消化在线: 欧洲溃疡性结肠炎和克罗恩病组织大会
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第八届欧洲溃疡性结肠炎和克罗恩病组织大会于2013年2月14日至16日在维也纳举行,大会主题为“炎症性肠炎(IBD)的新理念和当前挑战”。大会前两节的主题是炎症性肠炎(IBD)的早期阶段、我们对于阻止病情进展的选择以及是否有一扇“治疗的机会之窗”。
大会同时探讨了在临床上非常重要的主题:在生殖和青少年背景下的炎症性肠炎(IBD)管理。作为大会的最后一个亮点,Sander van Deventer演示了欧洲溃疡性结肠炎和克罗恩病组织的讲演,以庆祝IBD领域第一份抗肿瘤坏死因子(TNF)报告诞生20周年。我们选取了6份关于美沙拉秦的讲稿作为对此次大会的总结。
1、在英国,对5-氨基水杨酸疗法的坚持:配对样本研究
持续性指患者在连续的时间里不间断使用一种特定的药物,并且可能受到患者行为和临床策略的影响,这项研究的目的是用英国药房数据来评估口服5-ASA的持续性,研究分析经常因为复杂的因素如入选人数和患者特征而受到影响,这项研究通过进行匹配的样本分析,控制复杂的因素来获得一个标准的结论。RobinsonA.说:“绝大多数患者到试验结束时,没有继续使用他们先前应用的5-ASA剂型,口服的5-ASA的持续性是和其他所有剂型的5-ASA一样的,进一步的分析将探讨5-ASA的剂型变化和未连续用药如何影响研究结论。”
Persistence refers to the duration of time a patient continues to take a particular medication and may be influenced by both patientbehaviour and clinical strategies. The aim of this study was to assess persistence with oral 5-ASAs using a UK pharmacy database. Analyses of persistence are often challenged by confounding factors such as population size and patient characteristics. This study controlled for such confounding factors to obtain a standardised view by conducting a matched sample analysis. A. Robinson said: “a substantial majority of patients were not continuing to take their original 5-ASA formulation by the end of the study period. Persistence with oral 5-ASA is similar across all 5-ASA formulations. Further analyses will evaluate how a change in 5-ASA or failure to refill a prescription influence these results.”
2、在稳定的IBD患者中,不依从和5-氨基水杨酸替换伴随着复发风险的增加
5-ASA长期治疗是炎症性肠病(IBD)获得稳定的症状控制和预防复发的重要策略,造成5-ASA给药中断的因素例如依从性欠佳与复发风险增加相关,是否5-ASA制剂因为其独特的释放曲线而被认为是不可替代的,这一点尚存争议。本研究的目的在于核实在英国依从性不佳患者的复发风险,并且评估是否改变5-ASA制剂会增加复发风险。RobinsonA.说:“美沙拉秦依从性不佳显著增加英国患者复发的可能性。而且,在这项试验里,跟踪的患者中转换到另一种5-ASA剂型将比不转换的患者增加3.5倍复发风险。这项分析是第一次评估5-ASA转换的影响,在非临床环境用一种情况替代复发。这些数据可能会对疾病治疗产生实质性影响,但在取得确实的结论前,尚需进一步的研究。
Long-term therapy with 5-ASA is a crucial strategy for obtaining stable symptom control and preventing relapses in inflammatory bowel disease (IBD). Factors which disrupt consistent 5-ASA delivery such as non-adherence are associated with an increased risk of relapse. There is debate about whether 5-ASA formulations should be considered non-interchangeable due to their unique release profiles. The aim of this study was to verify the impact of non-adherence on relapse risk in a UK population, and to evaluate whether changes in 5-ASA formulation increase the risk of relapse.
A. Robinson said: Non-adherence to mesalazine significantly increased the likelihood of relapse in this UK population. Moreover, in this study, adherent patients switched to another 5-ASA had a 3.5 times greater risk of relapse compared to non-switched patients. This analysis represents the first evaluation of the impact of 5-ASA switch using a proxy for relapse in a non-clinical setting. These data may have substantial implications for disease management, but before making firm conclusions, further research is needed.
诞生20周年。我们选取了6份关于美沙拉秦的讲稿作为对此次大会的总结。
3、保持溃疡性结肠炎的缓解:5-氨基水杨酸
5-氨基水杨酸(5-ASAs)在溃疡性结肠炎(UC)诱导和维持缓解方面起关键作用,为了使这类患者最有效地持续缓解,许多问题一直没有得到充分的临床试验来评价,包括剂量、用药间隔、制备和给药的方法。Din S.等人建议:5-ASA制备或给药方案的不同不影响UC的持续缓解,低剂量和单一方式治疗可能有一个更有利的结果,表明治疗的一致性仍是保证5-ASA疗效的重要方面。病情严重性而不是病变范围可能在决定复发风险时是一个独立的危险因素。
5-Aminosalicylic Acids (5-ASAs) play a key role in both the induction and maintenance of remission in Ulcerative Colitis (UC). A number of questions remain poorly assessed by clinical trials including the dose, dose interval, preparation and delivery method that is most effective in maintaining remission in this group of patients. S. Din et al suggest : Differences in 5-ASA preparation or dosing schedules do not influence the maintenance of remission in UC. Low dose and uni-directional approaches to therapy may have a more favourable outcome indicating that concordance with therapy remains a vital aspect of 5-ASA efficacy. Disease severity and not disease extent may have an independent role in determining the risk of relapse.
4、坚持溃疡性结肠炎的5-氨基水杨酸疗法:英国的预算影响分析
依从5-ASA治疗可以减少溃疡性直肠炎患者复发几率。这个预算影响分析的目的是探索和量化在英国为防止疾病复发而坚持个人5-ASA治疗如何影响直接医疗费用。L. Yen说到:因为溃疡性结肠炎依从性差与昂贵的医疗资源利用相关,因此英国国民健康保险制度(NHS)更倾向于给5-ASA治疗依从性最高的患者以更多的补偿。
Adherence with 5-aminosalicylic acid (5-ASA) treatments has been shown to be associated with a reduction in disease relapses in patients with ulcerative colitis (UC). The aim of this budget impact analysis was to explore and quantify how adherence with individual 5-ASA treatments may impact direct medical costs, through prevented relapses, in the United Kingdom (UK).L. Yen said: As non-adherence in UC is associated with costly medical resource utilization, significant cost-offsets could be achieved within the NHS by favouring the 5-ASA treatment with the highest adherence.
5、IBD患者对输注英夫利昔单抗缩短1小时的耐受性:一个单中心队列研究
英夫利昔单抗治疗大大提高了IBD治疗效果,它能有效诱导和维持临床缓解。英夫利昔单抗,一种肿瘤坏死因子-α的嵌合单克隆抗体,需要静脉给药超过2小时,给药结束还要观察1小时。我们报道了对IBD患者缩短英夫利昔单抗注射时间1小时的经验,以期评价安全性及患者耐受性和可能出现的输液反应事件。L. Guidi说到:一个专门的IBD患者输液室能够给炎症性肠病患者更高质量的护理。定期维持治疗的情况下,加快1小时输注英夫利昔单抗是安全的,并且IBD患者群能够很好的耐受。
Infliximab therapy has greatly improved the management of inflammatory bowel disease (IBD), with efficacy in inducing and maintaining clinical remission. Infliximab, a chimeric monoclonal antibody to tumour necrosis factor alpha, requires intravenous administration in over 2 hours, with a further 1 hour of post-infusion observation. We reported our experience with shortened 1-hour infusions in IBD patients treated with infliximab with the aim to assess the safety and the tolerance of an accelerated infusion protocol and the incidence of possible infusion reactions.L. Guidi said: A dedicated IBD infusion unit can achieve a better quality of care in patients with inflammatory bowel disease. An accelerated 1-hour infliximab infusion was safe and well tolerated in our IBD patient cohort under scheduled maintenance therapy.
6、儿童炎症性肠病早期临床表现的人口学特征
炎症性肠病,包括克隆氏病及溃疡性结肠炎,是结肠与小肠的慢性疾病。该疾病在青少年(儿童及青年人)中较普遍,但在2岁以下儿童中极少见到。因此,5岁以下儿童IBD称为早发性IBD,被认为是特殊群体的特殊表型。但是,在这一问题上仍然没有足够的可用数据。该研究的目的是确定早发性IBD儿童患者的特点及临床进程。S. Szymanska说到:5岁以下儿童IBD包括溃疡性结肠炎、克隆氏病以及相对高比例的缺血性肠病。中重度早发性IBD经常被观察到。这些患者的疾病表现主要在结肠(包括直肠炎及左半结肠炎)。Inflammatorybowel disease (IBD), which includes Crohn's disease (CD) and Ulcerative colitis (UC) is a chronic condition of the colon and small intestine. The disease is common in young people (children and young adults) yet it is rather rare in children younger than 2 years of age. Therefore, IBD developing during the first years of life (under the age of 5) is called an early-onset IBD (EO-IBD) and it is considered to be a specific entity with a distinct phenotype. However, the available data on that issue are still insufficient. The objective of the study was to determine the characteristics and clinical course of children with early-onset IBD. S. Szymanska said: IBD in children younger than 5 years old includes UC, CD, and a relatively high proportion of IC. In early onset IBD severe and moderate course of a disease is usually observed. Disease manifestation in these patients is predominantly colonic (both proctitis and left-sided colitis).
mso-color-index:1;mso-font-kerning:12.0pt;language:en-US;mso-style-textfill-type: solid;mso-style-textfill-fill-themecolor:text1;mso-style-textfill-fill-color: black;mso-style-textfill-fill-alpha:100.0%'> said: A dedicated IBD infusion unit can achieve a better quality of care in patients with inflammatory bowel disease. An accelerated 1-hour infliximab infusion was safe and well tolerated in our IBD patient cohort under scheduled maintenance therapy.