1.Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients: A 12-week randomized placebo-controlled phase III trial with long-term extension
Chen YU ; Songmei GENG ; Bin YANG ; Yunhua DENG ; Fuqiu LI ; Xiaojing KANG ; Mingye BI ; Furen ZHANG ; Yi ZHAO ; Weili PAN ; Zhongwei TIAN ; Jinhua XU ; Zhenghua ZHANG ; Nan YU ; Xinsuo DUAN ; Shuping GUO ; Qing SUN ; Weiquan LI ; Juan TAO ; Zhijun LIU ; Yuanyuan YIN ; Gang WANG
Chinese Medical Journal 2024;137(10):1190-1198
Background::There is a need for effective and safe therapies for psoriasis that provide sustained benefits. The aim of this study was to assess the efficacy and safety of tildrakizumab, an anti-interleukin-23p19 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in Chinese patients.Methods::In this multi-center, double-blind, phase III trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned (1:1) to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and 4. Patients initially assigned to placebo were switched to receive tildrakizumab at weeks 12, 16, and every 12 weeks thereafter. Patients in the tildrakizumab group continued with tildrakizumab at week 16, and every 12 weeks until week 52. The primary endpoint was the Psoriasis Area and Severity Index (PASI 75) response rate at week 12.Results::At week 12, tildrakizumab demonstrated significantly higher PASI 75 response rates (66.4% [73/110] vs. 12.7% [14/110]; difference, 51.4% [95% confidence interval (CI), 40.72, 62.13]; P <0.001) and Physician’s Global Assessment (60.9% [67/110] vs. 10.0% [11/110]; difference, 49.1% [95% CI, 38.64, 59.62]; P <0.001) compared to placebo. PASI 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups, reaching maximal efficacy after 28 weeks (86.8% [92/106] vs. 82.4% [89/108]) and maintained up to 52 weeks (91.3% [95/104] vs. 87.4% [90/103]). Most treatment-emergent adverse events were mild and not related to tildrakizumab. Conclusion::Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.Trial registration::ClinicalTrials.gov, NCT05108766.
2.Expert consensus on perioperative basic prevention for lower extremity deep venous thrombosis in elderly patients with hip fracture (version 2024)
Yun HAN ; Feifei JIA ; Qing LU ; Xingling XIAO ; Hua LIN ; Ying YING ; Junqin DING ; Min GUI ; Xiaojing SU ; Yaping CHEN ; Ping ZHANG ; Yun XU ; Tianwen HUANG ; Jiali CHEN ; Yi WANG ; Luo FAN ; Fanghui DONG ; Wenjuan ZHOU ; Wanxia LUO ; Xiaoyan XU ; Chunhua DENG ; Xiaohua CHEN ; Yuliu ZHENG ; Dekun YI ; Lin ZHANG ; Hanli PAN ; Jie CHEN ; Kaipeng ZHUANG ; Yang ZHOU ; Sui WENJIE ; Ning NING ; Songmei WU ; Jinli GUO ; Sanlian HU ; Lunlan LI ; Xiangyan KONG ; Hui YU ; Yifei ZHU ; Xifen YU ; Chen CHEN ; Shuixia LI ; Yuan GAO ; Xiuting LI ; Leling FENG
Chinese Journal of Trauma 2024;40(9):769-780
Hip fracture in the elderly is characterized by high incidence, high disability rate, and high mortality and has been recognized as a public health issue threatening their health. Surgery is the preferred choice for the treatment of elderly patients with hip fracture. However, lower extremity deep venous thrombosis (DVT) has an extremely high incidence rate during the perioperative period, and may significantly increase the risk of patients′ death once it progresses to pulmonary embolism. In response to this issue, the clinical guidelines and expert consensuses all emphasize active application of comprehensive preventive measures, including basic prevention, physical prevention, and pharmacological prevention. In this prevention system, basic prevention is the basis of physical and pharmacological prevention. However,there is a lack of unified and definite recommendations for basic preventive measures in clinical practice. To this end, the Orthopedic Nursing Professional Committee of the Chinese Nursing Association and Nursing Department of the Orthopedic Branch of the China International Exchange and Promotive Association for Medical and Health Care organized relevant nursing experts to formulate Expert consensus on perioperative basic prevention for lower extremity deep venous thrombosis in elderly patients with hip fracture ( version 2024) . A total of 10 recommendations were proposed, aiming to standardize the basic preventive measures for lower extremity DVT in elderly patients with hip fractures during the perioperative period and promote their subsequent rehabilitation.
3.The relationships of the levels of receptor-interacting protein kinase 3 and mixed lineage kinase domain-like protein in peripheral blood with the severity of necrotizing enterocolitis in newborns
Yan HUANG ; Yumei LIANG ; Yanni FENG ; Songmei YANG
Journal of Clinical Medicine in Practice 2024;28(1):62-67
Objective To analyze the expressions of receptor-interacting protein kinase 3 (RIPK3) and mixed lineage kinase domain-like protein (MLKL) in peripheral blood of neonates with necrotizing enterocolitis (NEC) and their relationships with the severity of the disease. Methods Ninety-two children with NEC were selected and divided into NEC group, and further divided into mild group (grade Ⅰ,
4.Expert consensus on perioperative nursing management of nutrition for elderly patients with hip fractures (version 2023)
Chunhua DENG ; Xiaohua CHEN ; Zhihua YIN ; Yao JIANG ; Xiaoju TAN ; Yaping CHEN ; Junqin DING ; Luo FAN ; Leling FENG ; Yuyun GAN ; Xiaoyan GAO ; Jinli GUO ; Jing HU ; Chen HUANG ; Guiling HUANG ; Tianwen HUANG ; Yingchun HUANG ; Hui JIN ; Yan JIN ; Fangfang LI ; Hui LI ; Hui LIU ; Ping LIU ; Ning NING ; Lingyun SHI ; Guomin SONG ; Yani SUN ; Guangling WANG ; Jie WANG ; Qi WANG ; Xia WANG ; Xiaoyun WANG ; Yi WANG ; Songmei WU ; Jian YANG ; Yumei ZHANG ; Yang ZHOU ; Xiaoyan WANG ; Yuan GAO
Chinese Journal of Trauma 2023;39(5):394-403
Hip fractures are among the most common fractures in the elderly, presenting to be a leading cause of disability and mortality. Surgical treatment is currently the main treatment method for hip fractures. The incidence of perioperative malnutrition is increased after hip fractures in the elderly due to the comorbidities, decreased basal metabolic rate, accelerated protein breakdown, weakened anabolism and surgical stress. However, malnutrition not only increases the incidence of postoperative complications, but also leads to increased mortality, indicating an important role of perioperative nursing management of nutrition for the elderly patients with hip fractures. At present, there still lacks scientific guidance and application standards on perioperative nursing management of nutrition for the elderly patients with hip fractures. Therefore, the Orthopedic Nursing Committee of Chinese Nursing Association and the Editorial Board of Chinese Journal of Trauma organized relevant experts to formulate the Expert consensus on perioperative nursing management of nutrition for elderly patients with hip fractures ( version 2023) according to evidence-based medical evidences and their clinical experiences. Fourteen recommendations were made from aspects of nutrition screening, nutrition assessment, nutrition diagnosis, nutrition intervention and nutrition monitoring to provide guidance for perioperative nursing management of nutrition in elderly patients with hip fractures.
5.Application of tunneled subcutaneous pedicle flaps in repair of nasal alar defects
Na YAN ; Lijuan YANG ; Chan ZHAO ; Yan LIU ; Weihui ZENG ; Songmei GENG ; Xuanfeng TAN
Chinese Journal of Dermatology 2022;55(2):161-163
Objective:To investigate clinical efficacy of tunneled subcutaneous pedicle flaps in the repair of ipsilateral nasal alar defects.Methods:A total of 20 patients with nasal alar defects after excision of basal cell carcinoma, which were repaired with ipsilateral tunneled subcutaneous pedicle flaps, were retrospectively collected from January 2018 to January 2020. There were 11 male patients and 9 female patients, with an average age of 60.6 years (range, 48 - 76 years) . According to clinical manifestations, the basal cell carcinoma lesions could be classified into 3 types: nodular-ulcerative type (13 cases) , superficial type (4 cases) and pigmented type (3 cases) , and the skin lesions varied from 0.4 cm × 0.5 cm to 0.9 cm × 1.1 cm in size. All the patients received extended surgical resection of basal cell carcinoma, and nasal alar defects were repaired with tunneled subcutaneous pedicle flaps, with the size of flaps ranging from 0.7 cm × 0.8 cm to 1.2 cm × 1.4 cm.Results:All flaps survived successfully, the nasal alar defects were completely repaired, and all wounds healed primarily. During the postoperative follow-up of 6 - 24 months, neither recurrence of tumors nor obvious scar hyperplasia occurred on the nasal ala, and nasal morphology and appearance were favorable.Conclusion:The tunneled subcutaneous pedicle flap can be used for the repair of ipsilateral nasal alar defects following excision of tumors or other lesions, resulting in favorable therapeutic outcomes and aesthetic appearance.
6.Diagnostic value of endoscopic ultrasonography for choledocholithiasis before endoscopic retrograde cholangiopancreatography
Lu XIE ; Jianfeng YANG ; Songmei LOU ; Haitao HUANG ; Wen LYU ; Xiao ZHANG ; Xiaofeng ZHANG
Chinese Journal of Digestive Endoscopy 2018;35(3):163-166
Objective To evaluate the diagnostic value of endoscopic ultrasonography(EUS)for common bile duct(CBD)stones before endoscopic retrograde cholangiopancreatography(ERCP). Methods Data of patients with suspected CBD stones admitted to The First People′s Hospital of Hangzhou from July 2012 to July 2013 were reviewed. Diagnostic efficiency and rates of complications were analyzed between patients undergoing EUS(EUS group)and MRCP(MRCP group)before ERCP, and between patients who underwent EUS and ERCP in different sessions(non-one-session group)with those in one session(one-session group). Results A total of 657 patients were included. With ERCP and follow-up results as the gold standard, the sensitivity(97.5% VS 88.4%), accuracy(96.3% VS 88.0%)and negative predictive value(88.9% VS 60.0%)of EUS in the diagnosis of CBD stones were significantly higher than those of MRCP(P<0.05). There were no significant differences between one-session group and non-one-session group in the sensitivity(97.5% VS 97.4%), specificity(91.7% VS 90.0%), positive predictive value(98.3% VS 97.4%), negative predictive value(88.0% VS 90.0%), and accuracy (96.6% VS 95.9%)in diagnosis of CBD stones(P>0.05). There were no significant differences in incidence of postoperative complications of ERCP between EUS and MRCP group[5.4%(13/242)VS 5.1%(21/415),P>0.05],and between one-session group and non-one-session group[5.5%(8/145)VS 5.2%(5/97),P>0.05].Conclusion Preoperative EUS before ERCP could increase diagnostic sensitivity and negative pridictive value of CBD stones without increasing the incidence of complications.
7.Therapeutic value of endoscopic ultrasound-guided celiac plexus neurolysis for pain associated with advanced pancreatic carcinoma in 29 patients
Songmei LOU ; Xiaofeng ZHANG ; Haitao HUANG ; Wen LYU ; Jianfeng YANG
Chinese Journal of Digestive Endoscopy 2017;34(9):658-661
Objective To evaluate the clinical efficiency of endoscopic ultrasound-guided celiac plexus neurolysis(EUS-CPN)for pain associated with advanced pancreatic carcinoma.Methods EUS-CPN was performed in 29 patients with advanced pancreatic carcinoma in Hangzhou First People′s Hospital from May 2010 to April 2015. The pain status before and after treatment was measured by visual analogue scale (VAS),and the clinical efficacy was assessed by pain anesis rate(PAR). Results All the 29 patients successfully completed EUS-CPN. The mean VAS value of the first day after treatment(3.6±1.5)was lower than that of preoperative(8.2±2.3,P=0.00). The mean VAS value of 1 month after treatment(2.0±0.6) was statistically different compared with the value of the first day after treatment(P=0.00). There were 10, 9,4,and 3 patients who had complete,obvious,moderate and mild relief,respectively. Three patients had no pain relief. The overall efficiency rate was 79.3%(23/29). Conclusion EUS-CPN is a safe and effective method for relieving pain in pancreatic carcinoma.
8.The application of whole-procedure seamless nursing intervention for treatment of patients with acute coronary syndrome
Yang ZHAO ; Wenjie ZHANG ; Yi LIANG ; Jinchuan YAN ; Songmei CAO
Chinese Journal of Nursing 2017;52(4):426-430
Objective To investigate the feasibility and effects of whole-procedure seamless nursing intervention during regional collaborative treatment of patients with acute coronary syndrome.Methods Nursing intervention was performed on pre-hospital collaboration,transfer collaboration and catheter room collaboration during regional collaborative treatment of patients with ACS.Treatment time point,therapeutic effects and major hospitalization indicators were compared before(the control group) and after(the experimental group) implementation of nursing intervention.Results There were significant differences in mean FMC-to-B time,D-to-B time,referral time,obtaining informed consent time,mortality,LVEF and LVED between two groups(P<0.05).There were significant differences in days of hospitalization,expenditures,percentage of consumables,percentage of medication,and in-hospital mortality between two groups (P<0.05).Conclusion Whole-procedure nursing intervention can reduce time of regional collaborative treatment of patients with acute coronary syndrome,improve prognosis,decrease financial burden and increase efficiency of ACS treatment.
9.Validity and Reliability of the Chinese version of Psycho-Educational Profile for Children with Autism
Songmei YU ; Meixiang JIA ; Xiaoling YANG ; Dunke SUN
Chinese Mental Health Journal 2015;(9):697-702
Objective:To test the validity and reliability of Chinese version of Psycho-Educational Profile (C-PEP) for children with autism in order to develop an assessment tool suitable for Chinese autistic children.Methods:A sample of 438 children who were diagnosed as autism according to the Diagnostic and Statisti-cal Manual of Mental Disorders,Fourth Edition (DSM-IV)criteria and aged from 2 to 11 coming from four differ-ent medical or educational rehabilitation agencies of Beijing,Wuhan,Shenzhen and Changchun were selected.488 Children with 2 to 7 years old were sampled from ordinary kindergartens.This study examined the validity and reli-ability of C-PEP using autism sample.Construct validity was tested with the C-PEP by inter-subscale Pearson corre-lations and confirmative factor analysis.Criterion-related validity was tested with the Peabody Picture and Vocabula-ry Test (PPVT),Combined Raven Test (CRT),Adaptive Behavior Scale (ABS),Childhood Autism Rating Scale (CARS)and the age as criteria.Discriminate validity was obtained by comparing the differences between the typi-cal and autism samples with the total scores of C-PEP.Internal consistency and rater reliability of C-PEP were ex-amined by Cronbach α,ANOVA of rater variation and intra-class correlation coefficients.Results:The inter-sub-scale correlations of C-PEP were medium relevance,the subscale and domain correlations were relatively high.Confirmative factor analysis indicated a relatively high fitting index between the model and sample da-ta.Regarding the concurrent validity of the C-PEP,the development total score was significantly correlated with the Raven's IQ,PPVT IQ,and ADQ scores,pathological behavior total score was positively related to the CARS score.T test results showed that children with autism were significantly behind the typical children at all age lev-els.Results also revealed that the internal consistency based on coefficient alpha and the intra-class correlation coef-ficients of raters for all subtests of C-PEP were reliable.Conclusion:It suggests that the Chinese version of Psycho-Educational Profile (C-PEP)is of good validity and reliability,and it could be used as an effective tool for measur-ing children with autism.
10.Application of pre-hospital nursing intervention in the regional cooperative treatment of acute myocardial infarction
Songmei CAO ; Yang ZHAO ; Jinchuan YAN ; Yi LIANG ; Fang XU
Chinese Journal of Practical Nursing 2015;31(18):1350-1353
Objective To explore the effect of pre-hospital nursing intervention in the new regional cooperative rescue model on treatment delay and the therapeutic effect in patients with myocardial infarction.Methods From January 2012 to May 2014,158 patients with acute myocardial infraction (AMI) were selected.Patients were divided into two groups,intervention group and control group,The first medical contact to balloon(FMC-to-B) time,referral time,cardiac function were analysed.Results Mean FMC-to-B time [(94±21)min vs.(102±23) min],referral time in nursing intervention [(5±3) min vs.(9±4) min)] were significantly shorter than those in control group (t=2.14,6.67,P<0.05).After a month compared with control group,LVEF was increased [(54.8±6.9)% vs.(48.8±6.9)%],and LVED was deceased [(50.1±8.2) mm vs.(50.5±5.6)mm] in intervention group.Conclusions Pre-hospital nursing intervention can decrease the FMC-to-B time,which could improve the cardiac function.


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