Real-world efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis

BACKGROUND Real-world data on tofacitinib(TOF)covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis(UC)are scarce.AIM To investigate the long-term efficacy and safety of TOF treatment for UC,including clinical issues.METHODS We performed a retrospective single-center observational analysis of 111 UC patients administered TOF at Hyogo Medical University as a tertiary inflammatory bowel disease center.All consecutive UC patients who received TOF between May 2018 and February 2020 were enrolled.Patients were followed up until August 2020.The primary outcome was the clinical response rate at week 8.Secondary outcomes included clinical remission at week 8,cumulative persistence rate of TOF administration,colectomy-free survival,relapse after tapering of TOF and predictors of clinical response at week 8 and week 48.RESULTS The clinical response and remission rates were 66.3%and 50.5%at week 8,and 47.1%and 43.5%at week 48,respectively.The overall cumulative clinical remission rate was 61.7%at week 48 and history of anti-tumor necrosis factor-alpha(TNF-α)agents use had no influence(P=0.25).The cumulative TOF persistence rate at week 48 was significantly lower in patients without clinical remission than in those with remission at week 8(30.9%vs 88.1%;P<0.001).Baseline partial Mayo Score was significantly lower in responders vs non-responders at week 8(odds ratio:0.61,95%confidence interval:0.45-0.82,P=0.001).Relapse occurred in 45.7%of patients after TOF tapering,and 85.7%of patients responded within 4 wk after re-increase.All 6 patients with herpes zoster(HZ)developed the infection after achieving remission by TOF.CONCLUSION TOF was more effective in UC patients with mild activity at baseline and its efficacy was not affected by previous treatment with anti-TNF-αagents.Most relapsed patients responded again after re-increase of TOF and nearly half relapsed after tapering off TOF.Special attention is needed for tapering and HZ.

Clinical manifestation,lifestyle,and treatment patterns of chronic erosive gastritis:A multicenter real-world study in China

BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To explore the clinical characteristics,treatment patterns,and short-term outcomes in CEG patients in China.METHODS We recruited patients with chronic non-atrophic or mild-to-moderate atrophic gastritis with erosion based on endoscopy and pathology.Patients and treating physicians completed a questionnaire regarding history,endoscopic findings,and treatment plans as well as a follow-up questionnaire to investigate changes in symptoms after 4 wk of treatment.RESULTS Three thousand five hundred sixty-three patients from 42 centers across 24 cities in China were included.Epigastric pain(68.0%),abdominal distension(62.6%),and postprandial fullness(47.5%)were the most common presenting symptoms.Gastritis was classified as chronic non-atrophic in 69.9%of patients.Among those with erosive lesions,72.1%of patients had lesions in the antrum,51.0%had multiple lesions,and 67.3%had superficial flat lesions.In patients with epigastric pain,the combination of a mucosal protective agent(MPA)and proton pump inhibitor was more effective.For those with postprandial fullness,acid regurgitation,early satiety,or nausea,a MPA appeared more promising.CONCLUSION CEG is a multifactorial disease which is common in Asian patients and has non-specific symptoms.Gastroscopy may play a major role in its detection and diagnosis.Treatment should be individualized based on symptom profile.

Current Situation and Prospect of the Application of Real-World Evidence in Health Care

Objective To summarize the application of real-world evidence(RWE)in the medical and healthcare field of various countries,including relevant policies,application scenarios and application methods.Methods Relevant policies and application scenarios were obtained by consulting the official websites and public documents of various countries’healthcare institutions.Systematic literature retrieval was adopted to search PubMed,EMBASE,Cochrane Library,CNKI,CBM and Wanfang databases,and all papers related to real-world study and application were included.Then,these papers were classified and analyzed by country and application method.Results and Conclusion The RWE was mainly applied to supporting the preliminary approval of a new drug,expanding drug indications,accelerating approval or supporting conditional marketing authorizations and drug safety evaluation,etc.The United Kingdom,the United States,Germany,the Netherlands,Italy,Sweden,and France admitted RWE,but they treated the data obtained from RWE with caution.After systematic literature retrieval,a total of 701 articles were obtained,including relevant studies from 36 countries,among which the United States published 264 in total.The most common study was about using real-world data(RWD)to calculate treatment-related costs,which had a total of 259 studies.Secondly,158 articles were used for epidemiological analysis.Then,138 articles were about establishing risk models to analyze disease risk factors.A total of 70 articles were real-world efficacy evaluation of the drug treatment schemes,54 articles were about pharmacoeconomic evaluation with RWD as parameters.A total of 29 articles used RWD to build predictive models,and 15 articles used RWD to evaluate the health-related quality of life in patients.The application of RWE has been used widely in the medical and healthcare field of various countries.The application scenarios are gradually diversified,the application methods of RWD become mature,and the evidence quality of RWE is also improved greatly.

Clinical outcomes of second-line chemotherapy in patients with advanced pancreatic adenocarcinoma:a real-world study

Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition,the optimal second-line chemotherapy regimen has not been determined.This study aimed to compare the effectiveness of different types of second-line chemotherapy for APC.Methods:Patients with APC who received first-line treatment from January 2008 to January 2021 were considered eligible for this retrospective analysis.The primary and secondary endpoints were overall survival(OS)and progression-free survival(PFS),respectively.Results:Four hundred and thirty-seven and 617 patients were treated with 5-fluorouracil-and gemcitabine-based chemotherapy as first-line treatment,respectively.Demographic and clinical features,except age and liver metastasis,were comparable between the two groups(P<0.05).The median OS was 8.8 and 7.8 months in patients who received a 5-fluorouracil-and gemcitabine-based combined regimen for first-line therapy,respectively(HR=1.244,95%CI=1.090–1.419;P<0.001).The median OS was 5.6 and 1.9 months in patients who received second-line chemotherapy and supportive care,respectively(HR=0.766,95%CI=0.677–0.867;P<0.001).The median PFS was not significantly differently between gemcitabine or 5-fluorouracil monotherapy and combination therapy.Conclusions:A 5-fluorouracil-or gemcitabine-based combined regimen was shown to be as effective as a single 5-fluorouracil or gemcitabine regimen as second-line therapy for patients with APC.

Performance evaluation of seven multi-label classification methods on real-world patent and publication datasets

Purpose:Many science,technology and innovation(STI)resources are attached with several different labels.To assign automatically the resulting labels to an interested instance,many approaches with good performance on the benchmark datasets have been proposed for multi-label classification task in the literature.Furthermore,several open-source tools implementing these approaches have also been developed.However,the characteristics of real-world multi-label patent and publication datasets are not completely in line with those of benchmark ones.Therefore,the main purpose of this paper is to evaluate comprehensively seven multi-label classification methods on real-world datasets.Research limitations:Three real-world datasets differ in the following aspects:statement,data quality,and purposes.Additionally,open-source tools designed for multi-label classification also have intrinsic differences in their approaches for data processing and feature selection,which in turn impacts the performance of a multi-label classification approach.In the near future,we will enhance experimental precision and reinforce the validity of conclusions by employing more rigorous control over variables through introducing expanded parameter settings.Practical implications:The observed Macro F1 and Micro F1 scores on real-world datasets typically fall short of those achieved on benchmark datasets,underscoring the complexity of real-world multi-label classification tasks.Approaches leveraging deep learning techniques offer promising solutions by accommodating the hierarchical relationships and interdependencies among labels.With ongoing enhancements in deep learning algorithms and large-scale models,it is expected that the efficacy of multi-label classification tasks will be significantly improved,reaching a level of practical utility in the foreseeable future.Originality/value:(1)Seven multi-label classification methods are comprehensively compared on three real-world datasets.(2)The TextCNN and TextRCNN models perform better on small-scale datasets with more complex hierarchical structure of labels and more balanced document-label distribution.(3)The MLkNN method works better on the larger-scale dataset with more unbalanced document-label distribution.

A Situational Awareness Method for Initial Insulation Fault of Distribution Network Based on Multi-Feature Index Comprehensive Evaluation

Most ground faults in distribution network are caused by insulation deterioration of power equipment.It is difficult to find the insulation deterioration of the distribution network in time,and the development trend of the initial insulation fault is unknown,which brings difficulties to the distribution inspection.In order to solve the above problems,a situational awareness method of the initial insulation fault of the distribution network based on a multi-feature index comprehensive evaluation is proposed.Firstly,the insulation situation evaluation index is selected by analyzing the insulation fault mechanism of the distribution network,and the relational database of the distribution network is designed based on the data and numerical characteristics of the existing distribution management system.Secondly,considering all kinds of fault factors of the distribution network and the influence of the power supply region,the evaluation method of the initial insulation fault situation of the distribution network is proposed,and the development situation of the distribution network insulation fault is classified according to the evaluation method.Then,principal component analysis was used to reduce the dimension of the training samples and test samples of the distribution network data,and the support vector machine(SVM)was trained.The optimal parameter combination of the SVM model was found by the grid search method,and a multi-class SVM model based on 1-v-1 method was constructed.Finally,the trained multi-class SVM was used to predict 6 kinds of situation level prediction samples.The results of simulation examples show that the average prediction accuracy of 6 situation levels is above 95%,and the perception accuracy of 4 situation levels is above 96%.In addition,the insulation maintenance decision scheme under different situation levels is able to be given when no fault occurs or the insulation fault is in the early stage,which can meet the needs of power distribution and inspection for accurately sensing the insulation fault situation.The correctness and effectiveness of this method are verified.

A hierarchical enhanced data-driven battery pack capacity estimation framework for real-world operating conditions with fewer labeled data

Battery pack capacity estimation under real-world operating conditions is important for battery performance optimization and health management,contributing to the reliability and longevity of batterypowered systems.However,complex operating conditions,coupling cell-to-cell inconsistency,and limited labeled data pose great challenges to accurate and robust battery pack capacity estimation.To address these issues,this paper proposes a hierarchical data-driven framework aimed at enhancing the training of machine learning models with fewer labeled data.Unlike traditional data-driven methods that lack interpretability,the hierarchical data-driven framework unveils the“mechanism”of the black box inside the data-driven framework by splitting the final estimation target into cell-level and pack-level intermediate targets.A generalized feature matrix is devised without requiring all cell voltages,significantly reducing the computational cost and memory resources.The generated intermediate target labels and the corresponding features are hierarchically employed to enhance the training of two machine learning models,effectively alleviating the difficulty of learning the relationship from all features due to fewer labeled data and addressing the dilemma of requiring extensive labeled data for accurate estimation.Using only 10%of degradation data,the proposed framework outperforms the state-of-the-art battery pack capacity estimation methods,achieving mean absolute percentage errors of 0.608%,0.601%,and 1.128%for three battery packs whose degradation load profiles represent real-world operating conditions.Its high accuracy,adaptability,and robustness indicate the potential in different application scenarios,which is promising for reducing laborious and expensive aging experiments at the pack level and facilitating the development of battery technology.

Real-world clinical efficacy of tofacitinib in moderate-to-severe ulcerative colitis

Tofacitinib is an oral small-molecule Janus kinase(JAK)inhibitor that preferentially inhibits JAK1 and JAK3.Its efficacy in inducing and maintaining remission in ulcerative colitis(UC)as well as its safety profile has been demonstrated in multicenter,randomized,double-blind,placebo-controlled trials.Additionally,real-world studies evaluating the effectiveness and adverse effects of tofacitinib have been conducted,affirming its clinical efficacy in moderate-to-severe UC.

A Comparative Study of Metaheuristic Optimization Algorithms for Solving Real-World Engineering Design Problems

Real-world engineering design problems with complex objective functions under some constraints are relatively difficult problems to solve.Such design problems are widely experienced in many engineering fields,such as industry,automotive,construction,machinery,and interdisciplinary research.However,there are established optimization techniques that have shown effectiveness in addressing these types of issues.This research paper gives a comparative study of the implementation of seventeen new metaheuristic methods in order to optimize twelve distinct engineering design issues.The algorithms used in the study are listed as:transient search optimization(TSO),equilibrium optimizer(EO),grey wolf optimizer(GWO),moth-flame optimization(MFO),whale optimization algorithm(WOA),slimemould algorithm(SMA),harris hawks optimization(HHO),chimp optimization algorithm(COA),coot optimization algorithm(COOT),multi-verse optimization(MVO),arithmetic optimization algorithm(AOA),aquila optimizer(AO),sine cosine algorithm(SCA),smell agent optimization(SAO),and seagull optimization algorithm(SOA),pelican optimization algorithm(POA),and coati optimization algorithm(CA).As far as we know,there is no comparative analysis of recent and popular methods against the concrete conditions of real-world engineering problems.Hence,a remarkable research guideline is presented in the study for researchersworking in the fields of engineering and artificial intelligence,especiallywhen applying the optimization methods that have emerged recently.Future research can rely on this work for a literature search on comparisons of metaheuristic optimization methods in real-world problems under similar conditions.

Real-World Evidence in Localized Pancreatic: Coping with Uncertainty in Unselected Populations

Background: Localized pancreatic cancer, including resectable (R), borderline resectable (BR) and locally advanced unresectable disease (LAU), is considered in clinical guidelines for diverse treatment options based on clinical trials in selected populations. Hence, exploring with real world evidence (RWE) clinicians’ preferences for treatment options and their results seems pertinent. Methods: In a set of consecutive patients with localized pancreatic cancer assisted in a third level hospital from January 2013 to December 2022, medical records, symptoms, diagnostic process, distribution between subtypes, and treatment plans, with safety and efficacy results, were assessed. Results: A total of 152 patients with localized disease were included (43.4% R, 21.0% BR, 33.6% LAU). The population characteristics exemplified differences between daily practice and clinical trials. Tumor location and symptoms were as expected. Treatment plan was conditioned by PS or comorbidities in 23.0% of patients. In patients with R disease, surgery followed by different adjuvant chemotherapy (CT) regimes was the antineoplastic treatment of choice (64.8%) with efficacy results (OS 37.5 months;95% CI 18.4 - 56.7), in the range of contemporary standards. The common use of neoadjuvant CT for BR disease (94.4%), with surgery in 50% of them, and its results (OS 30.8 months;95% CI 10.5 - 51.2) reflected current controversies of treatment recommendations and evolution in this scenario. Paliative CT with or without radiotherapy was the standard specific treatment in LAU disease (95.1%) with survival results (PFS: 10.8 months;95% CI 8.8 - 12.7. OS: 20.3 months;95% CI 13.5 - 27.2) that justify the distinct character and the specific study of this entity. Conclusion: RWE for localized pancreatic cancer aroused from the analysis of this population confirms the distinct nature of patients assisted in daily practice, as well as mirrors the complexity of decision making in clinical assumptions in which achieving stronger evidence should be paramount.

Current status and prospects of research on safety situation awareness of high speed railway operation environment

Purpose–The safety of high-speed rail operation environments is an important guarantee for the safe operation of high-speed rail.The operating environment of the high-speed rail is complex,and the main factors affecting the safety of high-speed rail operating environment include meteorological disasters,perimeter intrusion and external environmental hazards.The purpose of the paper is to elaborate on the current research status and team research progress on the perception of safety situation in high-speed rail operation environment and to propose directions for further research in the future.Design/methodology/approach–In terms of the mechanism and spatio-temporal evolution law of the main influencing factors on the safety of high-speed rail operation environments,the research status is elaborated,and the latest research progress and achievements of the team are introduced.This paper elaborates on the research status and introduces the latest research progress and achievements of the team in terms of meteorological,perimeter and external environmental situation perception methods for high-speed rail operation.Findings–Based on the technical route of“situational awareness evaluation warning active control,”a technical system for monitoring the safety of high-speed train operation environments has been formed.Relevant theoretical and technical research and application have been carried out around the impact of meteorological disasters,perimeter intrusion and the external environment on high-speed rail safety.These works strongly support the improvement of China’s railway environmental safety guarantee technology.Originality/value–With the operation of CR450 high-speed trains with a speed of 400 kmper hour and the application of high-speed train autonomous driving technology in the future,new and higher requirements have been put forward for the safety of high-speed rail operation environments.The following five aspects of work are urgently needed:(1)Research the single factor disaster mechanism of wind,rain,snow,lightning,etc.for high-speed railways with a speed of 400 kms per hour,and based on this,study the evolution characteristics of multiple safety factors and the correlation between the high-speed driving safety environment,revealing the coupling disastermechanism ofmultiple influencing factors;(2)Research covers multi-source data fusion methods and associated features such as disaster monitoring data,meteorological information,route characteristics and terrain and landforms,studying the spatio-temporal evolution laws of meteorological disasters,perimeter intrusions and external environmental hazards;(3)In terms of meteorological disaster situation awareness,research high-precision prediction methods for meteorological information time series along high-speed rail lines and study the realization of small-scale real-time dynamic and accurate prediction of meteorological disasters along high-speed rail lines;(4)In terms of perimeter intrusion,research amulti-modal fusion perception method for typical scenarios of high-speed rail operation in all time,all weather and all coverage and combine artificial intelligence technology to achieve comprehensive and accurate perception of perimeter security risks along the high-speed rail line and(5)In terms of external environment,based on the existing general network framework for change detection,we will carry out research on change detection and algorithms in the surrounding environment of highspeed rail.

Current Situation and Countermeasures of Household Waste Classification in Feixi County, Hefei City

Feixi County has made significant progress in promoting waste classification,such as establishing a comprehensive classification system,and effectively reducing environmental pollution and waste volume.However,with the increase in waste generation,the county faces multiple challenges especially in the disposal of kitchen waste and improvement of residents environmental awareness.To address these issues,Feixi County has implemented various measures,such as strengthening the construction of infrastructure for waste classification,improving regulations and clearly defining responsibilities,enhancing residents environmental awareness to encourage their participation in waste classification through education and promotion,and increasing supervision to ensure effective implementation of the work.It emphasizes community governance,encourage all parties to participate in it,and strengthen publicity,education and training to enhance residents participation.Feixi County has achieved positive results,but efforts are needed to further improve facilities,raise awareness,enhance supervision,and ensure the continuous effectiveness of waste classification work to promote urban green sustainable development.

Utilization of Real-World Data in Drug Development

With the rapid development of modern science and technology, traditional randomized controlled trials have become insufficient to meet current scientific research needs, particularly in the field of clinical research. The emergence of real-world data studies, which align more closely with actual clinical evidence, has garnered significant attention in recent years. The following is a brief overview of the specific utilization of real-world data in drug development, which often involves large sample sizes and analyses covering a relatively diverse population without strict inclusion and exclusion criteria. Real-world data often reflects real clinical practice: treatment options are chosen according to the actual conditions and willingness of patients rather than through random assignment. Analysis based on real-world data also focuses on endpoints highly relevant to clinical benefits and the quality of life of patients. The booming big data technology supports the utilization of real-world data to accelerate new drug development, serving as an important supplement to traditional clinical trials.

Corrigendum:Exploration of the Current Situation and Mechanism Innovation of University Education Management under the New Situation

Correction A funding is added to the original publication(https://doi.org/10.26689/jcer.v8i10.8594).

Ways to Cultivate and Develop Human Resources in the New Situation

In the trend of globalization,digitization,and economic integration,human resources are the core competitiveness of enterprises,and cultivating and developing them is crucial for enhancing competitive advantages.This article delves into how human resource development drives enterprise innovation,promotes team collaboration,and optimizes performance management.Currently,although many enterprises are beginning to attach importance to human resource development,they still face problems such as insufficient investment,weak targeted training,and insufficient exploration of employee potential.Therefore,it is proposed that in the new situation,enterprises need to strengthen diversified training strategies,use digital tools to improve training efficiency,build a fair performance evaluation system,stimulate employee potential,and promote internal talent mobility.The implementation of these strategies will effectively enhance the efficiency of enterprise human resource management and consolidate market position.

Architectural Design and Urban Planning in the New Situation

Under the influence of the world economy,China’s economic development is very rapid,the people’s living standards have been greatly improved,and the urbanization process has been accelerated.As a part of urban planning,architecture plays an important role in urban planning and construction,so urban planning must be combined with the future development goals of the city,develop in an all-round way,strengthen architectural design,ensure the consistency of urban planning and architectural design,and create a good environment for urban development.Therefore,this paper analyzes the relationship between architectural design and urban planning under the new situation,clarifies the relationship between architectural design and urban planning,and strengthens urban construction.

Exploration and Reflection on Promoting Graduate Enrollment under the New Situation

Graduate enrollment is crucial for improving the quality of graduate education and building a high-quality education system.The current enrollment situation in some universities is severe,with problems such as insufficient attention to enrollment promotion and a single mode.To solve these problems,this article proposes measures such as leveraging the joint efforts of schools,formulating enrollment promotion plans at different levels,strengthening the construction of enrollment teams at both the school and college levels,enriching enrollment promotion forms,strengthening the construction of high-quality student sources,and building a quality evaluation system for student sources to attract more students to apply and continuously improve the quality of student sources.

Exploration of the Current Situation and Mechanism Innovation of University Education Management under the New Situation

In the new era,university education management should be oriented toward the cultivation of innovative talents and the construction of a comprehensive education system.It should develop capable and qualified higher-level talents in response to the social demand for talent application,thereby enhancing the overall educational competitiveness of universities and driving deep reforms in educational activities.However,in current educational practice,efficient educational management often focuses on curriculum development and cultural education,with insufficient attention paid to the development of students’comprehensive literacy.The talent cultivation and education programs are not yet perfect.This article explores the current situation of university education management activities under the new situation and considers practical methods for innovating university education management mechanisms.

Research on English Language and Literature Teaching Strategies Based on Situational Teaching Method

The teaching of English language and literature not only focuses on developing students’English language proficiency but also emphasizes their understanding and cognition of the cultural connotations behind the English language.This dual focus aims to cultivate students’cross-cultural communication skills and practical English skills.The application of the situational teaching method can create corresponding learning scenarios based on English language knowledge,thereby enriching students’learning experiences and understanding within these scenarios.This method has significant advantages in enhancing the effectiveness of English language and literature teaching.Consequently,this paper first analyzes the significance of applying the situational teaching method in university-level English language and literature instruction.It then proposes several strategies for implementing this method,with the goal of enhancing students’language awareness,cultural literacy,and comprehensive English skills.

Discussion on Cultural Integration and Educational Services for International Students from the Perspective of Situational Communication

From the perspective of situational communication,this paper aims to explore how to promote cultural integration and provide better educational services for international students in China.This paper first analyzes the basic assumptions and key factors of situational communication based on international students in China.Secondly,the relationship between situational communication and cultural integration and educational services for international students in China is discussed in depth.Additionally,the role of situational communication in educational services for international students in China,such as promoting cross-cultural communication,solving language barriers,and enhancing mutual understanding,is proposed.Lastly,from the perspective of situational communication,an optimization path of educational services and cultural integration for international students in China is proposed,including the provision of diversified educational resources,the enhancement of cross-cultural communication,and the establishment of an effective communication mechanism.This study expands the perspective of educational services for international students in China,provides a new theoretical framework and practical path,and offers a reference for promoting cultural integration and improving educational services for international students in China.