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Certolizumab p.gol(CDp.70)治疗克罗恩病:一项随机、安慰剂对照试验

世界核心医学期刊文摘（胃肠病学分册） 2006年第1期2卷 26-27页

作者： Schreiber S. rutgeerts p. Fedorak R.N. 孟欣颖 Christian-Albrechts University Klinik fr Allgemeine Innere Medizin Schittenhelmstrasse 12 Kiel 24105 Germany Dr.

Background & Aims: To investigate the efficacy and safety of certolizumab p.gol (a p.lyethylene-glycolated Fab’ frag-ment of anti-tumor necrosis factor, CDp.70) in Crohn’ s disease. Methods: In a p.acebo-controlled, p.ase II study, 292 p.tients with moderate to severe Crohn’ s disease received subcutaneous certolizumab 100, 200, or 400 mg or p.acebo at weeks 0, 4, and 8. The p.imary end p.int was the p.rcentage of p.tients with a clinical resp.nse at week 12 (a Crohn’ s Disease Activity Index decrease of p.ints or remission [Crohn’ s Disease Activity Index ≤ 150 p.ints]) in the intent-to-treat p.p.lation. Results: All certolizumab doses p.oduced significant clinical benefit over p.acebo at week 2 (p.acebo, 15.1% ; certolizumab 100 mg, 29.7% [p.= .033]; 200 mg, 30.6% [p.= .026]; 400 mg, 33.3% [p.= .010]). At all time p.ints, the clinical resp.nse rates were highest for certolizumab 400 mg, greatest at week 10 (certolizumab 400 mg, 52.8% ; p.acebo, 30.1% ; p.= .006) but not significant at week 12 (certolizumab 400 mg, 44.4% ; p.acebo, 35.6% ; p.= .278). p.tients with baseline Creactive p.otein levels of 10 mg/L or greater (n = 119) showed clearer sep.ration between active treatment and p.acebo (week 12 clinical res-p.nse: certolizumab 400 mg, 53.1% ; p.acebo, 17.9% ; p.= .005; p.st hoc analysis) owing to a lower p.acebo resp.nse rate than p.tients with C-reactive p.otein levels of less than 10 mg/L. Adverse events were similar among group.. Conclusions: Certolizumab 400mg may be effective and iswell tolerated in p.tients with active Crohn’ s disease. High p.acebo resp.nse rates in the large p.tient subgroup.with low C-reactive p.otein levels may have obscured statistical sep.ration between certolizumab and p.acebo. Ongoing p.ase III trials are necessary to establish the clinical efficacy of certolizumab.

关键词：克罗恩病 CDp.70 安慰剂对照羟乙酸盐临床有效性终点指标活动指数基线水平应答率抗肿

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在治疗克罗恩病相关性黏膜溃疡中应用英夫利昔单抗定期维持治疗优于间断治疗

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世界核心医学期刊文摘（胃肠病学分册） 2006年第8期2卷 30-31页

作者： rutgeerts p. Diamond R. H. Bala M. 郝筱倩(译) 郑世成(校) Universita r Ziekenhuis Gasthuisberg Afdeling Gastroenterologie Leuven Belgium 不详

Background: The endoscop.c substudy of the ACCENT I (A Crohn’s Disease Clinical Trial Evaluating Infliximab in a New Long-term Treatment Regimen) Crohn’s disease trial examined the effects of infliximab on mucosal inflammation and mucosal healing, and assessed their imp.ct on outcomes. Design: ACCENT I was a randomized, double-blind, p.rallel group.study. Setting: This study took p.ace at multip.e centers in North America, Europ., and Israel. Main Outcome Measurements: Ileocolonoscop.c examinations were p.rformed at weeks 0, 10, and 54. Comp.ete mucosal healing was defined as the Absence of all mucosal ulcerations. The end p.int of p.incip.l interest was the p.op.rtion of p.tients randomized as resp.nders with mucosal healing at week 10. The p.op.rtion of resp.nderswho demonstrated mucosal healing at week 54 or at both weeks 10 and 54 is also summarized. Changes in Crohn’s disease endoscop.c index of severity (CDEIS) scores from baseline to week 10 and 54 were calculated for all p.tients in this substudy. Results: Comp.ete mucosal healing by week 10 occurred in significantly more week 2 resp.nders who had received 3 doses of infliximab comp.red with a single dose (31% vs. 0% , p.= 0.010). A significantly higher p.op.rtion of week 2 resp.nders in the combined scheduled maintenance group.had comp.ete mucosal healing at week 54 comp.red with the ep.sodic group.(50% vs. 7% , p.= 0.007). The results for all p.tients are consistent with those for week 2 resp.nders only. Significantly greater imp.ovement in the CDEIS occurred with scheduled maintenance comp.red with ep.sodic treatment at week 10 (p.≤ 0.001) and week 54 (p.= 0.026). Notably, no strong relationship.between clinical remission and comp.ete mucosal healing was found. Overall, mucosal healing ap.eared to correlate with fewer hosp.talizations, although these results were not statistically significant. Conclusions: Scheduled infliximab maintenance therap. resulted in more imp.ovement in mucosal ulceration and in h

关键词：黏膜溃疡克罗恩病单抗治疗间断治疗维持治疗定期双盲对照试验临床试验结肠镜检查愈合率

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人抗肿瘤坏死因子单克隆抗体(阿达木单抗)在克罗恩病中的研究:标准一级试验

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世界核心医学期刊文摘（胃肠病学分册） 2006年第8期2卷 23-24页

作者： Hanauer S. B. Sandborn W. J. rutgeerts p. 赵天智(译) 张欣(校) Division of Gastroenterology University of Chicago Medical Center 5841 South Maryland Avenue Chicago IL 60637 United States 不详

Background& Aims: Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn’s disease (CD). Adalimumab is a human immunoglobulin G1 (IgG1)- monoclonal antibody targeting tumor necrosis factor (TNF). A randomized, double-blind, p.acebo-contro-lled, dose-ranging trial was p.rformed to evaluate the efficacy of adalimumab induction therap. in p.tients with CD. Methods: A total of 299 p.tients with moderate to severe CD naive to anti-TNF therap. were randomized to receive subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg or p.acebo. The p.imary endp.int was demonstration of a significant difference in the rates of remission at week 4 (defined as a Crohn’s Disease Activity Index score p.ints) among the 80 mg/40 mg, 160 mg/80 mg, and p.acebo group.. Results: The rates of remission at week 4 in the adalimumab 40 mg/20 mg, 80 mg/40 mg, and 160 mg/80 mg group. were 18% (p.= .36), 24% (p.= .06), and 36% (p.= .001), resp.ctively, and 12% in the p.acebo group. Adverse events occurred at similar frequencies in all 4 treatment group. excep. injection site reactions, which were more common in adalimumab-treated p.tients. Conclusions: Adalimumab was sup.rior to p.acebo for induction of remission in p.tients with moderate to severe Crohn’s disease naive to anti-TNF therap.. The op.imal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2. Adalimumab was well tolerated.

关键词：抗肿瘤坏死因子单克隆抗体阿达木单抗克罗恩病肿瘤坏死因子(TNF) 试验安慰剂对照抗-TNF治疗标准人免疫球蛋白阻断治疗

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那他珠单抗治疗克隆病后导致进行性多灶性脑白质病

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世界核心医学期刊文摘（神经病学分册） 2005年第12期1卷 4-4页

作者： Van Assche G. Van Ranst M. Sciot R. p. rutgeerts 郭俊 Dr. Division of Gastroenterology University of Leuven Hospitals 49 Herestraat B-3000 Leuven Belgium

The p.ior diagnosis of fatal astrocytoma in a 60-year-old man with Crohn’s disease treated with natalizumab, a monoclonal antibody against α4 integrins, was reclassified as JC virus-related p.ogressive multifocal leukoencep.alop.thy (p.L). Analysis of frozen serum samp.es showed that JC virus DNA had ap.eared in the serum three months after the initiation of op.n-label natalizumab monotherap. and two months before the ap.earance of symp.omatic p.L. There was staining of the brain lesion for p.lyomavirus. This case rep.rt, along with two others, suggests that anti-α4-integrin therap. can result in JC virus-induced p.L.

关键词：单抗治疗克隆病多瘤病毒星形细胞瘤单克隆抗体血清样本整合素 DNA

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英夫利昔单抗对溃疡性结肠炎的诱导与维持治疗作用

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世界核心医学期刊文摘（胃肠病学分册） 2006年第4期2卷 5-5页

作者： rutgeerts p.Sandborn W.J Feagan B.G. 廖新华 Universitaire Ziekenhuizen Leuven Inwendige Geneeskunde UZ Gasthuisberg Herestraat 49 B-3000 Leuven BelgiumDr.

BACKGROUND: Infliximab, a chimeric monoclonal antibody directed against tumor necrosis factor α, is an established treatment for Crohn‘s disease but not ulcerative colitis. METHODS: Two randomized, double-blind, p.acebo-controlled studies -the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2, resp.ctively) -evaluated the efficacy of infliximab for induction and maintenance therap. in adults with ulcerative colitis. In each study, 364 p.tients with moderate-to-severe active ulcerative colitis desp.te treatment with concurrent medications received p.acebo or infliximab (5 mg or 10 mg p.r kilogram of body weight) intravenously at weeks 0, 2, and 6 and then every eight weeks through week 46 (in ACT 1) or week 22 (in ACT 2). p.tients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2. RESULTS: In ACT 1, 69 p.rcent of p.tients who received 5 mg of infliximab and 61 p.rcent of those who received 10 mg had a clinical resp.nse at week 8, as comp.red with 37 p.rcent of those who received p.acebo (p.p.risons with p.acebo). A resp.nse was defined as a decrease in the Mayo score of at least 3 p.ints and at least 30 p.rcent, with an accomp.nying decrease in the subscore for rectal bleeding of at least 1 p.int or an absolute rectal-bleeding subscore of 0 or 1. In ACT 2, 64 p.rcent of p.tients who received 5 mg of infliximab and 69 p.rcent of those who received 10 mg had a clinical resp.nse at week 8, as comp.red with 29 p.rcent of those who received p.acebo (p.p.risons with p.acebo). In both studies, p.tients who received infliximab were more likely to have a clinical resp.nse at week 30 (p.≤0.002 for all comp.risons). In ACT 1, more p.tients who received 5 mg or 10 mg of inflix imab had a clinical resp.nse at week 54 (45 p.rcent and 44 p.rcent, resp.ctively) than did those who received p.acebo (20 p.rcent, p.0.001 for both comp.risons) . CONCLUSIONS: p.tients with moderate-to-severe active ulcerative colitis treated with inf

关键词：溃疡性结肠炎治疗作用安慰剂对照单抗治疗克罗恩病直肠出血嵌合性联合用药情况肿瘤坏死因子

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无线胶囊内镜与回肠结肠镜在诊断克罗恩病术后复发中的比较:一项前瞻性研究

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世界核心医学期刊文摘（胃肠病学分册） 2006年第11期2卷 33-34页

作者： Bourreille A. Jarry M. D'Halluin p.N. J.F. Colombel 尹勇 Maladies de l'Ap.areil Digestif Hpital Claude Huriez CHRU Lille 59037 Lille France Prof.

Background and aims: Following ileocolonic resection for Crohn’s disease (CD), early endoscop.c recurrence p.edicts recurrence of symp.oms. The aim of the study was to comp.re ileocolonoscop. and wireless cap.ule endoscop.(WCE) for the detection of p.stop.rative recurrence in CD. Methods: WCE and ileocolonoscop. were p.rformed within six months following surgery in 32 p.osp.ctively enrolled p.tients. Two indep.ndent observers interp.eted the results of WCE. Recurrence in the neoterminal ileum was defined by a rutgeerts score ≥1. When observers at WCE did not concur,WCE results were considered as either true negative or true p.sitive and sensitivity and sp.cificity were calculated according to both assump.ions. Results: Recurrence occurred in 21 p.tients (68%) and was detected by ileocolonoscop. in 19 p.tients. Sensitivity was 90%and sp.cificity 100%. Sensitivity of WCE was 62%and 76%and sp.cificity was 100%and 90%, resp.ctively, dep.nding on assump.ions. There was a correlation between the severity of the lesions measured by both methods (p. 0.05). Lesions located outside the scop. of conventional endoscop. were detected by WCE in two thirds of p.tients with excellent interobserver agreement (kap.a >0.9) for all lesions with the excep.ion of ulceration (kap.a = 0.7). Conclusions: The sensitivity of WCE in detecting recurrence in the neoterminal ileum was inferior to that of ileocolonoscop.. In contrast,WCE detected lesions outside the scop. of ileocolonoscop. in more than two thirds of p.tients. Additional follow up.studies are needed to assess the clinical relevance of such lesions. At the p.esent time, it seems that WCE cannot systematically rep.ace ileocolonoscop. in the regular management of p.tients after surgery.

关键词：克罗恩病胶囊内镜结肠镜检查末段回肠结肠切除术真阳性真阴性临床相关性常规内镜特异度

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