BACKGROUND Diabetes mellitus has become one of the major pandemics of the 21st century.In this scenario,nursing interventions are essential for improving self-care and quality of life in patients with type 2 diabetes ...BACKGROUND Diabetes mellitus has become one of the major pandemics of the 21st century.In this scenario,nursing interventions are essential for improving self-care and quality of life in patients with type 2 diabetes mellitus.Nursing interventions are crucial for managing the disease and preventing complications.AIM To analyse nursing interventions in recent years through a systematic review and meta-analysis and to propose improvements in care plans.METHODS This study conducted a systematic review and meta-analysis of the impact of nursing interventions on quantitative glycaemic variables,such as glycated haemoglobin and fasting plasma glucose.RESULTS After confirming that the combined effect of all studies from the past 5 years positively impacts quantitative variables,a descriptive analysis of the studies with the most significant changes was conducted.Based on this,an improvement in diabetic patient care protocols has been proposed through follow-up plans tailored to the patient’s technological skills.CONCLUSION The combined results obtained and the proposal for improvement developed in this manuscript could help to improve the quality of life of many people around the world.展开更多
BACKGROUND Epidural analgesia is the most effective analgesic method during labor.Butorphanol administered epidurally has been shown to be a successful analgesic method during labor.However,no comprehensive study has ...BACKGROUND Epidural analgesia is the most effective analgesic method during labor.Butorphanol administered epidurally has been shown to be a successful analgesic method during labor.However,no comprehensive study has examined the safety and efficacy of using butorphanol as an epidural analgesic during labor.AIM To assess butorphanol's safety and efficacy for epidural labor analgesia.METHODS The PubMed,Cochrane Library,EMBASE,Web of Science,China National Knowledge Infrastructure,and Google Scholar databases will be searched from inception.Other types of literature,such as conference abstracts and references to pertinent reviews,will also be reviewed.We will include randomized controlled trials comparing butorphanol with other opioids combined with local anesthetics for epidural analgesia during labor.There will be no language restrictions.The primary outcomes will include the visual analog scale score for the first stage of labor,fetal effects,and Apgar score.Two independent reviewers will evaluate the full texts,extract data,and assess the risk of bias.Publication bias will be evaluated using Egger's or Begg's tests as well as visual analysis of a funnel plot,and heterogeneity will be evaluated using the Cochran Q test,P values,and I2 values.Meta-analysis,subgroup analysis,and sensitivity analysis will be performed using RevMan software version 5.4.This protocol was developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA)Protocols statement,and the PRISMA statement will be used for the systematic review.RESULTS This study provides reliable information regarding the safety and efficacy of using butorphanol as an epidural analgesic during labor.CONCLUSION To support clinical practice and development,this study provides evidence-based findings regarding the safety and efficacy of using butorphanol as an epidural analgesic during labor.展开更多
This paper investigates the problem of global/semi-global finite-time consensus for integrator-type multi-agent sys-tems.New hyperbolic tangent function-based protocols are pro-posed to achieve global and semi-global ...This paper investigates the problem of global/semi-global finite-time consensus for integrator-type multi-agent sys-tems.New hyperbolic tangent function-based protocols are pro-posed to achieve global and semi-global finite-time consensus for both single-integrator and double-integrator multi-agent systems with leaderless undirected and leader-following directed commu-nication topologies.These new protocols not only provide an explicit upper-bound estimate for the settling time,but also have a user-prescribed bounded control level.In addition,compared to some existing results based on the saturation function,the pro-posed approach considerably simplifies the protocol design and the stability analysis.Illustrative examples and an application demonstrate the effectiveness of the proposed protocols.展开更多
This paper is concerned with consensus of a secondorder linear time-invariant multi-agent system in the situation that there exists a communication delay among the agents in the network.A proportional-integral consens...This paper is concerned with consensus of a secondorder linear time-invariant multi-agent system in the situation that there exists a communication delay among the agents in the network.A proportional-integral consensus protocol is designed by using delayed and memorized state information.Under the proportional-integral consensus protocol,the consensus problem of the multi-agent system is transformed into the problem of asymptotic stability of the corresponding linear time-invariant time-delay system.Note that the location of the eigenvalues of the corresponding characteristic function of the linear time-invariant time-delay system not only determines the stability of the system,but also plays a critical role in the dynamic performance of the system.In this paper,based on recent results on the distribution of roots of quasi-polynomials,several necessary conditions for Hurwitz stability for a class of quasi-polynomials are first derived.Then allowable regions of consensus protocol parameters are estimated.Some necessary and sufficient conditions for determining effective protocol parameters are provided.The designed protocol can achieve consensus and improve the dynamic performance of the second-order multi-agent system.Moreover,the effects of delays on consensus of systems of harmonic oscillators/double integrators under proportional-integral consensus protocols are investigated.Furthermore,some results on proportional-integral consensus are derived for a class of high-order linear time-invariant multi-agent systems.展开更多
This paper introduces a Kalman-type recursive state estimator for a class of discrete-time stochastic linear singular systems where the measurements are carried part by part periodically following a scheduling algorit...This paper introduces a Kalman-type recursive state estimator for a class of discrete-time stochastic linear singular systems where the measurements are carried part by part periodically following a scheduling algorithm.We consider that the system is in a network with limited allotted bandwidth,which refers to a situation where the total available bandwidth for data transmission through the network is limited.This limitation can occur for various reasons,such as network congestion,resource allocation policies,or bandwidth limitations imposed by network administrators.In such networks,the entire measurement vector cannot be transmitted to the estimator instantly.Thus,managing a network with a limited allotted bandwidth requires careful planning,monitoring,and implementing some scheduling strategies to optimize the use of measured data while estimating the system states.We show that a scheduling method,namely,round-robin protocol,is suitable for singular systems to deal with such a scenario.The upper bound of the prior error covariance is studied via a periodic Riccati equation(PRE).To retain the boundedness of prior error covariance,the stability of the PRE is examined by the observability properties of the round-robin-induced system.Finally,a simulation example is presented to show the effectiveness of the designed filtering scheme.展开更多
This paper is aimed at the distributed fault estimation issue associated with the potential loss of actuator efficiency for a type of discrete-time nonlinear systems with sensor saturation.For the distributed estimati...This paper is aimed at the distributed fault estimation issue associated with the potential loss of actuator efficiency for a type of discrete-time nonlinear systems with sensor saturation.For the distributed estimation structure under consideration,an estimation center is not necessary,and the estimator derives its information from itself and neighboring nodes,which fuses the state vector and the measurement vector.In an effort to cut down data conflicts in communication networks,the stochastic communication protocol(SCP)is employed so that the output signals from sensors can be selected.Additionally,a recursive security estimator scheme is created since attackers randomly inject malicious signals into the selected data.On this basis,sufficient conditions for a fault estimator with less conservatism are presented which ensure an upper bound of the estimation error covariance and the mean-square exponential boundedness of the estimating error.Finally,a numerical example is used to show the reliability and effectiveness of the considered distributed estimation algorithm.展开更多
In this editorial we comment on the article published in a recent issue of the World Journal of Clinical Cases.This article described a novel ultrasound-guided lateral recess block approach in treating a patient with ...In this editorial we comment on the article published in a recent issue of the World Journal of Clinical Cases.This article described a novel ultrasound-guided lateral recess block approach in treating a patient with lateral recess stenosis.The impact of spinal pain-related disability extends significantly,causing substantial human suffering and medical costs.Each county has its preferred treatment strategies for spinal pain.Here,we explore the lower back pain(LBP)treatment algorithm recommended in France.The treatment algorithm for LBP recommended by the French National Authority for Health emphasizes early patient activity and minimal medication use.It encourages the continuation of daily activities,limits excessive medication and spinal injections,and incorporates psychological assessments and non-pharmacological therapies for chronic cases.However,the algorithm may not aggressively address acute pain in the early stages,potentially delaying relief and increasing the risk of chronicity.Additionally,the recommended infiltrations primarily involve caudal epidural steroid injections,with limited consideration for other injection procedures,such as transforaminal or interlaminar epidural steroid injections.The fixed follow-up timeline may not accommodate patients who do not respond to initial treatment or experience intense pain,potentially delaying the exploration of alternative therapies.Despite these limitations,understanding the strengths and weaknesses of the French approach could inform adaptations in LBP treatment strategies globally,potentially enhancing patient outcomes and satisfaction across diverse healthcare systems.展开更多
The care of a patient involved in major trauma with exsanguinating haemorrhage is time-critical to achieve definitive haemorrhage control,and it requires coordinated multidisciplinary care.During initial resuscitation...The care of a patient involved in major trauma with exsanguinating haemorrhage is time-critical to achieve definitive haemorrhage control,and it requires coordinated multidisciplinary care.During initial resuscitation of a patient in the emergency department(ED),Code Crimson activation facilitates rapid decisionmaking by multi-disciplinary specialists for definitive haemorrhage control in operating theatre(OT)and/or interventional radiology(IR)suite.Once this decision has been made,there may still be various factors that lead to delay in transporting the patient from ED to OT/IR.Red Blanket protocol identifies and addresses these factors and processes which cause delay,and aims to facilitate rapid and safe transport of the haemodynamically unstable patient from ED to OT,while minimizing delay in resuscitation during the transfer.The two processes,Code Crimson and Red Blanket,complement each other.It would be ideal to merge the two processes into a single protocol rather than having two separate workflows.Introducing these quality improvement strategies and coor-dinated processes within the trauma framework of the hospitals/healthcare systems will help in further improving the multi-disciplinary care for the complex trauma patients requiring rapid and definitive haemorrhage control.展开更多
Protocol Reverse Engineering(PRE)is of great practical importance in Internet security-related fields such as intrusion detection,vulnerability mining,and protocol fuzzing.For unknown binary protocols having fixed-len...Protocol Reverse Engineering(PRE)is of great practical importance in Internet security-related fields such as intrusion detection,vulnerability mining,and protocol fuzzing.For unknown binary protocols having fixed-length fields,and the accurate identification of field boundaries has a great impact on the subsequent analysis and final performance.Hence,this paper proposes a new protocol segmentation method based on Information-theoretic statistical analysis for binary protocols by formulating the field segmentation of unsupervised binary protocols as a probabilistic inference problem and modeling its uncertainty.Specifically,we design four related constructions between entropy changes and protocol field segmentation,introduce random variables,and construct joint probability distributions with traffic sample observations.Probabilistic inference is then performed to identify the possible protocol segmentation points.Extensive trials on nine common public and industrial control protocols show that the proposed method yields higher-quality protocol segmentation results.展开更多
BACKGROUND Clozapine,the gold standard for resistant schizophrenia,is underused due to risks like clozapine-induced myocarditis(CIM).Non-specific biomarkers and inconsistent imaging,and the significant overlap with cl...BACKGROUND Clozapine,the gold standard for resistant schizophrenia,is underused due to risks like clozapine-induced myocarditis(CIM).Non-specific biomarkers and inconsistent imaging,and the significant overlap with clozapine-induced pneumonia(CIP)lead to misdiagnosis and premature discontinuation.AIM To develop a diagnostic algorithm for CIM to enhance accuracy,differentiate from CIP,and guide safe clozapine rechallenge.METHODS A systematic review of 119 PubMed studies(published between 1990 and April 2025)was conducted in accordance with PRISMA guidelines.The review analyzed CIM diagnosis and rechallenge outcomes,with a focus on biomarkers,imaging,and collaboration with cardiology.RESULTS CIM diagnosis relies on troponin and C-reactive protein;electrocardiography and echocardiography are inconsistently applied,and cardiac magnetic resonance imaging(CMR)is underused.Rechallenge was successful in 64.7%to 68.9%of 136 cases,with 2.9%resulting in fatal outcomes.Up to 65%of presumed CIM cases lack confirmation.A proposed protocol integrates chest computed tomography to exclude pneumonia and CMR for CIM confirmation,with echocardiography as an alternative.CONCLUSION A protocol involving multidisciplinary collaboration among computed tomography,CMR,and cardiology improves CIM diagnosis.Slow titration prevents CIM;adjust the dose for CIP and discontinue for confirmed CIM.展开更多
Accurate time synchronization is fundamental to the correct and efficient operation of Wireless Sensor Networks(WSNs),especially in security-critical,time-sensitive applications.However,most existing protocols degrade...Accurate time synchronization is fundamental to the correct and efficient operation of Wireless Sensor Networks(WSNs),especially in security-critical,time-sensitive applications.However,most existing protocols degrade substantially under malicious interference.We introduce iSTSP,an Intelligent and Secure Time Synchronization Protocol that implements a four-stage defense pipeline to ensure robust,precise synchronization even in hostile environments:(1)trust preprocessing that filters node participation using behavioral trust scoring;(2)anomaly isolation employing a lightweight autoencoder to detect and excise malicious nodes in real time;(3)reliability-weighted consensus that prioritizes high-trust nodes during time aggregation;and(4)convergence-optimized synchronization that dynamically adjusts parameters using theoretical stability bounds.We provide rigorous convergence analysis including a closed-form expression for convergence time,and validate the protocol through both simulations and realworld experiments on a controlled 16-node testbed.Under Sybil attacks with five malicious nodes within this testbed,iSTSP maintains synchronization error increases under 12%and achieves a rapid convergence.Compared to state-ofthe-art protocols like TPSN,SE-FTSP,and MMAR-CTS,iSTSP offers 60%faster detection,broader threat coverage,and more than 7 times lower synchronization error,with a modest 9.3%energy overhead over 8 h.We argue this is an acceptable trade-off for mission-critical deployments requiring guaranteed security.These findings demonstrate iSTSP’s potential as a reliable solution for secure WSN synchronization and motivate future work on large-scale IoT deployments and integration with energy-efficient communication protocols.展开更多
BACKGROUND Massive rotator cuff tears(RCTs)result in impaired shoulder function and quality of life.These tears lead to structural changes in the rotator cuff muscles,which compromise recovery after repair and increas...BACKGROUND Massive rotator cuff tears(RCTs)result in impaired shoulder function and quality of life.These tears lead to structural changes in the rotator cuff muscles,which compromise recovery after repair and increase re-tear rates.AIM To investigate the potential inhibitory effects of alpha-tocopherol(vitamin E)and OTR-4131 on muscle atrophy,fatty infiltration,and fibrosis in rotator cuff muscles following a massive RCT using a Wistar rat model,and establish a standardized methodology for evaluating potential therapeutic agents.METHODS This protocol outlines a controlled animal study using 40 male Wistar rats,randomized into five groups.The experimental groups will receive either systemic administration of alpha-tocopherol or local administration of OTR-4131 via intramuscular injection into the supraspinatus and infraspinatus muscles.Two sham groups will receive systemic and local saline injections respectively,while a control group will undergo no intervention.The interventions will be administered after surgical transection of the supraspinatus and infraspinatus tendons.Outcomes will be assessed via wet muscle weight measurements,muscle fiber diameter,fatty infiltration percentage,and fibrosis evaluation using histological methods.RESULTS The study anticipates that alpha-tocopherol and OTR-4131 will reduce muscle atrophy,fatty infiltration,and fibrosis compared to control and sham groups,supporting their potential protective role in rotator cuff muscle degeneration.CONCLUSION The results are expected to improve the understanding on the role of alpha-tocopherol and OTR-4131 in rotator cuff muscle protection after massive RCT and may serve as a foundation for further preclinical and clinical research aimed at improving rotator cuff repair outcomes.展开更多
“Flying Ad Hoc Networks(FANETs)”,which use“Unmanned Aerial Vehicles(UAVs)”,are developing as a critical mechanism for numerous applications,such as military operations and civilian services.The dynamic nature of F...“Flying Ad Hoc Networks(FANETs)”,which use“Unmanned Aerial Vehicles(UAVs)”,are developing as a critical mechanism for numerous applications,such as military operations and civilian services.The dynamic nature of FANETs,with high mobility,quick node migration,and frequent topology changes,presents substantial hurdles for routing protocol development.Over the preceding few years,researchers have found that machine learning gives productive solutions in routing while preserving the nature of FANET,which is topology change and high mobility.This paper reviews current research on routing protocols and Machine Learning(ML)approaches applied to FANETs,emphasizing developments between 2021 and 2023.The research uses the PRISMA approach to sift through the literature,filtering results from the SCOPUS database to find 82 relevant publications.The research study uses machine learning-based routing algorithms to beat the issues of high mobility,dynamic topologies,and intermittent connection in FANETs.When compared with conventional routing,it gives an energy-efficient and fast decision-making solution in a real-time environment,with greater fault tolerance capabilities.These protocols aim to increase routing efficiency,flexibility,and network stability using ML’s predictive and adaptive capabilities.This comprehensive review seeks to integrate existing information,offer novel integration approaches,and recommend future research topics for improving routing efficiency and flexibility in FANETs.Moreover,the study highlights emerging trends in ML integration,discusses challenges faced during the review,and discusses overcoming these hurdles in future research.展开更多
The current recommendation to avoid non-steroidal anti-inflammatory drugs(NSAIDs)in the management of dengue virus disease(DVD)is scientifically considered of very low to low certainty,despite being widely adopted wor...The current recommendation to avoid non-steroidal anti-inflammatory drugs(NSAIDs)in the management of dengue virus disease(DVD)is scientifically considered of very low to low certainty,despite being widely adopted worldwide.The same recommendation,initially made during the coronavirus disease 2019(COVID-19)pandemic,was subsequently proven incorrect.In this clinical report,we present evidence,for the first time globally,from a real-life practice that NSAIDs may actually be lifesaving in the early management of DVD as they have proved to be in COVID-19.Moreover,we propose that the personalized immunemodulatory Kelleni’s protocol,which includes nitazoxanide as a key component,can be safely and effectively used to manage various separate or concomitant viral infections and co-infections,including DVD.Importantly,this article contributes to the current medical knowledge in the global pursuit of a safe and effective broad-spectrum antiviral protocol that can be used to early manage multiple highly infectious viruses.However,it’s crucial that sufficiently powered controlled randomized clinical trials be conducted to thoroughly assess and evaluate the safety of NSAIDs in the early management of DVD as well as the efficacy of nitazoxanide with or without NSAIDs in its management.展开更多
Objective To discuss the flexible supervision and communication mode in the post-approval change(PAC)of drugs,to explore how to ensure the quality and availability of drugs during the changes,and to provide some sugge...Objective To discuss the flexible supervision and communication mode in the post-approval change(PAC)of drugs,to explore how to ensure the quality and availability of drugs during the changes,and to provide some suggestions and reference for promoting the timely marketing of drugs.Methods Based on the comparability protocol guidelines issued by the US FDA in October 2022,the regulatory status quo of PAC between China and the US was compared to explore the feasibility of implementing comparability protocols in China.Results and Conclusion According to the specific situation of post-approval of drug change supervision,some suggestions were put forward to optimize the PAC management procedure,such as establishing the communication pathways between holders and health authorities,publishing relevant guidance and strengthening training,so as to provide reference for the implementation of comparability protocols in China.展开更多
Focusing on the ultralow expansion functionality of the crystalized glass containing the cordierite crystal phase with the molar composition 20.7MgO·20.7Al_(2)O_(3)·51.6SiO_(2)·7.0TiO_(2),we systematica...Focusing on the ultralow expansion functionality of the crystalized glass containing the cordierite crystal phase with the molar composition 20.7MgO·20.7Al_(2)O_(3)·51.6SiO_(2)·7.0TiO_(2),we systematically investigated impacts of thermal treatment protocols on T dependence of coefficients of thermal expansion(CTE).Except for the phase compositions,morphology is identified as another important factor to control the T dependence of CTE.By using X-ray diffraction and scanning electron microscope,various modes of T dependence of CTE for crystallized glasses are ascribed to their different phase compositions and microstructure with finely dispersed nanoparticles.These understanding contributes to the further modification of CTE of the crystalized glass by altering their thermal treatment scenarios.展开更多
Developing highly active and stable oxygen evolution reaction(OER)catalysts necessitates the establishment of a comprehensive OER catalyst database.However,the absence of a standardized benchmarking protocol has hinde...Developing highly active and stable oxygen evolution reaction(OER)catalysts necessitates the establishment of a comprehensive OER catalyst database.However,the absence of a standardized benchmarking protocol has hindered this progress.In this work,we present a systematic protocol for electrochemical measurements to thoroughly evaluate the activity and stability of OER electrocatalysts.We begin with a detailed introduction to constructing the electrochemical system,encompassing experimental setup and the selection criteria for electrodes and electrolytes.Potential contaminants originating from electrolytes,cells,and electrodes are identified and their impacts are discussed.We also examine the effects of external factors,such as temperature,magnetic fields,and natural light,on OER measurements.The protocol outlines operational mechanisms and recommended settings for various electrochemical techniques,including cyclic voltammetry(CV),potentiostatic electrochemical impedance spectroscopy(PEIS),Tafel slope analysis,and pulse voltammetry(PV).We summarize existing evaluation methodologies for assessing intrinsic activities and long-term stabilities of catalysts.Based on these discussions,we propose a comprehensive protocol for evaluating OER electrocatalysts’performance.Finally,we offer perspectives on advancing OER catalysts from laboratory research to industrial applications.展开更多
Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods...Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods for CKD(stages 1–3)are lacking.Guben Tongluo Formula(GTF)is the experience formula of Professor Liqun He,a famous traditional Chinese medicine(TCM)doctor in Shanghai.Our previous studies demonstrated that GTF might effectively alleviate CKD via multi-mechanisms.As the first angiotensin-2 receptor antagonist for treating hypertension,losartan potassium(LP)could effectively reduce blood pressure,decrease cardiovascular risk,and delay the occurrence of end-stage renal disease.Thus,we design this clinical protocol of GTF combining LP to observe the efficacy and safety of GTF and try to provide a novel drug treatment method for treating CKD(stages 1–3)patients.Methods and analysis:This is a multicenter randomized controlled clinical trial.160 participants will be enrolled in this trial and divided into LP group,GTF group,LP+GTF group,and placebo group randomly assigning 1:1:1:1 principle.LP group will receive general treatments combining LP,GTF group will receive general treatments combining GTF,and the GTF+LP group will receive general treatments combining GTF and LP.Placebo group will receive general treatments combining placebo treatment.The primary evaluation index will be the change of serum creatinine after treatment.Secondary evaluation indexes include changes in blood urea nitrogen,serum uric acid,estimated glomerular filtration rate,etc.;immune indicators and renal fibrosis indicators,as well as TCM symptoms.Besides,vital sign indicators and adverse events will be closely observed.Ethics and dissemination:The protocol has been approved by the Ethics Committee of Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine(reference number:2024-7th-HIRB-094)and other ethics committees at each center.With the implementation of this clinical trial,it would offer a TCM formula for the treatment of CKD(stages 1–3)and clarify the underlying mechanism of GTF for alleviating CKD.Trial registration:This trial is registered with ChiCTR2400090125 and registered on September 24,2024.展开更多
UAV networks often encounter jamming attacks, under which multi-radio protocols have to switch radios to accelerate communication recovery. However, the existing protocols rely on exchange of hello messages to detect ...UAV networks often encounter jamming attacks, under which multi-radio protocols have to switch radios to accelerate communication recovery. However, the existing protocols rely on exchange of hello messages to detect jamming, leading to long sensing time and thus slow routing recovery. To address the issues raised by jamming attacks, we propose a new routing protocol, Electromagnetic Spectrum situation awareness Optimized Link State Routing (ESOLSR) protocol, to improve the existing OLSRv2 protocol. ESOLSR utilizes the spectrum situation awareness capability from the physical layer, and adopts joint-updating of link status, updating of interface functions, and adaptive adjustment of parameters. Our simulation results show that the improved protocol, ESOLSR, can recover routing and resume normal communication 26.6% faster compared to the existing protocols.展开更多
Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to c...Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to corticosteroids,immunological therapy,and biological agents,but their use is limited owing to their well-characterised side effects(e.g.osteoporosis and cushingoid feature).Therefore,there is an unmet medical need for novel treatments with a manageable safety profile for patients with mesalazine-refractory UC.New Wumei Pill is a novel and effective herbal prescription for the treatment of UC,and our preliminary study suggested that New Wumei Pill has a significant effect on patients with mesalazine-refractory UC.However,its effectiveness and safety has not been evaluated convincingly.Objectives:This trail aims to evaluate efficacy,safety and mechanisms of New Wumei Pill in the treatment of patients with mesalazine-refractory UC.Methods:This is a prospective,randomized,double-blind control trial,in which 72 patients with mesalazine-refractory mild-to-moderate UC will be randomized in a 1:1 ratio in the treatment and control group.Patients will be screened for eligibility at the outpatient and ward of the Department of Gastroenterology in Dongfang Hospital,Beijing University of Chinese Medicine.72 participants will undergo strict screening to meet the diagnostic criteria of mildly to moderately active UC,with modified Mayo score of 3-10 points.All patients will be administered by mesalazine enteric-coated tablets for 8 weeks,at the same time,the patients in treatment group will receive New Wumei Pill,while patients from control group will be administered by dummy New Wumei Pill.Results:The primary outcomes are clinical efficacy rate and clinical remission rate according to the modified Mayo score.The secondary outcomes are individual symptom score,TCM syndrome score,endoscopic response rate,mucosal healing rate,and quality of life scale score.Finally,biological samples from participants will be preserved to reveal the mechanisms of New Wumei Pill on UC.Conclusions:We hypothesize that the patients with mesalazine-refractory mild-to-moderate UC will benefit from New Wumei Pill.If successful,this trial will provide evidence of traditional Chinese medicine in the treatment of UC,and hold promises for novel options UC patients and policymakers.展开更多
文摘BACKGROUND Diabetes mellitus has become one of the major pandemics of the 21st century.In this scenario,nursing interventions are essential for improving self-care and quality of life in patients with type 2 diabetes mellitus.Nursing interventions are crucial for managing the disease and preventing complications.AIM To analyse nursing interventions in recent years through a systematic review and meta-analysis and to propose improvements in care plans.METHODS This study conducted a systematic review and meta-analysis of the impact of nursing interventions on quantitative glycaemic variables,such as glycated haemoglobin and fasting plasma glucose.RESULTS After confirming that the combined effect of all studies from the past 5 years positively impacts quantitative variables,a descriptive analysis of the studies with the most significant changes was conducted.Based on this,an improvement in diabetic patient care protocols has been proposed through follow-up plans tailored to the patient’s technological skills.CONCLUSION The combined results obtained and the proposal for improvement developed in this manuscript could help to improve the quality of life of many people around the world.
文摘BACKGROUND Epidural analgesia is the most effective analgesic method during labor.Butorphanol administered epidurally has been shown to be a successful analgesic method during labor.However,no comprehensive study has examined the safety and efficacy of using butorphanol as an epidural analgesic during labor.AIM To assess butorphanol's safety and efficacy for epidural labor analgesia.METHODS The PubMed,Cochrane Library,EMBASE,Web of Science,China National Knowledge Infrastructure,and Google Scholar databases will be searched from inception.Other types of literature,such as conference abstracts and references to pertinent reviews,will also be reviewed.We will include randomized controlled trials comparing butorphanol with other opioids combined with local anesthetics for epidural analgesia during labor.There will be no language restrictions.The primary outcomes will include the visual analog scale score for the first stage of labor,fetal effects,and Apgar score.Two independent reviewers will evaluate the full texts,extract data,and assess the risk of bias.Publication bias will be evaluated using Egger's or Begg's tests as well as visual analysis of a funnel plot,and heterogeneity will be evaluated using the Cochran Q test,P values,and I2 values.Meta-analysis,subgroup analysis,and sensitivity analysis will be performed using RevMan software version 5.4.This protocol was developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA)Protocols statement,and the PRISMA statement will be used for the systematic review.RESULTS This study provides reliable information regarding the safety and efficacy of using butorphanol as an epidural analgesic during labor.CONCLUSION To support clinical practice and development,this study provides evidence-based findings regarding the safety and efficacy of using butorphanol as an epidural analgesic during labor.
基金supported by the National Natural Science Foundation of China(62073019)。
文摘This paper investigates the problem of global/semi-global finite-time consensus for integrator-type multi-agent sys-tems.New hyperbolic tangent function-based protocols are pro-posed to achieve global and semi-global finite-time consensus for both single-integrator and double-integrator multi-agent systems with leaderless undirected and leader-following directed commu-nication topologies.These new protocols not only provide an explicit upper-bound estimate for the settling time,but also have a user-prescribed bounded control level.In addition,compared to some existing results based on the saturation function,the pro-posed approach considerably simplifies the protocol design and the stability analysis.Illustrative examples and an application demonstrate the effectiveness of the proposed protocols.
基金supported in part by the National Natural Science Foundation of China (NSFC)(61703086, 61773106)the IAPI Fundamental Research Funds (2018ZCX27)
文摘This paper is concerned with consensus of a secondorder linear time-invariant multi-agent system in the situation that there exists a communication delay among the agents in the network.A proportional-integral consensus protocol is designed by using delayed and memorized state information.Under the proportional-integral consensus protocol,the consensus problem of the multi-agent system is transformed into the problem of asymptotic stability of the corresponding linear time-invariant time-delay system.Note that the location of the eigenvalues of the corresponding characteristic function of the linear time-invariant time-delay system not only determines the stability of the system,but also plays a critical role in the dynamic performance of the system.In this paper,based on recent results on the distribution of roots of quasi-polynomials,several necessary conditions for Hurwitz stability for a class of quasi-polynomials are first derived.Then allowable regions of consensus protocol parameters are estimated.Some necessary and sufficient conditions for determining effective protocol parameters are provided.The designed protocol can achieve consensus and improve the dynamic performance of the second-order multi-agent system.Moreover,the effects of delays on consensus of systems of harmonic oscillators/double integrators under proportional-integral consensus protocols are investigated.Furthermore,some results on proportional-integral consensus are derived for a class of high-order linear time-invariant multi-agent systems.
基金supported by the Science and Engineering Research Board,New Delhi(No.MTR/2019/000494).
文摘This paper introduces a Kalman-type recursive state estimator for a class of discrete-time stochastic linear singular systems where the measurements are carried part by part periodically following a scheduling algorithm.We consider that the system is in a network with limited allotted bandwidth,which refers to a situation where the total available bandwidth for data transmission through the network is limited.This limitation can occur for various reasons,such as network congestion,resource allocation policies,or bandwidth limitations imposed by network administrators.In such networks,the entire measurement vector cannot be transmitted to the estimator instantly.Thus,managing a network with a limited allotted bandwidth requires careful planning,monitoring,and implementing some scheduling strategies to optimize the use of measured data while estimating the system states.We show that a scheduling method,namely,round-robin protocol,is suitable for singular systems to deal with such a scenario.The upper bound of the prior error covariance is studied via a periodic Riccati equation(PRE).To retain the boundedness of prior error covariance,the stability of the PRE is examined by the observability properties of the round-robin-induced system.Finally,a simulation example is presented to show the effectiveness of the designed filtering scheme.
基金supported in part by the National Natural Science Foundation of China(62073189,62173207)the Taishan Scholar Project of Shandong Province(tsqn202211129)。
文摘This paper is aimed at the distributed fault estimation issue associated with the potential loss of actuator efficiency for a type of discrete-time nonlinear systems with sensor saturation.For the distributed estimation structure under consideration,an estimation center is not necessary,and the estimator derives its information from itself and neighboring nodes,which fuses the state vector and the measurement vector.In an effort to cut down data conflicts in communication networks,the stochastic communication protocol(SCP)is employed so that the output signals from sensors can be selected.Additionally,a recursive security estimator scheme is created since attackers randomly inject malicious signals into the selected data.On this basis,sufficient conditions for a fault estimator with less conservatism are presented which ensure an upper bound of the estimation error covariance and the mean-square exponential boundedness of the estimating error.Finally,a numerical example is used to show the reliability and effectiveness of the considered distributed estimation algorithm.
基金Supported by The National Research Foundation of Korea Grant funded by the Korea Government,No.00219725.
文摘In this editorial we comment on the article published in a recent issue of the World Journal of Clinical Cases.This article described a novel ultrasound-guided lateral recess block approach in treating a patient with lateral recess stenosis.The impact of spinal pain-related disability extends significantly,causing substantial human suffering and medical costs.Each county has its preferred treatment strategies for spinal pain.Here,we explore the lower back pain(LBP)treatment algorithm recommended in France.The treatment algorithm for LBP recommended by the French National Authority for Health emphasizes early patient activity and minimal medication use.It encourages the continuation of daily activities,limits excessive medication and spinal injections,and incorporates psychological assessments and non-pharmacological therapies for chronic cases.However,the algorithm may not aggressively address acute pain in the early stages,potentially delaying relief and increasing the risk of chronicity.Additionally,the recommended infiltrations primarily involve caudal epidural steroid injections,with limited consideration for other injection procedures,such as transforaminal or interlaminar epidural steroid injections.The fixed follow-up timeline may not accommodate patients who do not respond to initial treatment or experience intense pain,potentially delaying the exploration of alternative therapies.Despite these limitations,understanding the strengths and weaknesses of the French approach could inform adaptations in LBP treatment strategies globally,potentially enhancing patient outcomes and satisfaction across diverse healthcare systems.
文摘The care of a patient involved in major trauma with exsanguinating haemorrhage is time-critical to achieve definitive haemorrhage control,and it requires coordinated multidisciplinary care.During initial resuscitation of a patient in the emergency department(ED),Code Crimson activation facilitates rapid decisionmaking by multi-disciplinary specialists for definitive haemorrhage control in operating theatre(OT)and/or interventional radiology(IR)suite.Once this decision has been made,there may still be various factors that lead to delay in transporting the patient from ED to OT/IR.Red Blanket protocol identifies and addresses these factors and processes which cause delay,and aims to facilitate rapid and safe transport of the haemodynamically unstable patient from ED to OT,while minimizing delay in resuscitation during the transfer.The two processes,Code Crimson and Red Blanket,complement each other.It would be ideal to merge the two processes into a single protocol rather than having two separate workflows.Introducing these quality improvement strategies and coor-dinated processes within the trauma framework of the hospitals/healthcare systems will help in further improving the multi-disciplinary care for the complex trauma patients requiring rapid and definitive haemorrhage control.
文摘Protocol Reverse Engineering(PRE)is of great practical importance in Internet security-related fields such as intrusion detection,vulnerability mining,and protocol fuzzing.For unknown binary protocols having fixed-length fields,and the accurate identification of field boundaries has a great impact on the subsequent analysis and final performance.Hence,this paper proposes a new protocol segmentation method based on Information-theoretic statistical analysis for binary protocols by formulating the field segmentation of unsupervised binary protocols as a probabilistic inference problem and modeling its uncertainty.Specifically,we design four related constructions between entropy changes and protocol field segmentation,introduce random variables,and construct joint probability distributions with traffic sample observations.Probabilistic inference is then performed to identify the possible protocol segmentation points.Extensive trials on nine common public and industrial control protocols show that the proposed method yields higher-quality protocol segmentation results.
文摘BACKGROUND Clozapine,the gold standard for resistant schizophrenia,is underused due to risks like clozapine-induced myocarditis(CIM).Non-specific biomarkers and inconsistent imaging,and the significant overlap with clozapine-induced pneumonia(CIP)lead to misdiagnosis and premature discontinuation.AIM To develop a diagnostic algorithm for CIM to enhance accuracy,differentiate from CIP,and guide safe clozapine rechallenge.METHODS A systematic review of 119 PubMed studies(published between 1990 and April 2025)was conducted in accordance with PRISMA guidelines.The review analyzed CIM diagnosis and rechallenge outcomes,with a focus on biomarkers,imaging,and collaboration with cardiology.RESULTS CIM diagnosis relies on troponin and C-reactive protein;electrocardiography and echocardiography are inconsistently applied,and cardiac magnetic resonance imaging(CMR)is underused.Rechallenge was successful in 64.7%to 68.9%of 136 cases,with 2.9%resulting in fatal outcomes.Up to 65%of presumed CIM cases lack confirmation.A proposed protocol integrates chest computed tomography to exclude pneumonia and CMR for CIM confirmation,with echocardiography as an alternative.CONCLUSION A protocol involving multidisciplinary collaboration among computed tomography,CMR,and cardiology improves CIM diagnosis.Slow titration prevents CIM;adjust the dose for CIP and discontinue for confirmed CIM.
基金this project under Geran Putra Inisiatif(GPI)with reference of GP-GPI/2023/976210。
文摘Accurate time synchronization is fundamental to the correct and efficient operation of Wireless Sensor Networks(WSNs),especially in security-critical,time-sensitive applications.However,most existing protocols degrade substantially under malicious interference.We introduce iSTSP,an Intelligent and Secure Time Synchronization Protocol that implements a four-stage defense pipeline to ensure robust,precise synchronization even in hostile environments:(1)trust preprocessing that filters node participation using behavioral trust scoring;(2)anomaly isolation employing a lightweight autoencoder to detect and excise malicious nodes in real time;(3)reliability-weighted consensus that prioritizes high-trust nodes during time aggregation;and(4)convergence-optimized synchronization that dynamically adjusts parameters using theoretical stability bounds.We provide rigorous convergence analysis including a closed-form expression for convergence time,and validate the protocol through both simulations and realworld experiments on a controlled 16-node testbed.Under Sybil attacks with five malicious nodes within this testbed,iSTSP maintains synchronization error increases under 12%and achieves a rapid convergence.Compared to state-ofthe-art protocols like TPSN,SE-FTSP,and MMAR-CTS,iSTSP offers 60%faster detection,broader threat coverage,and more than 7 times lower synchronization error,with a modest 9.3%energy overhead over 8 h.We argue this is an acceptable trade-off for mission-critical deployments requiring guaranteed security.These findings demonstrate iSTSP’s potential as a reliable solution for secure WSN synchronization and motivate future work on large-scale IoT deployments and integration with energy-efficient communication protocols.
基金thank the staff of the accredited animal facility of the laboratory of anatomy,Histology and Embryology of Aristotle University of Thessaloniki’s veterinary school for their assistance in animal handling and care.
文摘BACKGROUND Massive rotator cuff tears(RCTs)result in impaired shoulder function and quality of life.These tears lead to structural changes in the rotator cuff muscles,which compromise recovery after repair and increase re-tear rates.AIM To investigate the potential inhibitory effects of alpha-tocopherol(vitamin E)and OTR-4131 on muscle atrophy,fatty infiltration,and fibrosis in rotator cuff muscles following a massive RCT using a Wistar rat model,and establish a standardized methodology for evaluating potential therapeutic agents.METHODS This protocol outlines a controlled animal study using 40 male Wistar rats,randomized into five groups.The experimental groups will receive either systemic administration of alpha-tocopherol or local administration of OTR-4131 via intramuscular injection into the supraspinatus and infraspinatus muscles.Two sham groups will receive systemic and local saline injections respectively,while a control group will undergo no intervention.The interventions will be administered after surgical transection of the supraspinatus and infraspinatus tendons.Outcomes will be assessed via wet muscle weight measurements,muscle fiber diameter,fatty infiltration percentage,and fibrosis evaluation using histological methods.RESULTS The study anticipates that alpha-tocopherol and OTR-4131 will reduce muscle atrophy,fatty infiltration,and fibrosis compared to control and sham groups,supporting their potential protective role in rotator cuff muscle degeneration.CONCLUSION The results are expected to improve the understanding on the role of alpha-tocopherol and OTR-4131 in rotator cuff muscle protection after massive RCT and may serve as a foundation for further preclinical and clinical research aimed at improving rotator cuff repair outcomes.
基金support the findings of this study are openly available in(Scopus database)at www.scopus.com(accessed on 07 January 2025).
文摘“Flying Ad Hoc Networks(FANETs)”,which use“Unmanned Aerial Vehicles(UAVs)”,are developing as a critical mechanism for numerous applications,such as military operations and civilian services.The dynamic nature of FANETs,with high mobility,quick node migration,and frequent topology changes,presents substantial hurdles for routing protocol development.Over the preceding few years,researchers have found that machine learning gives productive solutions in routing while preserving the nature of FANET,which is topology change and high mobility.This paper reviews current research on routing protocols and Machine Learning(ML)approaches applied to FANETs,emphasizing developments between 2021 and 2023.The research uses the PRISMA approach to sift through the literature,filtering results from the SCOPUS database to find 82 relevant publications.The research study uses machine learning-based routing algorithms to beat the issues of high mobility,dynamic topologies,and intermittent connection in FANETs.When compared with conventional routing,it gives an energy-efficient and fast decision-making solution in a real-time environment,with greater fault tolerance capabilities.These protocols aim to increase routing efficiency,flexibility,and network stability using ML’s predictive and adaptive capabilities.This comprehensive review seeks to integrate existing information,offer novel integration approaches,and recommend future research topics for improving routing efficiency and flexibility in FANETs.Moreover,the study highlights emerging trends in ML integration,discusses challenges faced during the review,and discusses overcoming these hurdles in future research.
文摘The current recommendation to avoid non-steroidal anti-inflammatory drugs(NSAIDs)in the management of dengue virus disease(DVD)is scientifically considered of very low to low certainty,despite being widely adopted worldwide.The same recommendation,initially made during the coronavirus disease 2019(COVID-19)pandemic,was subsequently proven incorrect.In this clinical report,we present evidence,for the first time globally,from a real-life practice that NSAIDs may actually be lifesaving in the early management of DVD as they have proved to be in COVID-19.Moreover,we propose that the personalized immunemodulatory Kelleni’s protocol,which includes nitazoxanide as a key component,can be safely and effectively used to manage various separate or concomitant viral infections and co-infections,including DVD.Importantly,this article contributes to the current medical knowledge in the global pursuit of a safe and effective broad-spectrum antiviral protocol that can be used to early manage multiple highly infectious viruses.However,it’s crucial that sufficiently powered controlled randomized clinical trials be conducted to thoroughly assess and evaluate the safety of NSAIDs in the early management of DVD as well as the efficacy of nitazoxanide with or without NSAIDs in its management.
文摘Objective To discuss the flexible supervision and communication mode in the post-approval change(PAC)of drugs,to explore how to ensure the quality and availability of drugs during the changes,and to provide some suggestions and reference for promoting the timely marketing of drugs.Methods Based on the comparability protocol guidelines issued by the US FDA in October 2022,the regulatory status quo of PAC between China and the US was compared to explore the feasibility of implementing comparability protocols in China.Results and Conclusion According to the specific situation of post-approval of drug change supervision,some suggestions were put forward to optimize the PAC management procedure,such as establishing the communication pathways between holders and health authorities,publishing relevant guidance and strengthening training,so as to provide reference for the implementation of comparability protocols in China.
基金Funded by National Natural Science Foundation of China(No.52172007)Jiangsu Science and Technology Innovation Project for Carbon Peaking and Carbon Neutrality(No.BE2022035)。
文摘Focusing on the ultralow expansion functionality of the crystalized glass containing the cordierite crystal phase with the molar composition 20.7MgO·20.7Al_(2)O_(3)·51.6SiO_(2)·7.0TiO_(2),we systematically investigated impacts of thermal treatment protocols on T dependence of coefficients of thermal expansion(CTE).Except for the phase compositions,morphology is identified as another important factor to control the T dependence of CTE.By using X-ray diffraction and scanning electron microscope,various modes of T dependence of CTE for crystallized glasses are ascribed to their different phase compositions and microstructure with finely dispersed nanoparticles.These understanding contributes to the further modification of CTE of the crystalized glass by altering their thermal treatment scenarios.
基金supported by the Fundamental Research Funds for the Central Universities(20822041H4082)。
文摘Developing highly active and stable oxygen evolution reaction(OER)catalysts necessitates the establishment of a comprehensive OER catalyst database.However,the absence of a standardized benchmarking protocol has hindered this progress.In this work,we present a systematic protocol for electrochemical measurements to thoroughly evaluate the activity and stability of OER electrocatalysts.We begin with a detailed introduction to constructing the electrochemical system,encompassing experimental setup and the selection criteria for electrodes and electrolytes.Potential contaminants originating from electrolytes,cells,and electrodes are identified and their impacts are discussed.We also examine the effects of external factors,such as temperature,magnetic fields,and natural light,on OER measurements.The protocol outlines operational mechanisms and recommended settings for various electrochemical techniques,including cyclic voltammetry(CV),potentiostatic electrochemical impedance spectroscopy(PEIS),Tafel slope analysis,and pulse voltammetry(PV).We summarize existing evaluation methodologies for assessing intrinsic activities and long-term stabilities of catalysts.Based on these discussions,we propose a comprehensive protocol for evaluating OER electrocatalysts’performance.Finally,we offer perspectives on advancing OER catalysts from laboratory research to industrial applications.
基金supported by grants from Pudong New Area Traditional Chinese Medicine Brand Multiplication Plan-Chronic Nephropathy(PDZY-2021-0302)Construction of He Liqun’s famous TCM studio(PDZY-2022-0703)+2 种基金Clinical Observation on the Efficacy of Guben Tongluo Formula in Treating Chronic Kidney Disease Phase 1-3(PW2022D-12)Pilot Project of Inheritance,Innovation and Development of Traditional Chinese Medicine in Pudong New Area(YC-2023-0602)Pudong New Area’s Peak and Plateau Discipline Development in Clinical Medicine for Novel and Special Diseases(2025-PWXZ-15).
文摘Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods for CKD(stages 1–3)are lacking.Guben Tongluo Formula(GTF)is the experience formula of Professor Liqun He,a famous traditional Chinese medicine(TCM)doctor in Shanghai.Our previous studies demonstrated that GTF might effectively alleviate CKD via multi-mechanisms.As the first angiotensin-2 receptor antagonist for treating hypertension,losartan potassium(LP)could effectively reduce blood pressure,decrease cardiovascular risk,and delay the occurrence of end-stage renal disease.Thus,we design this clinical protocol of GTF combining LP to observe the efficacy and safety of GTF and try to provide a novel drug treatment method for treating CKD(stages 1–3)patients.Methods and analysis:This is a multicenter randomized controlled clinical trial.160 participants will be enrolled in this trial and divided into LP group,GTF group,LP+GTF group,and placebo group randomly assigning 1:1:1:1 principle.LP group will receive general treatments combining LP,GTF group will receive general treatments combining GTF,and the GTF+LP group will receive general treatments combining GTF and LP.Placebo group will receive general treatments combining placebo treatment.The primary evaluation index will be the change of serum creatinine after treatment.Secondary evaluation indexes include changes in blood urea nitrogen,serum uric acid,estimated glomerular filtration rate,etc.;immune indicators and renal fibrosis indicators,as well as TCM symptoms.Besides,vital sign indicators and adverse events will be closely observed.Ethics and dissemination:The protocol has been approved by the Ethics Committee of Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine(reference number:2024-7th-HIRB-094)and other ethics committees at each center.With the implementation of this clinical trial,it would offer a TCM formula for the treatment of CKD(stages 1–3)and clarify the underlying mechanism of GTF for alleviating CKD.Trial registration:This trial is registered with ChiCTR2400090125 and registered on September 24,2024.
基金supported in part by National Natural Science Foundation of China(Nos.61931011 and 62372230)the Jiangsu Provincial Key Research and Development Program,China(No.BE2021013-4).
文摘UAV networks often encounter jamming attacks, under which multi-radio protocols have to switch radios to accelerate communication recovery. However, the existing protocols rely on exchange of hello messages to detect jamming, leading to long sensing time and thus slow routing recovery. To address the issues raised by jamming attacks, we propose a new routing protocol, Electromagnetic Spectrum situation awareness Optimized Link State Routing (ESOLSR) protocol, to improve the existing OLSRv2 protocol. ESOLSR utilizes the spectrum situation awareness capability from the physical layer, and adopts joint-updating of link status, updating of interface functions, and adaptive adjustment of parameters. Our simulation results show that the improved protocol, ESOLSR, can recover routing and resume normal communication 26.6% faster compared to the existing protocols.
基金supported by the Unveiling and Leading Projects of Beijing University of Chinese Medicine(No.2023-JYB-JBQN-014)the China Association of Chinese Medicine Young Talent Support Project(No.CACM-2022-QNRC2-A02).
文摘Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to corticosteroids,immunological therapy,and biological agents,but their use is limited owing to their well-characterised side effects(e.g.osteoporosis and cushingoid feature).Therefore,there is an unmet medical need for novel treatments with a manageable safety profile for patients with mesalazine-refractory UC.New Wumei Pill is a novel and effective herbal prescription for the treatment of UC,and our preliminary study suggested that New Wumei Pill has a significant effect on patients with mesalazine-refractory UC.However,its effectiveness and safety has not been evaluated convincingly.Objectives:This trail aims to evaluate efficacy,safety and mechanisms of New Wumei Pill in the treatment of patients with mesalazine-refractory UC.Methods:This is a prospective,randomized,double-blind control trial,in which 72 patients with mesalazine-refractory mild-to-moderate UC will be randomized in a 1:1 ratio in the treatment and control group.Patients will be screened for eligibility at the outpatient and ward of the Department of Gastroenterology in Dongfang Hospital,Beijing University of Chinese Medicine.72 participants will undergo strict screening to meet the diagnostic criteria of mildly to moderately active UC,with modified Mayo score of 3-10 points.All patients will be administered by mesalazine enteric-coated tablets for 8 weeks,at the same time,the patients in treatment group will receive New Wumei Pill,while patients from control group will be administered by dummy New Wumei Pill.Results:The primary outcomes are clinical efficacy rate and clinical remission rate according to the modified Mayo score.The secondary outcomes are individual symptom score,TCM syndrome score,endoscopic response rate,mucosal healing rate,and quality of life scale score.Finally,biological samples from participants will be preserved to reveal the mechanisms of New Wumei Pill on UC.Conclusions:We hypothesize that the patients with mesalazine-refractory mild-to-moderate UC will benefit from New Wumei Pill.If successful,this trial will provide evidence of traditional Chinese medicine in the treatment of UC,and hold promises for novel options UC patients and policymakers.
