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 analyze the surveillance results of brucellosis in Shanxi Province, to gain a understanding of the epidemic characteristics and changing trend of brucellosis in Shanxi Province, and to provide scientific basis for formulating prevention and control strategies and measures for brucellosis.Methods:The surveillance data of brucellosis in Shanxi Province from Infectious Disease Reporting Information Management System of China Disease Prevention and Control Information System, and the active surveillance results of 5 national brucellosis surveillance sites from 2018 to 2023 were collected for descriptive analysis.Results:From 2018 to 2023, a total of 24 041 cases of human brucellosis were reported in Shanxi Province, with the number of cases increased from 2 800 in 2018 to 5 131 in 2023. The annual reported incidence was 11.22/100 000, ranging from 7.56/100 000 to 14.74/100 000, showing an overall upward trend (χ 2trend = 1 377.43, P < 0.001). The epidemic had affected all counties (cities and districts) in the province, mainly concentrated in Linfen City, Jinzhong City, Datong City, and Shuozhou City, with a total of 13 489 cases of human brucellosis reported, accounting for 56.11%. The population distribution was mainly composed of individuals aged 40 - 69 (17 682 cases), males (18 513 cases), farmers (20 295 cases), and household and unemployed individuals (1 017 cases). The onset of the disease showed obvious seasonality, with the peak time from March to August, accounting for 66.39% (15 961/24 041). A total of 14 130 occupational individuals were investigated at the surveillance sites, and 11 141 underwent serological tests, with a positive rate of 5.25% (585/11 141), including 299 new cases. The positive rate of serological tests was relatively high in Qinyuan County, at 8.51% (241/2 832). Etiological culture was conducted on 338 human blood samples, and 43 strains of Brucella were isolated, with a detection rate of 12.72%. All strains were Brucella melitensis, including 42 strains of Brucella melitensis biovar 3. Conclusions:The overall trend of human brucellosis epidemic in Shanxi Province from 2018 to 2023 is on the rise, and it is still at a high level. It is suggested to continue strengthening monitoring, study the epidemic situation in a timely manner, take comprehensive prevention and control measures, and effectively control the spread of brucellosis.

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 analyze the surveillance results of brucellosis in Shanxi Province, to gain a understanding of the epidemic characteristics and changing trend of brucellosis in Shanxi Province, and to provide scientific basis for formulating prevention and control strategies and measures for brucellosis.Methods:The surveillance data of brucellosis in Shanxi Province from Infectious Disease Reporting Information Management System of China Disease Prevention and Control Information System, and the active surveillance results of 5 national brucellosis surveillance sites from 2018 to 2023 were collected for descriptive analysis.Results:From 2018 to 2023, a total of 24 041 cases of human brucellosis were reported in Shanxi Province, with the number of cases increased from 2 800 in 2018 to 5 131 in 2023. The annual reported incidence was 11.22/100 000, ranging from 7.56/100 000 to 14.74/100 000, showing an overall upward trend (χ 2trend = 1 377.43, P < 0.001). The epidemic had affected all counties (cities and districts) in the province, mainly concentrated in Linfen City, Jinzhong City, Datong City, and Shuozhou City, with a total of 13 489 cases of human brucellosis reported, accounting for 56.11%. The population distribution was mainly composed of individuals aged 40 - 69 (17 682 cases), males (18 513 cases), farmers (20 295 cases), and household and unemployed individuals (1 017 cases). The onset of the disease showed obvious seasonality, with the peak time from March to August, accounting for 66.39% (15 961/24 041). A total of 14 130 occupational individuals were investigated at the surveillance sites, and 11 141 underwent serological tests, with a positive rate of 5.25% (585/11 141), including 299 new cases. The positive rate of serological tests was relatively high in Qinyuan County, at 8.51% (241/2 832). Etiological culture was conducted on 338 human blood samples, and 43 strains of Brucella were isolated, with a detection rate of 12.72%. All strains were Brucella melitensis, including 42 strains of Brucella melitensis biovar 3. Conclusions:The overall trend of human brucellosis epidemic in Shanxi Province from 2018 to 2023 is on the rise, and it is still at a high level. It is suggested to continue strengthening monitoring, study the epidemic situation in a timely manner, take comprehensive prevention and control measures, and effectively control the spread of brucellosis.

Objective To analyze the monitoring results of severe fever with thrombocytopenia syndrome (SFTS) in Shiyan, Hubei province, and to provide a scientific basis for the prevention and control of SFTS. Methods Descriptive epidemiological analysis was conducted on the surveillance data of SFTS, and real-time PCR was performed for detecting SFTSV RNA. Results A total of 54 laboratory-confirmed cases of SFTS were reported in Shiyan from 2011 to 2022, including 5 deaths (9.26%). The cases mainly occurred in March to October, with a peak in April to August (85.18%). People over 50 years old were the high-risk group (94.44%), and farmers were the high-risk occupation (92.59%). The male to female sex ratio was 0.64:1. The three northern counties (Danjiangkou City, Yunyang District, and Yunxi County) were high-incidence areas (90.74%). There was no statistical difference in the positive rates of sampling between within 7 days and 8-11 days after onset (66.67% vs. 57.14%) (Fisher's precision probability test , P＝0.674 ). Conclusion The incidence of SFTS in Shiyan is mainly sporadic, dominated by middle-aged and elderly people and farmers, and shows obvious seasonal and regional characteristics . It is necessary to strengthen vector management, health education, SFTS case reporting and sample collection, and inspection management of high-risk groups, and increase prevention and control efforts in the three northern counties of Shiyan.

Humans ; Aged ; Lung Diseases ; Pneumonia/drug therapy* ; Adrenal Cortex Hormones/therapeutic use* ; Pulmonary Disease, Chronic Obstructive/drug therapy* ; Administration, Inhalation ; Community-Acquired Infections/drug therapy*

Objective:To construct the quality evaluation scale of specification of management for humanistic caring in outpatients and test its reliability and validity.Methods:Referring to the group standards in Specification of Management for Humanistic Caring in Outpatients released by the China Association for Life Care,as well as relevant guidelines and literature,a pool of items for the quality evaluation scale of specification of management for humanistic caring in outpatients was formed.After expert consultation and expert argumentation,a quality evaluation scale of specification of management for humanistic caring in outpatients was constructed.From January to February 2024,243 hospital managers from 5 hospitals in Zhengzhou were selected as survey subjects to conduct item analysis,and reliability and validity testing on the scale.Results:Two rounds of expert inquiry and two rounds of expert argumentation were conducted,with questionnaire response rates of 92.00%and 100.00%,respectively,and expert authority coefficients of 0.952.In the second round of the expert inquiry scale,the mean importance score of the first-level indicators was 4.80 to 5.00,the full score ratio was 88.00%to 100.00%,the coefficient of variation was 0.04 to 0.17,and Kendall's coefficient of concordance was 0.857(P＜0.001);the mean importance score of the second-level indicators was 4.60 to 5.00,the full score ratio was 80.00%to 100.00%,the coefficient of variation was 0.00 to 0.21,and Kendall's coefficient of concordance was 0.775(P＜0.001);the mean importance score of the third-level indicators was 4.60 to 5.00,the full score ratio was 76.00%to 100.00%,the coefficient of variation was 0.00 to 0.21,and Kendall's coefficient of concordance was 0.830(P＜0.001).Finally,a quality evaluation scale of specification of management for humanistic caring in outpatients was formed,including 5 first-level indicators,25 second-level indicators,and 58 third-level indicators.Exploratory factor analysis produced 5 common factors with a cumulative variance contribution rate of 74.628%.The Pearson correlation coefficients between the five-factor scores ranged from 0.648 to 0.798,and the correlation coefficients between the factor scores and the total score of the scale ranged from 0.784 to 0.938.The scale-level content validity index(S-CVI)of the scale was 0.945,the item-content validity index(I-CVI)was 0.725 to 1.000,the Cronbach's alpha coefficient of the total scale was 0.973,and the retest reliability coefficient was 0.934.Conclusion:The constructed quality evaluation scale of specification of management for humanistic caring in outpatients has good scientific validity and reliability,and can be used as an evaluation tool for specification of management for humanistic caring in outpatients.

Objective To develop"a guideline for pressure injury risk assessment and prevention of neonates in NICU",and to provide guidance and references for clinical staff in the implementation of pressure injury assessment and prevention for neonates in NICU.Methods Based on the World Health 0rganization Guideline Development Manual and the results of systematic search for identified clinical problems,the GRADE method was used to evaluate the evidence and grade the recommendations,and the RIGHT report specifications were referred to for writing,and the guideline was developed and revised according to the results and recommendations of the expert review,so as to form the official guideline.Results The guideline included 2 aspects of pressure injury risk assessment and prevention,resulting in 12 clinical questions and 19 recommendations.Conclusion The guideline for risk assessment and prevention of pressure injury of neonates in NICU is an evidence-based guideline based on the best available evidence,clinical practice,and professional judgment,and it can provide a practical basis for scientific decision-making by clinical staff and managers.

The extremely low bioavailability of oral paclitaxel (PTX) mainly due to the complicated gastrointestinal environment, the obstruction of intestinal mucus layer and epithelium barrier. Thus, it is of great significance to construct a coordinative delivery system which can overcome multiple intestinal physicochemical obstacles simultaneously. In this work, a high-density PEGylation-based glycocholic acid-decorated micelles (PTX@GNPs) was constructed by a novel polymer, 9-Fluorenylmethoxycarbonyl-polyethylene glycocholic acid (Fmoc-PEG-GCA). The Fmoc motif in this polymer could encapsulate PTX via π‒π stacking to form the core of micelles, and the low molecular weight and non-long hydrophobic chain of Fmoc ensures the high-density of PEG. Based on this versatile and flexible carriers, PTX@GNPs possess mucus trapping escape ability due to the flexible PEG, and excellent intestine epithelium targeting attributed to the high affinity of GCA with apical sodium-dependent bile acid transporter. The in vitro and in vivo results showed that this oral micelle could enhance oral bioavailability of PTX, and exhibited similar antitumor efficacy to Taxol injection via intravenous route. In addition, oral PTX@GNPs administered with lower dosage within shorter interval could increase in vivo retention time of PTX, which supposed to remodel immune microenvironment and enhance oral chemotherapy efficacy by synergistic effect.

Objective:To investigate any anti-aging effect of repeated transcranial magnetic stimulation (rTMS) and explore the relationship between the effect and relief of clinical symptoms in patients with Parkinson′s disease (PD).Methods:A total of 108 PD patients were randomly divided into an rTMS group and a control group, each of 54, while another 54 healthy counterparts were selected to form a normal group. In addition to anti-PD drug therapy, the rTMS group was given daily rTMS treatment, 5 days a week for 4 weeks, while the control group received sham rTMS treatment, with no treatment of the normal group. Before the treatment and after 4 weeks of treatment as well as and 1 month after the ending of the treatment, the subjects′ clinical exercise symptoms were evaluated using the Unified Parkinson′s Disease Rating Scale (UPDRS), a timed exercise test and the 10m re-entry exercise test. Non-exercise symptoms were assessed using the Hamilton Depression Scale (HAMD), the Hamilton Anxiety Scale (HAMA) and the Mini-mental State Examination (MMSE). Fasting venous blood samples were analyzed to quantify the serum levels of tumor necrosis factor (TNF), interleukin-6 (IL-6), interleukin-1β (IL-1β) and matrix metalloproteinase-3 (MMP-3).Results:Four weeks and 1 month after the treatment, the average UPDRS scores, exercise test times and 10m re-entry exercise test results of the rTMS group were significantly better than those before treatment and significantly better than those of the control group at the same time point. The rTMS group′s average HAMA, HAMD and MMSE scores, as well as its average P300 latency and amplitude were also significantly better than those of the control group at the same time point and significantly better than those before treatment. After 4 weeks, the average MMP-3 content in the rTMS group was significantly lower than the control group′s average, and after a month the average levels of TNF, IL-6, IL-1β and MMP-3 of the rTMS group were all significantly different from those before treatment and those of the control group. The TNF, IL-6, IL-1β and MMP-3 levels were all positively correlated with the average UPDRS total score.Conclusion:High-frequency rTMS therapy can change the phenotypes related to cell senescence, and thus has good therapeutic effect on motor and non-motor symptoms of PD.