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英利昔单抗治疗斑块状银屑病随机对照试验的Meta分析

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中华皮肤科杂志 2007年第4期40卷 251-252页

作者：陈声利闫军刘毅姜祎群孙建方中国医学科学院、中国协和医科大学皮肤病研究所南京210042 济南市皮肤病防治院

近年的研究认为，TNF-α在银屑病的发病机制中起重要作用。患者皮损中TNF水平升高，经有效治疗后，患者血清和皮损中TNF水平下降，提示干扰TNF-α的作用可能减轻皮损的炎症。英利昔单抗是一种抗TNF-α的鼠-人嵌合的单克隆抗体，可高效... 详细信息

近年的研究认为，TNF-α在银屑病的发病机制中起重要作用。患者皮损中TNF水平升高，经有效治疗后，患者血清和皮损中TNF水平下降，提示干扰TNF-α的作用可能减轻皮损的炎症。英利昔单抗是一种抗TNF-α的鼠-人嵌合的单克隆抗体，可高效特异地结合TNF-α，从而使TNF-α不能与其受体结合。近年英利昔单抗在治疗斑块状银屑病中取得较好疗效，为银屑病治疗提供了一种新的选择。现对英利昔单抗治疗慢性斑块状银屑病的疗效和不良反应进行了系统评价，以期为临床医生和卫生决策者提供更多可靠信息。

关键词：斑块状银屑病单抗治疗 Meta分析随机对照试验抗TNF-α 英利昔单抗单克隆抗体发病机制

英利昔单抗联合甲氨蝶呤治疗类风湿关节炎的随机双盲临床研究

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中华风湿病学杂志 2006年第9期10卷 522-526页

作者：黄烽邓小虎张江林梁东风郭军华李胜光朱剑李晓峰解放军总医院风湿科北京100853

目的评价英利昔单抗与甲氨蝶呤(MTX)联合使用与单独使用MTX,在治疗类风湿关节炎(RA)中的疗效与安全性。方法本研究为随机、双盲、平行对照的临床试验。49例接受过至少3个月稳定剂量MTX治疗的活动性RA患者随机分为试验组(24例)和对照组(2... 详细信息

目的评价英利昔单抗与甲氨蝶呤(MTX)联合使用与单独使用MTX,在治疗类风湿关节炎(RA)中的疗效与安全性。方法本研究为随机、双盲、平行对照的临床试验。49例接受过至少3个月稳定剂量MTX治疗的活动性RA患者随机分为试验组(24例)和对照组(25例)。两组受试者在第0、2、6、14周分别接受3mg/kg的英利昔单抗或安慰剂静脉滴注,同时每周按固定剂量继续服MTX。并于试验的第0、2、6、14、18周随访,评价疗效和不良反应。以美国风湿病学会(ACR)疗效评价指标ACR20为主要疗效指标,ACR50、ACR70、晨僵时间、关节肿胀数、关节肿胀指数、关节压痛数、关节压痛指数；次要疗效指标为疼痛目视模拟测量表(VAS)评分、疲乏VAS评分、疾病总体状况的医生评价VAS评分、疾病总体状况的病人评价VAS评分、健康评价问卷(HAQ)评分。结果治疗后第2周时,英利昔单抗联合MTX组ACR20有效率为62．5%,对照组仅为8．0%(P=0．002)；晨僵时间、关节压痛数、关节压痛指数、关节肿胀数、关节肿胀指数、疼痛VAS、疲乏VAS、医生总体评价VAS、病人总体评价VAS、HAQ和血沉等较对照组也均有显著的改善(P＜0．05或P＜0．01)。第18周时,英利昔单抗联合MTX组ACR20有效率为79．2%,对照组只有48．0%(P=0．024)。两组之间不良事件发生率差异无统计学意义。结论英利昔单抗联合MTX治疗RA的疗效明显优于单用MTX的疗效,能迅速改善与RA有关的各项症状、体征和实验室炎性活动指标,具有良好的安全性。

关键词：关节炎,类风湿甲氨蝶呤生物医学研究英利昔单抗

英利昔单抗在消化系统疾病中的应用状况及前景

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中国医院用药评价与分析 2006年第3期6卷 151-153页

作者：陈垦广东药学院临床医学院附属第一医院广州市510800

目的:评价英利昔单抗在消化系统相关疾病治疗中的疗效和安全性。方法:收集国外相关文献进行综述、分析。结果及结论:英利昔单抗作为新一代的抗炎药通过中和TNF-α的生物学效应而发挥抗炎作用。对于克罗恩病、溃疡性结肠炎、酒精性肝病... 详细信息

目的:评价英利昔单抗在消化系统相关疾病治疗中的疗效和安全性。方法:收集国外相关文献进行综述、分析。结果及结论:英利昔单抗作为新一代的抗炎药通过中和TNF-α的生物学效应而发挥抗炎作用。对于克罗恩病、溃疡性结肠炎、酒精性肝病等消化系统疾病都有较好疗效,且在推荐的治疗范围内安全性良好。

关键词：英利昔单抗 TNF—α 临床评价安全性

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英利昔单抗治疗对系统性红斑狼疮患者较安全

基础医学与临床 2007年第4期27卷 469-469页

维也纳医科大学的Martin Aringer博士及其同事在1月的《关节炎和风湿病》（Arthritis Rheum，2007；56：274—279．）杂志上，虽然抗肿瘤坏死因子（TNF）-α抗体英利昔单抗（infkiximab）治疗可引起系统性红斑狼疮（SLE）患者某些暂时... 详细信息

维也纳医科大学的Martin Aringer博士及其同事在1月的《关节炎和风湿病》（Arthritis Rheum，2007；56：274—279．）杂志上，虽然抗肿瘤坏死因子（TNF）-α抗体英利昔单抗（infkiximab）治疗可引起系统性红斑狼疮（SLE）患者某些暂时性反应，但是似乎没有很大的临床意义。

关键词：系统性红斑狼疮患者单抗治疗 (TNF)-α 抗肿瘤坏死因子安全 Rheum 英利昔单抗医科大学

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英利昔单抗治疗克罗恩病引发的坏疽性脓皮病

世界核心医学期刊文摘（胃肠病学分册） 2005年第2期1卷 7-8页

作者： Sapienza M .S. Cohen S. Dimarino A.J. 陈云茹

Pyoderma gangrenosum (PG )is an ulcerating noninfectious disease of the skin seen in 1 to 5% of patients with in- flam matory boweldisease.The pathogenesis ofPG has yet to be determ ined but m ay be related to abnorm al Tcell responses and the production ofTNF-α,a powerfulproin- flam m atory cytokine.Inflixim ab,a chim eric m onoclonal antibody to TNF-α,has been approved forthe treatm entof Crohn s disease.W e presentfour patients with PG treated with Inflixim ab for fistulizing Crohn s in whom com plete healing ofPG was achieved.Four patients with active fis- tulizing Crohns disease and PG were treated.Allpatients were fem ales ranging in age from 48to 60years,with a m ean age of54years.Three offourpatientshad PG lesions located on the lowerextrem ities;one patienthad peristom al disease.All patients had at least colonic involvem ent of theirCrohn s.The patientsreceived eithera single infusion or a series ofthree 5m g /kg Inflixim ab infusions.Allfour patients dem onstrated rapid healing ofPG within 4weeksof the first infusion of Inflixim ab.PG healing followed im - provem ent in bowel *** plete resolution without recurrence was noted in all patients.Rapid resolution of PG wasnoted in fourfem ale patientswith fistulizing Crohn s disease treated with Inflixim ab.H ealing was com plete, without recurrence.The anti-TNF-αproperties of Inflix- im ab suggest that healing m ay be m ediated by the drugs effect on cytokine pathways,perhaps by blunted T cell activation early in the inflam m atory cascade.W e suggest an independenteffectofInflixim ab on PG.

关键词：克罗恩病英利昔单抗坏疽性脓皮病炎症性肠病致炎细胞因子非感染性疾病嵌合性细胞反应肠瘘单克隆抗体

英利昔单抗治疗难治性葡萄膜炎的前瞻性研究:初步的安全性和有效性结果

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世界核心医学期刊文摘（眼科学分册） 2005年第12期1卷 32-33页

作者： Suhler E.B Smith J.R Wertheim M.S 潘佳鸿 Casey Eye Institute 3375 SW Terwilliger Blvd Portland OR 97239- 4197 United States.Dr

Objective: Infliximab, a monoclonal antibody against tumor necrosis factor α , is approved by the US Food and Drug Administration for treatment of numerous autoimmune disorders. We conducted a prospective, open-label phase 2 clinical trial to assess the effectiveness of infliximab in treating refractory autoimmune uveitis. Methods: We prospectively enrolled 23 patients from the uveitis clinic of the Casey Eye Institute, Portland, Ore, into this trial. All patients meeting eligibility criteria received 3 infliximab infusions at weeks 0, 2, and 6. Clinical success was ascertained at week 10. Patients meeting initial criteria for success received an infusion at week 14 and every 8 weeks thereafter, with dose escalation permitted for breakthrough inflammation, and underwent outcome measurements at week 50. Results: All patients underwent outcome assessment at week 10. Eighteen (78% ) of these subjects met criteria for clinical success at this time. Success was judged by the composite clinical end point of visual acuity, control of intraocular inflammation, ability to taper concomitant medication therapy, and improvement in inflammatory signs on fluorescein angiography and/or ocular coherence tomography. Successful grading required improvement in at least 1 of 4 subcomponents and worsening in none. Seven of 14 patients enrolled for 1 year continued infliximab therapy and maintained their successful grading. Five did not complete 1 year of treatment because of significant adverse events, and 2 terminated treatment early for reasons unrelated to the study. Serious adverse events that were potentially related to infliximab included pulmonary embolus, congestive heart failure, lupus-like reaction in 2, and vitreous hemorrhage in 2 patients. Antinuclear antibodies developed in 15 of 20 enrolled patients receiving 3 or more infusions. Conclusions: Infliximab was an effective short-term immunosuppressive agent in most of the patients, with 18 of 23 meeting criteria for clinical success at week 10. Infliximab was effective in

关键词：葡萄膜炎英利昔单抗玻璃体出血自身免疫性疾病二期临床试验眼内炎肿瘤坏死因子α 眼科研究所单克隆抗体治愈情况

英利昔单抗单一疗法治疗银屑病关节炎时的细胞因子情况

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世界核心医学期刊文摘（皮肤病学分册） 2005年第12期1卷 40-41页

作者： Mastroianni A. Minutilli E. Mussi A. E. Berardesca 刘艳 Dr. Clinical Dermatology San Gallicano Dermatological Institute Via Chianesi 53 Rome Italy

Background: Biological therapies are a new breakthrough in the treatment of psoriasis and psoriatic arthritis (PsA). Among these, tumour necrosis factor (TNF)- α antagonists such as infliximab and etanercept are the most promising as TNF is considered to be essential in driving cytokine cascade at sites of cutaneous and synovial inflammation in this disease. Objectives: To evaluate the time- related response of serum cytokine release during infliximab monotherapy and assess serum cytokine levels in order to provide a fast, minimally invasive tool to monitor and/or predict efficacy of anti- TNF- α therapy. Methods: Twenty patients affected by PsA with Psoriasis Area and Severity Index (PASI) score between 0.4 and 42.8 were treated with infliximab for 30- 42 weeks. The assessment of arthritis severity was performed using the American College of Rheumatology (ACR) criteria and ultrasonography evaluation. The treatment schedule consisted of infliximab (5 mg kg- 1 intravenously) at 0, 2 and 6 weeks and every 12 weeks on an individual basis determined by therapeutic results and adverse events reported. At baseline and before every infusion blood samples were taken to assess serum cytokine levels [TNF- α , interleukin (IL- 6), E- selectin, vascular endothelial cell growth factor (VEGF), fibroblast growth factor (FGF), matrix metalloproteinase(MMP- 2)]. Results: Eighteen of 20 psoriatic patients achieved>50% improvement and 14 of 20 patients attained>75% improvement in the PASI score at 10 weeks. All arthritic patients achieved>50% improvement (ACR- 50) and 16 of 20 patients attained>75% improvement (ACR- 75) at 10 weeks. TNF- α did not decrease immediately during the first part of the study. A significant decrease was detected at week 12 (P < 0.01). In contrast, IL- 6, VEGF, FGF and E- selectin showed significant decreases after early infliximab infusions. PASI was not correlated with TNF- α in the serum but was significantly correlated with FGF, VEGF and MMP- 2. Treatment was well tolerated and there were no significan

关键词：银屑病关节炎英利昔单抗细胞因子 PASI 皮损面积血浆水平肿瘤坏死因子基质金属蛋白酶严重度细胞凋亡

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英利昔单抗维持类风湿性关节炎患者骨矿密度

基础医学与临床 2007年第9期27卷 1058-1058页

法国Edoard Herriot医院的Pierre Miossec博士及其同事在6月23日的《关节炎研究和治疗》（Arthritis Res Ther，2007；9．）杂志上指出，在类风湿性关节炎（RA）治疗中使用抗肿瘤坏死因子（TNF）药英利昔单抗（infliximab，Remicade）... 详细信息

法国Edoard Herriot医院的Pierre Miossec博士及其同事在6月23日的《关节炎研究和治疗》（Arthritis Res Ther，2007；9．）杂志上指出，在类风湿性关节炎（RA）治疗中使用抗肿瘤坏死因子（TNF）药英利昔单抗（infliximab，Remicade），似乎可防止也使用甲氨蝶呤治疗的反应者和非反应者的骨矿密度（BMD）降低。

关键词：类风湿性关节炎患者英利昔单抗骨矿密度甲氨蝶呤治疗抗肿瘤坏死因子 Pierre Res 反应

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英利昔单抗可改善银屑病关节炎的症状和体征

基础医学与临床 2005年第9期25卷 817-817页

加利福尼亚大学的A．Kavanaugh医生及其同事在8月的《风湿病年鉴》（Ann Rheum Dis2005；64：1150—1157）上报告了一项Ⅲ期试验结果，英利昔单抗（Remicade）可改善银屑病关节炎的症状和体征。

关键词：银屑病关节炎症状和体征英利昔单抗加利福尼亚 Rheum 试验结果风湿病