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Real-world efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis 被引量:4
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作者 Kentaro Kojima Kenji Watanabe +9 位作者 Mikio Kawai Soichi Yagi Koji Kaku Maiko Ikenouchi Toshiyuki Sato Koji Kamikozuru Yoko Yokoyama Tetsuya Takagawa Masahito Shimizu Shinichiro Shinzaki 《World Journal of Gastroenterology》 SCIE CAS 2024年第13期1871-1886,共16页
BACKGROUND Real-world data on tofacitinib(TOF)covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis(UC)are scarce.AIM To investigate the long-term efficacy and safety ... BACKGROUND Real-world data on tofacitinib(TOF)covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis(UC)are scarce.AIM To investigate the long-term efficacy and safety of TOF treatment for UC,including clinical issues.METHODS We performed a retrospective single-center observational analysis of 111 UC patients administered TOF at Hyogo Medical University as a tertiary inflammatory bowel disease center.All consecutive UC patients who received TOF between May 2018 and February 2020 were enrolled.Patients were followed up until August 2020.The primary outcome was the clinical response rate at week 8.Secondary outcomes included clinical remission at week 8,cumulative persistence rate of TOF administration,colectomy-free survival,relapse after tapering of TOF and predictors of clinical response at week 8 and week 48.RESULTS The clinical response and remission rates were 66.3%and 50.5%at week 8,and 47.1%and 43.5%at week 48,respectively.The overall cumulative clinical remission rate was 61.7%at week 48 and history of anti-tumor necrosis factor-alpha(TNF-α)agents use had no influence(P=0.25).The cumulative TOF persistence rate at week 48 was significantly lower in patients without clinical remission than in those with remission at week 8(30.9%vs 88.1%;P<0.001).Baseline partial Mayo Score was significantly lower in responders vs non-responders at week 8(odds ratio:0.61,95%confidence interval:0.45-0.82,P=0.001).Relapse occurred in 45.7%of patients after TOF tapering,and 85.7%of patients responded within 4 wk after re-increase.All 6 patients with herpes zoster(HZ)developed the infection after achieving remission by TOF.CONCLUSION TOF was more effective in UC patients with mild activity at baseline and its efficacy was not affected by previous treatment with anti-TNF-αagents.Most relapsed patients responded again after re-increase of TOF and nearly half relapsed after tapering off TOF.Special attention is needed for tapering and HZ. 展开更多
关键词 Ulcerative colitis tofacitinib Janus kinase inhibitor Real-world BIOLOGICS
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Tofacitinib for ulcerative colitis: A promising treatment option
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作者 Zong-Qiang Han Li-Na Wen 《World Journal of Gastroenterology》 SCIE CAS 2024年第40期4386-4392,共7页
A single center retrospective clinical study revealed the efficacy and safety of tofa-citinib in the treatment of ulcerative colitis(UC).This study has clinical reference value but also has some limitations.Previous s... A single center retrospective clinical study revealed the efficacy and safety of tofa-citinib in the treatment of ulcerative colitis(UC).This study has clinical reference value but also has some limitations.Previous studies,including this clinical trial,have shown that tofacitinib could be a promising treatment option for UC,but further clinical research is required to prove this point. 展开更多
关键词 tofacitinib Ulcerative colitis EFFICACY SAFETY Clinical trials
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Real-world clinical efficacy of tofacitinib in moderate-to-severe ulcerative colitis
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作者 Sara R Lopes Claudio Martins +1 位作者 Madalena Teixeira David Tomás 《World Journal of Gastroenterology》 SCIE CAS 2024年第34期3929-3931,共3页
Tofacitinib is an oral small-molecule Janus kinase(JAK)inhibitor that preferentially inhibits JAK1 and JAK3.Its efficacy in inducing and maintaining remission in ulcerative colitis(UC)as well as its safety profile has... Tofacitinib is an oral small-molecule Janus kinase(JAK)inhibitor that preferentially inhibits JAK1 and JAK3.Its efficacy in inducing and maintaining remission in ulcerative colitis(UC)as well as its safety profile has been demonstrated in multicenter,randomized,double-blind,placebo-controlled trials.Additionally,real-world studies evaluating the effectiveness and adverse effects of tofacitinib have been conducted,affirming its clinical efficacy in moderate-to-severe UC. 展开更多
关键词 Ulcerative colitis tofacitinib Real-world studies Inflammatory bowel disease Janus kinase inhibitor
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Janus激酶抑制药tofacitinib 被引量:1
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作者 崔刘福 白秋江 +1 位作者 李岩峰 赵军 《药物流行病学杂志》 CAS 2013年第11期624-626,共3页
Janus激酶活化的信号传导及转录激活因子(Janus-activatedkinaseSingaltransducersandactiva—torsoftranscription,JAK—STAT)是近年来新发现的一条与细胞因子密切相关的细胞内信号传导通路,参与细胞的增殖、分化、凋亡以及免疫调... Janus激酶活化的信号传导及转录激活因子(Janus-activatedkinaseSingaltransducersandactiva—torsoftranscription,JAK—STAT)是近年来新发现的一条与细胞因子密切相关的细胞内信号传导通路,参与细胞的增殖、分化、凋亡以及免疫调节等许多重要的生物学过程。Janus激酶是一种非受体型酪氨酸蛋白激酶。有4个家族成员,分别是JAKl、JAK2、TYK2和JAK3。前3者广泛存在于各种组织和细胞中,而JAK3仅存在于骨髓和淋巴系统。 展开更多
关键词 tofacitinib JANUS激酶 类风湿性关节炎 药理学 药动学 临床试验 药品不良反应
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Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis 被引量:1
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作者 Lisa M Lundquist Sabrina W Cole Martha L Sikes 《World Journal of Orthopedics》 2014年第4期504-511,共8页
Tofacitinib is the first in a new class of nonbiologic disease-modifying antirheumatic drugs(DMARDs), a targeted, synthetic DMARD, approved for the treatment of rheumatoid arthritis(RA) as monotherapy or in combinatio... Tofacitinib is the first in a new class of nonbiologic disease-modifying antirheumatic drugs(DMARDs), a targeted, synthetic DMARD, approved for the treatment of rheumatoid arthritis(RA) as monotherapy or in combination with methotrexate or other non-biologic DMARD. Tofacitinib, an orally administered Janus kinase(JAK) inhibitor, decreases T-cell activation, pro-inflammatory cytokine production, and cytokine signaling by inhibiting binding of type Ⅰcytokine receptors family and γ-chain cytokines to paired JAK1/JAK3 receptors. The net effect of tofacitinb's mechanism of action is decreased synovial inflammation and structural joint damage in RA patients. To date, six phase 3 trials have been conducted to evaluate the safety and efficacy of tofacitinib under the oral rheumatoid arthritis triaL s(ORAL) series. This review describes the pharmacology of the novel agent, tofacitinib, and details the safety and efficacy data of the ORAL trials. 展开更多
关键词 tofacitinib RHEUMATOID ARTHRITIS JANUS KINASE INHIBITOR
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Recurrent herpes zoster in a rheumatoid arthritis patient treated with tofacitinib: A case report and review of the literature 被引量:1
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作者 Qing-Xia Lin Hui-Juan Meng +1 位作者 Yun-Yan Pang Yan Qu 《World Journal of Clinical Cases》 SCIE 2022年第24期8703-8708,共6页
BACKGROUND Tofacitinib is an oral Janus kinase(JAK)inhibitor that is currently approved by the United States Food and Drug Administration for the treatment of rheumatoid arthritis(RA).Varicella zoster virus reactivati... BACKGROUND Tofacitinib is an oral Janus kinase(JAK)inhibitor that is currently approved by the United States Food and Drug Administration for the treatment of rheumatoid arthritis(RA).Varicella zoster virus reactivation leading to herpes zoster(HZ)is an adverse effect of this drug;however,recurrent HZ at the same site is a rare clinical condition.CASE SUMMARY A 70-year-old female RA patient had undergone 1-year of tofacitinib treatment(10 mg daily).About 1 mo after initiation of oral tofacitinib,she developed blisters on the left flank and abdomen and was diagnosed with HZ;antiviral therapy with acyclovir was resolutory.However,5 d prior to presentation at our hospital,erythema and blisters with severe pain recurred at the same site.Small clustered blisters and bullous were visible on the left lumbar abdomen and perineum,with a pain score of 8(visual analogue scale).Antiviral,nutritional supplement,analgesic and other treatments led to healing but over an atypically long period(approximately 26 d,vs approximately 1 wk).HZ is a common and serious adverse reaction of JAK inhibitors,but it rarely recurs.Our patient’s experience of HZ recurrence at the same site,with a wider affected area,more severe pain and longer healing period,is inconsistent with previous reports.CONCLUSION Same-anatomical site HZ recurrence may occur during oral tofacitinib treatment,with more severe clinical manifestations than in the initial occurrence. 展开更多
关键词 tofacitinib Herpes zoster Varicella zoster virus Recurrent infection Case report
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Refractory case of ulcerative colitis with idiopathic thrombocytopenic purpura successfully treated by Janus kinase inhibitor tofacitinib:A case report 被引量:1
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作者 Yoriaki Komeda Toshiharu Sakurai +7 位作者 Arito Hashimoto Tomoyuki Nagai Satoru Hagiwara Masatoshi Kudo Kazuko Sakai Kazuto Nishio Yasuyoshi Morita Itaru Matsumura 《World Journal of Clinical Cases》 SCIE 2020年第24期6389-6395,共7页
BACKGROUND Concomitant ulcerative colitis (UC) and idiopathic thrombocytopenic purpura(ITP) is a rare phenomenon. The management of UC with ITP can be challenging,since a decreased platelet count augments UC.CASE SUMM... BACKGROUND Concomitant ulcerative colitis (UC) and idiopathic thrombocytopenic purpura(ITP) is a rare phenomenon. The management of UC with ITP can be challenging,since a decreased platelet count augments UC.CASE SUMMARY A 24-year-old man with UC and steroid-resistant ITP experienced UC flare.Although continuous infusion of cyclosporine was initiated, UC did not improve.The administration of tofacitinib subsequently led to the induction of remission.The patient has maintained remission of UC and ITP for over one year ontofacitinib treatment. Whole transcriptomic sequencing was performed forinflamed rectal mucosae obtained before and after the initiation of Janus kinase(JAK) inhibitor, suggesting that distinct molecular signatures seemed to beregulated by JAK inhibitors and other conventional therapies including tumornecrosis factor lockers.CONCLUSION Tofacitinib should be considered in refractory cases of UC with ITP. 展开更多
关键词 Ulcerative colitis Idiopathic thrombocytopenic purpura tofacitinib Whole transcriptome analysis Case report Predictive biomarker
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Immediate-release tofacitinib reduces insulin resistance in nondiabetic active rheumatoid arthritis patients:A single-center retrospective study 被引量:1
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作者 Chrong-Reen Wang Hung-Wen Tsai 《World Journal of Diabetes》 SCIE 2022年第6期454-465,共12页
BACKGROUND An increased risk of insulin resistance(IR)has been identified in rheumatoid arthritis(RA),a chronic inflammatory disorder with elevated levels of pathogenic cytokines.Biologics targeting proinflammatory cy... BACKGROUND An increased risk of insulin resistance(IR)has been identified in rheumatoid arthritis(RA),a chronic inflammatory disorder with elevated levels of pathogenic cytokines.Biologics targeting proinflammatory cytokines can control the disease and improve insulin sensitivity in RA.Although Janus kinase(JAK)signaling can regulate cytokine receptors and participate in RA pathogenesis,it remains to be elucidated whether there is a reduction of IR in such patients under JAK inhibitor(JAKi)therapy.AIM To study the effect of JAKi treatment on the reduction of IR in RA patients with active disease.METHODS A retrospective study was carried out from April 1,2017 to March 31,2021 in a population of non-diabetic patients with active RA who were undergoing tofacitinib(TOF)therapy with 5 mg twice-daily immediate-release formulation.RESULTS Fifty-six RA patients,aged 30 years to 75 years(mean±SD:52.3±11.1)with disease activity score 28 values ranging from 4.54 to 7.37(5.82±0.74),were classified into high-IR(>2.0)and low-IR(≤2.0)groups based on their baseline homeostatic model assessment(HOMA)-IR levels.They had no previous exposure to JAKi,and received TOF therapy for no less than 6 mo.In 30 patients who were naïve to biologics,after a 24-week therapeutic period,the high-IR group showed reduced HOMA-IR levels (3.331 ± 1.036 vs 2.292 ± 0.707, P < 0.001). In another 26patients who were exposed to tumor necrosis factor-α or interleukin-6 blockers, the high-IR group,despite having achieved a decrease but with lower magnitude than in naïve patients, showedreduced HOMA-IR levels (2.924 ± 0.790 vs 2.545 ± 1.080, P = 0.018).CONCLUSIONIn this retrospective study, reduced IR was achieved in non-diabetic active RA patients following24 wk of TOF therapy. 展开更多
关键词 Insulin resistance Rheumatoid arthritis Diabetes mellitus tofacitinib Janus kinase inhibitor
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Tofacitinib for the treatment of ulcerative colitis: A review of the literature
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作者 Jessica Rosenberg Joshua M Steinberg Mark C Mattar 《World Journal of Meta-Analysis》 2019年第8期373-379,共7页
Ulcerative colitis (UC) is a chronic immune-mediated inflammatory condition affecting the colon. Recently, tofacitinib, an oral small molecule that is an inhibitor of the Janus kinase signal transduction pathway, was ... Ulcerative colitis (UC) is a chronic immune-mediated inflammatory condition affecting the colon. Recently, tofacitinib, an oral small molecule that is an inhibitor of the Janus kinase signal transduction pathway, was proven efficacious for inducing and maintaining remission in adult patients with moderate to severe UC in three global Phase III studies. The purpose of this review is to summarize existing data on the efficacy, safety, and quality of life issues related to use tofacitinib as well as highlight recent real-world experience with this drug among patients with UC. 展开更多
关键词 ULCERATIVE COLITIS tofacitinib Review INFLAMMATORY BOWEL disease TREATMENT
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Precautions before starting tofacitinib in persons with rheumatoid arthritis
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作者 Raktim Swarnakar Shiv Lal Yadav 《World Journal of Clinical Cases》 SCIE 2022年第36期13467-13469,共3页
Tofacitinib is an immunosuppressive and disease-modifying therapy in rheumatoid arthritis.It may result in many infections flaring up.It is important to take precautions of all kinds(cardiovascular,malignancy,infectio... Tofacitinib is an immunosuppressive and disease-modifying therapy in rheumatoid arthritis.It may result in many infections flaring up.It is important to take precautions of all kinds(cardiovascular,malignancy,infections etc.)before starting tofacitinib.In this article,we have highlighted important steps where we need to take precautions before starting tofacitinib. 展开更多
关键词 tofacitinib Rheumatoid arthritis DMARDS Disease-modifying PRECAUTION SIDE-EFFECTS
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Glucocorticoids combined with tofacitinib in the treatment of Castleman’s disease:A case report
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作者 Xiao-Rui Liu Mei Tian 《World Journal of Clinical Cases》 SCIE 2022年第29期10794-10802,共9页
BACKGROUND Castleman’s disease(CD),also known as vascular follicular lymphadenopathy is a rare proliferative disease of lymphoid tissue of unknown etiology that is clinically classified as unicentric CD(UCD) or multi... BACKGROUND Castleman’s disease(CD),also known as vascular follicular lymphadenopathy is a rare proliferative disease of lymphoid tissue of unknown etiology that is clinically classified as unicentric CD(UCD) or multicentric CD(MCD) depending on lymph node involvement.At present,idiopathic MCD(iMCD) is treated with interleukin-6 inhibitors,but some patients have poor clinical outcomes.This paper reports on a case of iMCD that achieved a good therapeutic effect after treatment with glucocorticoids combined with tofacitinib.The relevant data are summarized and reported below.CASE SUMMARY This paper reports on a case of MCD in a 49-year-old female with persistent peritoneal effusion as the first manifestation and combined with multiple lymphadenopathies.Lymph node biopsy showed Castleman’s disease-like changes.The ascites subsided after treatment with glucocorticoids and tofacitinib,indicating that the treatment was effective.CONCLUSION The combination of glucocorticoids with tofacitinib is an effective regimen for the treatment of CD. 展开更多
关键词 Castleman’s disease Multicentric Castleman’s disease Idiopathic multicentric Castleman’s disease Abdominal dropsy tofacitinib GLUCOCORTICOIDS Case report
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Inflammation responsive tofacitinib loaded albumin nanomedicine for targeted synergistic therapy in ulcerative colitis 被引量:1
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作者 Bang Li Xiaoyan Liu +7 位作者 Qi Long Xiaoduan Zhuang Yanfei Gao Barkat Ali Haoting Chen Dongyang Zhang Xinying Wang Weisheng Guo 《Nano Research》 SCIE EI CSCD 2023年第7期9873-9884,共12页
Patients with ulcerative colitis(UC)often loss responses over long term usage of conventional therapies.Tofacitinib,a pan-Janus kinases(JAK)inhibitor is approved for moderate to severe UC treatment,while dose-limiting... Patients with ulcerative colitis(UC)often loss responses over long term usage of conventional therapies.Tofacitinib,a pan-Janus kinases(JAK)inhibitor is approved for moderate to severe UC treatment,while dose-limiting systemic side effects including infections,cancers and lymphoma limit its popularity of clinical application.This study sought to construct an anti-mucosal vascular addressin cell-adhesion molecule-1(anti-MAdCAM-1)antibody modified reactive oxygen species(ROS)responsive human serum albumin-based nanomedicine denoted as THM,to improve the therapeutic efficacy of tofacitinib for UC treatment.THM has the drug releasing properties in response to ROS stimulation.In vitro studies show that THM selectively adhered to the endothelial cells and had obvious anti-inflammatory effect on macrophages.Meanwhile,the nanomedicine can inhibit the phenotypic switching of M1 macrophages and promote M2 polarization to produce anti-inflammatory medicators during wound healing.In addition,in vivo fluorescence imaging verified that THM exhibited enhanced preferential accumulation and extended retention in inflamed colon.Moreover,THM significantly reduced the production of proinflammatory cytokines in the colon and suppressed the homing of T cells to the gut in dextran sodium sulfate induced experimental colitis.This work elucidates that the inflamed colon-targeted delivery of tofacitinib by nanomedicine is promising for UC treatment and sheds light on addressing the unmet medical need. 展开更多
关键词 ulcerative colitis mucosal vascular addressin cell-adhesion molecule-1(MAdCAM-1) tofacitinib reactive oxygen species(ROS)-responsive targeted delivery
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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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作者 Mengyan Wang Yu Xue +14 位作者 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 《Chinese Medical Journal》 SCIE CAS CSCD 2023年第3期331-340,共10页
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 life.... 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 life.This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.Methods:The study was designed as a multicenter,open-label,randomized controlled trial.Eligible 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,China.Patients 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 tofacitinib.Efficacy and safety were assessed up to 6 months.Results:Overall,122 eligible patients were enrolled,with 41 in the continuation group,42 in the dose-reduction group,and 39 in the withdrawal group.After 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 group.Conclusion: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 state.Trial Registration:Chictr.org,ChiCTR2000039799. 展开更多
关键词 tofacitinib Rheumatoid arthritis WITHDRAWAL Dose reduction
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CYP3A4基因位点多态性对托法替布治疗类风湿关节炎临床疗效及药品不良反应的影响 被引量:1
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作者 王钦 金智华 蔡亮亮 《中国药业》 CAS 2024年第7期48-53,共6页
目的探讨CYP3A4*4,CYP3A4*18,CYP3A4*1G基因位点多态性对托法替布治疗类风湿关节炎(RA)临床疗效及药品不良反应(ADR)的影响。方法选取医院风湿免疫科2020年2月至2022年8月收治的RA患者309例作为RA组,予枸橼酸托法替布片,每日2次,每次5 ... 目的探讨CYP3A4*4,CYP3A4*18,CYP3A4*1G基因位点多态性对托法替布治疗类风湿关节炎(RA)临床疗效及药品不良反应(ADR)的影响。方法选取医院风湿免疫科2020年2月至2022年8月收治的RA患者309例作为RA组,予枸橼酸托法替布片,每日2次,每次5 mg,共治疗6个月;选取同期的健康人群165例作为对照组。采用荧光聚合酶链反应(PCR)法检测CYP3A4*4,CYP3A4*18,CYP3A4*1G基因位点多态性;根据美国风湿病学学会(ACR)制订的ACR20标准评价托法替布的临床疗效,以是否符合ACR20标准,将RA患者分为改善组(181例)和未改善组(128例);统计治疗期间RA患者与托法替布相关的ADR,采用Karch和Lasagna评定法判定因果关系,以因果关系是否判定为肯定、很可能和可能,将RA患者分为ADR组(58例)和无ADR组(251例)。结果RA组和对照组患者的CYP3A4*4,CYP3A4*18,CYP3A4*1G基因位点多态性均无显著差异(P>0.05)。改善组和未改善组患者的疾病活动度差异显著(P<0.05),CYP3A4*4,CYP3A4*18,CYP3A4*1G基因位点多态性均无显著差异(P>0.05)。ADR累及系统为实验室检验异常、皮肤系统、消化系统、呼吸系统、血液系统,分别发生27例、11例、7例、5例、3例;ADR严重程度为轻度51例,中度7例。ADR组和无ADR组患者的CYP3A4*1G基因位点多态性差异显著(P<0.05),CYP3A4*4和CYP3A4*18基因位点多态性均无显著差异(P>0.05)。结论CYP3A4*1G基因位点多态性与托法替布治疗RA的ADR有相关性。使用托法替布时,应监测患者的CYP3A4*1G基因位点多态性,必要时调整剂量,保证用药安全。 展开更多
关键词 细胞色素P450酶 基因位点多态性 托法替布 类风湿关节炎 临床疗效 药品不良反应
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托法替布片药物利用评价标准建立及应用
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作者 曹迪 程军 +1 位作者 张士洋 司福国 《中南药学》 CAS 2024年第7期1909-1914,共6页
目的建立托法替布片药物利用评价标准(DUE),为托法替布片临床合理使用提供参考。方法参考国内外托法替布药品说明书、相关诊疗指南、专家共识及临床研究,建立托法替布片DUE标准,并以此标准回顾性分析某三甲医院2021年1月1日—2023年9月3... 目的建立托法替布片药物利用评价标准(DUE),为托法替布片临床合理使用提供参考。方法参考国内外托法替布药品说明书、相关诊疗指南、专家共识及临床研究,建立托法替布片DUE标准,并以此标准回顾性分析某三甲医院2021年1月1日—2023年9月30日托法替布片门诊处方的合理性。结果共纳入1086张托法替布片门诊处方,用药适应证符合率93.6%,用法用量符合率93.6%,4张处方存在潜在的药物相互作用。结论该院托法替布片使用较合理,但在适应证、用法用量、药物相互等方面仍存在一定的问题,应加强干预,确保患者用药安全。 展开更多
关键词 托法替布片 药物利用评价 合理用药 评价标准
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托法替布用于类固醇难治性免疫相关性心肌炎病例分析
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作者 李金银 姜玲 +2 位作者 陈莉 王黎铭 杨晓燕 《中国临床医学》 2024年第4期565-570,共6页
免疫检查点抑制剂(immune checkpoint inhibitors,ICIs)是近年来抗肿瘤治疗的重要药物,能为患者带来显著的生存收益。然而ICIs引起的免疫相关性不良反应不容忽视,特别是ICIs相关性心肌炎,发生率低但致死率高。糖皮质激素是目前治疗ICIs... 免疫检查点抑制剂(immune checkpoint inhibitors,ICIs)是近年来抗肿瘤治疗的重要药物,能为患者带来显著的生存收益。然而ICIs引起的免疫相关性不良反应不容忽视,特别是ICIs相关性心肌炎,发生率低但致死率高。糖皮质激素是目前治疗ICIs相关性心肌炎的首选及核心方案。在激素治疗过程中,如病情加重,可联合吗替麦考酚酯(mycophenolate mofetil,MMF)、他克莫司、英夫利昔单抗等其中1种药物。阿仑单抗和阿巴西普对于糖皮质激素治疗无效的严重心肌炎患者可能有效,但阿巴西普可能促进肿瘤的生长。本文对1例使用特瑞普利单抗联合西妥昔单抗以及伊立替康抗肿瘤方案出现免疫相关性心肌炎,随即采用糖皮质激素联合人免疫球蛋白治疗失败后,加用口服托法替布,心肌损伤生物标志物显著下降的结肠癌患者进行分析讨论,以期为临床类固醇难治性免疫相关性心肌炎提供新的治疗思路。 展开更多
关键词 托法替布 类固醇 免疫相关性心肌炎 免疫检查点抑制剂
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Game changer:How Janus kinase inhibitors are reshaping the landscape of ulcerative colitis mana
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作者 Antonio M Caballero-Mateos Guillermo Arturo Cañadas-de la Fuente 《World Journal of Gastroenterology》 SCIE CAS 2024年第35期3942-3953,共12页
Recent advancements in the treatment landscape of ulcerative colitis(UC)have ushered in a new era of possibilities,particularly with the introduction of Janus kinase(JAK)-signal transducer and activator of transcripti... Recent advancements in the treatment landscape of ulcerative colitis(UC)have ushered in a new era of possibilities,particularly with the introduction of Janus kinase(JAK)-signal transducer and activator of transcription inhibitors.These novel agents offer a paradigm shift in UC management by targeting key signaling pathways involved in inflammatory processes.With approved JAK inhibitors(JAKis),such as tofacitinib,filgotinib,and upadacitinib,clinicians now have powerful tools to modulate immune responses and gene expression,potentially revolutionizing the treatment algorithm for UC.Clinical trials have demonstrated the efficacy of JAKis in inducing and maintaining remission,presenting viable options for patients who have failed conventional therapies.Real-world data support the use of JAKis not only as first-line treatments but also in subsequent lines of therapy,particularly in patients with aggressive disease phenotypes or refractory to biologic agents.The rapid onset of action and potency of JAKis have broadened the possibilities in the management strategies of UC,offering timely relief for patients with active disease and facilitating personalized treatment approaches.Despite safety concerns,including cardiovascular risks and infections,ongoing research and post-marketing surveillance will continue to refine our understanding of the risk-benefit profile of JAKis in UC management. 展开更多
关键词 Ulcerative colitis Janus kinase inhibitors Filgotinib tofacitinib Upadacitinib
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某院托法替布超说明书适应证用药循证医学评价
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作者 孙超 《实用药物与临床》 CAS 2024年第9期682-688,共7页
目的了解某院门诊托法替布超说明书适应证用药情况,为该药的合理使用提供参考。方法调取某院2022年6月1日-2023年12月31日开具枸橼酸托法替布片的门诊患者的所有处方,对患者基本情况、诊断等进行统计分析,将诊断与最新版药品说明书进行... 目的了解某院门诊托法替布超说明书适应证用药情况,为该药的合理使用提供参考。方法调取某院2022年6月1日-2023年12月31日开具枸橼酸托法替布片的门诊患者的所有处方,对患者基本情况、诊断等进行统计分析,将诊断与最新版药品说明书进行比对,将所有超说明书适应证用药诊断与美国食品药品监督管理局(FDA)批准的适应证、Micromedex数据库、国内外指南与专家共识、《马丁代尔大药典》等进行比对,同时在PubMed、Cochrane数据库、中国知网(CNKI)等收集循证医学证据,参照Micromedex数据库的Thomson分级系统,对超说明书适应证用药进行循证医学等级评价并提出分级管理建议。结果共收集到使用托法替布的门诊处方1024张,其中符合说明书适应证用药的有946例(92.38%),超说明书适应证用药78例(7.62%)。超说明书适应证用药临床诊断有14种,系统性红斑狼疮、斑秃(普秃)和干燥综合征居前3位。超说明书适应证用药有1种已被FDA批准,1种循证医学证据存在冲突,9种存在不同级别的循证医学证据支持,其余3种(干燥综合征、结缔组织病、慢性肾炎)未能查询到循证医学证据。最终参考Thomson分级标准判定溃疡性结肠炎证据等级为Category A,有效性及推荐等级为Class IIb或以上,建议同意使用;斑秃(普秃)等4种适应证证据等级为Category B,有效性及推荐等级为Class IIb或以上,建议限制使用;皮肌炎等5种适应证证据等级为Category C,有效性及推荐等级为Class IIb或以上,建议特殊使用;系统性红斑狼疮等4种适应证循证医学证据冲突或不足,建议禁止使用。结论该院托法替布超说明书适应证用药现象普遍,虽多数有循证医学证据支持,但仍需进一步规范,从而促进临床合理用药。 展开更多
关键词 托法替布 循证医学 超说明书 合理用药
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国产枸橼酸托法替布片的药动学及生物等效性研究
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作者 鲁萍 王杰 +2 位作者 尹小丽 张顺芝 吴蔚 《医药导报》 北大核心 2024年第2期203-207,共5页
目的通过探讨2种枸橼酸托法替布片在健康人群中的药动学特征,评价其生物等效性和安全性。方法采用随机、两周期、自身交叉设计,空腹/餐后各纳入36例受试者,每周期分别服用枸橼酸托法替布片(T或R)5 mg各1片,采用液相色谱-串联质谱(LC-MS/... 目的通过探讨2种枸橼酸托法替布片在健康人群中的药动学特征,评价其生物等效性和安全性。方法采用随机、两周期、自身交叉设计,空腹/餐后各纳入36例受试者,每周期分别服用枸橼酸托法替布片(T或R)5 mg各1片,采用液相色谱-串联质谱(LC-MS/MS)法检测血浆中托法替布片的浓度,Phoenix WinNonlin软件进行分析,计算药动学参数,评价其生物等效性。结果受试者单次口服T和R后,空腹组托法替布的主要药动学参数血药峰浓度(C_(max))分别为(57.54±13.95)、(59.17±12.31)ng·mL^(-1);浓度-时间曲线下面积(AUC_(0-t))分别为(143.83±34.58),(142.13±33.00)ng·h·mL^(-1);AUC_(0-∞)分别为(147.39±35.27)、(146.15±34.64)ng·h·mL^(-1);达峰时间(t_(max))均为0.50 h,餐后组托法替布的主要药动学参数C_(max)分别为(57.16±17.56)、(55.19±21.98)ng·mL^(-1);AUC_(0-t)分别为(165.47±41.63)、(162.04±41.84)ng·h·mL^(-1);AUC_(0-∞)分别为(171.88±44.15)、(168.05±44.21)ng·h·mL^(-1);t_(max)均为1.0 h,两制剂空腹组和餐后组C_(max)、AUC_(0-t)、AUC_(0-∞)几何均值比的90%置信区间分别为96.35%(90.11%~103.03%)和105.91%(95.20%~117.83%)、101.02%(98.76%~103.34%)和102.23%(99.67%~104.86%)、100.77%(98.53%~103.06%)和102.40%(99.81%~105.06%),均在80.00%~125.00%内。结论2种枸橼酸托法替布片在中国健康人群中生物等效,并且安全性良好。 展开更多
关键词 枸橼酸托法替布片 药动学 生物等效
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Navigating treatment resistance:Janus kinase inhibitors for ulcerative colitis
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作者 Jonathan Soldera 《World Journal of Clinical Cases》 SCIE 2024年第24期5468-5472,共5页
The management of refractory ulcerative colitis(UC)and acute severe UC(ASUC)is challenging due to the lack of standardized approaches in cases resistant to multiple treatments.In this editorial,I investigate the effic... The management of refractory ulcerative colitis(UC)and acute severe UC(ASUC)is challenging due to the lack of standardized approaches in cases resistant to multiple treatments.In this editorial,I investigate the efficacy and safety of Janus kinase inhibitors,particularly upadacitinib and tofacitinib,in controlling severe and refractory disease.I highlight a notable case report by Xu et al,which explores the case of a patient with primary nonresponse to two classes of biologics and two fecal microbiota transplants who exhibited a remarkable response to upadacitinib.Furthermore,I discuss the use of tofacitinib in refractory UC and ASUC,either as monotherapy or in combination with biologics,which has shown promising response rates.Additionally,emerging evidence of upadacitinib efficacy in ASUC is presented.Overall,these cases emphasize the complex nature of managing refractory ASUC and the potential of small-molecule therapies to achieve remission.Further research is needed to refine treatment strategies for patients with treatment-resistant UC. 展开更多
关键词 Inflammatory bowel disease Ulcerative colitis Janus kinase inhibitor Upadacitinib tofacitinib INFLIXIMAB
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