Objective:This cross-sectional study assessed the methodological quality of systematic reviews(SRs)of Chinese herbal medicine(CHM)published in Chinese between Jan 2021 and Sep 2022.Methods:Chinese language CHM SRs wer...Objective:This cross-sectional study assessed the methodological quality of systematic reviews(SRs)of Chinese herbal medicine(CHM)published in Chinese between Jan 2021 and Sep 2022.Methods:Chinese language CHM SRs were identified through literature searches across 3 international and 4 Chinese databases.Methodological quality was appraised using A MeaSurement Tool to Assess systematic Reviews 2.Logistic regressions were used to explore associations between bibliographical characteristics and quality.Results:Analyses of methodological quality found that among the 213 sampled SRs,69.5%were of critically low quality,30.5%were of low quality,and none achieved high or moderate quality.Common shortcomings included the failure to identify the studies excluded from the analysis,failure to disclose funding sources,and limited evaluation of the potential impact of bias on conclusions.Logistic regressions revealed that SRs led by corresponding authors affiliated with universities or academic institutions tended to be of lower quality than SRs led by authors affiliated with hospitals or clinical facilities.Conclusion:Recent Chinese language CHM SRs exhibited limited methodological quality,making them unlikely to support the development of clinical practice guidelines.Urgent initiatives are needed to enhance training for researchers,peer-reviewers and editors involved in the preparation and publication of SRs.Adoption of Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines in Chinese language journals is crucial to improve the relevance of SRs for Chinese medicine development.Addressing deficiencies in methodology and reporting is essential for promoting evidence-based practices and informed clinical decisions in Chinese medicine.展开更多
Objective: This study assessed the methodological quality of systematic reviews/meta-analysis of the effectiveness of probiotics against irritable bowel syndrome (IBS) using the accepted methodological quality assessm...Objective: This study assessed the methodological quality of systematic reviews/meta-analysis of the effectiveness of probiotics against irritable bowel syndrome (IBS) using the accepted methodological quality assessment scale AMSTAR and explored the factors that influenced the quality of methodology. It was designed to provide a reference for future research and systematic reviews/metaanalysis. Methods: The methodological quality of existing systematic reviews/meta-analysis was evaluated using the AMSTAR scale. Influencing factors of methodological quality were statistically analyzed using RevMan 5.3 software. The included systematic reviews/metaanalysis must include the following characteristics:(1) methods using systematic evaluation/meta-analysis,(2) probiotic intervention, and (3) language limitation to Chinese and English. Results: The AMSTAR score was 5-9 (7.42 ± 1.22), and the quality is above average. The factors affecting the methodological quality are the number of authors and whether they cooperate with the institution. Conclusions: Studies have shown that current systematic reviews/meta-analysis of the effectiveness of probiotics on IBS does not fully comply with methodological quality standards, and therefore the methodological quality of research in this area needs to be strengthened. To better clarify how probiotics affect IBS, future systematic reviews and meta-analyses should not only follow methodological quality standards but also include more effective outcome measures, and they should focus more on the discussion of research results. We look forward to the development of higher-quality randomized controlled trials in the future.展开更多
In the State of Santa Catarina, Brazil, especially in the Itajai valley, there are records of accidents and disasters mainly associated to landslides and floods, which have caused significant damages and losses, inclu...In the State of Santa Catarina, Brazil, especially in the Itajai valley, there are records of accidents and disasters mainly associated to landslides and floods, which have caused significant damages and losses, including human lives. In order to make the coexistence with such natural disasters possible, most particularly with floods, a integration is required among the technical, political, environmental, and human knowledge. Measures that encompass integrated actions for the entire river basin, with the help from an updated technical cadastre and tools, such as the GIS, allow the development of planning tools that might effectively help the people to live with the water, or else to cope with floods in a more appropriate manner. This paper attempts to propose a methodology for urban flood control, based on the integration among the several public entities involved in the flood control, along with the CTM （Multipurpose Technical Cadastre） and GIS tool. In order to solve or minimize the problems, the model proposed here aims at promoting a balance between the agents involved, and enables to rank the degrees of importance assigned to the different needs, thus allowing to eliminate or to improve those areas and processes that are duplicated or superimposed.展开更多
Background:Stroke is not only high in morbidity and mortality but also poses a great burden of disease and it is also the most reported disease in Chinese medicine systematic reviews.Therefore,the quality of such evid...Background:Stroke is not only high in morbidity and mortality but also poses a great burden of disease and it is also the most reported disease in Chinese medicine systematic reviews.Therefore,the quality of such evidence couldn’t be ignored.This study aims to use a measurement tool to assess systematic reviews(AMSTAR)to assess the methodological qualities of SR/Meta-analyses of Chinese medicine on stroke.Methods:Systematic searching of seven electronic databases and PROSPERO registration platform was carried out.Two researchers separately selected studies,extracted bibliographical characteristics and scored every included study independently after training.Total score and the proportion of each item completion were explored in different subgroup comparisons.Spearman rank correlation and multivariable logistic regression were used to measure the association between bibliographical characteristics and total score or each item.Results:Total average score of AMSTAR 1.0 checklists of 234 systematic reviews/Meta-analyses was 4.47(95%CI 4.27–4.68)and the qualities were unsatisfied especially in terms of priori setting(2.14%),grey literature inclusion(5.13%),providing a list of excluded studies(2.14%)and conflict of interest(0.00%).No improvement was found in 3 years even after the publication of AMSTAR.Chinese or nonregistered systematic reviews/Meta-analyses showed even worse methodological qualities(P<0.01).Positive correlation was found between individual items and number of pages,number of authors,research questions,languages or Meta-analyse separately(P<0.05).Conclusion:The methodological qualities of systematic reviews/Meta-analyses of Chinese medicine on stroke are poor especially Chinese studies,non-registered studies,brief studies and studies without Meta-analyse or cooperation.There is no obvious improvement over these years even after the publication of AMSTAR tool,so it is urgent to promote the use of AMSTAR or develop other efficient methods to control the quantity and monitor the quality in future.展开更多
BACKGROUND Online surveys can align with youth’s increased use of the internet and can be a mechanism for expanding youth participation in research.This is particularly important during the coronavirus disease 2019(C...BACKGROUND Online surveys can align with youth’s increased use of the internet and can be a mechanism for expanding youth participation in research.This is particularly important during the coronavirus disease 2019(COVID-19)pandemic,when inperson interactions are limited.However,the advantages and drawbacks of online systems used for research need to be carefully considered before utilizing such methodologies.AIM To describe and discuss the strengths and limitations of an online system developed to recruit adolescent girls for a sexual health research study and conduct a three-month follow up survey.METHODS This methodology paper examines the use of an online system to recruit and follow participants three months after their medical visit to evaluate a mobile sexual and reproductive health application,Health-E You/Salud iTuTM,for adolescent girls attending school-based health centers(SBHCs)across the United States.SBHC staff gave adolescent girls a web link to an online eligibility and consent survey.Participants were then asked to complete two online surveys(baseline and 3-month follow-up).Surveys,reminders,and incentives to complete them were distributed through short message service(SMS)text messages.Upon completing each survey,participants were also sent an email with a link to an electronic gift card as a thank-you for their participation.Barriers to implementing this system were discussed with clinicians and staff at each participating SBHC.RESULTS This online recruitment and retention system enabled participant recruitment at 26 different SBHCs in seven states across the United States.Between September 2021 and June 2022,415 adolescent girls were screened using the Qualtrics online survey platform,and 182 were eligible to participate.Of those eligible,78.0%(n=142)completed the baseline survey.Participants were racially,geographically,and linguistically diverse.Most of the participants(89.4%)were non-White,and 40.8%spoke Spanish.A total of 62.0%(n=88)completed the 3-month follow-up survey.Limitations of this system included reliance on internet access(via Wi-Fi or cell service),which was not universally available or reliable.In addition,an individual unrelated to the study obtained the survey link,filled out multiple surveys,and received multiple gift cards before the research team discovered and stopped this activity.As a result,additional security protocols were instituted.CONCLUSION Online systems for health research can increase the reach and diversity of study participants,reduce costs for research personnel time and travel,allow for continued study operation when in-person visits are limited(such as during the COVID-19 pandemic),and connect youth with research using technology.However,there are challenges and limitations to online systems,which include limited internet access,intermittent internet connection,data security concerns,and the potential for fraudulent users.These challenges should be considered prior to using online systems for research.展开更多
Aims:This study aims to investigate the methodological quality of the systematic reviews of music therapy for Alzheimer’s Disease in the past five years,and to explore their compliance with each AMSTAR(A Measure Tool...Aims:This study aims to investigate the methodological quality of the systematic reviews of music therapy for Alzheimer’s Disease in the past five years,and to explore their compliance with each AMSTAR(A Measure Tool to Assess Systematic Reviews)item.Based on the above,this study is intended to facilitate the evidence transformation of music therapy in Alzheimer's Disease.Method:Cochrane Library,Web of Science,Embase and PubMed were searched from 2017-2021,to obtain the systematic reviews of music therapy among Alzheimer’s Disease.We used the AMSTAR,to evaluate their methodological quality.Additionally,their compliance with 16 AMSTAR items was investigated.Results:12 systematic reviews were included in this study.The methodological quality of 10 articles was“very low”,1 article was“low”,and 1 article was“high”.The 12 systematic reviews had 25%to 100%compliance with 16 AMSTAR items.Conclusion:The methodological quality of systematic reviews of music therapy among Alzheimer’s Disease in the recent five years is not high,and needs to be further improved.Future research should continue to explore the factors that affect their methodological quality,to promote the transformation of evidence-based evidence.展开更多
Background:Methodological issues and challenges hinder the high-quality development of acupuncture clinical studies.Objective:To systematically summarize the methodological issues,challenges,and recommendations in acu...Background:Methodological issues and challenges hinder the high-quality development of acupuncture clinical studies.Objective:To systematically summarize the methodological issues,challenges,and recommendations in acupuncture clinical research using the participant,intervention,comparison,outcome,and study design(PICOS)framework to generate a comprehensive list of methodological questions and recommendations.Methods:We searched seven databases for articles on the methodological aspects of clinical acupuncture research from their inception to March 24,2023.Two researchers independently screened the titles,ab-stracts,and full text of each article.Data extraction and analyses were performed for the eligible studies.Finally,the methodological challenges and recommendations for acupuncture clinical studies are listed,and the frequency of methodological challenges is displayed in a sunburst chart.Results:A total of 226 studies were included in the review,most of which originated in China(173,77%),followed by the United States(25,11%)and the United Kingdom(12,5%).Clinical research on acupuncture faces methodological challenges that span the five elements of the PICOS framework.The most frequently mentioned issues were related to comparison,followed by study design and interven-tions.If further categorized,the establishment of the control group is undoubtedly the most concerning issue for researchers.Conclusion:This review provides a comprehensive overview of the challenges and recommendations for each aspect of the PICOS framework in clinical acupuncture research.展开更多
Robust preclinical models of transgender male(TGM) gender-affirming hormone therapy(GAHT) can inform clinicians of the isolated effects of GAHT;however existing models vary significantly in approach. We aimed to asses...Robust preclinical models of transgender male(TGM) gender-affirming hormone therapy(GAHT) can inform clinicians of the isolated effects of GAHT;however existing models vary significantly in approach. We aimed to assess existing methodology and how it influences circulating sex-hormone levels in rodent models of TGM GAHT to provide recommendations of best practise. Pub Med, Embase, and Scopus databases were systematically searched for studies that investigated GAHT in rodent models and were published from inception to the 1st of August 2024. Study characteristics and methodology were extracted and compared. Post-intervention circulating sex hormone concentrations were the primary outcome used to determine whether successful gender affirming hormone therapy had been achieved. Sixteen experimental rodent studies were included. Studies were performed on mice( n = 11) and rats( n = 5). Subcutaneous(SC) pellets and SC silastic implants were featured in some studies but weekly SC injections of testosterone enanthate was the preferred method. Sesame oil was the preferred solvent for injected testosterone formulations. Weekly doses of ~ 450 μg(mice) and ~ 420–900 μg(rats) consistently induced the testosterone levels of the male counterpart. Similarly, 10 mg of unesterified testosterone in a SC silastic implant in mice or 10 mg/100 g in rats were also successful methods. Most studies administered hormones for 6–8 weeks before performing post-treatment assessments. This review demonstrates that methods largely varied across studies and successfully identifies the effective methodological approaches that improve the reproducibility and accuracy of preclinical models. Representing an integral step forward to bridging gaps in preclinical transgender healthcare research.展开更多
BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological...BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological information in the included papers can often be lacking or unclear,and reviewers usually need to contact the authors of included studies for clarifications.Contacting authors is recommended,but it is unclear how often SR teams do it,or what the level of response is.AIM To investigate how often reviewers undertake contact with the authors of included randomized controlled trials(RCTs)for clarification on data and risk of bias concerns,to explore the factors that influence whether SR authors contact or do not contact the authors,and the content and level of responses.METHODS We conducted a systematic electronic database search in MEDLINE using the search string“(systematic review)”AND“(RCT OR randomized OR trial)”for articles published between 1 January 2024 and 19 February 2024,without language restrictions.Screening and data extraction was done independently by two reviewers,and conflicts resolved by a senior author.Contact authors of included SRs were contacted for clarifications.RESULTS Of the 329 included SRs,38%(n=125)explicitly mentioned contact with the authors of included studies.The remaining 62%(n=204)did not.We attempted contact with all SR teams for clarifications and received 90 responses(19.4%).Of the 50 respondents who did not explicitly mention contact in their SRs,25(50%)replied that they did make contact.We received a total of 64 responses on the level and content of information sought.The mean±SD contacts SR teams made were 10(10),replies received 5(6.7),and response waiting time 10.1(28.3)weeks.Resources,time,poor previous experience,perceived likelihood of poor response and bias concerns were reported as barriers to attempting contact.CONCLUSION The majority of SRs published in 2024 did not confirm seeking clarifying or missing information from primary study authors.However,SR teams reported that 50%of contacted primary authors respond.Additional research can clarify this rate of response and establish methods to increase the integration of this core methodological element in SRs.展开更多
Urban transportation systems are facing severe challenges due to the rapid growth of the urban population,especially in China.Suspended monorail system(SMS),as a sky rail transportation form,can effectively alleviate ...Urban transportation systems are facing severe challenges due to the rapid growth of the urban population,especially in China.Suspended monorail system(SMS),as a sky rail transportation form,can effectively alleviate urban traffic congestion due to its independent right-of-way and minimal ground footprint.However,the SMS possesses a special traveling system with unique vehicle structure and bridge configuration,which results in significant differences in both the mechanisms and dynamics problems associated with train–bridge interaction(TBI)when contrasted with those of traditional railway systems.Therefore,a thorough understanding of the SMS dynamics is essential for ensuring the operational safety of the system.This article presents a state-of-the-art review of the TBI modeling methodologies,critical dynamic features,field tests,and practice of the SMS in China.Firstly,the development history,technical features,and potential dynamics problems of the SMS are briefly described,followed by the mechanical characteristics and mechanisms of the train–bridge interactive systems.Then,the modeling methodology of the fundamental elements in the suspended monorail TBI is systematically reviewed,including the suspended train subsystem,bridge subsystem,train–bridge interaction relationships,system excitations,and solution method.Further,the typical dynamic features of the TBI under various operational scenarios are elaborated,including different train speeds,a variety of line sections,and a natural wind environment.Finally,the first new energy-based SMS test line in the world is systematically introduced,including the composition and functionality of the system,the details of the conducted field tests,and the measured results of the typical dynamic responses.At the end of the paper,both the guidance on further improvement of the SMS and future research topics are proposed.展开更多
Background Early embryo development plays a pivotal role in determining pregnancy outcomes,postnatal development,and lifelong health.Therefore,the strategic selection of functional nutrients to enhance embryo developm...Background Early embryo development plays a pivotal role in determining pregnancy outcomes,postnatal development,and lifelong health.Therefore,the strategic selection of functional nutrients to enhance embryo development is of paramount importance.In this study,we established a stable porcine trophectoderm cell line expressing dual fluorescent reporter genes driven by the CDX2 and TEAD4 gene promoter segments using lentiviral transfection.Results Three amino acid metabolites—kynurenic acid,taurine,and tryptamine—met the minimum z-score criteria of 2.0 for both luciferase and Renilla luciferase activities and were initially identified as potential metabolites for embryo development,with their beneficial effects validated by qPCR.Given that the identified metabolites are closely related to methionine,arginine,and tryptophan,we selected these three amino acids,using lysine as a standard,and employed response surface methodology combined with our high-throughput screening cell model to efficiently screen and optimize amino acid combination conducive to early embryo development.The optimized candidate amino acid system included lysine(1.87 mmol/L),methionine(0.82 mmol/L),tryptophan(0.23 mmol/L),and arginine(3 mmol/L),with the ratio of 1:0.43:0.12:1.60.In vitro experiments confirmed that this amino acid system enhances the expression of key genes involved in early embryonic development and improves in vitro embryo adhesion.Transcriptomic analysis of blastocysts suggested that candidate amino acid system enhances early embryo development by regulating early embryonic cell cycle and differentiation,as well as improving nutrient absorption.Furthermore,based on response surface methodology,400 sows were used to verify this amino acid system,substituting arginine with the more cost-effective N-carbamoyl glutamate(NCG),a precursor of arginine.The optimal dietary amino acid requirement was predicted to be 0.71%lysine,0.32%methionine,0.22%tryptophan,and 0.10%NCG for sows during early gestation.The optimized amino acid system ratio of the feed,derived from the peripheral release of essential amino acids,was found to be 1:0.45:0.13,which is largely consistent with the results obtained from the cell model optimization.Subsequently,we furtherly verified that this optimal dietary amino acid system significantly increased total litter size,live litter size and litter weight in sows.Conclusions In summary,we successfully established a dual-fluorescent high-throughput screening cell model for the efficient identification of potential nutrients that would promote embryo development and implantation.This innovative approach overcomes the limitations of traditional amino acid nutrition studies in sows,providing a more effective model for enhancing reproductive outcomes.展开更多
Chinese medicine,with its rich historical roots and holistic approach,has been a fundamental aspect of healthcare in East Asia and is now gaining global recognition.Founded on centuries of empirical knowledge and phil...Chinese medicine,with its rich historical roots and holistic approach,has been a fundamental aspect of healthcare in East Asia and is now gaining global recognition.Founded on centuries of empirical knowledge and philosophical insight,Chinese medicine draws heavily from classical texts to guide its practices in herbal medicine and acupuncture.Despite its cultural and historical significance,integrating Chinese medicine into global healthcare systems presents challenges,notably the need for evidence-based practices to enhance credibility,ensure patient safety,and foster broader acceptance within the medical community.This paper explores how Chinese medicine can adopt evidence-based practices by incorporating principles of Western medicine into its research methodologies.It reviews the origins and philosophical foundations of Chinese medicine,examining its reliance on classical texts and empirical methods.The paper also highlights the differences between the personalised approach of Chinese medicine,which tailors treatments to individual needs,and the standardised protocols typical of Western medicine.Additionally,it addresses methodological challenges in Chinese medicine research,such as inconsistent diagnostic criteria and insufficient design rigour.To bridge these gaps,innovative research methodologies that respect the unique variability of Chinese medicine are needed.By adopting evidence-based practices and rigorous scientific validation,Chinese medicine can enhance its legitimacy and facilitate its integration into the global healthcare landscape.展开更多
Methodological quality(risk of bias)assessment is an important step before study initiation usage.Therefore,accurately judging study type is the first priority,and the choosing proper tool is also important.In this re...Methodological quality(risk of bias)assessment is an important step before study initiation usage.Therefore,accurately judging study type is the first priority,and the choosing proper tool is also important.In this review,we introduced methodological quality assessment tools for randomized controlled trial(including individual and cluster),animal study,non-randomized interventional studies(including follow-up study,controlled before-and-after study,before-after/pre-post study,uncontrolled longitudinal study,interrupted time series study),cohort study,case-control study,cross-sectional study(including analytical and descriptive),observational case series and case reports,comparative effectiveness research,diagnostic study,health economic evaluation,prediction study(including predictor finding study,prediction model impact study,prognostic prediction model study),qualitative study,outcome measurement instruments(including patient-reported outcome measure development,content validity,structural validity,internal consistency,cross-cultural validity/measurement invariance,reliability,measurement error,criterion validity,hypotheses testing for construct validity,and responsiveness),systematic review and meta-analysis,and clinical practice guideline.The readers of our review can distinguish the types of medical studies and choose appropriate tools.In one word,comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.展开更多
This paper introduces the conception of open complex giant system and the methodology for dealing with the system, with stress on its profound significance in development of science and technology. The authors conclud...This paper introduces the conception of open complex giant system and the methodology for dealing with the system, with stress on its profound significance in development of science and technology. The authors conclude that the reductionism underlying the exact science is not suitable to open complex giant system, and the only feasible alternative is the meta-synthetic engineering from the qualitative to the quantitative.展开更多
Unconventional oil and gas resources have become the most important and realistic field for increasing China’s domestic oil and gas reserves and production.At present,the production scale does not match the massive a...Unconventional oil and gas resources have become the most important and realistic field for increasing China’s domestic oil and gas reserves and production.At present,the production scale does not match the massive amount of resources and the rapid growth of proven geological reserves.The challenges of technology,cost,management,and methodology restrict large-scale and economic development.Based on successful practices,a"one engine with six gears"system engineering methodology is put forward,which includes life-cycle management,overall synergy,interdisciplinary cross-service integration,marketoriented operation,socialized support,digitalized management,and low-carbon and green development.The methodology has been proved to be effective in multiple unconventional oil and gas national demonstration areas,including the Jimusar continental shale oil demonstration area.Disruptive views are introduced-namely,that unconventional oil and gas do not necessarily yield a low return,nor do they necessarily have a low recovery factor.A determination to achieve economic benefit must be a pervasive underlying goal for managers and experts.Return and recovery factors,as primary focuses,must be adhered to during China’s development of unconventional oil and gas.The required methodology transformation includes a revolution in management systems to significantly decrease cost and increase production,resulting in technological innovation.展开更多
This paper presents the evaluation of an aqueous two-phase system （ATPS） for extracting elastase produced by Bacillus sp. EL31410. The elastase and cell partition behavior in polyethylene glycol （PEG）/salt systems...This paper presents the evaluation of an aqueous two-phase system （ATPS） for extracting elastase produced by Bacillus sp. EL31410. The elastase and cell partition behavior in polyethylene glycol （PEG）/salt systems was investigated. The suitable system for elastase extraction was PEG/KHEPO4-KEHPO4, in which elastase is mainly partitioned into the PEG-rich phase, while the cells remained in the other phase. The influence of defined system parameters （e.g. PEG molecular mass, pH, NaCl addition） on the partitioning behavior of elastase is described. The concentration of phase forming components, PEG and KHEPO4-KEHPO4, was optimized for elastase recovery by means of response surface methodology, and it was found that they greatly influenced extraction recovery. The optimal ATPS was 23.1% （w/w） PEG 2000 and 11.7% （w/w） KHEPO4-KEHPO4. The predicted recovery was about 89.5%, so this process is suggested to be a rapid and convenient method for elastase extraction.展开更多
In this paper,an Unmanned Aerial Vehicle(UAV)enabled Mobile Edge Computing(MEC)system is studied,in which UAV acts as server to offer computing offloading service to the Mobile Users(MUs)with limited computing capabil...In this paper,an Unmanned Aerial Vehicle(UAV)enabled Mobile Edge Computing(MEC)system is studied,in which UAV acts as server to offer computing offloading service to the Mobile Users(MUs)with limited computing capability and energy budget.We aim to minimize the total energy consumption of MUs by jointly optimizing the bit allocation for uplink,computing at the UAV and downlink,along with the UAV trajectory in a unified framework.To this end,a trajectory constraint model is employed to avoid sudden changes of velocity and acceleration during flying.Due to high-order information in use,we lead to a more reasonable nonconvex optimization problem than prior arts.An Alternating Direction Method of Multipliers(ADMM)method is introduced to solve the optimization problem,which is decomposed into a set of easy subproblems,to meet the requirement on the efficiency in edge computing.Numerical results demonstrate that our approach leads a smoother UAV trajectory,significantly save the energy consumption for UAV during flying.展开更多
The development of nano drug delivery systems(NDDSs)provides new approaches to fighting against diseases.The NDDSs are specially designed to serve as carriers for the delivery of active pharmaceutical ingredients(APIs...The development of nano drug delivery systems(NDDSs)provides new approaches to fighting against diseases.The NDDSs are specially designed to serve as carriers for the delivery of active pharmaceutical ingredients(APIs)to their target sites,which would certainly extend the benefit of their unique physicochemical characteristics,such as prolonged circulation time,improved targeting and avoiding of drugresistance.Despite the remarkable progress achieved over the last three decades,the understanding of the relationships between the in vivo pharmacokinetics of NDDSs and their safety profiles is insufficient.Analysis of NDDSs is far more complicated than the monitoring of small molecular drugs in terms of structure,composition and aggregation state,whereby almost all of the conventional techniques are inadequate for accurate profiling their pharmacokinetic behavior in vivo.Herein,the advanced bioanalysis for tracing the in vivo fate of NDDSs is summarized,including liquid chromatography tandemmass spectrometry(LC-MS/MS),Forster resonance energy transfer(FRET),aggregation-caused quenching(ACQ)fluorophore,aggregation-induced emission(AIE)fluorophores,enzyme-linked immunosorbent assay(ELISA),magnetic resonance imaging(MRI),radiolabeling,fluorescence spectroscopy,laser ablation inductively coupled plasma MS(LA-ICP-MS),and size-exclusion chromatography(SEC).Based on these technologies,a comprehensive survey of monitoring the dynamic changes of NDDSs in structure,composition and existing form in system(i.e.carrier polymers,released and encapsulated drug)with recent progress is provided.We hope that this review will be helpful in appropriate application methodology for investigating the pharmacokinetics and evaluating the efficacy and safety profiles of NDDSs.展开更多
基金supported by Chinese Medicine Development Fund of the Hong Kong SAR(No.21B2/018A)。
文摘Objective:This cross-sectional study assessed the methodological quality of systematic reviews(SRs)of Chinese herbal medicine(CHM)published in Chinese between Jan 2021 and Sep 2022.Methods:Chinese language CHM SRs were identified through literature searches across 3 international and 4 Chinese databases.Methodological quality was appraised using A MeaSurement Tool to Assess systematic Reviews 2.Logistic regressions were used to explore associations between bibliographical characteristics and quality.Results:Analyses of methodological quality found that among the 213 sampled SRs,69.5%were of critically low quality,30.5%were of low quality,and none achieved high or moderate quality.Common shortcomings included the failure to identify the studies excluded from the analysis,failure to disclose funding sources,and limited evaluation of the potential impact of bias on conclusions.Logistic regressions revealed that SRs led by corresponding authors affiliated with universities or academic institutions tended to be of lower quality than SRs led by authors affiliated with hospitals or clinical facilities.Conclusion:Recent Chinese language CHM SRs exhibited limited methodological quality,making them unlikely to support the development of clinical practice guidelines.Urgent initiatives are needed to enhance training for researchers,peer-reviewers and editors involved in the preparation and publication of SRs.Adoption of Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines in Chinese language journals is crucial to improve the relevance of SRs for Chinese medicine development.Addressing deficiencies in methodology and reporting is essential for promoting evidence-based practices and informed clinical decisions in Chinese medicine.
文摘Objective: This study assessed the methodological quality of systematic reviews/meta-analysis of the effectiveness of probiotics against irritable bowel syndrome (IBS) using the accepted methodological quality assessment scale AMSTAR and explored the factors that influenced the quality of methodology. It was designed to provide a reference for future research and systematic reviews/metaanalysis. Methods: The methodological quality of existing systematic reviews/meta-analysis was evaluated using the AMSTAR scale. Influencing factors of methodological quality were statistically analyzed using RevMan 5.3 software. The included systematic reviews/metaanalysis must include the following characteristics:(1) methods using systematic evaluation/meta-analysis,(2) probiotic intervention, and (3) language limitation to Chinese and English. Results: The AMSTAR score was 5-9 (7.42 ± 1.22), and the quality is above average. The factors affecting the methodological quality are the number of authors and whether they cooperate with the institution. Conclusions: Studies have shown that current systematic reviews/meta-analysis of the effectiveness of probiotics on IBS does not fully comply with methodological quality standards, and therefore the methodological quality of research in this area needs to be strengthened. To better clarify how probiotics affect IBS, future systematic reviews and meta-analyses should not only follow methodological quality standards but also include more effective outcome measures, and they should focus more on the discussion of research results. We look forward to the development of higher-quality randomized controlled trials in the future.
文摘In the State of Santa Catarina, Brazil, especially in the Itajai valley, there are records of accidents and disasters mainly associated to landslides and floods, which have caused significant damages and losses, including human lives. In order to make the coexistence with such natural disasters possible, most particularly with floods, a integration is required among the technical, political, environmental, and human knowledge. Measures that encompass integrated actions for the entire river basin, with the help from an updated technical cadastre and tools, such as the GIS, allow the development of planning tools that might effectively help the people to live with the water, or else to cope with floods in a more appropriate manner. This paper attempts to propose a methodology for urban flood control, based on the integration among the several public entities involved in the flood control, along with the CTM （Multipurpose Technical Cadastre） and GIS tool. In order to solve or minimize the problems, the model proposed here aims at promoting a balance between the agents involved, and enables to rank the degrees of importance assigned to the different needs, thus allowing to eliminate or to improve those areas and processes that are duplicated or superimposed.
基金the National Natural Science Funding(81904055)of China.
文摘Background:Stroke is not only high in morbidity and mortality but also poses a great burden of disease and it is also the most reported disease in Chinese medicine systematic reviews.Therefore,the quality of such evidence couldn’t be ignored.This study aims to use a measurement tool to assess systematic reviews(AMSTAR)to assess the methodological qualities of SR/Meta-analyses of Chinese medicine on stroke.Methods:Systematic searching of seven electronic databases and PROSPERO registration platform was carried out.Two researchers separately selected studies,extracted bibliographical characteristics and scored every included study independently after training.Total score and the proportion of each item completion were explored in different subgroup comparisons.Spearman rank correlation and multivariable logistic regression were used to measure the association between bibliographical characteristics and total score or each item.Results:Total average score of AMSTAR 1.0 checklists of 234 systematic reviews/Meta-analyses was 4.47(95%CI 4.27–4.68)and the qualities were unsatisfied especially in terms of priori setting(2.14%),grey literature inclusion(5.13%),providing a list of excluded studies(2.14%)and conflict of interest(0.00%).No improvement was found in 3 years even after the publication of AMSTAR.Chinese or nonregistered systematic reviews/Meta-analyses showed even worse methodological qualities(P<0.01).Positive correlation was found between individual items and number of pages,number of authors,research questions,languages or Meta-analyse separately(P<0.05).Conclusion:The methodological qualities of systematic reviews/Meta-analyses of Chinese medicine on stroke are poor especially Chinese studies,non-registered studies,brief studies and studies without Meta-analyse or cooperation.There is no obvious improvement over these years even after the publication of AMSTAR tool,so it is urgent to promote the use of AMSTAR or develop other efficient methods to control the quantity and monitor the quality in future.
基金Supported by a Patient-Centered Outcomes Research Institute(PCORI)Dissemination and Implementation Award,No.DI-2020C2-20372.
文摘BACKGROUND Online surveys can align with youth’s increased use of the internet and can be a mechanism for expanding youth participation in research.This is particularly important during the coronavirus disease 2019(COVID-19)pandemic,when inperson interactions are limited.However,the advantages and drawbacks of online systems used for research need to be carefully considered before utilizing such methodologies.AIM To describe and discuss the strengths and limitations of an online system developed to recruit adolescent girls for a sexual health research study and conduct a three-month follow up survey.METHODS This methodology paper examines the use of an online system to recruit and follow participants three months after their medical visit to evaluate a mobile sexual and reproductive health application,Health-E You/Salud iTuTM,for adolescent girls attending school-based health centers(SBHCs)across the United States.SBHC staff gave adolescent girls a web link to an online eligibility and consent survey.Participants were then asked to complete two online surveys(baseline and 3-month follow-up).Surveys,reminders,and incentives to complete them were distributed through short message service(SMS)text messages.Upon completing each survey,participants were also sent an email with a link to an electronic gift card as a thank-you for their participation.Barriers to implementing this system were discussed with clinicians and staff at each participating SBHC.RESULTS This online recruitment and retention system enabled participant recruitment at 26 different SBHCs in seven states across the United States.Between September 2021 and June 2022,415 adolescent girls were screened using the Qualtrics online survey platform,and 182 were eligible to participate.Of those eligible,78.0%(n=142)completed the baseline survey.Participants were racially,geographically,and linguistically diverse.Most of the participants(89.4%)were non-White,and 40.8%spoke Spanish.A total of 62.0%(n=88)completed the 3-month follow-up survey.Limitations of this system included reliance on internet access(via Wi-Fi or cell service),which was not universally available or reliable.In addition,an individual unrelated to the study obtained the survey link,filled out multiple surveys,and received multiple gift cards before the research team discovered and stopped this activity.As a result,additional security protocols were instituted.CONCLUSION Online systems for health research can increase the reach and diversity of study participants,reduce costs for research personnel time and travel,allow for continued study operation when in-person visits are limited(such as during the COVID-19 pandemic),and connect youth with research using technology.However,there are challenges and limitations to online systems,which include limited internet access,intermittent internet connection,data security concerns,and the potential for fraudulent users.These challenges should be considered prior to using online systems for research.
基金supported by National Natural Science Foundation of China(No.81603565)Tianjin University of Traditional Chinese Medicine Postgraduate Research Innovation Project(YJSKC-20201032).
文摘Aims:This study aims to investigate the methodological quality of the systematic reviews of music therapy for Alzheimer’s Disease in the past five years,and to explore their compliance with each AMSTAR(A Measure Tool to Assess Systematic Reviews)item.Based on the above,this study is intended to facilitate the evidence transformation of music therapy in Alzheimer's Disease.Method:Cochrane Library,Web of Science,Embase and PubMed were searched from 2017-2021,to obtain the systematic reviews of music therapy among Alzheimer’s Disease.We used the AMSTAR,to evaluate their methodological quality.Additionally,their compliance with 16 AMSTAR items was investigated.Results:12 systematic reviews were included in this study.The methodological quality of 10 articles was“very low”,1 article was“low”,and 1 article was“high”.The 12 systematic reviews had 25%to 100%compliance with 16 AMSTAR items.Conclusion:The methodological quality of systematic reviews of music therapy among Alzheimer’s Disease in the recent five years is not high,and needs to be further improved.Future research should continue to explore the factors that affect their methodological quality,to promote the transformation of evidence-based evidence.
基金Supported by National Natural Science Foundation of China:81973968,82274660China Center for Evidence Based Traditional Chinese Medicine:2020YJSZX-1.
文摘Background:Methodological issues and challenges hinder the high-quality development of acupuncture clinical studies.Objective:To systematically summarize the methodological issues,challenges,and recommendations in acupuncture clinical research using the participant,intervention,comparison,outcome,and study design(PICOS)framework to generate a comprehensive list of methodological questions and recommendations.Methods:We searched seven databases for articles on the methodological aspects of clinical acupuncture research from their inception to March 24,2023.Two researchers independently screened the titles,ab-stracts,and full text of each article.Data extraction and analyses were performed for the eligible studies.Finally,the methodological challenges and recommendations for acupuncture clinical studies are listed,and the frequency of methodological challenges is displayed in a sunburst chart.Results:A total of 226 studies were included in the review,most of which originated in China(173,77%),followed by the United States(25,11%)and the United Kingdom(12,5%).Clinical research on acupuncture faces methodological challenges that span the five elements of the PICOS framework.The most frequently mentioned issues were related to comparison,followed by study design and interven-tions.If further categorized,the establishment of the control group is undoubtedly the most concerning issue for researchers.Conclusion:This review provides a comprehensive overview of the challenges and recommendations for each aspect of the PICOS framework in clinical acupuncture research.
文摘Robust preclinical models of transgender male(TGM) gender-affirming hormone therapy(GAHT) can inform clinicians of the isolated effects of GAHT;however existing models vary significantly in approach. We aimed to assess existing methodology and how it influences circulating sex-hormone levels in rodent models of TGM GAHT to provide recommendations of best practise. Pub Med, Embase, and Scopus databases were systematically searched for studies that investigated GAHT in rodent models and were published from inception to the 1st of August 2024. Study characteristics and methodology were extracted and compared. Post-intervention circulating sex hormone concentrations were the primary outcome used to determine whether successful gender affirming hormone therapy had been achieved. Sixteen experimental rodent studies were included. Studies were performed on mice( n = 11) and rats( n = 5). Subcutaneous(SC) pellets and SC silastic implants were featured in some studies but weekly SC injections of testosterone enanthate was the preferred method. Sesame oil was the preferred solvent for injected testosterone formulations. Weekly doses of ~ 450 μg(mice) and ~ 420–900 μg(rats) consistently induced the testosterone levels of the male counterpart. Similarly, 10 mg of unesterified testosterone in a SC silastic implant in mice or 10 mg/100 g in rats were also successful methods. Most studies administered hormones for 6–8 weeks before performing post-treatment assessments. This review demonstrates that methods largely varied across studies and successfully identifies the effective methodological approaches that improve the reproducibility and accuracy of preclinical models. Representing an integral step forward to bridging gaps in preclinical transgender healthcare research.
文摘BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological information in the included papers can often be lacking or unclear,and reviewers usually need to contact the authors of included studies for clarifications.Contacting authors is recommended,but it is unclear how often SR teams do it,or what the level of response is.AIM To investigate how often reviewers undertake contact with the authors of included randomized controlled trials(RCTs)for clarification on data and risk of bias concerns,to explore the factors that influence whether SR authors contact or do not contact the authors,and the content and level of responses.METHODS We conducted a systematic electronic database search in MEDLINE using the search string“(systematic review)”AND“(RCT OR randomized OR trial)”for articles published between 1 January 2024 and 19 February 2024,without language restrictions.Screening and data extraction was done independently by two reviewers,and conflicts resolved by a senior author.Contact authors of included SRs were contacted for clarifications.RESULTS Of the 329 included SRs,38%(n=125)explicitly mentioned contact with the authors of included studies.The remaining 62%(n=204)did not.We attempted contact with all SR teams for clarifications and received 90 responses(19.4%).Of the 50 respondents who did not explicitly mention contact in their SRs,25(50%)replied that they did make contact.We received a total of 64 responses on the level and content of information sought.The mean±SD contacts SR teams made were 10(10),replies received 5(6.7),and response waiting time 10.1(28.3)weeks.Resources,time,poor previous experience,perceived likelihood of poor response and bias concerns were reported as barriers to attempting contact.CONCLUSION The majority of SRs published in 2024 did not confirm seeking clarifying or missing information from primary study authors.However,SR teams reported that 50%of contacted primary authors respond.Additional research can clarify this rate of response and establish methods to increase the integration of this core methodological element in SRs.
基金supported by the National Natural Science Foundation of China(Grant Nos.52202483,52108476,and 52388102)。
文摘Urban transportation systems are facing severe challenges due to the rapid growth of the urban population,especially in China.Suspended monorail system(SMS),as a sky rail transportation form,can effectively alleviate urban traffic congestion due to its independent right-of-way and minimal ground footprint.However,the SMS possesses a special traveling system with unique vehicle structure and bridge configuration,which results in significant differences in both the mechanisms and dynamics problems associated with train–bridge interaction(TBI)when contrasted with those of traditional railway systems.Therefore,a thorough understanding of the SMS dynamics is essential for ensuring the operational safety of the system.This article presents a state-of-the-art review of the TBI modeling methodologies,critical dynamic features,field tests,and practice of the SMS in China.Firstly,the development history,technical features,and potential dynamics problems of the SMS are briefly described,followed by the mechanical characteristics and mechanisms of the train–bridge interactive systems.Then,the modeling methodology of the fundamental elements in the suspended monorail TBI is systematically reviewed,including the suspended train subsystem,bridge subsystem,train–bridge interaction relationships,system excitations,and solution method.Further,the typical dynamic features of the TBI under various operational scenarios are elaborated,including different train speeds,a variety of line sections,and a natural wind environment.Finally,the first new energy-based SMS test line in the world is systematically introduced,including the composition and functionality of the system,the details of the conducted field tests,and the measured results of the typical dynamic responses.At the end of the paper,both the guidance on further improvement of the SMS and future research topics are proposed.
基金supported by National Natural Science Foundation of China (32172747 and 32425052)
文摘Background Early embryo development plays a pivotal role in determining pregnancy outcomes,postnatal development,and lifelong health.Therefore,the strategic selection of functional nutrients to enhance embryo development is of paramount importance.In this study,we established a stable porcine trophectoderm cell line expressing dual fluorescent reporter genes driven by the CDX2 and TEAD4 gene promoter segments using lentiviral transfection.Results Three amino acid metabolites—kynurenic acid,taurine,and tryptamine—met the minimum z-score criteria of 2.0 for both luciferase and Renilla luciferase activities and were initially identified as potential metabolites for embryo development,with their beneficial effects validated by qPCR.Given that the identified metabolites are closely related to methionine,arginine,and tryptophan,we selected these three amino acids,using lysine as a standard,and employed response surface methodology combined with our high-throughput screening cell model to efficiently screen and optimize amino acid combination conducive to early embryo development.The optimized candidate amino acid system included lysine(1.87 mmol/L),methionine(0.82 mmol/L),tryptophan(0.23 mmol/L),and arginine(3 mmol/L),with the ratio of 1:0.43:0.12:1.60.In vitro experiments confirmed that this amino acid system enhances the expression of key genes involved in early embryonic development and improves in vitro embryo adhesion.Transcriptomic analysis of blastocysts suggested that candidate amino acid system enhances early embryo development by regulating early embryonic cell cycle and differentiation,as well as improving nutrient absorption.Furthermore,based on response surface methodology,400 sows were used to verify this amino acid system,substituting arginine with the more cost-effective N-carbamoyl glutamate(NCG),a precursor of arginine.The optimal dietary amino acid requirement was predicted to be 0.71%lysine,0.32%methionine,0.22%tryptophan,and 0.10%NCG for sows during early gestation.The optimized amino acid system ratio of the feed,derived from the peripheral release of essential amino acids,was found to be 1:0.45:0.13,which is largely consistent with the results obtained from the cell model optimization.Subsequently,we furtherly verified that this optimal dietary amino acid system significantly increased total litter size,live litter size and litter weight in sows.Conclusions In summary,we successfully established a dual-fluorescent high-throughput screening cell model for the efficient identification of potential nutrients that would promote embryo development and implantation.This innovative approach overcomes the limitations of traditional amino acid nutrition studies in sows,providing a more effective model for enhancing reproductive outcomes.
文摘Chinese medicine,with its rich historical roots and holistic approach,has been a fundamental aspect of healthcare in East Asia and is now gaining global recognition.Founded on centuries of empirical knowledge and philosophical insight,Chinese medicine draws heavily from classical texts to guide its practices in herbal medicine and acupuncture.Despite its cultural and historical significance,integrating Chinese medicine into global healthcare systems presents challenges,notably the need for evidence-based practices to enhance credibility,ensure patient safety,and foster broader acceptance within the medical community.This paper explores how Chinese medicine can adopt evidence-based practices by incorporating principles of Western medicine into its research methodologies.It reviews the origins and philosophical foundations of Chinese medicine,examining its reliance on classical texts and empirical methods.The paper also highlights the differences between the personalised approach of Chinese medicine,which tailors treatments to individual needs,and the standardised protocols typical of Western medicine.Additionally,it addresses methodological challenges in Chinese medicine research,such as inconsistent diagnostic criteria and insufficient design rigour.To bridge these gaps,innovative research methodologies that respect the unique variability of Chinese medicine are needed.By adopting evidence-based practices and rigorous scientific validation,Chinese medicine can enhance its legitimacy and facilitate its integration into the global healthcare landscape.
基金supported(in part)by the Entrusted Project of National commission on health and health of China(No.2019099)the National Key Research and Development Plan of China(2016YFC0106300)the Nature Science Foundation of Hubei Province(2019FFB03902)。
文摘Methodological quality(risk of bias)assessment is an important step before study initiation usage.Therefore,accurately judging study type is the first priority,and the choosing proper tool is also important.In this review,we introduced methodological quality assessment tools for randomized controlled trial(including individual and cluster),animal study,non-randomized interventional studies(including follow-up study,controlled before-and-after study,before-after/pre-post study,uncontrolled longitudinal study,interrupted time series study),cohort study,case-control study,cross-sectional study(including analytical and descriptive),observational case series and case reports,comparative effectiveness research,diagnostic study,health economic evaluation,prediction study(including predictor finding study,prediction model impact study,prognostic prediction model study),qualitative study,outcome measurement instruments(including patient-reported outcome measure development,content validity,structural validity,internal consistency,cross-cultural validity/measurement invariance,reliability,measurement error,criterion validity,hypotheses testing for construct validity,and responsiveness),systematic review and meta-analysis,and clinical practice guideline.The readers of our review can distinguish the types of medical studies and choose appropriate tools.In one word,comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.
文摘This paper introduces the conception of open complex giant system and the methodology for dealing with the system, with stress on its profound significance in development of science and technology. The authors conclude that the reductionism underlying the exact science is not suitable to open complex giant system, and the only feasible alternative is the meta-synthetic engineering from the qualitative to the quantitative.
基金supported by the Project of Basic Science Center for the National Natural Science Foundation of China(72088101)。
文摘Unconventional oil and gas resources have become the most important and realistic field for increasing China’s domestic oil and gas reserves and production.At present,the production scale does not match the massive amount of resources and the rapid growth of proven geological reserves.The challenges of technology,cost,management,and methodology restrict large-scale and economic development.Based on successful practices,a"one engine with six gears"system engineering methodology is put forward,which includes life-cycle management,overall synergy,interdisciplinary cross-service integration,marketoriented operation,socialized support,digitalized management,and low-carbon and green development.The methodology has been proved to be effective in multiple unconventional oil and gas national demonstration areas,including the Jimusar continental shale oil demonstration area.Disruptive views are introduced-namely,that unconventional oil and gas do not necessarily yield a low return,nor do they necessarily have a low recovery factor.A determination to achieve economic benefit must be a pervasive underlying goal for managers and experts.Return and recovery factors,as primary focuses,must be adhered to during China’s development of unconventional oil and gas.The required methodology transformation includes a revolution in management systems to significantly decrease cost and increase production,resulting in technological innovation.
基金Project (No. 20276064) supported by the National Natural ScienceFoundation of China
文摘This paper presents the evaluation of an aqueous two-phase system （ATPS） for extracting elastase produced by Bacillus sp. EL31410. The elastase and cell partition behavior in polyethylene glycol （PEG）/salt systems was investigated. The suitable system for elastase extraction was PEG/KHEPO4-KEHPO4, in which elastase is mainly partitioned into the PEG-rich phase, while the cells remained in the other phase. The influence of defined system parameters （e.g. PEG molecular mass, pH, NaCl addition） on the partitioning behavior of elastase is described. The concentration of phase forming components, PEG and KHEPO4-KEHPO4, was optimized for elastase recovery by means of response surface methodology, and it was found that they greatly influenced extraction recovery. The optimal ATPS was 23.1% （w/w） PEG 2000 and 11.7% （w/w） KHEPO4-KEHPO4. The predicted recovery was about 89.5%, so this process is suggested to be a rapid and convenient method for elastase extraction.
基金the Defense Industrial Technology Development Program of China(No.JCKY2017601C006)the National Key Research and Development Program of China(No.2016YFB0502602)+1 种基金the National Natural Science Foundation of China(No.91538204)in part supported by Shenzhen Science and Technology Program,China(No.KQTD2016112515134654)。
文摘In this paper,an Unmanned Aerial Vehicle(UAV)enabled Mobile Edge Computing(MEC)system is studied,in which UAV acts as server to offer computing offloading service to the Mobile Users(MUs)with limited computing capability and energy budget.We aim to minimize the total energy consumption of MUs by jointly optimizing the bit allocation for uplink,computing at the UAV and downlink,along with the UAV trajectory in a unified framework.To this end,a trajectory constraint model is employed to avoid sudden changes of velocity and acceleration during flying.Due to high-order information in use,we lead to a more reasonable nonconvex optimization problem than prior arts.An Alternating Direction Method of Multipliers(ADMM)method is introduced to solve the optimization problem,which is decomposed into a set of easy subproblems,to meet the requirement on the efficiency in edge computing.Numerical results demonstrate that our approach leads a smoother UAV trajectory,significantly save the energy consumption for UAV during flying.
基金financial support from the National Natural Science Foundation of China(Grant Nos.81673396 and 81872831)the Science and Technology Major Specialized Projects for‘Significant New Drugs Creation’of the 13th Five-year Plan(2017ZX09101001 and 2018ZX09721002007)。
文摘The development of nano drug delivery systems(NDDSs)provides new approaches to fighting against diseases.The NDDSs are specially designed to serve as carriers for the delivery of active pharmaceutical ingredients(APIs)to their target sites,which would certainly extend the benefit of their unique physicochemical characteristics,such as prolonged circulation time,improved targeting and avoiding of drugresistance.Despite the remarkable progress achieved over the last three decades,the understanding of the relationships between the in vivo pharmacokinetics of NDDSs and their safety profiles is insufficient.Analysis of NDDSs is far more complicated than the monitoring of small molecular drugs in terms of structure,composition and aggregation state,whereby almost all of the conventional techniques are inadequate for accurate profiling their pharmacokinetic behavior in vivo.Herein,the advanced bioanalysis for tracing the in vivo fate of NDDSs is summarized,including liquid chromatography tandemmass spectrometry(LC-MS/MS),Forster resonance energy transfer(FRET),aggregation-caused quenching(ACQ)fluorophore,aggregation-induced emission(AIE)fluorophores,enzyme-linked immunosorbent assay(ELISA),magnetic resonance imaging(MRI),radiolabeling,fluorescence spectroscopy,laser ablation inductively coupled plasma MS(LA-ICP-MS),and size-exclusion chromatography(SEC).Based on these technologies,a comprehensive survey of monitoring the dynamic changes of NDDSs in structure,composition and existing form in system(i.e.carrier polymers,released and encapsulated drug)with recent progress is provided.We hope that this review will be helpful in appropriate application methodology for investigating the pharmacokinetics and evaluating the efficacy and safety profiles of NDDSs.
