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Risk of tuberculosis in patients with rheumatoid arthritis treated with biological and targeted drugs:meta-analysis of randomized clinical trials

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Chinese Medical Journal 2022年第4期135卷 409-415页

作者： Xiaojian Ji Lidong Hu Yiwen Wang Siliang Man Xingkang Liu Chuan Song Jiaxin Zhang Jian Zhu Jianglin Zhang Feng Huang Department of Rheumatology and Immunology The First Medical CenterChinese PLA General HospitalBeijing 100853China Xiamen Key Laboratory of Translational Medicine for Nucleic Acid Metabolism and Regulation Xiang’an Hospital of Xiamen UniversityXiamenFujian 361102China

Background:Concerns exist regarding the potential development of tuberculosis in patients with rheumatoid arthritis(RA)treated with biological and targeted *** assessed systematically whether biological therapy increased the risk of tuberculosis in patients with RA by meta-analysis of randomized controlled trials(RCTs).Methods:A systematic literature search was conducted in PubMed,Embase,the Cochrane Library,and China Biology Medicine disc for RCTs evaluating biological therapy in patients with RA from inception through August *** meta-analysis and network meta-analysis were performed to compare the risk of tuberculosis for each biologics class in patients with *** odds ratio(Peto OR)and its 95%confidence interval(CI)were calculated as the primary effect ***:In total,39 studies with 20,354 patients were included in this meta-analysis,and 82 patients developed *** risk of tuberculosis was increased in patients treated with biologics compared with non-biologics(Peto OR:3.86,95%CI:2.36-6.32,P<0.001).Also,tumor necrosis factor-α(TNF-α)inhibitors had a higher probability of developing tuberculosis than placebo(Peto OR:3.98,95%CI:2.30-6.88,P<0.001).However,network meta-analysis demonstrated that there was no significant difference in the risk of tuberculosis for each biologics class in patients with ***,tuberculosis was significantly more common in patients treated with a high dose compared with patients receiving a low dose of tofacitinib(Peto OR:7.39,95%CI:2.00-27.31,P=0.003).Conclusion:This meta-analysis demonstrates the evidence of an elevated risk of tuberculosis in patients with RA treated with TNF-αinhibitors,and a dose-dependent elevated risk of tuberculosis in patients treated with tofacitinib.

关键词： rheumatoid arthritis Biological therapy Tuberculosis Systematic review Meta-analysis Network meta-analysis

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LC-MS/MS method for the quantitation of serum tocilizumab in rheumatoid arthritis patients using rapid tryptic digestion without IgG purification

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Journal of Pharmaceutical Analysis 2022年第6期12卷 852-859页

作者： Takashi Mochizuki Kaito Shibata Takafumi Naito Kumiko Shimoyama Noriyoshi Ogawa Masato Maekawa Junichi Kawakami Department of Hospital Pharmacy Hamamatsu University School of MedicineHamamatsu431-3192Japan Department of Pharmacy Shinshu University HospitalMatsumotoNagano390-8621Japan Third Division Department of Internal MedicineHamamatsu University School of MedicineHamamatsu431-3192Japan Department of Laboratory Medicine Hamamatsu University School of MedicineHamamatsu431-3192Japan

The quantitation of serum tocilizumab using liquid chromatography tandem-mass spectrometry(LC-MS/MS)method has not been widely applied in clinical settings because of its time-consuming and costly sample *** present study aimed to develop a validated LC-MS/MS method for detecting serum tocilizumab by utilizing immobilized trypsin without an immunoglobulin G purification step and evaluate its applicability in the treatment of rheumatoid arthritis(RA)patients administered intravenously or subcutaneously with *** tocilizumab-derived signature peptide was deciphered using a nano-LC system coupled to a hybrid quadrupole-orbitrap mass *** serum tocilizumab was rapidly digested by immobilized trypsin for 30 *** chromatographic peak of the signature peptide and that of the internal standard were separated from the serum digests for a total run time of 15 *** calibration curve of serum tocilizumab concentration was linear with a range of 2-200 μg/*** intra-and inter-day accuracy and relative standard deviation(RSD)were 90.7%-109.4%and<10%,*** serum tocilizumab concentrations in the RA patients receiving intravenous and subcutaneous injections were 5.8-28.9 and 2.4-63.5 μg/mL,*** serum tocilizumab concentrations using the current method positively correlated with those using the enzyme-linked immunosorbent assay,although a systematic error was observed between these *** conclusion,a validated LC-MS/MS method with minimal sample pretreatments for monitoring serum tocilizumab concentrations in RA patients was developed.

关键词： Tocilizumab LC-MS/MS Immobilized trypsin IgG purification Proteomics rheumatoid arthritis

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Efficacy,safety,and cost-effectiveness of triple therapy in preventing relapse in rheumatoid arthritis:A randomized controlled trial(ESCoRT study)

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Chinese Medical Journal 2022年第18期135卷 2200-2209页

作者： Juan Zhao Wei Zhou Yangfeng Wu Xiaoyan Yan Li Yang Zhuoli Zhang Department of Rheumatology and Clinical Immunology Peking University First HospitalBeijing 100034China Peking University Clinical Research Institute(PUCRI) Beijing 100083China Peking University School of Public Health Beijing 100083China

Background:Biological agents,such as tumor necrosis factor inhibitors(TNFi),have been widely used in rheumatoid arthritis(RA)patients and greatly improved goal *** aim of this study was to investigate whether conventional synthetic diseasemodifying anti-rheumatic drugs(csDMARDs)combination was better in reducing relapse than methotrexate(MTX)monotherapy,and more cost-effective than continuing TNFi plus MTX in RA patients who achieved low disease activity(LDA)with TNFi and MTX ***:RA patients who failed to csDMARDs received an induction therapy of MTX plus TNFi for maximally 12 *** achieving LDA in 12 weeks were randomly assigned at a 1:1:1 ratio into three groups:(A)adding hydroxychloroquine and sulfasalazine for the first 12 weeks and then discontinuing TNFi for the following 48 weeks;(B)maintaining TNFi and MTX for 60 weeks;and(C)maintaining TNFi and MTX for the first 12 weeks and then discontinuing TNFi for the following 48 *** primary outcome was ***:A total of 117 patients were enrolled for induction therapy and 67 patients who achieved LDA within 12 weeks were randomized,with 24,21,and 22 patients in groups A,B,and C,*** relapse rates of groups A and B during the entire 60 weeks were comparable[10/22(45.5%)vs.7/20(35.0%),χ^(2)=0.475,P=0.491],however,significantly lower than that of group C[10/22(45.5%)vs.17/20(85.0%),χ^(2)=5.517,P=0.019;7/20(35.0%)vs.17/20(85.0%),χ^(2)=11.035,P=0.004,respectively].Taking RMB 100,000 Yuan as the threshold of willingness to pay,compared to MTX monotherapy(group C),both TNFi maintenance and triple csDMARDs therapies were cost-effective,but triple csDMARDs therapy was ***:For RA patients who have achieved LDA with TNFi and MTX,csDMARDs triple therapy was a cost-effective option in favor of reducing *** registration:***,NCT02320630.

关键词： Conventional synthetic disease-modifying anti-rheumatic drugs Cost-effectiveness Relapse rheumatoid arthritis Tumor necrosis factor inhibitors

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Data Mining Study on Prescription Patterns of Different Dosage Forms of Chinese Herbal Medicines for Treating and Improving Immune-Inflammatory Indices in Patients with rheumatoid arthritis

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Chinese Journal of Integrative Medicine 2022年第3期28卷 215-222页

作者： HUANG Dan LIU Jian XIN Ling XIE Jin-gui ZHU Qiang CHEN Pei-sheng SHEN Zhi-bin MENG Qing-he WANG Hai-yan Department of Rheumatology First Affiliated Hospital of Anhui University of Chinese MedicineHefei(230031)China The School of Management University of Science and Tech no logy of ChinaHefei(230026)China An hui Jiren Pharmaceutical Co. Ltd.BozhouAnhui Provinee(236800)China Department of Acupuncture Huangshan Hospital of Chinese MedicineHuangshanAnhui Province(245000)China Department of Internal Medicine Bozhou Hospital of Chinese MedicineBozhouAnhui Province(236800)China

Objective:To explore the prescription patterns of different dosage forms of Chinese herbal medicines(CHMs)for the treatment of rheumatoid arthritis(RA)and their effects on immune-inflammatory ***:Clinical data were collected from patients with RA in 4 hospitals(3 Class A comprehensive hospitals and 1 Class B comprehensive hospital)in Anhui Province,China,from August 2012 to June 2018 via the electronic medical record gathering *** extraction of prescription information,each prescribed herb was quantified and standardized according to the knowledge base to establish a database of RA treatment *** medical records were divided into the granules group and decoction pieces *** herbs and their combination patterns were obtained from the two groups of cases using Liquorice *** in immune-inflammatory and hepatic and renal function indices were compared between the two groups using SPSS 23.0 *** Aprior module of SPSS Clementine 11.1 software was applied to analyse the correlation between CHMs and improvement in ***,the ORACLE 10 g tool was used to evaluate the random walk model of the immune-inflammatory indices between the two ***:(1)We retrospectively analysed 35,898 prescriptions for 6,829 patients with RA who received CHM *** were 3,816 patients in the granules group and 3,013 in the decoction pieces group.(2)The core herbs were Pi(Spleen)-strengthening and dampness-resolving drugs,blood-activating and stasis-resolving drugs,wind/dampness-dispelling drugs and heatclearing and detoxifying drugs.(3)Both dosage forms could improve immune-inflammatory indices in RA patients,with similar efficacy and no influence on hepatic or renal function.(4)Herba Siegesbeckiae and Oldenlandia had a stronger association with immune-inflammatory indices in the two groups.(5)The immune-inflammatory indices showed obvious improvement after treatment with granules and decoction pieces of CHMs,and

关键词： rheumatoid arthritis Chinese heral medicine granules decoction pieces data mining

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Mechanism of Gentisic Acidon rheumatoid arthritis BasedonmiR-19b-3p/RAF1 Axis

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Chinese Journal of Integrative Medicine 2023年第6期29卷 508-516页

作者： DING Dou ZHANG Qi ZENG Fu-jia CAI Ming-xing GAN Yuan DONG Xiao-jun Department of Traditional Chinese Medicine Zunyi Medical and Pharmaceutical CollegeZunyi(563006)Guizhou ProvinceChina

Objective To investigate the therapeutic effect of gentisic acid(GA)on rheumatoid arthritis(RA)based on the miR-19b-3p/RAF1 *** The cell counting kit-8 method was used to detect the growth inhibitory effect of different concentrations of GA on MH7A cells,and the drug concentration of GA was determined in the *** quantificational real-time polymerase chain reaction(qRT-PCR)was used to detect the expression of miR-19b-3p and ***1,extracellular regulated protein kinases1/2(ERK1/2)and phospho-ERK1/2(p-ERK1/2)were examined by Western *** methods(dual-luciferase assay,qRT-PCR and Western blot analysis)were used to verify miR-19b-3p targeting *** cytometry was performed to detect MH7A cell *** and wound healing assays were used to determine the invasion and migration capacities of MH7A *** The growth of MH7A cells was gradually inhibited with increasing GA *** the GA concentration exceeded 80 mmol/L,GA was significantly cytotoxic to MH7A cells,so the half maximal inhibitory concentration of GA for MH7A cells was calculated as 67.019 mmol/*** upregulated miR-19b-3p expression,downregulated RAF1 expression,inhibited ERK1/2 phosphorylation,induced MH7A cell apoptosis and suppressed MH7A cell invasion and migration(P<0.05 or P<0.01).RAF1 was identified as the target of miR-19b-3p and reversed inhibitory effects on miR-19b-3p expression(P<0.05 or P<0.01).The miR-19b-3p inhibitor upregulated RAF1 expression and ERK1/2 phosphorylation,suppressed MH7A cell apoptosis and induced MH7A cell invasion and migration(P<0.01).Conclusion GA regulated miR-19b-3p/RAF1 axis to mediate ERK pathway and inhibit the development of RA.

关键词： gentisic acid rheumatoid arthritis miR-19b-3p RAF1 MAPK/ERK

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Continuation,reduction,or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control:a multicenter,open-label,randomized controlled trial

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Chinese Medical Journal 2023年第3期136卷 331-340页

作者： Mengyan Wang Yu Xue Fang Du Lili Ma Liang-jing Lu Lindi Jiang Yi-Li Tao Chengde Yang Hui Shi Honglei Liu Xiaobing Cheng Junna Ye Yutong Su Dongbao Zhao Sheng-Ming Dai Jialin Teng Qiongyi Hu Department of Rheumatology and Immunology Ruijin HospitalShanghai Jiao Tong University School of MedicineShanghai 200025China Department of Rheumatology and Immunology Huashan Hospital Affiliated to Fudan UniversityShanghai 200040China Department of Rheumatology Renji HospitalShanghai Jiaotong University School of MedicineShanghai 200127China Department of Rheumatology Zhongshan HospitalFudan UniversityShanghai 200032China Department of Rheumatology and Immunology Shanghai Sixth People’s HospitalShanghai Jiao Tong University School of MedicineShanghai 200233China Department of Rheumatology and Immunology Changhai HospitalNaval Medical UniversityShanghai 200433China

Background:rheumatoid arthritis(RA),a chronic systemic autoimmune disease,is characterized by synovitis and progressive damage to the bone and cartilage of the joints,leading to disability and reduced quality of *** study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease ***:The study was designed as a multicenter,open-label,randomized controlled *** patients who were taking tofacitinib(5 mg twice daily)and had achieved sustained RA remission or low disease activity(disease activity score in 28 joints[DAS28]≤3.2)for at least 3 months were enrolled at six centers in Shanghai,*** were randomly assigned(1:1:1)to one of three treatment groups:continuation of tofacitinib(5 mg twice daily);reduction in tofacitinib dose(5 mg daily);and withdrawal of *** and safety were assessed up to 6 ***:Overall,122 eligible patients were enrolled,with 41 in the continuation group,42 in the dose-reduction group,and 39 in the withdrawal *** 6 months,the percentage of patients with a DAS28-erythrocyte sedimentation rate(ESR)of<3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups(20.5%,64.3%,and 95.1%,respectively;P<0.0001 for both comparisons).The average flare-free time was 5.8 months for the continuation group,4.7 months for the dose reduction group,and 2.4 months for the withdrawal ***:Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy,while standard or reduced doses of tofacitinib maintained a favorable *** Registration:***,ChiCTR2000039799.

关键词： Tofacitinib rheumatoid arthritis Withdrawal Dose reduction

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Ultrasmall iron-quercetin metal natural product nanocomplex with antioxidant and macrophage regulation in rheumatoid arthritis

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Acta Pharmaceutica Sinica B 2023年第4期13卷 1726-1739页

作者： Zhihui Han Xiang Gao Yuanjie Wang Shuning Cheng Xiaoyan Zhong Yong Xu Xiaozhong Zhou Zengli Zhang Zhuang Liu Liang Cheng Institute of Functional Nano&Soft Materials(FUNSOM) Collaborative Innovation Center of Suzhou Nano Science and TechnologySoochow UniversitySuzhou 215123China Department of Orthopedics The Second Affiliated Hospital of Soochow UniversitySuzhou 215004China Department of Environmental Health School of Public HealthSoochow UniversitySuzhou 215123China School of Materials and Energy Guangdong University of TechnologyGuangzhou 510006China

Oxidative stress,due to the disruption of the balance between reactive oxygen species(ROS)generation and the antioxidant defense system,plays an important role in the pathogenesis of rheumatoid arthritis(RA).Excessive ROS leads to the loss of biological molecules and cellular functions,release of many inflammatory mediators,stimulate the polarization of macrophages,and aggravate the inflammatory response,thus promoting osteoclasts and bone ***,foreign antioxidants would effectively treat ***,ultrasmall iron-quercetin natural coordination nanoparticles(Fe-Qur NCNs)with excellent anti-inflammatory and antioxidant properties were constructed to effectively treat ***-Qur NCNs obtained by simple mixing retain the inherent ability to remove ROS of quercetin and have a better water-solubility and *** vitro experiments showed that Fe-Qur NCNs could effectively remove excess ROS,avoid cell apoptosis,and inhibit the polarization of inflammatory macrophages by reducing the activation of the nuclear factor-κ-gene binding(NF-κB)*** vivo experiments showed that the swollen joints of mice with rheumatoid arthritis treated with Fe-Qur NCNs significantly improved,with Fe-Qur NCNs largely reducing inflammatory cell infiltration,increasing antiinflammatory macrophage phenotypes,and thus inhibiting osteoclasts,which led to bone *** study demonstrated that the new metal-natural coordination nanoparticles could be an effective therapeutic agent for the prevention of RA and other diseases associated with oxidative stress.

关键词： Metal-natural coordination nanoparticles ROS scavenge Macrophage polarization rheumatoid arthritis Antioxidant Inflammation Nanomedicine Apoptosis

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Flare and change in disease activity among patients with stable rheumatoid arthritis following coronavirus disease 2019 vaccination: A prospective Chinese cohort study

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中华医学杂志（英文版） 2023年第19期136卷 2324-2329页

作者： Yan Geng Yong Fan Yu Wang Xuerong Deng Lanlan Ji Xiaohui Zhang Zhibo Song Hong Huang Yanni Gui Haoze Zhang Xiaoying Sun Guangtao Li Juan Zhao Zhuoli Zhang China 100034

Background: Vaccination has been shown effective in controlling the global coronavirus disease 2019 (COVID-19) pandemic and reducing severe cases. This study was to assess the flare and change in disease activity after COVID-19 vaccination in patients with stable rheumatoid arthritis (RA). Methods: A prospective cohort of RA patients in remission or with low disease activity was divided into a vaccination group and a non-vaccination group based on their COVID-19 vaccination status. Each of them was examined every 3 to 6 months. In the vaccination group, disease activity was compared before and after vaccination. The rates of flare defined as disease activity scores based on 28-joint count (DAS28) >3.2 with ΔDAS28 ≥0.6 were compared between vaccination and non-vaccination groups. Results: A total of 202 eligible RA patients were enrolled. Of these, 98 patients received no vaccine shot (non-vaccination group), and 104 patients received two doses of vaccine (vaccination group). The median time interval from pre-vaccination visit to the first immunization and from the second dose of vaccine to post-vaccination visit was 67 days and 83 days, respectively. The disease activity scores at pre-vaccination and post-vaccination visits in the vaccination group patients were similar. At enrollment, gender, RA disease course, seropositivity, and disease activity were comparable across the two groups. Flare was observed in five (4.8%) of the vaccination group patients and nine (9.2%) of the non-vaccination group patients at post-vaccination assessment ( P = 0.221). In terms of safety, 29 (27.9%) patients experienced adverse events (AEs) after vaccination. No serious AEs occurred. Conclusions: COVID-19 vaccinations had no significant effect on disease activity or risk of flare in RA patients in remission or with low disease activity. Patients with stable RA should be encouraged to receive the COVID-19 vaccination.

关键词： COVID-19 vaccination rheumatoid arthritis Disease activity Flare Adverse events

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Extracellular sulfatase-2 is overexpressed in rheumatoid arthritis and mediates the TNF-α-induced inflammatory activation of synovial fibroblasts

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Cellular & Molecular Immunology 2022年第10期19卷 1185-1195页

作者： Ruby J.Siegel Anil K.Singh Paul M.Panipinto Farheen S.Shaikh Judy Vinh Sang U.Han H.Mark Kenney Edward M.Schwarz Cynthia S.Crowson Sadik A.Khuder Basil S.Khuder David A.Fox Salahuddin Ahmed Department of Pharmaceutical Sciences Washington State University College of Pharmacy and Pharmaceutical SciencesSpokaneWAUSA Department of Pathology and Laboratory Medicine University of Rochester Medical CenterRochesterNYUSA Center for Musculoskeletal Research University of Rochester Medical CenterRochesterNYUSA Department of Quantitative Health Sciences and Division of Rheumatology Mayo ClinicRochesterMNUSA Department of Medicine and Public Health University of ToledoToledoOHUSA Department of Pathology and Laboratory Medicine Phoenix Children’s HospitalPhoenixAZUSA Department of Medicine Division of Rheumatology and Clinical Autoimmunity Center of ExcellenceUniversity of Michigan Medical SystemAnn ArborMIUSA Division of Rheumatology University of Washington School of MedicineSeattleWAUSA

Extracellular sulfatase-2(Sulf-2)influences receptor-ligand binding and subsequent signaling by chemokines and growth factors,yet Sulf-2 remains unexplored in inflammatory cytokine signaling in the context of rheumatoid arthritis(RA).In the present study,we characterized Sulf-2 expression in RA and investigated its potential role in TNF-α-induced synovial inflammation using primary human RA synovial fibroblasts(RASFs).Sulf-2 expression was significantly higher in serum and synovial tissues from patients with RA and in synovium and serum from hTNFtg *** sequencing analysis of TNF-α-stimulated RASFs showed that Sulf-2 siRNA modulated~2500 genes compared to scrambled *** Pathway Analysis of RNA sequencing data identified Sulf-2 as a primary target in fibroblasts and macrophages in *** blot,ELISA,and qRT‒PCR analyses confirmed that Sulf-2 knockdown reduced the TNF-α-induced expression of ICAM1,VCAM1,CAD11,PDPN,CCL5,CX3CL1,CXCL10,and *** studies identified the protein kinase C-delta(PKCδ)and c-Jun N-terminal kinase(JNK)pathways as key in the TNF-α-mediated induction of proteins related to cellular adhesion and *** of Sulf-2 abrogated TNF-α-induced RASF ***-2 knockdown with siRNA and inhibition by OKN-007 suppressed the TNF-α-induced phosphorylation of PKCδand JNK,thereby suppressing the nuclear translocation and DNA binding activity of the transcription factors AP-1 and NF-κBp65 in human ***,Sulf-2 expression positively correlated with the expression of TNF receptor 1,and coimmunoprecipitation assays demonstrated the binding of these two proteins,suggesting they exhibit crosstalk in TNF-α*** study identified a novel role of Sulf-2 in TNF-αsignaling and the activation of RA synoviocytes,providing the rationale for evaluating the therapeutic targeting of Sulf-2 in preclinical models of RA.

关键词： Sulfatase-2 TNF-α rheumatoid arthritis Synovial fibroblasts Signal transduction

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Biological regulation on synovial fibroblast and the treatment of rheumatoid arthritis by nobiletin-loaded tetrahedral framework nucleic acids cargo tank

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Chinese Chemical Letters 2023年第2期34卷 446-451页

作者： Yuting Wen Mei Zhang Yangxue Yao Yang Gao Xiaolin Zhang Yunfeng Lin Xiaoxiao Cai State Key Laboratory of Oral Diseases National Clinical Research Center for Oral DiseasesWest China Hospital of StomatologySichuan UniversityChengdu 610041China

The hyperplasia and destruction of synovial tissue have an important impact on the development of rheumatoid arthritis(RA), the abnormal proliferation and migration of synovial fibroblast in synovial tissue is similar to tumor cells. Targeting anomalous synovial fibroblast and designing a high bioavailability nano drug delivery system can reduce the dosage for the treatment of rheumatoid arthritis and it is of great significance to reduce toxic and side effects and improve curative effect. In this experiment, the nobiletin-loaded tetrahedral framework nucleic acids cargo tank was established, carrying antiinflammatory small molecule monomer drug nobiletin with minimal bioavailability. Both in vitro cell experiments and in vivo animal studies proved the nano cargo tank enhance the role of nobiletin in reducing the invasiveness of pathological synovial fibroblast and promote their apoptosis, effectively alleviate the disease development of rheumatoid arthritis.

关键词： Tetrahedral framework nucleic acids Nobiletin rheumatoid arthritis Synovial fibroblast Apoptosis

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