition.KDIGO grade 2 and 3 had higher proportions of receiving transplants,diuretics,organ support(mechanical ventilation,application of vasoactive medications,and renal replacement therapy),and admissions to the intensive care unit(ICU),and with higher in-hospital mortality rates and 28-day mortality rates.Regression analysis found that creatinine,β2-MG,APTT,transplantation,and chemotherapy were independent risk factors for the development of AKI;the application of vasoactive drugs was both an independent risk factor for the development of AKI and for death at 28 days;and chemotherapy,length of hospitalization,and HGB and fibrinogen levels were protective factors for death at 28 days.Conclusion:AKI in EBV-HLH has high incidence and high rate of progression to severe disease and death,early attention should be given and strengthened in order to carry out early treatment and improve the prognosis of patients.

Objective:To analyze the type and distribution characteristics of irregular antibodies in 71847 hospitalized patients who prepared to accept blood transfusion,and to explore their role in safe blood transfusion. Methods:71847 patients who applied for red blood transfusion from January 2020 to October 2023 were selected.All specimens were screened and identified for the irregular antibody by microcolumn gel antiglobulin technique.Results:Among the 71847 patients preparing for accept blood transfusion,301 cases tested positive for irregular antibodies (0.42％).Of these 301 antibody-positive patients,252 (83.72％)exhibited alloantibodies.The Rh blood group system was the most common,accounting for 179 cases (59.47％).Antibodies in Rh blood group system included anti-E (135,44.85％),anti-E+c (24,7.97％),anti-C+e (10,3.32％),anti-c (6,1.99％),anti-D (3,1.00％),and anti-D+C (1,0.33％).By analyzing 301 cases with irregular antibodies,it found the positive rate of>60 years old group was higher than that in≤60 years old (0.61％vs 0.33％),female group was higher than that in male group (0.50％ vs 0.31％),internal medicine and gynaecology and obstetrics groups were both higher than that in surgery group (1.25％ vs 0.20％;0.32％ vs 0.20％),group with pregnancy/transfusion history was higher than that in non-pregnancy/transfusion history (0.64％ vs 0.13％),the differences were statistically significant (P<0.05). Conclusion:In the routine monitoring of the blood group,it is necessary to detect RhE,so as to reduce the positive rate of irregular antibodies greatly and further ensure the safety of blood transfusion.

Objective:To summarize the clinical characteristics of patients with combined pneumocystis jiroveci pneumonia (PJP ) after allogeneic hematopoietic stem cell transplantation (allo-HSCT ). Methods:The clinical manifestations,laboratory tests,imaging findings,and treatment outcomes of 21 allo-HSCT patients with PJP diagnosed at the First Affiliated Hospital of Soochow University and Soochow Hopes Hematology Hospital from July 2018 to July 2023 were retrospective analyzed.Results:Among the 21 patients,the male-to-female ratio was 2.5:1,and the median age was 36 years old with a range of 15-62 years.The median time to diagnosis of PJP after transplantation was 225 days.The clinical manifestations lack specificity,and the main clinical symptoms include respiratory symptoms (dyspnea,cough,sputum,etc.) and fever.Laboratory examination revealed peripheral blood lymphocyte counts decreased in 15 cases,CD4+T lymphocyte absolute values less than 200 cells/μl in 19 patients,C-reactive protein levels significantly increased in 20 patients,lactate dehydrogenase levels increased in 14 patients,and 1,3-β-D-glucan detection levels increased in 14 patients.Chest CT manifestations can be divided into three types:ground glass type,nodular type,and mixed type.Among them,the incidence of ground glass type was the highest (18/21),with 2 cases of nodular type and 1 case of mixed type.The sequence number of Pneumocystis jiroveci was detected through mNGS (15-57570),and 11 patients had mixed infections.In terms of treatment,TMP-SMX,Caspofungin,and methylprednisolone were administered,and 17 patients achieved improvement in their condition.Four patients died,all of whom died from respiratory failure.Conclusion:PJP is a critically ill condition after hematopoietic stem cell transplantation,and diagnosis is difficult.Early diagnosis can achieve better prognosis.The sensitivity of mNGS in diagnosing PJP is high,providing the possibility of early and accurate diagnosis for clinical practice,which is worthy of application and promotion.

Objective:To explore the understanding on health-related quality of life(HRQoL)among the Chinese populations and to develop a HRQoL conceptual framework that can be used to guide the development of Chinese HRQoL instruments.Methods:Respondents of Chinese general population and patients populations were recruited from 31 provinces in China.One-to-one semi-structured qualitative interviews were conducted to collect the views and perceptions on HRQoL.Based on the grounded theory,multi-level coding of qualitative interviews was carried out,and the framework method was used to sort out and summarize the coding to develop the HRQoL conceptual framework in China.Results:A total of 68 respondents were included in the study.The study extracted 1 558 open coding from the qualitative interview,which were analyzed and sorted into 180 axial coding and 31 selective coding(dimensions).The HRQoL conceptual framework for the Chinese population with 6 themes was finally summarized.Conclusions:The HRQoL conceptual framework based on the health concepts and preferences of the Chinese population contains 6 themes,refers to symptoms,physical function,emotion,cognition,activities and social function.In particular,the items of appetite,sleep and fatigue identifies may reflect Chinese cultural specific perceptions on important aspects of HRQoL.

Objective: Poor bone quality is a risk factor for postoperative complications after degenerative lumbar fusion surgery. The magnetic resonance imaging-based vertebral bone quality (VBQ) score is a good tool for assessing bone quality, and this is the first meta-analysis performed to summarize the predictive value of the VBQ score for cage subsidence and screw loosening in patients undergoing degenerative lumbar surgery. Methods: Studies were comprehensively searched in electronic databases. The quality of the studies was assessed. The pooled sensitivity, specificity and summary receiver operating characteristic curve were calculated. Publication bias was assessed and meta-regression was conducted. Results: We ultimately included 9 studies with a total of 1,404 patients with a mean age of 60.4 years and a percentage of females of 57.0%. According to the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) tool to assess methodological quality, the quality of the included studies was relatively low and risks of bias might exist. Results showed that a high VBQ was significantly associated with cage subsidence and screw loosening, and risk factor analysis revealed that the merged odds ratio was 5.37 for cage subsidence and 3.87 for screw loosening. With a VBQ cutoff value of 3.34±0.45, the pooled sensitivity and specificity for the diagnosis of postoperative complications were 0.75 and 0.75, respectively, and the area under the curve was 0.82 (95% confidence interval, 0.78–0.85). Conclusion A high VBQ was associated with a high risk of cage subsidence and screw loosening in patients who underwent degenerative lumbar surgery. The VBQ score could be considered for identifying high-risk patients for further evaluation.

Objective To understand the current status of nurses'health promotion lifestyle in tertiary comprehensive hospitals,explore the category characteristics of nurses'health promotion lifestyle,and analyze the influencing factors under different categories.Methods From March to April 2023,a multi-stage sampling method was used to select 1326 nurses from 10 tertiary comprehensive hospitals in Hunan Province as the research subjects.A cross-sectional survey was conducted by General Information Questionnaire,Health Promotion Lifestyle Profile Scale,Self-Rated Abilities for Health Practices Scale,Health Behavior Self-Efficacy Assessment Scale,and Nursing Work Environment Scale.Latent profile analysis(LPA)of nurses'health promotion lifestyle was conducted,and the influencing factors of different profiles were explored through univariate analysis and logistic regression analysis.Results A total of 1220 nurses were included,and the score of Health Promotion Lifestyle Profile Scale was(62.61±18.67)points.Nurses'health promotion lifestyle in tertiary comprehensive hospitals can be divided into 3 profiles,namely survival type(25.41％),vitality type(21.97％)and normal type(52.62％).The results of logistic regression analysis showed that coping strategies for stress,non-occupational physical activity,perceived health status,health behavior self-efficacy,and nursing work environment are the influencing factors of nurses'health promotion lifestyle in tertiary comprehensive hospitals(P＜0.05).Conclusion Nurses'health promotion lifestyle in tertiary comprehensive hospitals exhibit significant heterogeneity.It is recommended that nursing managers carry out individualized interventions based on the characteristics of nurses in different categories.Health behavior self-efficacy can be used as the core of intervention to improve nurses'health promotion lifestyles.

AIM To investigate the consistency of chemical constituents between formula granules and standard decoction of Coptidis Rhizoma.METHODS Eighteen batches of standard decoctions were prepared,after which the extraction rate and contents,transfer rates of magnolflorine,jatrorrhizine,columbamine,epiberberine,coptisine,palmatine,berberin were determined,HPLC characteristic chromatograms were established.RESULTS There were 11 common peaks in the characteristic chromatograms of 18 batches of standard decoctions and 24 batches of formula granules with the similarities of 0.861-1.000,which were clusterd into two categories.The formula granules and standard decoction demonstrated approximated extraction rate and contents,transfer rates of index constituents.CONCLUSION The chemical constituents between formula granules and standard decoction of Coptidis Rhizoma display good consistency,which can provide references for the quality control,process research and clinical application of the former.