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.

ObjectiveTo explore the compliance related factors of repeated screening for colorectal cancer in Jiading District， and to provide a scientific basis for the prevention and control of colorectal cancer. MethodsBased on the natural population cohort in Jiading District， and the screening situation in 2017‒2019 and 2020‒2022， the study subjects were divided into the groups of never participating in screening and participating in screening. Subjects in the participating group were further divided into participating in one round of screening or having repeated screening. SPSS 21.0 software was used to analyze the demographic characteristics of each group. χ² test or Fisher precise probability test were used to conduct univariate analysis of the factors such as gender， age， education level， marital status， retirement status， and type of medical insurance. Factors with the significant difference （P<0.05） were selected for inclusion in multivariate analysis， and factors related to compliance with repeated screening were analyzed by multivariate logistic regression. ResultsA total of 8 179 subjects were included in the study， including 3 323 males （40.6%） and 4 856 females （59.4%）. The average age of the subjects was （61.26±6.06） years old. A total of2 652 （32.4%） had educated in primary school or below， 4 242 （51.9%） in secondary school， and 1 285 （15.7%） in higher secondary school. Mostly， 7 579 （92.7%） were married. Among the participants， 4 062 people had never participated in screening， 4 117 people had participated in screening， and 1 485 of them had repeated screening， with a repeated screening rate of 18.2%. Multivariate logistic regression analysis showed that women had better compliance with repeated screening than men （OR=1.31， 95%CI： 1.14‒1.50）. Compared with the population aged 50 to 54 years， the population aged 55‒59 years （OR=1.57， 95%CI： 1.19‒2.08）， 60-64 years （OR=2.77， 95%CI： 2.13‒3.61）， and 65-69 years （OR=3.31， 95%CI： 2.51‒4.36） had higher compliance with repeated screening. Compared with employees' medical insurance， residents' medical insurance group had worse compliance with repeated screening （OR=0.76， 95%CI： 0.66‒0.87）. People with a history of intestinal polyps were more likely to undergo repeat screening than those without （OR=2.07， 95%CI： 1.50‒2.87）. ConclusionCompliance with repeated screening for colorectal cancer still needs to be improved， and there are differences in compliance with repeated screening for different populations with different characteristics. Identifying groups that are unlikely to adhere to community-based colorectal cancer screening and taking targeted interventions can help improve the continued compliance of residents with colorectal cancer screening.

Objective To investigate the clinical characteristics of primary Sj?gren's syndrome (pSS) complicating atherosclerosis(AS).Methods The clinical data of the patients with PSS in the rheumatology department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai Univer-sity of Traditional Chinese Medicine from January 2019 to January 2022 were retrospectively analyzed.The pa-tients were divided into the complication group (n=108) and non-complicating group (n=106) according to whether or not complicating AS.The differences in the general data,laboratory indicators and carotid intima-media thickness (IMT) were compared between the two groups.The risk factors were analyzed.Results Compared with the non-complicating group,the age in the complicating group was bigger[66.00(61.25,69.00)years old vs. 59.00(50.75,65.25)years old],the disease course was longer[128.00(108.25,141.75)months vs. 94.00 (74.75,112.25)months],the levels of ESR,monocyte count,interleukin-6 (IL-6),interleukin-2 receptor (IL-2R),total cholesterol and low density lipoprotein-cholesterol were higher[27.00(14.10,48.00)mm/h vs. 22.00(12.00,36.50)mm/h;0.40(0.30,0.50)×109/L vs. 0.30(0.30,0.50)×109/L;3.56(2.17,5.95)pg/mL vs. 2.62(1.00,5.15)pg/mL;519.00(403.00,662.00)U/mL vs. 441.00(348.00,592.00)U/mL;(4.86±1.17)mmol/L vs. (4.55±1.10)mmol/L;(3.07±0.80)mmol/L vs. (2.82±0.78)mmol/L],IMT was larger[left side:0.80(0.80,0.90)mm vs. 0.80(0.78,0.80)mm;right side:0.80(0.80,0.90)mm vs. 0.80 (0.80,0.80)mm],and the differences were statistically significant (P<0.05).The multivariate logistic re-gression analysis results showed that the long disease course (OR=1.080) and ERS level increase (OR=1.021) were the independent risk factors of AS occurrence in pSS (P<0.05).Conclusion There are differ-ences in the serologic indicators between the pSS patients with complicating AS and the pSS patients without complicating AS,and the disease course and ESR level have the influence on it.

Objective To explore the relationship between the use of proton pump inhibitors(PPIs)and the short-term and long-term prognosis of patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Methods Clinical data of AECOPD patients admitted to the intensive care unit(ICU)from January 2008 to December 2019 were extracted from the MIMIC-Ⅳ database.Patients were divided into PPIs group and non PPIs group based on whether PPIs were used during ICU treatment.Compare the general conditions of two groups of patients and plot survival curves using Kaplan-Meier method to compare the differences in survival rates between the two groups at 28 d and 90 d,respectively.Cox proportional hazards regression was used to analyze the association between PPIs usage and 28 d and 90 d mortality risk in two groups of patients.Results A total of 447 patients were included,including 358 in the PPIs group and 89 in the non PPIs group.The 28 d mortality rate and 90 d mortality rate of the PPIs group were 15.64％and 23.46％,respectively,which were lower than those of the non PPIs group(31.46％and 40.45％,respectively)(P＜0.05).The Kaplan-Meier curve analysis showed that the 28 d and 90 d survival rates of the PPIs group were higher than those in the non PPIs group(P＜0.001).The Cox proportional hazards regression analysis showed that after adjusting for all included variables,the hazard ratio(HR)for 28 d and 90 d mortality in the PPIs group were 0.58(95％CI 0.35 to 0.94,P=0.030),0.63(95％CI 0.41 to 0.96,P=0.022),respectively,compared to the non PPIs group.Conclusion In AECOPD patients,the use of PPIs may be reduce the 28 d and 90 d mortality risks.

Objective:To investigate the diagnostic accuracy of serological indicators and evaluate the diagnostic value of a new established combined serological model on identifying the minimal hepatic encephalopathy (MHE) in patients with compensated cirrhosis.Methods:This prospective multicenter study enrolled 263 compensated cirrhotic patients from 23 hospitals in 15 provinces, autonomous regions and municipalities of China between October 2021 and August 2022. Clinical data and laboratory test results were collected, and the model for end-stage liver disease (MELD) score was calculated. Ammonia level was corrected to the upper limit of normal (AMM-ULN) by the baseline blood ammonia measurements/upper limit of the normal reference value. MHE was diagnosed by combined abnormal number connection test-A and abnormal digit symbol test as suggested by Guidelines on the management of hepatic encephalopathy in cirrhosis. The patients were randomly divided (7∶3) into training set ( n=185) and validation set ( n=78) based on caret package of R language. Logistic regression was used to establish a combined model of MHE diagnosis. The diagnostic performance was evaluated by the area under the curve (AUC) of receiver operating characteristic curve, Hosmer-Lemeshow test and calibration curve. The internal verification was carried out by the Bootstrap method ( n=200). AUC comparisons were achieved using the Delong test. Results:In the training set, prevalence of MHE was 37.8% (70/185). There were statistically significant differences in AMM-ULN, albumin, platelet, alkaline phosphatase, international normalized ratio, MELD score and education between non-MHE group and MHE group (all P<0.05). Multivariate Logistic regression analysis showed that AMM-ULN [odds ratio ( OR)=1.78, 95% confidence interval ( CI) 1.05-3.14, P=0.038] and MELD score ( OR=1.11, 95% CI 1.04-1.20, P=0.002) were independent risk factors for MHE, and the AUC for predicting MHE were 0.663, 0.625, respectively. Compared with the use of blood AMM-ULN and MELD score alone, the AUC of the combined model of AMM-ULN, MELD score and education exhibited better predictive performance in determining the presence of MHE was 0.755, the specificity and sensitivity was 85.2% and 55.7%, respectively. Hosmer-Lemeshow test and calibration curve showed that the model had good calibration ( P=0.733). The AUC for internal validation of the combined model for diagnosing MHE was 0.752. In the validation set, the AUC of the combined model for diagnosing MHE was 0.794, and Hosmer-Lemeshow test showed good calibration ( P=0.841). Conclusion:Use of the combined model including AMM-ULN, MELD score and education could improve the predictive efficiency of MHE among patients with compensated cirrhosis.

Objective:To explore the impact of PM 2.5 concentration in Shanghai on the incidence of allergic rhinitis（AR） in the population, and provide strategies for early warning and prevention of AR. Methods:Collect daily average concentrations of atmospheric pollutants monitored in Shanghai from January 1, 2017 to December 31, 2019, and clinical data of AR patients from five hospitals in Shanghai during the same period. We used a time-series analysis additive Poisson regression model to analyze the correlation between PM 2.5 levels and outpatient attendance for AR patients. Results:During the study period, a total of 56 500 AR patients were included, and the daily average concentration of PM 2.5 was（35.28±23.07）μg/m³. There is a correlation between the concentration of PM 2.5 and the number of outpatient attendance for AR cases. There is a positive correlation between the daily average number of outpatient for AR and levels of PM 2.5 air pollution（（P<0.05）） . We found that every 10 μg/m³ increase in PM 2.5, the impact of on the number of AR visits was statistically significant on the same day, the first day behind, and the second day behind, with the strongest impact being the exposure on the same day. Every 10 μg/m³ increases in PM 2.5, the number of outpatient visits increased by 0.526% on the same day（95%CI 1.000 50-1.010 04）. Conclusion:The atmospheric PM 2.5 concentration in Shanghai is positively correlated with the number of outpatient for AR, and PM 2.5 exposure is an independent factor in the onset of AR. This provides an important theoretical basis for AR.
Humans ; Particulate Matter/analysis* ; Air Pollutants/adverse effects* ; Incidence ; China/epidemiology* ; Air Pollution/adverse effects* ; Rhinitis, Allergic/etiology*

Objective: To study the incidence of bloodstream infections, pathogen distribution, and antibiotic resistance profile in patients with hematological malignancies. Methods: From January 2018 to December 2021, we retrospectively analyzed the clinical characteristics, pathogen distribution, and antibiotic resistance profiles of patients with malignant hematological diseases and bloodstream infections in the Department of Hematology, Nanfang Hospital, Southern Medical University. Results: A total of 582 incidences of bloodstream infections occurred in 22,717 inpatients. From 2018 to 2021, the incidence rates of bloodstream infections were 2.79%, 2.99%, 2.79%, and 2.02%, respectively. Five hundred ninety-nine types of bacteria were recovered from blood cultures, with 487 (81.3%) gram-negative bacteria, such as Klebsiella pneumonia, Escherichia coli, and Pseudomonas aeruginosa. Eighty-one (13.5%) were gram-positive bacteria, primarily Staphylococcus aureus, Staphylococcus epidermidis, and Enterococcus faecium, whereas the remaining 31 (5.2%) were fungi. Enterobacteriaceae resistance to carbapenems, piperacillin/tazobactam, cefoperazone sodium/sulbactam, and tigecycline were 11.0%, 15.3%, 15.4%, and 3.3%, with a descending trend year on year. Non-fermenters tolerated piperacillin/tazobactam, cefoperazone sodium/sulbactam, and quinolones at 29.6%, 13.3%, and 21.7%, respectively. However, only two gram-positive bacteria isolates were shown to be resistant to glycopeptide antibiotics. Conclusions: Bloodstream pathogens in hematological malignancies were broadly dispersed, most of which were gram-negative bacteria. Antibiotic resistance rates vary greatly between species. Our research serves as a valuable resource for the selection of empirical antibiotics.
Humans ; Bacteremia/epidemiology* ; Cefoperazone ; Sulbactam ; Retrospective Studies ; Drug Resistance, Bacterial ; Microbial Sensitivity Tests ; Hematologic Neoplasms ; Sepsis ; Anti-Bacterial Agents/pharmacology* ; Gram-Negative Bacteria ; Gram-Positive Bacteria ; Piperacillin, Tazobactam Drug Combination ; Escherichia coli

Objective: To analyze and compare therapy responses, outcomes, and incidence of severe hematologic adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia (CML) . Methods: Data of patients with chronic phase CML diagnosed between January 2006 and November 2022 from 76 centers, aged ≥18 years, and received initial flumatinib or imatinib therapy within 6 months after diagnosis in China were retrospectively interrogated. Propensity score matching (PSM) analysis was performed to reduce the bias of the initial TKI selection, and the therapy responses and outcomes of patients receiving initial flumatinib or imatinib therapy were compared. Results: A total of 4 833 adult patients with CML receiving initial imatinib (n=4 380) or flumatinib (n=453) therapy were included in the study. In the imatinib cohort, the median follow-up time was 54 [interquartile range (IQR), 31-85] months, and the 7-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.2%, 88.4%, 78.3%, and 63.0%, respectively. The 7-year FFS, PFS, and OS rates were 71.8%, 93.0%, and 96.9%, respectively. With the median follow-up of 18 (IQR, 13-25) months in the flumatinib cohort, the 2-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.4%, 86.5%, 58.4%, and 46.6%, respectively. The 2-year FFS, PFS, and OS rates were 80.1%, 95.0%, and 99.5%, respectively. The PSM analysis indicated that patients receiving initial flumatinib therapy had significantly higher cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) and higher probabilities of FFS than those receiving the initial imatinib therapy (all P<0.001), whereas the PFS (P=0.230) and OS (P=0.268) were comparable between the two cohorts. The incidence of severe hematologic adverse events (grade≥Ⅲ) was comparable in the two cohorts. Conclusion: Patients receiving initial flumatinib therapy had higher cumulative incidences of therapy responses and higher probability of FFS than those receiving initial imatinib therapy, whereas the incidence of severe hematologic adverse events was comparable between the two cohorts.
Adult ; Humans ; Adolescent ; Imatinib Mesylate/adverse effects* ; Incidence ; Antineoplastic Agents/adverse effects* ; Retrospective Studies ; Pyrimidines/adverse effects* ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy* ; Treatment Outcome ; Benzamides/adverse effects* ; Leukemia, Myeloid, Chronic-Phase/drug therapy* ; Aminopyridines/therapeutic use* ; Protein Kinase Inhibitors/therapeutic use*

ObjectiveTo investigate the late detection of HIV/AIDS cases in the elderly in Jilin Province and analyze its influencing factors， to provide theoretical basis for improving their life quality. MethodsThe first CD4 values of HIV/AIDS patients aged 50 years and above living in Jilin Province were used to estimate late detection， and the influencing factors of late detection in elderly cases were analyzed. ResultsThe average CD4 cell count of newly reported HIV/AIDS cases aged 50 and above in Jilin Province from 1996 to 2021 was （230.55±191.97）， the low value group accounted for the largest proportion （50.8%）， and the late detection rate was 59.3% （1397/2325）. The late detection cases were mainly from sexual transmission （46.8% for same-sex and 48.2% for heterosexual contact）. From the perspective of sample sources， most of the late detection patients were diagnosed while testing for other illnesses， followed by testing and consulting. In terms of contact history， the late detection of cases of men who have sex with men was higher. The binary logistic regression analysis showed that gender， marriage， sample source and report year were the factors affecting the late detection of AIDS. The late detection rate of males was higher， and cases of married couples were more likely to be late detection. With the increase of report year， the late detection rate decreased， and testing and counseling could effectively reduce the late detection rate of AIDS. ConclusionThe CD4 cell count in the first detection of HIV/AIDS in the elderly in Jilin Province is low， and the late detection rate of male cases is high. In recent years， the expansion of voluntary counseling and testing in Jilin Province has effectively reduced the late detection rate of HIV/AIDS. At the same time， sex education should be strengthened for the elderly， healthy marital relationships should be advocated and more attention should be paid to the mental health of the elderly.

Objective: To investigate the prognostic factors of children with congenital heart disease (CHD) who had undergone cardiopulmonary resuscitation (CPR) in pediatric intensive care unit (PICU) in China. Methods: From November 2017 to October 2018, this retrospective multi-center study was conducted in 11 hospitals in China. It contained data from 281 cases who had undergone CPR and all of the subjects were divided into CHD group and non-CHD group. The general condition, duration of CPR, epinephrine doses during resuscitation, recovery of spontaneous circulation (ROSC), discharge survival rate and pediatric cerebral performance category in viable children at discharge were compared. According to whether malignant arrhythmia is the direct cause of cardiopulmonary arrest or not, children in CHD and non-CHD groups were divided into 2 subgroups: arrhythmia and non-arrhythmia, and the ROSC and survival rate to discharge were compared. Data in both groups were analyzed by t-test, chi-square analysis or ANOVA, and logistic regression were used to analyze the prognostic factors for ROSC and survival to discharge after cardiac arrest (CA). Results: The incidence of CA in PICU was 3.2% (372/11 588), and the implementation rate of CPR was 75.5% (281/372). There were 144 males and 137 females with median age of 32.8 (5.6, 42.7) months in all 281 CPA cases who received CPR. CHD group had 56 cases while non-CHD had 225 cases, with the percentage of 19.9% (56/281) and 80.1% (225/281) respectively. The proportion of female in CHD group was 60.7% (34/56) which was higher than that in non-CHD group (45.8%, 103/225) (χ²=4.00, P=0.045). There were no differences in ROSC and rate of survival to discharge between the two groups (P>0.05). The ROSC rate of children with arthythmid in CHD group was 70.0% (28/40), higher than 6/16 for non-arrhythmic children (χ²=5.06, P=0.024). At discharge, the pediatric cerebral performance category scores (1-3 scores) of CHD and non-CHD child were 50.9% (26/51) and 44.9% (92/205) respectively. Logistic regression analysis indicated that the independent prognostic factors of ROSC and survival to discharge in children with CHD were CPR duration (odds ratio (OR)=0.95, 0.97; 95%CI: 0.92~0.97, 0.95~0.99; both P<0.05) and epinephrine dosage (OR=0.87 and 0.79, 95%CI: 0.76-1.00 and 0.69-0.89, respectively; both P<0.05). Conclusions: There is no difference between CHD and non-CHD children in ROSC and survival rate of survival to discharge was low. The epinephrine dosage and the duration of CPR are related to the ROSC and survival to discharge of children with CHD.
Cardiopulmonary Resuscitation ; Child ; Child, Preschool ; Female ; Heart Arrest/therapy* ; Heart Defects, Congenital/therapy* ; Humans ; Intensive Care Units, Pediatric ; Male ; Retrospective Studies