1.Construction of a prediction efficacy model for PD-1 inhibitor in advanced esophageal squamous cell carcinoma
Shanshan WU ; Xiaojie HUANG ; Xiaochun XIE ; Shaokai HUANG ; Lina HUANG ; Xiaofen WANG
China Pharmacy 2025;36(17):2154-2159
OBJECTIVE To develop a prediction model for durable clinical benefit (DCB) in patients with advanced esophageal squamous cell carcinoma (ESCC) receiving programmed death-1 (PD-1) inhibitor. METHODS The clinical data of patients with advanced ESCC who received PD-1 inhibitor in Jieyang People’s Hospital were retrospectively collected between January 2020 to December 2023. Predictors were screened by least absolute shrinkage and selection operator (Lasso) regression, and a multivariable Logistic regression model was developed to predict DCB. A nomogram was constructed based on the model. Internal validation of the prediction model was performed by using the Bootstrap method, and the model was evaluated by the receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis. RESULTS A total of 91 patients with advanced ESCC were included. The results of Lasso regression combined with Logistic regression analysis indicated that the baseline lymphocyte monocyte ratio (LMR) [odds ratio (OR)=1.97, 95% confidence interval (CI): 1.15-3.36, P=0.013], albumin (ALB) content (OR=1.35, 95%CI: 1.13-1.60, P<0.001), body mass index (BMI) category 1 [normal vs. low: OR= 0.28, 95%CI (0.09-0.96), P=0.042], BMI category 2 [overweight-obesity vs. low: OR=0.08, 95%CI (0.01-0.59), P=0.013], and treatment regimen [monotherapy vs. monotherapy combination therapy: OR=0.07, 95%CI (0.01-0.50), P=0.008] were predictive factors for patients with advanced ESCC to achieve DCB when treated with PD-1 inhibitor. A prediction model was constructed based on the above indicators. Internal validation of the model using the Bootstrap method showed an area under the curve of 0.831 (95%CI: 0.746-0.904), with specificity of 74.4% and sensitivity of 75.0%. The Hosmer-Lemeshow test yielded χ2= 9.930, P=0.270, and the calibration curve slope was close to 1. The decision curve analysis demonstrated that the model exhibited good clinical utility within a threshold range of 0.1 to 1.0. CONCLUSIONS The prediction model based on baseline LMR, ALB content, BMI, and treatment regimen demonstrates robust predictive performance and clinical utility for assessing therapeutic efficacy of PD-1 inhibitor in the treatment of advanced ESCC.
2.Effects of psychological stress on inflammatory bowel disease via affecting the microbiota-gut-brain axis.
Yuhan CHEN ; Xiaofen CHEN ; Suqin LIN ; Shengjun HUANG ; Lijuan LI ; Mingzhi HONG ; Jianzhou LI ; Lili MA ; Juan MA
Chinese Medical Journal 2025;138(6):664-677
Inflammatory bowel disease (IBD) is an idiopathic intestinal inflammatory condition with chronic and relapsing manifestations and is characterized by a disturbance in the interplay between the intestinal microbiota, the gut, and the brain. The microbiota-gut-brain axis involves interactions among the nervous system, the neuroendocrine system, the gut microbiota, and the host immune system. Increasing published data indicate that psychological stress exacerbates the severity of IBD due to its negative effects on the microbiota-gut-brain axis, including alterations in the stress response of the hypothalamic-pituitary-adrenal (HPA) axis, the balance between the sympathetic nervous system and vagus nerves, the homeostasis of the intestinal flora and metabolites, and normal intestinal immunity and permeability. Although the current evidence is insufficient, psychotropic agents, psychotherapies, and interventions targeting the microbiota-gut-brain axis show the potential to improve symptoms and quality of life in IBD patients. Therefore, further studies that translate recent findings into therapeutic approaches that improve both physical and psychological well-being are needed.
Humans
;
Inflammatory Bowel Diseases/metabolism*
;
Stress, Psychological/microbiology*
;
Gastrointestinal Microbiome/physiology*
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Brain/metabolism*
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Hypothalamo-Hypophyseal System
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Pituitary-Adrenal System
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Animals
3.Formulation and interpretation of the Guidelines for the Pharmacist-managed Clinics Service and Document Writing and Usage(Reference)
Lijuan YANG ; Quanzhi LI ; Kejing WANG ; Xiaofen YE ; Zining WANG ; Xuelian YAN ; Liang HUANG ; Juan LI ; Jiancun ZHEN
China Pharmacy 2025;36(11):1301-1305
The writing of pharmacist-managed clinics documents (hereinafter referred to as “outpatient medication record”) is a necessary part of pharmacist-managed clinics service. Outpatient medication record is an important carrier to reflect the quality of pharmacist-managed clinics service. The Chinese Hospital Association Pharmaceutical Specialized Committee was entrusted by the Pharmaceutical Administration Department of the National Health Commission to lead the formulation of the Guidelines for the Pharmacist-managed Clinics Service and Document Writing and Usage (Reference) (hereinafter referred to as Guidelines) according to the compilation method of group standards and the technical route of “documentation combing→framework establishment→draft writing→opinion collection→Guidelines formation”. The Guidelines standardizes the basic requirements of pharmacist-managed clinics record management and the basic content of record, and provides a general template and two specialized templates including pregnant and lactating pharmacist-managed clinics record template and cough and asthma pharmacist-managed clinics record template, which provides a reference for medical institutions to write pharmacist-managed clinics record. This paper introduces the formulation process of Guidelines and analyzes the key contents of Guidelines, which is helpful for the application practice of Guidelines and further improves the quality of pharmacist-managed clinics work.
4.Correlation of TRPV1 and inflammatory cytokines in peripheral blood in patients with schizophrenia
Rui XU ; Yuan LI ; Xiaofen LI ; Shijing WANG ; Xiaowei WANG ; Huan HUANG ; Hao LIU ; Xuan GONG ; Huiling WANG
Chinese Journal of Psychiatry 2025;58(10):742-749
Objectives:This study aims to investigate the expression changes of transient receptor potential vanilloid type 1 (TRPV1) channel and inflammatory factors in the peripheral blood of patients with schizophrenia, and to evaluate their potential value for diagnostic prediction.Methods:This cross-sectional study was conducted at Renmin Hospital of Wuhan University from September 2023 to June 2024. A total of 35 patients with schizophrenia (patient group) from the outpatient/inpatient departments and 35 age-and sex-matched healthy individuals (control group) were recruited. Psychiatric symptoms and cognitive function were evaluated using the Positive and Negative Syndrome Scale (PANSS) and the Brief Assessment of Cognition in Schizophrenia (BACS), respectively. The between-group comparisons of the total scores of these two instruments were calculated using independent samples t-tests. Fasting peripheral blood samples were collected from all participants. Plasma and peripheral blood mononuclear cells (PBMCs) were isolated for subsequent analysis. TRPV1 protein expression was quantified by Western blotting, while inflammatory cytokines, including tumor necrosis factor-α (TNF-α), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6), and interleukin-10 (IL-10), were measured using enzyme-linked immunosorbent assay (ELISA). The between-group differences in TRPV1 and inflammatory cytokines were analyzed using the analysis of covariance (ANCOVA), controlling for age and sex. Pearson correlation analysis was employed to examine relationships between continuous variables, controlling for years of education, age, and sex. The diagnostic performance of TRPV1 and inflammatory cytokines for schizophrenia was assessed using receiver operating characteristic (ROC) curve analysis. Results:Significant between-group differences were observed in BACS total and subscale scores ( t=2.57-9.72, all P<0.01). Compared with the control group, the patient group exhibits significantly decreased expression of TRPV1, IL-4, and IL-10 ( t=6.78, 2.75, 2.53, all P<0.01), increased expression of TNF-α, IL-2, and IL-6 ( t=4.08, 2.64, 2.63, all P<0.01), and an increased IL-6/IL-10 ratio ( t=3.18, P<0.01). Correlation analyses revealed that in the patient group, the TRPV1 expression level was negatively correlated with levels of TNF-α and IL-6, and positively correlated with levels of IL-4 and IL-10 ( r=-0.589, -0.234, 0.341, 0.293, all P<0.05). In the patient group, the TRPV1 expression level was negatively correlated with the negative symptom score of PANSS ( r=-0.299, P<0.05), and the IL-6 level was positively correlated with the negative symptom score, the general pathology score, and the total score of PANSS ( r=0.387, 0.356, 0.321, all P<0.05). The TRPV1 level was positively correlated with the total score of BACS in both the control group and the patient group ( r=0.144, 0.828, all P<0.01). The IL-6/IL-10 ratio was positively correlated with the total score of PANSS and negatively correlated with the total score of BACS in the patient group ( r=0.623, -0.333, all P<0.05). The area under the ROC curve for the combination of TRPV1 level and IL-6/IL-10 ratio was 0.98 (95% confidence interval=0.96 to 1.00). Conclusions:Patients with schizophrenia exhibit reduced expression levels of TRPV1 along with an imbalanced inflammatory response. The combined assessment of TRPV1 level and IL-6/IL-10 ratio has demonstrated a high predictive and diagnostic value for schizophrenia.
5.Application of continuous oral care plan led by dental specialist nurses in adolescent fixed orthodontic patients
Qian LIU ; Fang HUANG ; Yuehua LIU ; Hualin LU ; Chunyan YANG ; Qiang LI ; Xiaofen LIU
Chinese Journal of Practical Nursing 2025;41(23):1780-1787
Objective:To explore the application efficacy of the continuous oral care program led by dental nurses in adolescent patients with fixed orthodontics and to provide a reference for continuous care to enhance the oral health level of patients.Methods:A randomized controlled trial was carried out in the Orthodontic Department of Shanghai Stomatological Hospital from June to December 2022. A total of 132 adolescent patients with fixed orthodontics were selected through the convenience sampling method and divided into the experimental group and the control group by the random number table method, with 66 patients in each group. The experimental group was provided with the continuous oral care program led by dental specialist nurses, while the control group received routine care. The intervention lasted for 12 months. The Oral Health Impact Scale, the Oral Health Self-Management Ability Questionnaire, and the plaque index were utilized to assess the intervention effect before and after the intervention.Results:A total of 65 participants in the experimental group completed the study, with an age of (14.41 ± 1.60) years, comprising 32 males and 33 females. In the control group, 64 participants completed the study, with an age of (14.15 ± 1.69) years, including 28 males and 36 females. Prior to intervention, there were no statistically significant differences in scores for oral health self-management ability, Oral Health Impact Profile-14, or total plaque index between the experimental and control groups (all P>0.05). Following intervention, the score for oral health self-management ability in the experimental group was (77.42 ± 11.70) points, significantly higher than (70.47 ± 17.49) points of the control group ( t = 2.65, P<0.05). Additionally, the score on the Oral Health Impact Profile-14 for the experimental group was (16.40 ± 3.45) points and their total plaque index was measured at 1.68 ± 0.55 both significantly lower than those recorded in the control group at (18.16 ± 3.79) points and a total plaque index of 1.92 ± 0.47 respectively ( t = - 2.75, - 2.55, both P<0.05). Conclusions:The implementation of the continuous oral care program led by dental specialist nurses is conducive to improving the oral health self-management ability of adolescent patients with fixed orthodontics, reducing dental plaque, improving oral cleanliness, and improving the oral health-related quality of life of patients.
6.Determination of polymyxin E in human plasma by LC-MS/MS and its application in therapeutic drug monitoring
Yan CHEN ; Xiaolan HUANG ; Yi LI ; Xin LI ; Beining GUO ; Yaxin FAN ; Hailan WU ; Mengting CHEN ; Wanzhen LI ; Jing ZHANG ; Xiaofen LIU
Chinese Journal of Infection and Chemotherapy 2025;25(2):155-161
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.
7.Determination of polymyxin E in human plasma by LC-MS/MS and its application in therapeutic drug monitoring
Yan CHEN ; Xiaolan HUANG ; Yi LI ; Xin LI ; Beining GUO ; Yaxin FAN ; Hailan WU ; Mengting CHEN ; Wanzhen LI ; Jing ZHANG ; Xiaofen LIU
Chinese Journal of Infection and Chemotherapy 2025;25(2):155-161
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.
8.Application of continuous oral care plan led by dental specialist nurses in adolescent fixed orthodontic patients
Qian LIU ; Fang HUANG ; Yuehua LIU ; Hualin LU ; Chunyan YANG ; Qiang LI ; Xiaofen LIU
Chinese Journal of Practical Nursing 2025;41(23):1780-1787
Objective:To explore the application efficacy of the continuous oral care program led by dental nurses in adolescent patients with fixed orthodontics and to provide a reference for continuous care to enhance the oral health level of patients.Methods:A randomized controlled trial was carried out in the Orthodontic Department of Shanghai Stomatological Hospital from June to December 2022. A total of 132 adolescent patients with fixed orthodontics were selected through the convenience sampling method and divided into the experimental group and the control group by the random number table method, with 66 patients in each group. The experimental group was provided with the continuous oral care program led by dental specialist nurses, while the control group received routine care. The intervention lasted for 12 months. The Oral Health Impact Scale, the Oral Health Self-Management Ability Questionnaire, and the plaque index were utilized to assess the intervention effect before and after the intervention.Results:A total of 65 participants in the experimental group completed the study, with an age of (14.41 ± 1.60) years, comprising 32 males and 33 females. In the control group, 64 participants completed the study, with an age of (14.15 ± 1.69) years, including 28 males and 36 females. Prior to intervention, there were no statistically significant differences in scores for oral health self-management ability, Oral Health Impact Profile-14, or total plaque index between the experimental and control groups (all P>0.05). Following intervention, the score for oral health self-management ability in the experimental group was (77.42 ± 11.70) points, significantly higher than (70.47 ± 17.49) points of the control group ( t = 2.65, P<0.05). Additionally, the score on the Oral Health Impact Profile-14 for the experimental group was (16.40 ± 3.45) points and their total plaque index was measured at 1.68 ± 0.55 both significantly lower than those recorded in the control group at (18.16 ± 3.79) points and a total plaque index of 1.92 ± 0.47 respectively ( t = - 2.75, - 2.55, both P<0.05). Conclusions:The implementation of the continuous oral care program led by dental specialist nurses is conducive to improving the oral health self-management ability of adolescent patients with fixed orthodontics, reducing dental plaque, improving oral cleanliness, and improving the oral health-related quality of life of patients.
9.Correlation of TRPV1 and inflammatory cytokines in peripheral blood in patients with schizophrenia
Rui XU ; Yuan LI ; Xiaofen LI ; Shijing WANG ; Xiaowei WANG ; Huan HUANG ; Hao LIU ; Xuan GONG ; Huiling WANG
Chinese Journal of Psychiatry 2025;58(10):742-749
Objectives:This study aims to investigate the expression changes of transient receptor potential vanilloid type 1 (TRPV1) channel and inflammatory factors in the peripheral blood of patients with schizophrenia, and to evaluate their potential value for diagnostic prediction.Methods:This cross-sectional study was conducted at Renmin Hospital of Wuhan University from September 2023 to June 2024. A total of 35 patients with schizophrenia (patient group) from the outpatient/inpatient departments and 35 age-and sex-matched healthy individuals (control group) were recruited. Psychiatric symptoms and cognitive function were evaluated using the Positive and Negative Syndrome Scale (PANSS) and the Brief Assessment of Cognition in Schizophrenia (BACS), respectively. The between-group comparisons of the total scores of these two instruments were calculated using independent samples t-tests. Fasting peripheral blood samples were collected from all participants. Plasma and peripheral blood mononuclear cells (PBMCs) were isolated for subsequent analysis. TRPV1 protein expression was quantified by Western blotting, while inflammatory cytokines, including tumor necrosis factor-α (TNF-α), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6), and interleukin-10 (IL-10), were measured using enzyme-linked immunosorbent assay (ELISA). The between-group differences in TRPV1 and inflammatory cytokines were analyzed using the analysis of covariance (ANCOVA), controlling for age and sex. Pearson correlation analysis was employed to examine relationships between continuous variables, controlling for years of education, age, and sex. The diagnostic performance of TRPV1 and inflammatory cytokines for schizophrenia was assessed using receiver operating characteristic (ROC) curve analysis. Results:Significant between-group differences were observed in BACS total and subscale scores ( t=2.57-9.72, all P<0.01). Compared with the control group, the patient group exhibits significantly decreased expression of TRPV1, IL-4, and IL-10 ( t=6.78, 2.75, 2.53, all P<0.01), increased expression of TNF-α, IL-2, and IL-6 ( t=4.08, 2.64, 2.63, all P<0.01), and an increased IL-6/IL-10 ratio ( t=3.18, P<0.01). Correlation analyses revealed that in the patient group, the TRPV1 expression level was negatively correlated with levels of TNF-α and IL-6, and positively correlated with levels of IL-4 and IL-10 ( r=-0.589, -0.234, 0.341, 0.293, all P<0.05). In the patient group, the TRPV1 expression level was negatively correlated with the negative symptom score of PANSS ( r=-0.299, P<0.05), and the IL-6 level was positively correlated with the negative symptom score, the general pathology score, and the total score of PANSS ( r=0.387, 0.356, 0.321, all P<0.05). The TRPV1 level was positively correlated with the total score of BACS in both the control group and the patient group ( r=0.144, 0.828, all P<0.01). The IL-6/IL-10 ratio was positively correlated with the total score of PANSS and negatively correlated with the total score of BACS in the patient group ( r=0.623, -0.333, all P<0.05). The area under the ROC curve for the combination of TRPV1 level and IL-6/IL-10 ratio was 0.98 (95% confidence interval=0.96 to 1.00). Conclusions:Patients with schizophrenia exhibit reduced expression levels of TRPV1 along with an imbalanced inflammatory response. The combined assessment of TRPV1 level and IL-6/IL-10 ratio has demonstrated a high predictive and diagnostic value for schizophrenia.
10.Clinical distribution and drug resistance analysis of carbapenem-resistant Pseudomonas aeruginosa from 2018 to 2022
China Modern Doctor 2024;62(16):70-73
Objective The clinical distribution characteristics and drug resistance of carbapenem-resistant Pseudomonas aeruginosa(CRPA)were analyzed to provide reference for clinical anti-infection treatment.Methods The data of hospitalized patients with Pseudomonas aeruginosa(PA)cultured and isolated from Enze Hospital,Taizhou Enze Medical Center(Group)from January 2018 to December 2022 were retrospectively analyzed,and the clinical departments,specimen types,patient ages and sensitivity to commonly used antibiotics for CRPA strains were statistically analyzed.Results A total of 1660 strains of PA were collected,of which 314 strains(18.92%)were CRPA.The detection rate of CRPA strains was the highest in 2018.The detection departments were mainly intensive medicine,respiratory and critical care medicine.The specimen types were mainly sputum.The age of patients was mainly between 61-80 years old.According to the drug sensitivity,there were small fluctuations in the resistance rates of CRPA strains to common antibacterial drugs.The resistance rate of piperacillin was lower than 40%,while the resistance rate of ticarcillin/clavulanate was consistently higher than 50%.The resistance rates of aminoglycosides and piperacillin/tazobactam were lower than 15%.Conclusion From 2018 to 2022,the detection rate of CRPA strains decreased first and then increased.The resistance rate of piperacillin/tazobactam was lower than 15%in past 5 years,so it can be preferred for clinical empirical treatment.

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