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Evidence-based expert consensus on clinical management of safety of Bruton's tyrosine kinase inhibitors(2024)

Chinese Journal of Cancer Research 2024年第3期36卷 240-257页

作者： Zaiwei Song Dan Jiang Lingling Yu Yixuan Chen Daobin Zhou Yue Li Depei Wu Lingli Zhang Liyan Miao Jun Ma Jun Zhu Hongmei Jing Rongsheng Zhao Department of Hematology and Oncology Harbin Institute of Hematology and Oncology Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of Lymphoma Peking University Cancer Hospital&Institute Department of Hematology Peking University Third Hospital the Steering Committee the Consensus Panel and the Evidence Synthesis Group Evidence-based Pharmacy Professional Committee of Chinese Pharmaceutical Association(CPA) Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association(CPA) Division of therapeutic Drug monitoring of Chinese Pharmacological Society(CPS) Expert Committee on Lymphoma of Chinese Society of Clinical Oncology(CSCO) Expert Committee on Leukemia of Chinese Society of Clinical Oncology(CSCO) Society of Integrative Cardio-Oncology of China Anti-Cancer Association(CACA) Department of Pharmacy Peking University Third Hospital Chinese Society of Hematology of Chinese Medical Association(CMA) Hospital Pharmacy Professional Committee of Cross-Straits Medicine Exchange Association(SMEA) Institute for Drug Evaluation Peking University Health Science Center therapeutic Drug monitoring and Clinical Toxicology Center Peking University Department of Pharmacy Administration and Clinical Pharmacy School of Pharmaceutical Sciences Peking University Department of Hematology Peking Union Medical College Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Department of Cardiology the First Affiliated Hospital Harbin Medical University Department of Hematology the First Affiliated Hospital of Soochow University Department of Pharmacy Evidence-based Pharmacy Center West China Second Hospital Sichuan University Department of Pharmacy the First Affiliated Hospital of Soochow University

Bruton's tyrosine kinase inhibitors(BTKis) have revolutionized the treatment of B-cell lymphomas. However,safety issues related to the use of BTKis may hinder treatment continuity and further affect clinical efficacy. A comprehensive and systematic expert consensus from a pharmacological perspective is lacking for safety issues associated with BTKi treatment. A multidisciplinary consensus working group was established, comprising 35 members from the fields of hematology, cardiovascular disease, cardio-oncology, clinical pharmacy, and evidence-based medicine. This evidence-based expert consensus was formulated using an evidence-based approach and the Delphi method. The Joanna Briggs Institute Critical Appraisal(JBI) tool and Grading of Recommendations Assessment, Development, and Evaluation(GRADE) approach were used to rate the quality of evidence and grade the strength of recommendations, respectively. This consensus provides practical recommendations for BTKis medication based on nine aspects within three domains, including the management of common adverse drug events such as bleeding, cardiovascular events, and hematological toxicity, as well as the management of drug-drug interactions and guidance for special populations. This multidisciplinary expert consensus could contribute to promoting a multi-dimensional, comprehensive and standardized management of BTKis.

关键词： Consensus BTK inhibitors safety adverse drug events drug-drug interactions

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Declining responsiveness of childhood Plasmodium falciparum infections to artemisinin-based combination treatments ten years following deployment as first-line antimalarials in Nigeria

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Infectious Diseases of Poverty 2019年第4期8卷 96-97页

作者： Akintunde Sowunmi Godwin Ntadom Kazeem Akano Folasade O.Ibironke Adejumoke I.Ayede Chimere Agomo Onikepe A.Folarin Grace O.Gbotosho Christian Happi Stephen Oguche Henrietta U.Okafor Martin Meremikwu Philip Agomo William Ogala Ismaila Watila Olugbenga Mokuolu Finomo Finomo Joy C.Ebenebe Nma Jiya Jose Ambe Robinson Wammanda George Emechebe Wellington Oyibo Francis Useh Temitope Aderoyeje Titilope M.Dokunmu Omobolaji T.Alebiosu Sikiru Amoo Oluwabunmi K.Basorun Olubunmi A.Wewe Chukwuebuka Okafor Odafe Akpoborie Bayo Fatunmbi Elsie O.Adewoye Nnenna M.Ezeigwe Ayoade Oduola antimalarial therapeutic efficacy monitoring group National Malaria Elimination ProgrammeThe Federal Ministry of HealthAbujaNigeria Department of Pharmacology and therapeutics University of IbadanIbadanNigeria 不详

Background:The development and spread of artemisinin-resistant Plasmodium falciparum malaria in Greater Mekong Subregion has created impetus for continuing global monitoring of efficacy of artemisinin-based combination therapies(ACTs). This post analyses is aimed to evaluate changes in early treatment response markers 10 years after the adoption of ACTs as first-line treatments of uncomplicated falciparum malaria in Nigeria.Methods: At 14 sentinel sites in six geographical areas of Nigeria, we evaluated treatment responses in 1341 children under 5 years and in additional 360 children under 16 years with uncomplicated malaria enrolled in randomized trials of artemether-lumefantrine versus artesunate-amodiaquine at 5-year interval in 2009-2010 and 2014-2015 and at 2-year interval in 2009-2010 and 2012-2015, respectively after deployment in 2005.Results: Asexual parasite positivity 1 day after treatment initiation (APPD1) rose from 54 to 62% and 2 days after treatment initiation from 5 to 26% in 2009-2010 to 2014-2015(P=0.002 and P 75 000 μl^-1, haematocrit > 27% 1 day post-treatment initiatiortreatment with artemether-lumefantrine and enrolment in 2014-2015 independently predicted APPD1. In paralle , Kaplan-Meier estimated risk of recurrent infections by day 28 rose from 8 to 14% (P=0005) and from 9 to 15%(P=0.02) with artemether-lumefantrine and artesunate-amodiaquine, respectively. Mean asexual parasitaemia half-life increased significantly from 1.1 h to 1.3h within 2 years (P<0.0001).Conclusions:These data indicate declining parasitological responses through time to the two ACTs may be due to emergence of parasites with reduced susceptibility or decrease in immunity to

关键词： Declining responsiveness Falciparum malaria Children Artemisinin-based combination treatment Nigeria

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Reduced efficacy of single-dose albendazole against Ascaris lumbricoides, and Trichuris trichiura, and high reinfection rate after cure among school children in southern Ethiopia: a prospective cohort study

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Infectious Diseases of Poverty 2024年第1期13卷 95-96页

作者： Tigist Dires Gebreyesus Eyasu Makonnen Tafesse Tadele Kalkidan Mekete Habtamu Gashaw Heran Gerba Eleni Aklillu Department of Global Public Health Karolinska Institutet Karolinska University Hospital Stockholm Sweden Ethiopian Food and Drug Authority Addis Ababa Ethiopia Center for Innovative Drug Development and therapeutic Trials for Africa College of Health Sciences Addis Ababa University Addis Ababa Ethiopia Departments of Pharmacology and Clinical Pharmacy College of Health Sciences Addis Ababa University Addis Ababa Ethiopia College of Medicine and Health Sciences Hawassa University Hawassa Ethiopia Ethiopian Public Health Institute Addis Ababa Ethiopia

Background Mass drug administration(MDA)program of albendazole to at-risk populations as preventive chemo-therapy is the core public health intervention to control soil-transmitted helminths(STHs).Achieving this goal relies on drug effectiveness in reducing the parasite reservoirs in the community and preventing reinfection.We assessed the effcacy of albendazole against STH parasite infection and reinfection status after cure.Methods A total of 984 schoolchildren infected with at least one type of STH parasite(hookworm,Ascaris lumbri-coides,Trichuris trichiura)in southern Ethiopia were enrolled and received albendazole and praziquantel in MDA campaign conducted from January to March 2019.Stool exams at week-4 and at week-8 of post-MDA were done using Kato Katz technique.The primary outcome was effcacy assessed by cure rate(CR)and fecal egg reduction rates(ERRs)at four weeks of post-MDA.The secondary outcome was reinfection status defined as parasite egg positivity at eight weeks among those who were cured at 4 weeks of post-MDA.group comparisons in CR and related factors were assessed with chi-square or Fisher's exact tests.Predictors of CR were examined through univariate and multi-variate regression analyses.Results The overall CR and ERR for hookworm infection were 97.2%(95%CI:94.6-99.4)and 97.02%,respectively.The overall CR and ERR for A.lumbricoides were 71.5%(95%CI:68.3-74.6)and 84.5% respectively.The overall CR and ERR and for T.trichiura were 49.5%(95%CI:44.8-54.2)and 68.3%,respectively.The CR among moderate T.trichiura infec-tion intensity was 28.6%.Among children cured of hookworm,A.lumbricoides and T.trichiura at week 4 post-MDA,4.6%,18.3% and 52.4% became reinfected at week-8 post-MDA,respectively.Significantly lower CR(36.6%)and higher reinfection after cure(60.6%)among A.lumbricoides and T.trichiura coinfected children than A.lumbricoides only(CR=69.6%,reinfection rate=15.1%)or T.trichiura only infected children(CR=55.6%,reinfection rate=47.1%)was observed.Pre-treatment coinfection with≥two types of

关键词： Soil transmitted helminths Neglected tropical diseases Preventive chemotherapy Albendazole School age children Ethiopia

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Drug-eluting bead transarterial chemoembolization as neoadjuvant therapy pre-liver transplantation for advanced-stage hepatocellular carcinoma

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World Journal of Gastrointestinal Oncology 2024年第6期16卷 2476-2486页

作者： Zhao-Dan Ye Li Zhuang Meng-Chen Song Zhe Yang Wu Zhang Jing-Feng Zhang Guo-Hong Cao Department of Radiology Shulan(Hangzhou)Hospital Affiliated to Zhejiang Shuren University Shulan International Medical CollegeHangzhou 310022Zhejiang ProvinceChina Department of Hepatobiliary and Pancreatic Surgery Shulan(Hangzhou)Hospital Affiliated to Zhejiang Shuren University Shulan International Medical CollegeHangzhou 310022Zhejiang ProvinceChina Diagnostic and therapeutic Center for Difficult Diseases Hwa Mei HospitalUniversity of Chinese Academy of SciencesNingbo 315010Zhejiang ProvinceChina

BACKGROUND The objectives of this study were to assess the safety and efficacy of drug-eluting bead transarterial chemoembolization(DEB-TACE)as neoadjuvant therapy before liver transplantation(LT)for advanced-stage hepatocellular carcinoma(HCC)and to analyze the prognostic factors.AIM To determine whether DEB-TACE before LT is superior to LT for advanced-stage HCC.METHODS A total of 99 individuals diagnosed with advanced HCC were studied retrospectively.The participants were categorized into the following two groups based on whether they had received DEB-TACE before LT:DEB-TACE group(n=45)and control group(n=54).The participants were further divided into two subgroups based on the presence or absence of segmental portal vein tumor thrombus(PVTT).The DEB-TACE group consisted of two subgroups:group A(n=31)without PVTT and group B(n=14)with PVTT.The control group also had two subgroups:group C(n=37)without PVTT and group D(n=17)with PVTT.Data on patient demographics,disease characteristics,therapy response,and adverse events(AEs)were collected.The overall survival(OS)and recurrence-free survival(RFS)rates were assessed using Kaplan-Meier curves.Univariate and multivariate Cox regression analyses were conducted to determine the parameters that were independently related to OS and RFS.RESULTS The DEB-TACE group exhibited an overall response rate of 86.6%.Following therapy,there was a significant decrease in the median alpha-fetoprotein(AFP)level(275.1 ng/mL vs 41.7 ng/mL,Pgroup than in the control group(68.9%vs 38.9%,P=0.003;86.7%vs 63.0%,P=0.008).Within the subgroups,group A had higher 2-year rates of RFS and OS compared to group C(71.0%vs 45.9%,P=0.038;83.8%vs 62.2%,P=0.047).The 2-year RFS rate of group B was markedly superior to that of group D(64.3%vs 23.5%,P=0.002).Results from multivariate analyses showed that pre-LT DEB-TACE[hazard ratio(HR)=2.73,95%confidence interval(CI):1.44-5.14,P=0.04

关键词： Hepatocellular carcinoma Liver transplantation Portal vein tumor thrombus Drug-eluting bead transarterial chemoembolization Neoadjuvant treatment

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Reliable Data Collection Model and Transmission Framework in Large-Scale Wireless Medical Sensor Networks

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Computer Modeling in Engineering & Sciences 2024年第7期140卷 1077-1102页

作者： Haosong Gou Gaoyi Zhang RenêRipardo Calixto Senthil Kumar Jagatheesaperumal Victor Hugo C.de Albuquerque China Mobile group Sichuan Co. Ltd.Chengdu640041China Department of Teleinformatics Engineering Federal University of CearáFortaleza60455-970Brazil Department of Electronics&Communication Engineering Mepco Schlenk Engineering CollegeSivakasi626005India

Large-scale wireless sensor networks(WSNs)play a critical role in monitoring dangerous scenarios and responding to medical emergencies.However,the inherent instability and error-prone nature of wireless links present significant challenges,necessitating efficient data collection and reliable transmission services.This paper addresses the limitations of existing data transmission and recovery protocols by proposing a systematic end-to-end design tailored for medical event-driven cluster-based large-scale WSNs.The primary goal is to enhance the reliability of data collection and transmission services,ensuring a comprehensive and practical approach.Our approach focuses on refining the hop-count-based routing scheme to achieve fairness in forwarding reliability.Additionally,it emphasizes reliable data collection within clusters and establishes robust data transmission over multiple hops.These systematic improvements are designed to optimize the overall performance of the WSN in real-world scenarios.Simulation results of the proposed protocol validate its exceptional performance compared to other prominent data transmission schemes.The evaluation spans varying sensor densities,wireless channel conditions,and packet transmission rates,showcasing the protocol’s superiority in ensuring reliable and efficient data transfer.Our systematic end-to-end design successfully addresses the challenges posed by the instability of wireless links in large-scaleWSNs.By prioritizing fairness,reliability,and efficiency,the proposed protocol demonstrates its efficacy in enhancing data collection and transmission services,thereby offering a valuable contribution to the field of medical event-drivenWSNs.

关键词： Wireless sensor networks reliable data transmission medical emergencies cluster data collection routing scheme

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Enhancement in Bioavailability of CurCousin^®, A Minor Metabolite from Curcuma longa by Addition of BioPerine^® —A Pharmacokinetic Study

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Journal of Biosciences and Medicines 2024年第2期12卷 282-293页

作者： Muhammed Majeed Kalyanam Nagabhushanam Sarang Bani Anjali Pandey Smitha Thazhathidath Sami-Sabinsa group Limited Bengaluru India Sabinsa Corporation New Jersey USA

In recent years, metabolic syndrome has been a growing health concern across the world. The role of nutraceuticals and functional foods in this area has a significant place due to the adverse effects of contemporary modes of treatment. CurCousin® is a nutritional ingredient containing bioactive Calebin A, (analog of Curcumin) with self-affirmed GRAS status. CurCousin® has been a clinically studied dietary supplement ingredient with a positive impact on body weight, lipid levels and metabolic health. Bioenhancers play an important role in increasing the bioavailability of the active in turn enhancing efficacy as well as reducing the dosage required to achieve the therapeutic effect. This study investigated the possible pharmacokinetic interaction between CurCousin® at two different doses (2.25 and 4.5 mg/kg) in the presence and absence of BioPerine® (0.27 mg/kg), a natural bioenhancer in Sprague-Dawley rats. The results revealed that the addition of BioPerine® into CurCousin® (2.25 mg/kg) half the dose when administered enhances the bioavailability and was equipotent to CurCousin® (4.5 mg/kg) double the dose without BioPerine®. Thus, leading to future clinical studies to evaluate its improved pharmacological efficacy as well as reduced therapeutic dosage.

关键词： Metabolic Health Bioavailability Pharmacokinetics CurCousin® BioPerine® Calebin A

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A novel herbal combination ameliorates ovarian dysfunction and regulates altered biochemical parameters in rats with letrozole-induced polycystic ovary syndrome

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Asian pacific Journal of Reproduction 2023年第1期12卷 23-34页

作者： Sunita Shailajan Sasikumar Menon Swati Singh Yugandhara Patil Herbal Research Lab(Department of Botany) Ramnarain Ruia Autonomous CollegeMatungaMumbai-400019India therapeutic Drug monitoring Laboratory Sion(East)Mumbai-400022India

Objective:To investigate the potential activity of novel herbal combination and novel herbal formulation(syrup)in female Sprague Dawley rats with letrozole-induced polycystic ovary syndrome(PCOS).Methods:Forty-two rats were randomly divided into seven groups with six rats in each group.group 1 received 0.5%carboxy methylcellulose orally for 37 days and served as the normal control group.group 2 was orally administered with letrozole of 1 mg/kg for 21 days and served as the PCOS induction group without treatment.group 3 to 7 were administered with letrozole of 1 mg/kg for 21 days orally to induce PCOS,and then respectively received clomiphene citrate at 1 mg/kg,100 and 200 mg/kg of novel herbal combination,200 mg/kg of novel herbal formulation(syrup),and 400 mg/kg of marketed formulation of Pushyanuga churna,once daily for 15 days.Effects of the novel herbal combination and its syrup formulation were evaluated on the hormonal profile,the levels of antioxidants,the lipid profile and on the ovarian morphology,using letrozole-induced PCOS model in rats.Results:Letrozole caused alterations in hormonal levels and lipid levels similar to PCOS and ovarian histology showed presence of ovarian cysts confirming the induction of PCOS in rats.On treatment with the novel herbal combination and its syrup formulation in PCOS-induced rats,the altered hormonal and lipid profiles showed significant recovery to normal levels.Ovarian histology confirmed the restoration of folliculogenesis in the PCOS-induced rats.The treatment with the syrup formulation of novel herbal combination was found to be more effective than novel herbal combination and showed better recovery in various parameters evaluated.The results of the study,however,suggested that treatment with novel herbal combination and its syrup formulation provided minimal protection against oxidative stress caused due to the induction of PCOS.Conclusions:The integrated approach for management of PCOS is to counterbalance the limitations associated with modern therapy.Both the no

关键词： Polycystic ovarian syndrome Polyherbal combination Letrozole Pushyanuga churna Clomiphene citrate Histopathology Biochemical Herbal

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Population pharmacokinetic model of valproate and prediction of valproate serum concentrations in children with epilepsy

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Acta Pharmacologica Sinica 2004年第12期25卷 10-17页

作者： De-chun JIANG, Li WANG2 Department of Pediatrics, Peking University First Hospital, therapeuticDrug monitoring and Clinical Toxicology, Center of Peking University, Beijing 100034, China Department of Pediatrics Peking University First Hospital Therapeutic Drug Monitoring and Clinical Toxicology Center of Peking University 北京 100034

AIM: Using sparse data of valproate (VPA) serum concentrations to build a population pharmacokinetic (PPK) model of VPA in Chinese children with epilepsy and to predict serum concentrations for new patients using a Bayesian approach. METHODS: Two hundred epileptic children, whose VPA serum concentrations were collected, were divided randomly into two groups (A and B, n=100 each). The PPK parameter values of group A were calculated to establish a PPK Model by using the NPEM Program of USC*PACK software. Based on it, VPA serum concentrations of group B were predicted with the Bayesian Fitting Program of the USC*PACK software. To assess the accuracy and precision of prediction, a paired-comparisons t-test was run between predicted and ob- served concentrations, and then the mean prediction error (MPE), mean square prediction error (MSPE), root mean square prediction error (RMSPE), and coincidence rates for different percentages of prediction error were all calculated. RESULTS: Optimum PPK parameters were: Ka, 2.522±2.743 h-1; Vs, 0.329±0.496 L/kg; and Kel, 0.0438±0.0384 h-1. For group B, there was no significant difference between predicted and observed concentrations. MPE was -0.43 mg/L, MSPE was 115.40 (mg/L)2, and RMSPE was 5.47 mg/L. The coincidence rates for percent- ages of prediction error, which were less than 5 %, 10 %, 15 %, 20 %, 25 %, and 30 %, were 62 %, 74 %, 82 %, 85 %, 89 %, and 93 %, respectively. CONCLUSION: A PPK model of VPA in epileptic children was successfully established. Based on it, VPA serum concentrations can be predicted accurately with a Bayesian approach.

关键词： pharmacokinetics valproic acid epilepsy Bayes theorem USC*PACK software

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Online Capacitor Voltage Transformer Measurement Error State Evaluation Method Based on In-Phase Relationship and Abnormal Point Detection

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Smart Grid and Renewable Energy 2024年第1期15卷 34-48页

作者： Yongqi Liu Wei Shi Jiusong Hu Yantao Zhao Pang Wang College of Railway Transportation Hunan University of Technology Zhuzhou China Wasion group Co. Ltd. Changsha China

The assessment of the measurement error status of online Capacitor Voltage Transformers (CVT) within the power grid is of profound significance to the equitable trade of electric energy and the secure operation of the power grid. This paper advances an online CVT error state evaluation method, anchored in the in-phase relationship and outlier detection. Initially, this method leverages the in-phase relationship to obviate the influence of primary side fluctuations in the grid on assessment accuracy. Subsequently, Principal Component Analysis (PCA) is employed to meticulously disentangle the error change information inherent in the CVT from the measured values and to compute statistics that delineate the error state. Finally, the Local Outlier Factor (LOF) is deployed to discern outliers in the statistics, with thresholds serving to appraise the CVT error state. Experimental results incontrovertibly demonstrate the efficacy of this method, showcasing its prowess in effecting online tracking of CVT error changes and conducting error state assessments. The discernible enhancements in reliability, accuracy, and sensitivity are manifest, with the assessment accuracy reaching an exemplary 0.01%.

关键词： Capacitor Voltage Transformer Measurement Error Online monitoring Principal Component Analysis Local Outlier Factor

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Develop potential multi-target drugs by self-assembly of quercetin with amino acids and metal ion to achieve significant efficacy in anti-Alzheimer’s disease

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Nano Research 2022年第6期15卷 5173-5182页

作者： Chunling Zhu Yuheng Yang Xiaowen Li Xingyu Chen Xucong Lin Xiaoping Wu Institute of Food Safety and Environment monitoring College of ChemistryFuzhou UniversityFuzhou 350116China

Exploring multi-target drugs(MTDs)is a prevalent method against Alzheimer’s disease(AD).However,the current developed MTDs based on the“framework combination”technique or using flavonoids have not realized better healing effects owing to a complex metabolic process and low bioavailability.Here,we propose an alternative strategy to develop self-assembled nanoparticles(NPs)as MTDs using 9-fluorenylmethyloxycarbonyl-tryptophan(Fmoc-Trp),quercetin(Que),and Fe^(2+)as building blocks through coordination and electrostatic interaction to generate Fmoc-Trp-Fe^(2+)-Que(FTFQ)NPs.Whether in cell or in vivo,FTFQ NPs exhibited considerable biocompatibility attributing to the inherent biological affinity of assembly units.By combining the advantages of assemble approach and nanostructures,the obtained FTFQ NPs greatly enhanced the bioavailability of Que and displayed synergistic therapeutic effects through reducing Aβaggregation in direct/indirect means and eliminating the toxicity induced by ROS and Aβoligomer/fibrils.Furthermore,FTFQ NPs could obviously restore the AD zebrafish’s mobility and stimulus response ability.More importantly,developing self-assembly NPs as MTDs could be an efficient and general method to promote other novel MTDs by extending the assemble units to other drugs,peptides,and metal ions.Based on above benefits,these self-assembled NPs could be as potential MTDs and show great promising application in AD treatment.

关键词： Alzheimer’s disease multi-target drugs(MTDs) self-assembled nanoparticles(NPs) quercetin(Que)

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