Objective:To evaluate the efficacy and safety of combining third-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) with brain radiotherapy in patients with newly diagnosed EGFR mutation-positive non-small cell lung cancer (NSCLC) with brain metastases. Methods:A retrospective analysis was performed on the clinical data of patients with newly diagnosed EGFR-mutant NSCLC with brain metastases who received first-line treatment with third-generation EGFR-TKI with or without brain radiotherapy at the Fourth Affiliated Hospital of Guangxi Medical University between January 2018 and December 2022. Patients treated with EGFR-TKI plus brain radiotherapy were assigned to the combination group, while those treated with EGFR-TKI alone were assigned to the monotherapy group. Intracranial progression-free survival (iPFS), progression-free survival (PFS), overall survival (OS), intracranial disease control rate (iDCR), intracranial objective response rate (iORR), and adverse events were compared between groups. Subgroup analyses were performed according to EGFR exon 19 deletion (19del) and exon 21L858R mutation status. Survival was estimated using the Kaplan-Meier method, with the log-rank test applied for group comparisons and univariate analysis, while multivariate analysis was conducted using Cox proportional hazards regression model. Results:A total of 107 patients were included: 57 (53%) in the monotherapy group and 50 (47%) in the combination group. The combination therapy significantly improved iORR (80% vs. 60%, P=0.023), prolonged median OS (37.7 vs. 31.6 months, P=0.004), and extended median iPFS (21.8 vs. 16.7 months, P=0.018). The iDCR was 100% in both groups, and the difference in median PFS was not statistically significant (18.6 vs. 15.2 months, P=0.086). In the 19del subgroup ( n=53), patients in the combination group had longer OS ( P=0.028) and iPFS ( P=0.028). In the 21L858R subgroup ( n=54), the median OS was also longer in the combination group ( P=0.050). Multivariate analysis identified TKI monotherapy and an Eastern Cooperative Oncology Group (ECOG) performance status score=2 as independent adverse prognostic factors for iPFS, while TKI monotherapy, age ≥65 years, ECOG score=2, and >3 brain metastases were the independent adverse prognostic factors for OS. The incidence of adverse events did not differ significantly between groups (all P>0.05). Conclusions:First-line combination therapy with third-generation EGFR-TKI and cranial radiotherapy provides superior efficacy and acceptable safety compared with EGFR-TKI monotherapy in patients with EGFR-mutant lung adenocarcinoma and brain metastases. Both EGFR 19del and 21L858R mutation subgroups benefit from the combined treatment approach.

Objective:To investigate the status and influencing factors of substantial weight retention in patients with gestational diabetes mellitus (GDM) in early postpartum.Methods:This cross-sectional study employed a convenience sampling method to select 373 patients with GDM who underwent a 6-week postpartum health check at the Postpartum Health Clinic of Women′s Hospital of Nanjing Medical University from February to July in 2023. According to postpartum weight retention (PPWR) on the survey day, the participants were divided into a substantial PPWR group (≥5 kg, 139 cases) and a non-substantial PPWR group (<5 kg, 234 cases). Independent sample t-tests and χ2 tests were used to compare differences in demographic data, clinical data, and biochemical indicators between the two groups. Binary logistic regression was used to analyze the influencing factors of early substantial postpartum weight retention in patients with GDM. Results:A total of 37.27% (139/373) of GDM patients experienced substantial postpartum weight retention at 6 weeks postpartum. The rates of diabetes in family history, excessive gestational weight gain, gestational hypertension, and infant neonatal intensive care unit (NICU) admission in substantial PPWR group were all significantly higher than those in the non-substantial PPWR group (32.37% vs 23.08%, 73.38% vs 20.09%, 13.67% vs 5.56%, 21.58% vs 9.83%) (all P<0.05); but the proportion of overweight or obese before pregnancy and postpartum self-monitoring of blood glucose were both lower in the substantial PPWR group than those in the non-substantial PPWR group (25.18% vs 41.03%, 17.99% vs 27.78%)(all P<0.05). Binary logistic regression indicated that family history of diabetes ( OR=2.826, 95% CI: 1.517-5.265), excessive gestational weight gain ( OR=19.240, 95% CI: 10.360-35.732), and infant NICU admission ( OR=2.447, 95% CI: 1.150-5.205) were positively related to the occurrence of substantial weight retention in patients with GDM in early postpartum, whereas pre-pregnancy overweight or obesity ( OR=0.189, 95% CI: 0.100-0.360) was negatively correlated to substantial weight retention in patients with GDM in early postpartum (all P<0.05). Conclusion:Substantial weight retention is prevalent among GDM patients in early postpartum, which is significantly influenced by family history of diabetes, pre-pregnancy overweight or obesity, excessive gestational weight gain, and infant NICU admission history.

Objective:To investigate the mediating effect of psychological flexibility between recurrence risk perception and health behavior in stroke patients.Methods:From July to December 2024, 233 stroke patients at the First Affiliated Hospital of Zhengzhou University were selected using convenience sampling. Electronic questionnaires were used to collect patients' general information, perception of stroke recurrence risk, health behavior, and psychological flexibility.Results:The scores for recurrence risk perception, psychological flexibility, and health behavior of 233 stroke patients were (39.75±4.39), (47.45±4.19), and (54.04±3.78), respectively. Health behavior were positively correlated with recurrence risk perception ( r=0.495, P<0.01), and negatively correlated with psychological flexibility ( r=-0.367, P<0.01). Psychological flexibility partially mediated the relationship between recurrence risk perception and health behavior, with an effect value of 0.080 and an effect proportion of 17.5% (0.080/0.458) . Conclusions:Recurrence risk perception not only directly predicts health behavior in stroke patients but also indirectly influences their health behavior through psychological flexibility. Healthcare providers should enhance recurrence risk perception among stroke patients and incorporate the improvement of psychological flexibility as part of intervention strategies to improve patients' health behavior.

Objective:It aims to improve the accessment indexes of medical insurance drug value in China,it introduces a societal value dimension by combining international frontier research with China's medical insurance practices,and explores methods to improve the evaluation of drug accessment for medical insurance negotiations in China.Method:Based on Multi-Criteria Decision Analysis(MCDA),it uses literature review and related international guidelines to establishing a pool of social value evaluation indicators for medicines negotiated under China's medical insurance system.Based on the results of expert interviews(qualitative analysis)and Delphi method questionnaire surveys(quantitative analysis),indicators were selected,and the Analytic Hierarchy Process was used to calculate indicator weights,clarify indicator connotations,and establish scoring criteria.Result:A set of societal value framework are developed,composing 5 core indicators,13 secondary indicators and 4 innovative tertiary indicators.Conclusion:drug value assessment of national insurance is proposed to introduce societal value such as unmet needs,disease severity,and public health impact.It is proposed to calculate the comprehensive societal value score for the drug based on MCDA,adjust the pathway for the threshold of Quality-adjusted Life-year,so as to conduct further discuss.

Objective:To investigate the mediating effect of psychological flexibility between recurrence risk perception and health behavior in stroke patients.Methods:From July to December 2024, 233 stroke patients at the First Affiliated Hospital of Zhengzhou University were selected using convenience sampling. Electronic questionnaires were used to collect patients' general information, perception of stroke recurrence risk, health behavior, and psychological flexibility.Results:The scores for recurrence risk perception, psychological flexibility, and health behavior of 233 stroke patients were (39.75±4.39), (47.45±4.19), and (54.04±3.78), respectively. Health behavior were positively correlated with recurrence risk perception ( r=0.495, P<0.01), and negatively correlated with psychological flexibility ( r=-0.367, P<0.01). Psychological flexibility partially mediated the relationship between recurrence risk perception and health behavior, with an effect value of 0.080 and an effect proportion of 17.5% (0.080/0.458) . Conclusions:Recurrence risk perception not only directly predicts health behavior in stroke patients but also indirectly influences their health behavior through psychological flexibility. Healthcare providers should enhance recurrence risk perception among stroke patients and incorporate the improvement of psychological flexibility as part of intervention strategies to improve patients' health behavior.

Objective To develop and validate an efficient and simple liquid chromatography with tandem mass spectrometry(LC-MS/MS)method for determination of polymyxin E in human plasma,and apply the established method in therapeutic drug monitoring(TDM)of polymyxin E.Methods The LC-MS/MS platform was based on AB SCIEX HPLC-4500MD system.Gradient elution was performed with 0.2％formic acid in water and 0.2％formic acid in acetonitrile.Phenomenex Kinetex XB-C18 column(100 mm × 2.1 mm,2.6 μm)were used.The analytes were detected by electrospray ionization(ESI)positive multiple reaction monitoring mode.The ion pairs for analytes(polymyxins E1,E2)and internal standard(polymyxins B1)were m/z 390.7→101.3,m/z 386.0→101.2,and m/z 402.3→101.2,respectively.Plasma samples were processed with protein precipitation method.Results Polymyxin E1 and E2 showed good linearity in the range of 0.031 2-6.24 mg/L and 0.006 15-1.23 mg/L,respectively.The within-run accuracy of polymyxin E1 and E2 in plasma ranged from 89.4％to 99.8％and 91.5％to 108.2％,respectively,while the between-run accuracy ranged from 91.8％to 104.7％and 95.6％to 105.2％,respectively.The within-run precision of polymyxin E1 and E2 in plasma ranged from 4.9％to 8.9％and 2.8％to 8.5％,respectively,while the between-run precision ranged from 4.1％to 7.6％and 4.2％to 9.8％,respectively.The average internal standard normalized matrix effect factors of polymyxins E1 and E2 were 96.9％-111.2％and 106.1％-112.8％in blank plasma samples from 6 different sources,102.5％-106.8％and 98.8％-105.2％in lipemic plasma,respectively,107.8％-108.9％and 106.9％-1 07.4％in hemolyzed plasma,respectively.The precision of matrix effects was less than 15.0％.The average recovery rate was 102.9％-107.5％for polymyxin E1 and E2,and 107.0％for internal standard polymyxin B1.The precision was less than 3.7％.Conclusions In this study,a simple and efficient LC-MS/MS method was established for determination of polymyxin E1 and E2 in human plasma,which is reliable in the therapeutic drug monitoring and pharmacokinetic study of polymyxin E.

Objective:It aims to improve the accessment indexes of medical insurance drug value in China,it introduces a societal value dimension by combining international frontier research with China's medical insurance practices,and explores methods to improve the evaluation of drug accessment for medical insurance negotiations in China.Method:Based on Multi-Criteria Decision Analysis(MCDA),it uses literature review and related international guidelines to establishing a pool of social value evaluation indicators for medicines negotiated under China's medical insurance system.Based on the results of expert interviews(qualitative analysis)and Delphi method questionnaire surveys(quantitative analysis),indicators were selected,and the Analytic Hierarchy Process was used to calculate indicator weights,clarify indicator connotations,and establish scoring criteria.Result:A set of societal value framework are developed,composing 5 core indicators,13 secondary indicators and 4 innovative tertiary indicators.Conclusion:drug value assessment of national insurance is proposed to introduce societal value such as unmet needs,disease severity,and public health impact.It is proposed to calculate the comprehensive societal value score for the drug based on MCDA,adjust the pathway for the threshold of Quality-adjusted Life-year,so as to conduct further discuss.

Objective To develop and validate an efficient and simple liquid chromatography with tandem mass spectrometry(LC-MS/MS)method for determination of polymyxin E in human plasma,and apply the established method in therapeutic drug monitoring(TDM)of polymyxin E.Methods The LC-MS/MS platform was based on AB SCIEX HPLC-4500MD system.Gradient elution was performed with 0.2％formic acid in water and 0.2％formic acid in acetonitrile.Phenomenex Kinetex XB-C18 column(100 mm × 2.1 mm,2.6 μm)were used.The analytes were detected by electrospray ionization(ESI)positive multiple reaction monitoring mode.The ion pairs for analytes(polymyxins E1,E2)and internal standard(polymyxins B1)were m/z 390.7→101.3,m/z 386.0→101.2,and m/z 402.3→101.2,respectively.Plasma samples were processed with protein precipitation method.Results Polymyxin E1 and E2 showed good linearity in the range of 0.031 2-6.24 mg/L and 0.006 15-1.23 mg/L,respectively.The within-run accuracy of polymyxin E1 and E2 in plasma ranged from 89.4％to 99.8％and 91.5％to 108.2％,respectively,while the between-run accuracy ranged from 91.8％to 104.7％and 95.6％to 105.2％,respectively.The within-run precision of polymyxin E1 and E2 in plasma ranged from 4.9％to 8.9％and 2.8％to 8.5％,respectively,while the between-run precision ranged from 4.1％to 7.6％and 4.2％to 9.8％,respectively.The average internal standard normalized matrix effect factors of polymyxins E1 and E2 were 96.9％-111.2％and 106.1％-112.8％in blank plasma samples from 6 different sources,102.5％-106.8％and 98.8％-105.2％in lipemic plasma,respectively,107.8％-108.9％and 106.9％-1 07.4％in hemolyzed plasma,respectively.The precision of matrix effects was less than 15.0％.The average recovery rate was 102.9％-107.5％for polymyxin E1 and E2,and 107.0％for internal standard polymyxin B1.The precision was less than 3.7％.Conclusions In this study,a simple and efficient LC-MS/MS method was established for determination of polymyxin E1 and E2 in human plasma,which is reliable in the therapeutic drug monitoring and pharmacokinetic study of polymyxin E.

Objective:To investigate the status and influencing factors of substantial weight retention in patients with gestational diabetes mellitus (GDM) in early postpartum.Methods:This cross-sectional study employed a convenience sampling method to select 373 patients with GDM who underwent a 6-week postpartum health check at the Postpartum Health Clinic of Women′s Hospital of Nanjing Medical University from February to July in 2023. According to postpartum weight retention (PPWR) on the survey day, the participants were divided into a substantial PPWR group (≥5 kg, 139 cases) and a non-substantial PPWR group (<5 kg, 234 cases). Independent sample t-tests and χ2 tests were used to compare differences in demographic data, clinical data, and biochemical indicators between the two groups. Binary logistic regression was used to analyze the influencing factors of early substantial postpartum weight retention in patients with GDM. Results:A total of 37.27% (139/373) of GDM patients experienced substantial postpartum weight retention at 6 weeks postpartum. The rates of diabetes in family history, excessive gestational weight gain, gestational hypertension, and infant neonatal intensive care unit (NICU) admission in substantial PPWR group were all significantly higher than those in the non-substantial PPWR group (32.37% vs 23.08%, 73.38% vs 20.09%, 13.67% vs 5.56%, 21.58% vs 9.83%) (all P<0.05); but the proportion of overweight or obese before pregnancy and postpartum self-monitoring of blood glucose were both lower in the substantial PPWR group than those in the non-substantial PPWR group (25.18% vs 41.03%, 17.99% vs 27.78%)(all P<0.05). Binary logistic regression indicated that family history of diabetes ( OR=2.826, 95% CI: 1.517-5.265), excessive gestational weight gain ( OR=19.240, 95% CI: 10.360-35.732), and infant NICU admission ( OR=2.447, 95% CI: 1.150-5.205) were positively related to the occurrence of substantial weight retention in patients with GDM in early postpartum, whereas pre-pregnancy overweight or obesity ( OR=0.189, 95% CI: 0.100-0.360) was negatively correlated to substantial weight retention in patients with GDM in early postpartum (all P<0.05). Conclusion:Substantial weight retention is prevalent among GDM patients in early postpartum, which is significantly influenced by family history of diabetes, pre-pregnancy overweight or obesity, excessive gestational weight gain, and infant NICU admission history.

Objective:To evaluate the efficacy and safety of combining third-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) with brain radiotherapy in patients with newly diagnosed EGFR mutation-positive non-small cell lung cancer (NSCLC) with brain metastases. Methods:A retrospective analysis was performed on the clinical data of patients with newly diagnosed EGFR-mutant NSCLC with brain metastases who received first-line treatment with third-generation EGFR-TKI with or without brain radiotherapy at the Fourth Affiliated Hospital of Guangxi Medical University between January 2018 and December 2022. Patients treated with EGFR-TKI plus brain radiotherapy were assigned to the combination group, while those treated with EGFR-TKI alone were assigned to the monotherapy group. Intracranial progression-free survival (iPFS), progression-free survival (PFS), overall survival (OS), intracranial disease control rate (iDCR), intracranial objective response rate (iORR), and adverse events were compared between groups. Subgroup analyses were performed according to EGFR exon 19 deletion (19del) and exon 21L858R mutation status. Survival was estimated using the Kaplan-Meier method, with the log-rank test applied for group comparisons and univariate analysis, while multivariate analysis was conducted using Cox proportional hazards regression model. Results:A total of 107 patients were included: 57 (53%) in the monotherapy group and 50 (47%) in the combination group. The combination therapy significantly improved iORR (80% vs. 60%, P=0.023), prolonged median OS (37.7 vs. 31.6 months, P=0.004), and extended median iPFS (21.8 vs. 16.7 months, P=0.018). The iDCR was 100% in both groups, and the difference in median PFS was not statistically significant (18.6 vs. 15.2 months, P=0.086). In the 19del subgroup ( n=53), patients in the combination group had longer OS ( P=0.028) and iPFS ( P=0.028). In the 21L858R subgroup ( n=54), the median OS was also longer in the combination group ( P=0.050). Multivariate analysis identified TKI monotherapy and an Eastern Cooperative Oncology Group (ECOG) performance status score=2 as independent adverse prognostic factors for iPFS, while TKI monotherapy, age ≥65 years, ECOG score=2, and >3 brain metastases were the independent adverse prognostic factors for OS. The incidence of adverse events did not differ significantly between groups (all P>0.05). Conclusions:First-line combination therapy with third-generation EGFR-TKI and cranial radiotherapy provides superior efficacy and acceptable safety compared with EGFR-TKI monotherapy in patients with EGFR-mutant lung adenocarcinoma and brain metastases. Both EGFR 19del and 21L858R mutation subgroups benefit from the combined treatment approach.