Objective:To investigate the alterations in gut microbiota diversity and inflammatory cytokine levels among patients with varying severities of insomnia, and to explore their interrelationships, in order to provide a theoretical basis for understanding the pathophysiology of insomnia.Methods:A total of 42 patients with chronic insomnia who visited the First Hospital of Hebei Medical University between March and December 2023 were enrolled in the insomnia group, and 22 age-and sex-matched healthy volunteers were recruited from the same hospital as the control group. General demographic data were collected, and Mini-International Neuropsychiatric Interview (MINI) was used to screen for comorbid psychiatric disorders. The Self-Rating Depression Scale (SDS) and the Self-Rating Anxiety Scale (SAS) were employed to evaluate individual′s depressive and anxiety symptoms. Sleep quality and insomnia severity were assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI), Participants′ gastrointestinal function and symptoms over the past week were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS). Fecal and blood samples were collected from all participants. Gut microbiota diversity was analyzed using 16S rRNA sequencing. Differential taxa were identified using linear discriminant analysis effect size (LEfSe) and random forest analysis. Serum levels of inflammatory cytokines were measured by enzyme-linked immunosorbent assay (ELISA). Spearman correlation analysis was used to explore the relationships between insomnia symptoms, microbial diversity indices, key microbial taxa, and inflammatory markers. Multiple linear regression analysis was conducted to identify factors associated with insomnia severity.Results:Compared to the control group, both the mild insomnia group and the moderate-to-severe insomnia group showed significantly higher GSRS scores ( Z=-3.51, -2.72, both P<0.05). The Chao1 index was significantly lower in the mild and moderate-to-severe insomnia groups than in controls ( Z=-3.53, -3.87, both P<0.05). Similarly, the Observed species index was lower in both the mild and moderate-to-severe groups ( Z=-3.33, -3.74, both P<0.05). The Shannon index was significantly reduced in the moderate-to-severe group compared to both the mild group and controls ( Z=-2.81, -2.23, both P<0.05). The Simpson index in the moderate-to-severe group also tended to be lower than in the mild group ( Z=-1.95, P=0.051). Beta diversity differed significantly among the mild insomnia group, the moderate-to-severe insomnia group ( P<0.05), and the control group ( F=2.96, 3.12, both P<0.05). Random forest analysis identified Ruminococcus_D and Klebsiella as key microbial genera distinguishing between mild and moderate-to-severe insomnia. Inflammatory cytokine levels were significantly elevated in both insomnia groups compared to controls ( P<0.05). PSQI scores were negatively correlated with the Shannon index, the Observed species index, and the relative abundance of Ruminococcus_D ( r=-0.34, -0.30, and -0.25, respectively; all P<0.05). Multiple linear regression revealed that serum IL-1β (β=0.339, 95% CI=0.014-0.716, P=0.042) and Ruminococcus_D (β=-0.309, 95% CI=-194.591--8.318, P=0.034) were independent predictors of insomnia severity. Conclusion:Elevated inflammatory cytokine levels and reduced gut microbial richness may be closely associated with increased insomnia severity. Additionally, Ruminococcus_D and IL-1β may be important factors contributing to the severity of insomnia in affected individuals.

Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.

Objective To explore predictive factors of severe community-acquired pneumonia (CAP) complicated with respiratory failure (RF) and to develop and internally validate a clinical prediction model. Methods A retrospective study was conducted on 350 patients with severe CAP admitted to Tianyou Hospital Affiliated to Wuhan University of Science and Technology from September 2022 to December 2024. Patients were randomly divided into a training set (n＝245) and a validation set (n＝105) in a 7∶3 ratio, and further categorized into RF and non-RF groups. LASSO regression was applied to optimize variable selection. Multivariate logistic analysis was used to construct the prediction model, followed by internal validation. Results Univariate regression analysis identified male, hypertension, diabetes, coronary heart disease, age, CURB-65 score, white blood cell count, neutrophil count, C-reactive protein (CRP), serum amyloid A, procalcitonin, and hospital stay as risk factors for RF in severe CAP, while albumin level was a protective factor. LASSO regression selected CURB-65 score, albumin level, and CRP for inclusion in the final model. The area under the receiver operating characteristic curve was 0.903 in the training set and 0.919 in the validation set. Calibration curve analysis demonstrated excellent agreement between predicted and observed probabilities in both sets, and Hosmer-Lemeshow goodness-of-fit tests indicated no significant deviations. Threshold probabilities ranged from 0.01 to 0.99 in both training and validation sets. Conclusions CURB-65 score, albumin level, and CRP are independent predictors of RF in severe CAP. The clinical prediction model based on these factors exhibits strong discrimination, calibration, goodness-of-fit, and clinical utility.

Objectives:To systematically evaluate the clinicopathological features and diagnosis and treatment characteristics of cervical metastasis in ovarian cancer patients in order to reduce misdiagnosis and missed diagnosis.Methods:Studies on cervical metastasis of ovarian cancer were searched in PubMed, Web of Science, CNKI, SinoMed, Wanfang, and VIP databases, and the search period was from the establishment of the database to September 30, 2024. After literature screening and data extraction by two researchers, descriptive analysis was used to systematically evaluate the included studies.Results:A total of 21 studies were included, including 87 patients, of which 11 were case reports and 10 were retrospective series of case studies. Qualitative analysis showed that the most common clinical manifestations were abnormal vaginal bleeding and drainage (61.4%, 27/44). The most common pathological type was high-grade serous carcinoma (71.4%, 40/56). 97.0% (33/34) of the patients had International Federation of Gynecology and Obstetrics (FIGO) stage Ⅲ to Ⅳ. In 30.6%(19/62) of patients, the diagnosis of ovarian primary and cervical metastases was not synchronized. Among them, 17.7%(11/62) of the primary lesions were diagnosed 6(range from 1 to 26)months earlier than the metastases. 12.9%(8/62) of the primary lesions were diagnosed 1(range from 1 to 6)months later. The median overall survival was 5 months (range 1/10 to 120 months).Conclusions:Cervical metastasis of ovarian cancer is rare, its clinical manifestations can be similar to primary cervical cancer, the differential diagnosis is difficult, the overall prognosis is poor, timely and accurate diagnosis, reasonable planning and treatment of cervical metastasis of ovarian cancer are very important for the prognosis of patients.

Objective:To understand the current situation and the relevant factors of the intrinsic capacity of the elderly in nursing institutions.Methods:It was a cross-sectional study. From December 2023 to February 2024, a total of 10 elderly people living in 5 institutions in Huaihua City, Hunan Province, 3 institutions in Changsha City, and 2 institutions in Yinchuan City, Ningxia Hui Autonomous Region, were conveniently selected. Relevant clinical data of the participants were collected through questionnaires. The 5 dimensions of motor, psychological, cognitive, vitality, and perceptual were selected to evaluate the intrinsic capacity of the participants, and their total intrinsic capacity scores were calculated by using the Short Physical Performance Battery, Geriatric Depression Scale, Mini-mental State Examination, Short-Form Mini-Nutritionalas Assessment and the Complaints Sensory Functioning, respectively. Multiple linear stepwise regression models were used to analyze the correlates of intrinsic competence in older adults in nursing facilities.Results:Two hundred and seventy institutionalized older adults were included in the analysis, aged (80.9±8.5) years, 117(43.33%) were male, and the length of residence in an institution was 1.50(0.83, 3.00) years.The intrinsic capacity score of the 270 institutionalized older adults was 2.24±0.97, of which 265(98.15%) had declining intrinsic capacity and 5(1.85%) had good intrinsic capacity. The results of multiple linear stepwise regression analysis showed that literacy level, economic source, occupation, frequency of exercise, use of smartphones, use of elderly mobility aids, and whether or not the elderly living in the nursing home received financial support from the state were independently associated with the intrinsic ability of the elderly living in the nursing home (all P<0.05). Conclusions:The overall level of intrinsic capacity of the investigated elderly in nursing homes is low, and literacy level, economic source, occupation, use of smartphones, use of elderly mobility aids, and whether the nursing home receives state financial support are independent correlates of the intrinsic ability of the elderly in nursing homes.

Objective To explore the microstructural alterations in the white matter of patients with Parkinson's disease(PD)with depression(PD-D)by Tract-based Spatial Statistics(TBSS),with the aim of identifying neuroimaging biomarkers for early diagnosis.Methods Participants with PD were recruited from the Parkinson Progression Marker Initiative database and categorized into PD-D group(n=50)and PD without depression(PD-ND)group(n=31)based on the Geriatric Depression Scale(GDS-15).Age-and gender-matched healthy volunteers were also included in healthy control(HC)group(n=23).All subjects underwent brain MRI-DTI scans.TBSS was utilized to compare fractional anisotropy(FA),mean diffusivity(MD),axial diffusivity(AD),and radial diffusivity(RD)values among groups and to perform Pearson correlation analysis with clinical PD data.Results Compared with HC group,FA values were significantly reduced and MD values were significantly increased in bilateral cingulate(hippocampus),crus,parahippocampal,inferior fronto-occipital fasciculus,inferior longitudinal fasciculus,uncinate fasciculus,superior longitudinal fasciculus(SLF),SLF(temporal),thalamic radiation and corticospinal tract of PD-D group(all P＜0.05).Compared with PD-ND group,MD values were significantly higher in the left cingulum(cingulate gyrus),left inferior fronto-occipital fasciculus,left SLF,left SLF(temporal),left thalamic radiation and left corticospinal tract of PD-D group,while AD values were significantly higher in the left SLF of PD-D group(all P＜0.05).Correlation analysis revealed that AD values in the left SLF were positively correlated with Epworth sleepiness scale score and GDS-15 score(r=0.192,P=0.043;r=0.443,P＜0.01).MD values in the differential brain regions were negatively correlated with Montreal cognitive assessment scale scores(r=-0.187,P=0.047)and positively correlated with GDS-15 scores(r=0.485,P＜0.01).Conclusion This study demonstrate that TBSS can reveal microstructural changes in the brains of PD-D patients,which may serve as neuroimaging biomarkers and provide guidance for clinical diagnosis and treatment.

Objective To explore the microstructural alterations in the white matter of patients with Parkinson's disease(PD)with depression(PD-D)by Tract-based Spatial Statistics(TBSS),with the aim of identifying neuroimaging biomarkers for early diagnosis.Methods Participants with PD were recruited from the Parkinson Progression Marker Initiative database and categorized into PD-D group(n=50)and PD without depression(PD-ND)group(n=31)based on the Geriatric Depression Scale(GDS-15).Age-and gender-matched healthy volunteers were also included in healthy control(HC)group(n=23).All subjects underwent brain MRI-DTI scans.TBSS was utilized to compare fractional anisotropy(FA),mean diffusivity(MD),axial diffusivity(AD),and radial diffusivity(RD)values among groups and to perform Pearson correlation analysis with clinical PD data.Results Compared with HC group,FA values were significantly reduced and MD values were significantly increased in bilateral cingulate(hippocampus),crus,parahippocampal,inferior fronto-occipital fasciculus,inferior longitudinal fasciculus,uncinate fasciculus,superior longitudinal fasciculus(SLF),SLF(temporal),thalamic radiation and corticospinal tract of PD-D group(all P＜0.05).Compared with PD-ND group,MD values were significantly higher in the left cingulum(cingulate gyrus),left inferior fronto-occipital fasciculus,left SLF,left SLF(temporal),left thalamic radiation and left corticospinal tract of PD-D group,while AD values were significantly higher in the left SLF of PD-D group(all P＜0.05).Correlation analysis revealed that AD values in the left SLF were positively correlated with Epworth sleepiness scale score and GDS-15 score(r=0.192,P=0.043;r=0.443,P＜0.01).MD values in the differential brain regions were negatively correlated with Montreal cognitive assessment scale scores(r=-0.187,P=0.047)and positively correlated with GDS-15 scores(r=0.485,P＜0.01).Conclusion This study demonstrate that TBSS can reveal microstructural changes in the brains of PD-D patients,which may serve as neuroimaging biomarkers and provide guidance for clinical diagnosis and treatment.

Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.

Objective:To investigate the alterations in gut microbiota diversity and inflammatory cytokine levels among patients with varying severities of insomnia, and to explore their interrelationships, in order to provide a theoretical basis for understanding the pathophysiology of insomnia.Methods:A total of 42 patients with chronic insomnia who visited the First Hospital of Hebei Medical University between March and December 2023 were enrolled in the insomnia group, and 22 age-and sex-matched healthy volunteers were recruited from the same hospital as the control group. General demographic data were collected, and Mini-International Neuropsychiatric Interview (MINI) was used to screen for comorbid psychiatric disorders. The Self-Rating Depression Scale (SDS) and the Self-Rating Anxiety Scale (SAS) were employed to evaluate individual′s depressive and anxiety symptoms. Sleep quality and insomnia severity were assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI), Participants′ gastrointestinal function and symptoms over the past week were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS). Fecal and blood samples were collected from all participants. Gut microbiota diversity was analyzed using 16S rRNA sequencing. Differential taxa were identified using linear discriminant analysis effect size (LEfSe) and random forest analysis. Serum levels of inflammatory cytokines were measured by enzyme-linked immunosorbent assay (ELISA). Spearman correlation analysis was used to explore the relationships between insomnia symptoms, microbial diversity indices, key microbial taxa, and inflammatory markers. Multiple linear regression analysis was conducted to identify factors associated with insomnia severity.Results:Compared to the control group, both the mild insomnia group and the moderate-to-severe insomnia group showed significantly higher GSRS scores ( Z=-3.51, -2.72, both P<0.05). The Chao1 index was significantly lower in the mild and moderate-to-severe insomnia groups than in controls ( Z=-3.53, -3.87, both P<0.05). Similarly, the Observed species index was lower in both the mild and moderate-to-severe groups ( Z=-3.33, -3.74, both P<0.05). The Shannon index was significantly reduced in the moderate-to-severe group compared to both the mild group and controls ( Z=-2.81, -2.23, both P<0.05). The Simpson index in the moderate-to-severe group also tended to be lower than in the mild group ( Z=-1.95, P=0.051). Beta diversity differed significantly among the mild insomnia group, the moderate-to-severe insomnia group ( P<0.05), and the control group ( F=2.96, 3.12, both P<0.05). Random forest analysis identified Ruminococcus_D and Klebsiella as key microbial genera distinguishing between mild and moderate-to-severe insomnia. Inflammatory cytokine levels were significantly elevated in both insomnia groups compared to controls ( P<0.05). PSQI scores were negatively correlated with the Shannon index, the Observed species index, and the relative abundance of Ruminococcus_D ( r=-0.34, -0.30, and -0.25, respectively; all P<0.05). Multiple linear regression revealed that serum IL-1β (β=0.339, 95% CI=0.014-0.716, P=0.042) and Ruminococcus_D (β=-0.309, 95% CI=-194.591--8.318, P=0.034) were independent predictors of insomnia severity. Conclusion:Elevated inflammatory cytokine levels and reduced gut microbial richness may be closely associated with increased insomnia severity. Additionally, Ruminococcus_D and IL-1β may be important factors contributing to the severity of insomnia in affected individuals.