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| 1 | Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis:a multi-center parallel-group double-blind randomized controlled trial显示文摘OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group. | Liu Jian Wang Yuan Huang Chuanbing Xu Jianhua Li Zhijun Xu Liang He Liyun Sun Yue Wang Yali Xu Shengqian Zhao Ping Mao Tongjun Tan Bin Zhu Fubing Zhang Pingheng Fang Li | 2015 | Journal of Traditional Chinese Medicine2015，35，5： | 27 |
| 2 | 从脾治痹探讨显示文摘痹证的发生与机体正气的亏虚,以及外界环境有密切关系,而脾虚贯穿其发病过程,是发病关键,从脾治痹贯穿痹证治疗的始终。通过梳理从脾治痹的理论渊源、治法研究、临床研究及实验研究,探讨从脾治痹的优势。 | 黄旦 刘健 万磊 姜辉 孙玥 龙琰 | 2021 | 风湿病与关节炎2021，10，1： | 25 |
| 3 | 基于新安医学理论的中药新风胶囊治疗类风湿关节炎的研究显示文摘在新安医学理论指导下,系统开展了中医痹病理论研究、临床研究和药学研究,提出脾虚致痹理论及从脾治痹治则,创制具有益气健脾、化湿通络的中药复方新风胶囊,系统观察新风胶囊治疗类风湿关节炎的临床疗效,并应用现代科学技术开展新风胶囊药效学、药理学研究,优化新风胶囊制剂工艺,为提高新风胶囊临床疗效及中药制剂的推广应用提供依据。 | 刘健 纵瑞凯 许霞 姜辉 | 2014 | 风湿病与关节炎2014，3，11： | 23 |
| 4 | 类风湿关节炎患者肺功能变化及中药新风胶囊干预研究显示文摘类风湿关节炎(RA)是一种以慢性滑膜炎症为主要特征的自身免疫疾病,关节炎症刺激可导致关节内软骨和骨的破坏,反复迁延多年,最终导致关节畸变及功能丧失[1-2]。然而RA病变并非局限于关节局部,常伴有关节以外的其他脏器病变,甚至可引起主要脏器的血管炎而危及生命[3]。因肺组织含有丰富的结缔组织和血管,因此,RA肺部受累的概率比其他组织增加,且随着RA病程延长,肺受累的概率逐步增高。研究显示[4],约有11%RA患者会继发肺间质纤维化改变,最终出现肺功能的减低。RA中医证候呈现脾虚湿盛、虚实夹杂的特征[5]。既往研究发现[6-9],治疗RA肺功能损伤采用“从脾论治”原则,将具有健脾化湿通络功效的中药复方“新风胶囊”应用于临床,取得了良好的临床效果,并对RA肺功能损伤患者和佐剂关节炎(AA)肺功能下降的大鼠亦有一定疗效。 | 刘健 万磊 黄传兵 汪元 范海霞 郭雯 | 2014 | 中国临床保健杂志2014，17，1： | 15 |
| 5 | 健脾化湿通络法调节类风湿关节炎免疫炎症反应的研究进展显示文摘类风湿关节炎是一种由遗传、环境等多种因素引起的慢性、炎症性自身免疫性疾病,常反复发作,病情缠绵难愈。健脾化湿通络法是刘健以新安医学为理论基础,结合多年临床经验,提出的一种治痹大法,应用于临床,疗效显著。健脾化湿通络法能通过调节T、B细胞,细胞因子网络平衡,以及胸腺、脾脏免疫来调控类风湿关节炎免疫,抑制炎症反应,减轻类风湿关节炎的临床症状及系统病变,提高生活质量。 | 文建庭 刘健 孙艳秋 张颖 龙琰 | 2020 | 风湿病与关节炎2020，9，1： | 14 |
| 6 | 基于PI3K/AKT/mTOR通路、HIF-1α、ES观察新风胶囊对佐剂关节炎大鼠滑膜血管新生的影响显示文摘目的:观察新风胶囊(XFC)对佐剂关节炎(AA)大鼠滑膜PI3K/AKT/mTOR通路的影响。方法:将大鼠随机分成正常对照组、模型对照组、甲氨蝶呤组、雷公藤多苷组、XFC组。采用免疫组化法检测滑膜微血管密度(MVD)表达,酶联免疫吸附法检测白介素(IL)-6、IL-10、HIF-1α、VEGF-A表达,免疫印迹法检测PI3K、AKT1、p-AKT1、mTOR、ES蛋白在滑膜血管中表达。结果:模型对照组滑膜组织MVD计数升高,血清IL-6、VEGF、HIF-1α和滑膜PI3K、AKT1、p-AKT1、mTOR、ES表达显著升高,血清IL-10表达量降低;治疗后,XFC组MVD呈高计数量,HIF-1α、IL-6、VEGF-A表达降低,滑膜PI3K、p-AKT1、mTOR、ES蛋白表达降低,血清IL-10升高。结论:XFC通过调节PI3K/AKT/mTOR信号通路、HIF-1α、ES表达改善AA滑膜血管新生。 | 张晓军 刘健 万磊 黄传兵 | 2017 | 中国免疫学杂志2017，33，4： | 13 |
| 7 | Effects of Xinfeng Capsule(新风胶囊) on the Expression of Platelet Derived Growth Factor in Synovium of Adjuvant Arthritis Rats显示文摘Objective:To observe the effects of Xinfeng Capsule(新风胶囊,XFC)on platelet parameters in peripheral blood and expression of platelet derived growth factor(PDGF)in synovium of adjuvant arthritis(AA)rats.Methods:A total of 40 male Sprague-Dawley(SD)rats were randomized into 5 groups:normal control(NC),AA model control(MC),methotrexate(MTX)treatment,Tripterygium wilfordii polycoride tablet(TPT)treatment,and XFC treatment.Excluding the NC group,the AA model was induced by intracutaneous injection of 0.1 mL Freund's complete adjuvant in the right hind limb.Induction of AA and the effects of drug treatments were assessed by voix pedis swelling,arthritis index(Al),body mass,and the pathological changes of joints and cartilage with a light microscopy.Platelet parameters in peripheral blood were detected with an automated hematology analyzer.PDGF in synovium was detected with immunohistochemical methods and PDGF mRNA expression in synovium was detected with reverse transcription polymerase chain reaction.Results:Compared with the NC group,the MC group had significantly increased voix pedis swelling,Al,platelet(PLT)and plateletcrit(PCT)in peripheral blood and PDGF as well as PDGF mRNA in synovium(all P<0.01)and the joint cartilage was also highly degenerated.Compared with the MC group,the 3 treated groups had significantly decreased voix pedis swelling,Al,PLT,PCT,PDGF,and PDGF mRNA(P<0.01).The body mass in the XFC group was significantly higher than those in MTX and TPT groups(P<0.05).The levels of PLT,PCT,PDGF,and PDGF mRNA in the XFC group showed a decreasing tendency with no significant difference compared with the MTX and TPT groups(P>0.05).PDGF and PDGF mRNA of AA rats were positively correlated with voix pedis swelling,Al,PLT,and PCT(P<0.05 or P<0.01).Conclusions:The expression and biosynthesis of PDGF increase in the synovium of AA rats and correlate with voix pedis swelling,Al,PLT,and PCT.XFC can decrease the levels of PDGF,PDGF mRNA,PLT,and PCT,thereby mitigating inflammation induced by platelet activation and reducing voix pedis swelling and the Al in AA rats. | 纵瑞凯 刘健 | 2014 | Chinese Journal of Integrative Medicine2014，20，9： | 12 |
| 8 | 雷公藤甲素对佐剂关节炎肺功能降低大鼠Notch通路受体和配体基因表达的影响显示文摘目的观察雷公藤甲素(TPT)对佐剂关节炎(AA)大鼠Notch受体、配体表达的影响。方法将40只大鼠随机分为正常对照(NC)组、模型(MC)组、甲氨喋呤(MTX)组、TPT组,每组10只,分别向除NC组外的其余动物右后足跖皮内注射弗氏完全佐剂0.1 m L致炎,复制AA大鼠模型,致炎后第12填开始给药。NC组及MC组均给予生理盐水,其余组分别给予MTX、TPT。给药30 d后,检测各组足趾肿胀度(E)、关节炎指数(AI)、肺功能、Notch受体/配体的变化。结果 MC组大鼠E、AI、Notch3、Notch4、Delta1表达明显升高;肺功能参数、Notch1、Jagged1、Jagged2表达降低(P<0.01);与MC组比较,TPT组肺功能参数、Notch1、Jagged1、Jagged2的表达升高,E、AI及Notch3、Notch4、Delta1表达降低,疗效优于对照组MTX(P<0.05,P<0.01)。结论 TPT可能是通过上调Delta1、Notch3、Notch4的表达、下调Jagged1、Jagged2、Notch1表达,降低炎症反应和免疫复合物沉积,改善AA关节和肺部症状。 | 万磊 刘健 黄传兵 谌曦 汪元 张皖东 刘磊 程园园 冯云霞 | 2015 | 南方医科大学学报2015，35，10： | 11 |
| 9 | Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial显示文摘BACKGROUND:Rheumatoid arthritis(RA),as a common systemic inflammatory autoimmune disease,affects approximately 1 in 100 individuals.Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA.Xinfeng Capsule,a patent Chinese herbal medicine,has been used in the treatment of RA in recent years.Despite its reported clinical efficacy,there are no large-sample,multicenter,randomized trials that support the use of Xinfeng Capsule for RA.Therefore,we designed a randomized,double-blind,multicenter,placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA.METHODS AND DESIGN:This is a 12-week,randomized,placebo-controlled,double-blind,multicenter trial on the treatment of RA.The participants will be randomly assigned to the experimental group and the control group at a ratio of 1:1.Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo(imitation leflunomide).The control group will receive leflunomide and an herbal placebo(imitation Xinfeng Capsule).The American College of Rheumatology(ACR)Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule.The primary outcome measure will be the percentage of study participants who achieve an ACR 20%response rate(ACR20),which will be measured every 4 weeks after randomization.Secondary outcomes will include the ACR50 and ACR70 responses,the side effects of the medications,the Disease Activity Score 28,RA biomarkers,quality of life,and X-rays of the hands and wrists.The first four of the secondary outcomes will be measured every4 weeks and the others will be measured at baseline and after 12 weeks of treatment.DISCUSSION:The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA.TRIAL REGISTRATION:This trial has been registered in ClinicalTrials.gov.The identifier is NCT01774877. | Jian Liu Chuan-bing Huang Yuan Wang Gui-qin Xu Yuan-yuan Cheng Yun-xia Feng Lei Liu Ya-jun Qi | 2013 | Journal of Integrative Medicine2013，11，6： | 8 |
| 10 | Effect of Xinfeng capsule on nuclear factor kappa B/tumor necrosis factor alpha and transforming growth factor beta 1/Smads pathways in rats with cardiac injuries induced by adjuvant arthritis显示文摘OBJECTIVE: To investigate effects of Xinfeng capsule(XFC) on cardiac function in rats with adjuvant arthritis(AA) and explore the mechanism of these effects.METHODS: Forty-eight rats were randomly divided into normal control(NC), model control(MC), methotrexate(MTX) and XFC groups of equal size. In all groups except for the NC group, 0.1 m L Freund's complete adjuvant(FCA) was intracutaneously injected in the right rear vola pedis to induce inflammation. Drugs were applied beginning 19 days after induction of inflammation. Normal saline was administered to the NC and MC groups and 1 mg/100 g MTX(weekly) and 0.12 g/100 g XFC(daily) to the MTX and XFC groups, respectively. Rats were sacrificed after 30 day of treatment. Toe swelling degree(TSD), arthritis index(AI), cardiac function and expression of nuclear factor kappa B(NF-κB) / tumor necrosis factor alpha(TNF-α) and transforming growth factor beta 1(TGF-β1)/Smads pathway proteins were measured.RESULTS: In the MC group, TSD and AI were greatly increased, while parameters of cardiac function were decreased and morphological analysis showed myocardial cell damage. Expression of TNF-α, NF-κB, Smad2, P-Smad2, Smad4 and TGF-β1 proteins were elevated in cardiac tissue, while Smad7 expression was decreased.TSD and AI values closely correlated to parameters of cardiac function and to levels of proteins in the NF-κB/TNF-α and TGF-β1/Smads pathways. Certain correlations were identified among TGF-β1 and NF-κB, Smad2, P-Smad2 and Smad4.With XFC intervention, both TSD and AI were decreased and parameters of cardiac function and ultrastructure of myocardial cells improved.Expressions of NF-κB, Smad2, and Smad4 proteins were greatly decreased and Smad7 expression was elevated, as compared with levels in the MC and MTX groups.CONCLUSION: XFC regulates expression of proteins in the NF-κB/TNF-α and TGF-β1/Smads pathways, decreases immune complex deposition in cardiac tissue and improves cardiac function in AA rats via upregulation of Smad7. | Huang Chuanbing Wan Lei Liu Jian | 2016 | Journal of Traditional Chinese Medicine2016，36，1： | 7 |
| 11 | 类风湿关节炎肺功能变化及中药新风胶囊干预的研究述评显示文摘类风湿关节炎除关节和骨破坏外,常出现肺间质纤维化改变,临床表现为肺功能降低。而类风湿关节炎肺功能降低与'脾气亏虚'密切相关,中医证候呈现'脾虚湿盛、虚实夹杂'的特征。拟用健脾化湿通络法治疗类风湿关节炎肺功能损伤,并采用具有健脾化湿、通络止痛的中药复方新风胶囊应用于临床和动物实验研究中,取得了良好疗效。 | 刘健 万磊 黄传兵 汪元 范海霞 郭雯 | 2014 | 风湿病与关节炎2014，3，1： | 6 |
| 12 | Effect of Xinfeng capsule on pulmonary function in a adjuvant arthritis rat model显示文摘OBjECTIVE:To observe the relationship between reduced pulmonary function and regulatory T cells(Tregs)and helper T cells(Th)1/Th2 drift in a rat model of adjuvant arthritis(AA),and to study the impact of Xinfeng capsule(XFC)on pulmonary function and investigate the mechanism of action.METHODS:Forty rats were randomly divided into normal control group(NC),model control group(MC),Tripterygium glycosides tablet group(TPT),and XFC group,with 10 in each.Except for the NCgroup,AA was induced in all rats by intracutaneous injection of 0.1 mL Freund's complete adjuvant in the right paw.On the 19th day after modeling,the NC and MC groups were given physiological saline(0.9%),while the TPT and XFC groups were given TPT(10 mg/kg)and XFC(2.4 g/kg),once daily,respectively.Thirty days after administration,changes in paw swelling,arthritis index(AI),pulmonary function,levels of serumγ-interferon(IFN-γ)and interleukin(IL)-4,Tregs in peripheral blood,and IFN-γ,IL-4,Forkhead box transcription factor 3(FoxP3)in lung tissue were observed by enzyme-linked immunosorbent assay,flow cytometry,polymerase chain reaction,and western blot.RESULTS:Compared with the NC group,paw swelling,AI,IFN-γ,and Th1/Th2 were increased,and pulmonary function parameters,IL-4,FoxP3 were decreased significantly in the MC group(P<0.05 or P<0.01).Pulmonary function parameters,Treg,IL-4,FoxP3(and mRNA)were higher,and paw swelling,AI,and IFN-γ(and mRNA)were lower in the XFC group than those in the MC group.The XFC group was also much better than theTPT group in improving pulmonary function,FoxP3 mRNA,IFN-γ,IL-4,Th1/Th2,and IL-10(P<0.05 or P<0.01).CONCLUSION:Xinfeng capsule can improve pulmonary function by regulating the levels of Tregs,inhibiting the activation of Th1 to Th2 cells,inducing drift,maintaining cell immune suppression,correcting the imbalance of Th1/Th2,and reducing inflammatory mediators. | Lei Wan Jian Liu Chuanbing Huang Yuan Wang Li Zheng | 2014 | Journal of Traditional Chinese Medicine2014，34，1： | 5 |
| 13 | 佐剂性关节炎大鼠心肺功能损伤与NF-κBp65/TNF-α、TGF-β1/Smads信号通路激活的相关性研究显示文摘目的研究佐剂关节炎(AA)大鼠心肺功能变化与NF-κBp65/TNF-α、TGF-β1/Smad通路的关系。方法将30只大鼠随机均分为正常对照(NC)组和模型对照(MC)组,向MC组大鼠右后足跖皮内注射弗氏完全佐剂0.1 ml致炎,复制成AA模型。致炎19 d后,观察大鼠足跖肿胀度、关节炎指数(AI),采用超声诊断仪检测大鼠心功能、小动物肺功能仪检测肺功能变化,免疫印迹法检测大鼠心肺NF-κBp65、TNF-α、TGF-β1、Smad2、Smad4、Smad7蛋白表达。结果与正常组比较,AA大鼠足趾肿胀,AI升高,心肺功能参数降低,心肺组织NF-κBp65、TNF-α、TGF-β1、Smad2、Smad4蛋白表达升高,Smad7降低(P<0.01或P<0.05);相关性分析显示,AA大鼠心肺功能参数与NF-κBp65/TNF-α、TGF-β1/Smad通路存在关联。结论 AA大鼠心肺功能损伤可能与NF-κBp65/TNF-α、TGF-β1/Smad通路过度激活有关。 | 黄传兵 万磊 刘健 纵瑞凯 曹云祥 朱艳 | 2014 | 免疫学杂志2014，30，5： | 4 |
| 14 | 佐剂性关节炎大鼠心肺功能损伤与TGF-β1/Smad2、4、7通路的关系显示文摘目的研究佐剂性关节炎(AA)大鼠心肺功能变化与转化生长因子β1(TGF-β1)/Smad2、4、7通路的关系。方法将30只大鼠随机均分为正常对照组和模型组,向模型组大鼠右后足跖皮内注射弗氏完全佐剂0.1 ml致炎,复制成AA模型。致炎19 d后,观察大鼠足跖肿胀度、关节炎指数(AI),采用超声诊断仪检测大鼠心功能、小动物肺功能仪检测肺功能变化,免疫印迹法检测大鼠心肺TGF-β1、Smad2、Smad4、Smad7蛋白表达。结果与正常对照组比较,模型组大鼠足趾肿胀度、AI升高,心肺功能降低,心肺组织TGF-β1、Smad2、Smad4蛋白表达升高,Smad7降低(P<0.01,P<0.05);相关性分析显示,足趾肿胀度与75%肺活量的最大呼气流量(FEF75)呈负相关,AI与左房舒张末期内径(LA)呈正相关,与用力最大呼气流量(MFEF)呈负相关,TGF-β1与左心室短轴缩短率(FS)、50%肺活量的最大呼气流量(FEF50)呈负相关,Smad2与左室舒张末期内径(LV)呈正相关,Smad4与舒张早期峰值流速(E峰)、FEF75呈负相关,Smad7与FEF75、MFEF呈正相关(P<0.01,P<0.05)。结论AA大鼠心肺功能损伤可能与TGF-β1/Smad2、4、7信号通路过度激活有关。 | 黄传兵 万磊 刘健 李明 纵瑞凯 曹云祥 朱艳 | 2014 | 安徽医科大学学报2014，49，7： | 2 |
| 15 | 健脾化湿通络方对佐剂关节炎大鼠滑膜血管新生的影响显示文摘目的观察健脾化湿通络方对佐剂关节炎大鼠滑膜血管PI3K/AKT/m TOR信号通路及缺氧诱导因子(HIF-1α)、血管内皮细胞生长因子A(VEGF-A)、滑膜微血管密度(MVD)、内皮抑素(ES)的影响。方法 50只大鼠随机均分成5组:正常对照组,模型对照组,甲氨蝶呤组,雷公藤多苷片组,健脾化湿通络方组。除正常对照组外,其余各组均采用弗氏完全佐剂建立佐剂关节炎大鼠模型。造模成功后,各治疗组给予相应药物灌胃,连续30 d。采用免疫组化法检测滑膜血管MVD表达,酶联免疫吸附法检测血清白细胞介素-6(IL-6)、IL-10、HIF-1α、VEGF-A表达,免疫印迹法检测滑膜血管PI3K、AKT、p-AKT、m TOR、ES蛋白表达。结果与正常对照组比较,模型对照组大鼠足跖肿胀度、关节炎指数升高,滑膜组织MVD计数升高,血清IL-6、VEGF、HIF-1α和滑膜血管PI3K、AKT、p-AKT、m TOR、ES表达显著升高,IL-10降低(P<0.05或P<0.01)。与模型对照组比较,健脾化湿通络方组MVD计数和血清VEGF-A、HIF-1α、IL-6表达降低,滑膜PI3K、p-AKT、m TOR、ES降低,血清IL-10升高。结论健脾化湿通络方通过调节PI3K/AKT/m TOR通路、HIF-1α及ES表达改善滑膜血管新生。 | 张晓军 刘健 万磊 黄传兵 | 2016 | 北京中医药大学学报2016，39，11： | 0 |
| 16 | 亚低温治疗在心肺脑复苏中的应用及护理进展显示文摘亚低温治疗在心肺脑复苏中已被临床上广泛应用,本文重点探讨亚低温治疗的作用机制及护理措施,并进行文献复习,以期对临床有指导意义。 | 刘瑞华 | 2015 | 中外女性健康研究2015，0，17： | 0 |
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