1.Differences in deltamethrin resistance and kdr gene mutation in Culex tritaeniorhynchus population in and outside the Yellow Sea wetland
Xiao-er ZHANG ; Zhi-ming WU ; Ye TIAN ; Qian CUI ; Yu-qian JI ; Huan WANG ; Shu-juan YANG ; Yi-chao ZHAO ; Yu WANG ; Hua-yu YIN ; Yu DING ; Guo-jin YAN ; Min-sen ZHAO ; Shou-gang ZHANG ; Bing-dong SONG ; Hong-na CHEN ; Jian GAO ; Wei-fang YANG ; Yu-fu ZHANG ; Hui LIU ; Hong-liang CHU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(2):101-107
Objective To gain insights into the biological characteristics of different populations of Culex tritaeniorhynchus within and around the Yellow Sea wetland from the perspective of the occurrence of resistance, we investigated the levels of resistance to deltamethrin and kdr gene mutation in the wetland and its peripheral areas. Methods Specimens were collected from Cx. tritaeniorhynchus populations at two monitoring sites in the Rare Bird National Nature Reserve and Tiaozi Ni Wetland Scenic Area, and also from two populations in Yancheng City and the Liuhe District of Nanjing, and the resistance of these mosquitoes to deltamethrin was determined using the CDC biotest bottle method. For each concentration of deltamethrin assessed, a random subset of exposed specimens was selected for amplification of the kdr gene fragment, followed by Sanger sequencing to identify and analyze resistance-associated mutations. Results The LC50 levels of deltamethrin among mosquitoes from the four populations in Luhe, Yancheng, the Rare Bird National Nature Reserve and the Tiaozi Ni Wetland Scenic Area were 2.048 5, 7.798 2, 3.473 3, and 17.695 5 mg/mL, respectively, with corresponding concentrations of deltamethrin ranging from 0.005 to 5.000,0.050 to 50.000,0.050 to 25.000 and 0.050 to 50.000 mg/mL, respectively. Furthermore, the ranges of the KT50 values were 11.76-107.43, 67.05-216.30,29.77-107.43 and 28.40-329.51 min; the 1-h knockdown rates were 34.58%-99.15%, 9.52%-43.80%, 55.09%-73.01%, and 10.09%-68.07%; and the 24-h mortality rates were 12.15%-67.52%,9.52%-79.56%,13.17%-82.21%, and 11.01%-78.99%, respectively. With respect to kdr gene mutation, we assayed a total of 63,70,59, and 57 mosquitoes for the four populations, for which we detected L1014F mutation frequencies of 14.29%, 35.00%, 20.34%, and 31.58%, respectively, with a majority of these mutations being heterozygous for resistance. In addition, five adult mosquitoes were identified has having synonymous mutations at site 1011[i. e. , AAT(asparagine)mutation to AAC(asparagine)]. Conclusions Our findings revealed the clear resistance of Cx. tritaeniorhynchus to deltamethrin in the Yancheng region of the Yellow Sea wetland, and the resistance phenotype and kdr frequency of Cx. tritaeniorhynchus in the wetland environment were comparable to those of Cx. tritaeniorhynchus in the wetland environment, thereby indicating that the resistance of different populations of Cx. tritaeniorhynchus was homogeneous under the pressure of different insecticide selection within and around the wetland. However, the underlying mechanisms need to be further studied.
2.Application of single-microport assisted micro-uni-port thoracoscopy surgery in up-lobectomy
Pu ZHANG ; Ziliang LI ; Huan LIU ; Kang GUO ; Juan CHEN ; Jiangli SHANG ; Sanming DENG ; Kai CUI ; Wenhai LI ; Wuping WANG ; Xiaofei LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(08):1240-1245
Objective To analyze the technical essentials of single-microport assisted micro-uni-port thoracoscopic surgery, and to investigate its surgical efficacy and promotional value. Methods Clinical data of patients who consecutively underwent radical upper lobectomy in the Department of Thoracic Surgery of Xi'an International Medical Center Hospital from March 2023 to June 2024 were retrospectively analyzed. According to the surgical approach, patients were divided into two groups: the single-microport assisted group (underwent upper lobectomy via single-microport assisted micro-uni-port thoracoscopy) and the traditional uniportal group (underwent traditional uniportal thoracoscopic lobectomy). Clinical outcomes were compared between the two groups. Results A total of 62 patients were enrolled. There were 30 patients in the single-microport assisted group, with a mean age of (57.4±10.8) years, and 32 patients in the traditional uniportal thoracoscopic group, with a mean age of (57.6±8.7) years. The baseline data were comparable between the two groups. All patients in both groups successfully underwent minimally invasive surgery without conversion to thoracotomy. The operative time in the single-microport assisted group was significantly shorter than that in the traditional uniportal group [(146.03±30.79) min vs. (171.41±36.41) min, P=0.004]. However, there were no statistically significant differences between the two groups in intraoperative blood loss, number of dissected lymph nodes, duration of chest tube drainage, postoperative pain score, postoperative hospital stay, hospitalization cost, or incidence of postoperative complications (all P>0.05). Conclusion Single-microport assisted micro-uni-port thoracoscopic surgery for upper lobectomy can maximally integrate the advantages of three-port and uni-port VATS while effectively avoiding their disadvantages. It significantly shortens the operative time without increasing postoperative pain or complications, and represents a more minimally invasive, safer, and more convenient surgical approach.
3.The efficacy of plasma gasdermin D C-terminal fragment in the early diagnosis of sepsis
Yuexian LYU ; Xiu BI ; Ying LIU ; Shujing CUI ; Lixin ZHAO ; Ge GAO ; Jianxia WANG ; Juan LI ; Jun LI
The Journal of Practical Medicine 2025;41(12):1899-1906
Objective To assess the effectiveness of the Gasdermin D C-terminal fragment(GSDMD-CT)as a novel plasma biomarker for the clinical diagnosis of sepsis.Methods Between July 2021 and November 2024,245 patients from Tangshan Gongren Hospital were enrolled in this study.In accordance with the diagnostic criteria for sepsis and the systemic inflammatory response syndrome(SIRS),patient samples were classified into the sepsis group and the SIRS group.Meanwhile,healthy individuals were selected as the healthy control(HC)group.Sepsis patients were further categorized into the Gram-positive bacterial group,the Gram-negative bacterial group,and the fungal group based on the type of pathogen infection.The levels of GSDMD-CT,C-reactive protein(CRP),and procalcitonin(PCT)were measured in all subjects.Nonparametric tests were employed to compare the differences in various indices among different groups.The diagnostic value of GSDMD-CT in sepsis was evalu-ated by constructing the receiver operating characteristic(ROC)curve.Spearman's correlation analysis was used to examine the relationships among GSDMD-CT,CRP,and PCT.Results The plasma GSDMD-CT levels in the sepsis group 23.02(16.71,33.01)pg/mL and in the SIRS group 16.52(11.26,22.22)pg/mL were significantly higher than those in the healthy control group 7.02(4.42,11.43)pg/mL(U=-10.175,-7.890,P<0.001).Moreover,the plasma GSDMD-CT levels in the sepsis group were significantly higher than those in the SIRS group(U=-2.941,P<0.05).In the Gram-positive bacterial group,the Gram-negative bacterial group,and the fungal group,the GSDMD-CT levels were 23.01(17.16,27.51)pg/mL,23.41(16.78,35.50)pg/mL,and 16.29(14.53,56.27)pg/mL,respectively.When compared with the healthy control group,the GSDMD-CT levels in these three groups were all significantly higher(P<0.05).However,there were no significant differences in GSDMD-CT levels among these three groups(P>0.05).The area under the curve(AUC)of plasma GSDMD-CT for diagnosing sepsis was 0.881(95%confidence interval:0.833~0.929),with a Youden index(YI)of 0.695,a sensitivity of 85.0%,and a specificity of 84.5%.Spearman correlation analysis indicated a weak correlation between GSDMD-CT and C-reactive protein(CRP)(r=0.32,P<0.001)and a positive correlation between GSDMD-CT and procalci-tonin(PCT)(r=0.65,P<0.001).Conclusion GSDMD-CT exhibits significant clinical value in the diagnosis of sepsis and holds great potential as a biomarker in the diagnostic process of sepsis.
4.Pathological diagnosis of solid pancreatic lesions with endoscopic ultrasound-guided fine needle aspiration: a series study of 311 cases
Xiaoxiao WEN ; Xiaoyi LIU ; Jinfeng CUI ; Lichao ZHANG ; Wenxuan LIU ; Haiyan YANG ; Yuan WANG ; Li YI ; Lei LOU ; Juan WANG ; Yuehong LI ; Wenxin WU ; Xianghong ZHANG
Chinese Journal of Pathology 2025;54(1):52-58
Objective:To investigate the combined application of cytology, cell block histology and immunohistochemistry to improve the diagnostic accuracy of solid pancreatic lesions in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples.Methods:The pathological data of EUS-FNA in 311 cases of solid pancreatic lesions submitted to the Second Hospital of Hebei Medical University, Shijiazhuang, China from May 2019 to September 2023 were retrospectively analyzed. The cases included pancreatic ductal adenocarcinoma (PDAC, 172 cases), solid pseudopapillary neoplasm (SPN, 12 cases), neuroendocrine tumors (PNET, 14 cases) and chronic pancreatitis (113 cases). The cytological features of smears, the histology of cell block sections and the diagnostic markers in PDAC, SPN and PNET were analyzed. The diagnostic accuracies of cytology, cell block histology/immunohistochemistry and combination of the two methods for classifying these pancreatic solid lesions were evaluated.Results:Irregular arrangement of atypical (cancer) cells, anisonucleosis and nuclear atypia were the typical cytological features of PDAC, while presence of pseudopapillae with a myxoid/hyalinized fibrovascular core and low adhesion/salt-and-pepper chromatin were diagnostic features of SPN and NET, respectively. Immunohistochemical results showed that CK7 and CK19 were the most sensitive markers of pancreatic ductal epithelia, and the diffuse strong expression of S-100P (102/111, 91.9%) and aberrant expression of p53 (80/111, 72.1%) were important immunophenotypic markers of PDAC. Various degrees of CDX2 expression could be found in 66.4% PDAC. The expression of CD10, PR, vimentin, CD99 and cyclinD1 and the aberrant expression of β-catenin were the immunophenotypic features of SPN, while the expression of CgA, Syn and CD56 were indispensable immunemarkers for the diagnosis of PNET. Overall, cytology had higher sensitivity than cell block histology (93.9% versus 82.8%) and lower specificity (92.9% versus 99.1%), while the combination of the two methods significantly improved the sensitivity to 96.9% in solid pancreatic lesions. The combination of cytology and cell block histology could significantly improve the diagnostic efficacy of EUS-FNA in PDAC.Conclusions:Integrated diagnosis based on cytology (including rapid on-site evaluation), cell block histology and immunohistochemical findings could significantly improve the diagnostic yield of EUS-FNA in classifying solid pancreatic lesions.
5.Evaluation of left ventricular function changes in pregnant women with different severities of hypertensive disorders of pregnancy by strain and tissue-tracking mitral annular displacement parameters
Ziyue WANG ; Xinxia WANG ; Hezhou LI ; Juan WU ; Junling ZHANG ; Yun LIU ; Yu CUI ; Manyu LI ; Yulu MIAO
Chinese Journal of Ultrasonography 2025;34(9):784-791
Objective:To evaluate the changes in left ventricular structure and function in pregnant women with different severities of hypertensive disorders of pregnancy(HDP)using conventional echocardiographic parameters,strain,and tissue-tracking mitral annulus displacement(TMAD)parameters,and to validate and compare the application value of strain and TMAD parameters.Methods:A total of 148 singleton pregnant women with HDP and 100 healthy pregnant women(HP group)who attended the Third Affiliated Hospital of Zhengzhou University from October 2023 to July 2024 were selected. Conventional echocardiographic parameters,strain,and TMAD parameters were collected. Based on the severity of the disease,HDP patients were divided into the gestational hypertension group(GH group, n=49),non-severe preeclampsia group(NSPE group, n=35),and severe preeclampsia group(SPE group, n=64). The differences in various parameters between the HP,GH,NSPE,and SPE groups were compared. The correlation between the displacement ratio of the midpoint of the mitral valve annulus in the apical 4-chamber(AP4 Midpt%),the displacement ratio of the midpoint of the mitral valve annulus in the apical 2-chamber(AP2 Midpt%)and left ventricular global longitudinal strain(LVGLS)were analyzed,and ROC curves were plotted to analyze and compare the diagnostic efficacies of LVGLS,AP4 Midpt% and AP2 Midpt% for left ventricular function changes in HDP pregnant women. Results:① The analysis revealed no statistically significant differences in maternal age and height between the HP group and the HDP subgroups(all P>0.05). In contrast,statistically significant differences were observed in gestational age,systolic blood pressure,diastolic blood pressure,body mass index,and body surface area(all P<0.05). Additionally,significant differences were noted in left ventricular mass,left ventricular interventricular septum thickness at end-diastole,left ventricular posterior wall thickness at end-diastole,left ventricular end-diastolic dimension,left ventricular end-systolic dimension,left ventricular end-diastolic volume,left ventricular end-systolic volume,and stroke volume between the HP group and the HDP subgroups(all P<0.05),while the difference in left ventricular ejection fraction was not statistically significant( P>0.05). ② Significant differences were identified in strain and TMAD parameters between the HP group and the HDP subgroups(all P<0.05),with LVGLS,AP4 Midpt% and AP2 Midpt% exhibited the largest effect sizes( η p2=0.457,0.453,0.351). A progressive decline in strain and TMAD parameters was observed as the severity of HDP increased. ③ There were strong positive correlations between AP4 Midpt%,AP2 Midpt% and LVGLS( r=0.752,0.747;all P<0.001). ④ LVGLS,AP4 Midpt% and AP2 Midpt% all demonstrated significant diagnostic efficacies for changes in left ventricular function in HDP(AUC=0.840,0.847,0.791),and the differences in AUC among the 3 curves were not statistically significant(all P>0.05).⑤ The success rate of collecting TMAD parameters was significantly higher than that of strain parameters(99.24% vs. 93.58%, P<0.001). Conclusions:As the severity of the disease worsens,the changes of left ventricular structure and function in pregnant women with HDP become more and more significant. Both strain and TMAD parameters can early and sensitively identify the subclinical damage of left ventricular systolic function in HDP pregnant women,and both of them have the same diagnostic value. TMAD parameters can be used as a reliable substitute parameter of LVGLS in HDP pregnant women.
6.Analysis of clinical characteristics and current diagnosis and treatment status of IgG4-related diseases in the real world
Xiufang WANG ; Lina CUI ; Gui JIA ; Linhua ZHENG ; Ruiqing SUN ; Juan DENG ; Yulong SHANG ; Changcun GUO ; Ying HAN
Chinese Journal of Hepatology 2025;33(7):645-651
Objective:To retrospectively analyze the current status of consultation, clinical characteristics, and treatment status of patients with IgG4-related disease (IgG4-RD) in order to provide assistance and a basis for early and standardized diagnosis and treatment.Methods:IgG4-RD cases admitted to our hospital from June 2015 to October 2023 were collected. The details of patients' basic information, initial symptoms, department visits, laboratory and imaging findings, histopathological examination results, and treatment plans were recorded. A statistical descriptive analysis was performed on the data.Results:A total of 105 patients with IgG4-RD were included, with a median age of 59.0 (18.0, 78.0) years. The main departments visited were clinical immunology and gastroenterology (83.8%, 88/105). The median diagnostic duration was eight months, with a maximum of 300 months, and 33.3% (35/105) of patients needed over one year for diagnosis. 92 cases underwent histopathological examinations and IgG4 staining, with a total positivity rate of 87.0% (80/92). Among these, sixteen cases underwent pathological examination after surgery, with a positivity rate of 100%; the remaining 76 cases out of 92 underwent liver biopsy, with a positivity rate of 76.1%. Out of these, there were 22 cases from the pancreas, 21 from the submaxillary gland, nine from the labial gland, and seven each from the duodenal papilla and liver, with positivity rates of 81.8%, 81.0%, 55.6%, 85.7%, and 85.7%, respectively. Eleven cases (10.5%) with normal serum IgG4 were diagnosed based on multi-organ involvement and pathological results. 94 cases (89.5%) had elevated IgG4, with a predominance of>2.70 g/L. The median follow-up period for the 87 cases was 14 months. Two cases had poor response, twelve patients relapsed, five cases relapsed without combined drug treatment after surgery, five cases relapsed due to drug withdrawal, and two cases relapsed while tapering off steroids.Conclusions:As a multisystem disease, IgG4-RD still faces the difficulties of time-consuming diagnosis and inappropriate treatment. Therefore, it is necessary to rely on a multidisciplinary collaboration model to improve the awareness level and promote the early and standardized diagnosis and treatment of patients with IgG4-RD.
7.Pathological diagnosis of solid pancreatic lesions with endoscopic ultrasound-guided fine needle aspiration: a series study of 311 cases
Xiaoxiao WEN ; Xiaoyi LIU ; Jinfeng CUI ; Lichao ZHANG ; Wenxuan LIU ; Haiyan YANG ; Yuan WANG ; Li YI ; Lei LOU ; Juan WANG ; Yuehong LI ; Wenxin WU ; Xianghong ZHANG
Chinese Journal of Pathology 2025;54(1):52-58
Objective:To investigate the combined application of cytology, cell block histology and immunohistochemistry to improve the diagnostic accuracy of solid pancreatic lesions in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples.Methods:The pathological data of EUS-FNA in 311 cases of solid pancreatic lesions submitted to the Second Hospital of Hebei Medical University, Shijiazhuang, China from May 2019 to September 2023 were retrospectively analyzed. The cases included pancreatic ductal adenocarcinoma (PDAC, 172 cases), solid pseudopapillary neoplasm (SPN, 12 cases), neuroendocrine tumors (PNET, 14 cases) and chronic pancreatitis (113 cases). The cytological features of smears, the histology of cell block sections and the diagnostic markers in PDAC, SPN and PNET were analyzed. The diagnostic accuracies of cytology, cell block histology/immunohistochemistry and combination of the two methods for classifying these pancreatic solid lesions were evaluated.Results:Irregular arrangement of atypical (cancer) cells, anisonucleosis and nuclear atypia were the typical cytological features of PDAC, while presence of pseudopapillae with a myxoid/hyalinized fibrovascular core and low adhesion/salt-and-pepper chromatin were diagnostic features of SPN and NET, respectively. Immunohistochemical results showed that CK7 and CK19 were the most sensitive markers of pancreatic ductal epithelia, and the diffuse strong expression of S-100P (102/111, 91.9%) and aberrant expression of p53 (80/111, 72.1%) were important immunophenotypic markers of PDAC. Various degrees of CDX2 expression could be found in 66.4% PDAC. The expression of CD10, PR, vimentin, CD99 and cyclinD1 and the aberrant expression of β-catenin were the immunophenotypic features of SPN, while the expression of CgA, Syn and CD56 were indispensable immunemarkers for the diagnosis of PNET. Overall, cytology had higher sensitivity than cell block histology (93.9% versus 82.8%) and lower specificity (92.9% versus 99.1%), while the combination of the two methods significantly improved the sensitivity to 96.9% in solid pancreatic lesions. The combination of cytology and cell block histology could significantly improve the diagnostic efficacy of EUS-FNA in PDAC.Conclusions:Integrated diagnosis based on cytology (including rapid on-site evaluation), cell block histology and immunohistochemical findings could significantly improve the diagnostic yield of EUS-FNA in classifying solid pancreatic lesions.
8.The efficacy of plasma gasdermin D C-terminal fragment in the early diagnosis of sepsis
Yuexian LYU ; Xiu BI ; Ying LIU ; Shujing CUI ; Lixin ZHAO ; Ge GAO ; Jianxia WANG ; Juan LI ; Jun LI
The Journal of Practical Medicine 2025;41(12):1899-1906
Objective To assess the effectiveness of the Gasdermin D C-terminal fragment(GSDMD-CT)as a novel plasma biomarker for the clinical diagnosis of sepsis.Methods Between July 2021 and November 2024,245 patients from Tangshan Gongren Hospital were enrolled in this study.In accordance with the diagnostic criteria for sepsis and the systemic inflammatory response syndrome(SIRS),patient samples were classified into the sepsis group and the SIRS group.Meanwhile,healthy individuals were selected as the healthy control(HC)group.Sepsis patients were further categorized into the Gram-positive bacterial group,the Gram-negative bacterial group,and the fungal group based on the type of pathogen infection.The levels of GSDMD-CT,C-reactive protein(CRP),and procalcitonin(PCT)were measured in all subjects.Nonparametric tests were employed to compare the differences in various indices among different groups.The diagnostic value of GSDMD-CT in sepsis was evalu-ated by constructing the receiver operating characteristic(ROC)curve.Spearman's correlation analysis was used to examine the relationships among GSDMD-CT,CRP,and PCT.Results The plasma GSDMD-CT levels in the sepsis group 23.02(16.71,33.01)pg/mL and in the SIRS group 16.52(11.26,22.22)pg/mL were significantly higher than those in the healthy control group 7.02(4.42,11.43)pg/mL(U=-10.175,-7.890,P<0.001).Moreover,the plasma GSDMD-CT levels in the sepsis group were significantly higher than those in the SIRS group(U=-2.941,P<0.05).In the Gram-positive bacterial group,the Gram-negative bacterial group,and the fungal group,the GSDMD-CT levels were 23.01(17.16,27.51)pg/mL,23.41(16.78,35.50)pg/mL,and 16.29(14.53,56.27)pg/mL,respectively.When compared with the healthy control group,the GSDMD-CT levels in these three groups were all significantly higher(P<0.05).However,there were no significant differences in GSDMD-CT levels among these three groups(P>0.05).The area under the curve(AUC)of plasma GSDMD-CT for diagnosing sepsis was 0.881(95%confidence interval:0.833~0.929),with a Youden index(YI)of 0.695,a sensitivity of 85.0%,and a specificity of 84.5%.Spearman correlation analysis indicated a weak correlation between GSDMD-CT and C-reactive protein(CRP)(r=0.32,P<0.001)and a positive correlation between GSDMD-CT and procalci-tonin(PCT)(r=0.65,P<0.001).Conclusion GSDMD-CT exhibits significant clinical value in the diagnosis of sepsis and holds great potential as a biomarker in the diagnostic process of sepsis.
9.Changing trends of isolation rates of multidrug-resistant organisms in Shaanxi Province from 2014 to 2023 and comparison with national average levels
Qiaodi GUI ; Yanyan GONG ; Cui WANG ; Juan MA
Chinese Journal of Nosocomiology 2025;35(21):3304-3309
OBJECTIVE To investigate the changes of isolation rates of multidrug-resistant organisms(MDROs)in Shaanxi Province from 2014 to 2023 so as to provide theoretical bases for prevention,control and surveillance of drug-resistant organisms.METHODS The data of MDROs that were detected by the networked units of Shaanxi Antimicrobial Resistance Surveillance System in 10 years from 2014 to 2023 were analyzed by WHONET 5.6 soft-ware and were compared with the national average levels.RESULTS The isolation rates of MDROs generally showed downward trends from 2014 to 2023(all P<0.05).The isolation rate of methicillin-resistant Staphylo-coccus aureus(MRSA)dropped from 45.7%to 35.8%,and that of methicillin-resistant coagulase-negative Staph-ylococcus(MRCNS)decreased from 81.8%to 75.8%,higher than the national average levels.The isolation rate of vancomycin-resistant Enterococcus faecium(VREfm)dropped from 3.1%to 0.5%,and that of vancomycin-re-sistant Enterococcus faecalis(VRE fa)declined from 1.7%to 0,equal to or slightly lower than the national aver-age levels.Among the Streptococcus pneumoniae strains,the isolation rate of erythromycin-resistant S.pneumon-iae(ERSP)was higher than that of the penicillin-resistant S.pneumoniae(PRSP),the isolation rate of PRSP showed a downward trend(from 8.0%to 0.8%),while the isolation rate of ERSP rose slightly(from 96.2%to 98%),slightly higher than the national average levels.The isolation rate of carbapenem-resistant Escherichia coli(CR-ECO)showed a downward trend(from 2.3%to 1.0%),the isolation rate of carbapenem-resistant Klebsiella pneumoniae(CR-KPN)fluctuated and showed slightly rising trend(from 6.1%to 8.2%),slightly lower than the national average levels.The isolation rates of carbapenem-resistant Acinetobacter baumannii(CR-ABA)and carbapenem-resistant Pseudomonas aeruginosa(CR-PAE)strains showed downward trends(with CR-ABA de-creasing from 66.2%to 60.3%,CR-PAE declining from 32.6%to 19.7%),slightly higher than the national aver-age levels.CONCLUSIONS The isolation rates of the MDROs showed downward trends in Shaanxi Province from 2014 to 2023 except for ERSP and CRKP.The isolation rates of VRE and CRE are lower than the national average levels,while the isolation rates of other MDROs are slightly higher than the national average levels.
10.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
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.


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