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肠白塞病诊断与管理的共识意见(第 2 版):抗 TNFα 单克隆抗体的适应证。

The 2nd edition of consensus statements for the diagnosis and management of intestinal Behçet's disease: indication of anti-TNFα monoclonal antibodies.

机构信息

Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan,

出版信息

J Gastroenterol. 2014 Jan;49(1):156-62. doi: 10.1007/s00535-013-0872-4. Epub 2013 Aug 18.

Abstract

BACKGROUND

Clinical evidence regarding intestinal Behçet's disease (BD) management is lacking and intestinal lesions are a poor prognostic factor. In 2007, the Japan consensus statement for diagnosis and management of intestinal BD was developed. Recently, the efficacy of anti-tumor necrosis factor (TNF)α monoclonal antibodies (mAbs), and infliximab (IFX) was reported and adalimumab (ADA) was approved for intestinal BD in Japan. This study renewed consensus-based practice guidelines for diagnosis and treatment of intestinal BD focusing on the indication of anti-TNFα mAbs.

METHODS

An expert panel of Japanese gastroenterology and rheumatology specialists was involved. Clinical statements for ratings were extracted from the literature, a professional group survey, and by an expert panel discussion, which rated clinical statements on a nine-point scale. After the first round of ratings, a panelist meeting discussed areas of disagreement and clarified areas of uncertainty. The list of clinical statements was revised after the panelist meeting and a second round of ratings was conducted.

RESULTS

Fifteen relevant articles were selected. Based on the first edition consensus statement, improved clinical statements regarding indications for anti-TNFα mAbs use were developed. After a two-round modified Delphi approach, the second edition of consensus statements was finalized.

CONCLUSIONS

In addition to standard therapies in the first edition, anti-TNFα mAbs (ADA and IFX) should be considered as a standard therapy for intestinal BD. Colchicines, thalidomide, other pharmacological therapy, endoscopic therapy, and leukocytapheresis were deemed experimental therapies.

摘要

背景

缺乏关于肠贝赫切特病(BD)管理的临床证据,且肠病变是预后不良的因素。2007 年,日本制定了肠贝赫切特病的诊断和治疗共识声明。最近,报道了抗肿瘤坏死因子(TNF)α 单克隆抗体(mAbs)和英夫利昔单抗(IFX)的疗效,阿达木单抗(ADA)在日本被批准用于肠 BD。本研究针对抗 TNFα mAbs 的适应证,更新了基于共识的肠 BD 诊断和治疗实践指南。

方法

日本消化科和风湿科专家组成了一个专家小组。从文献、专业组调查和专家小组讨论中提取了用于评分的临床陈述,并对临床陈述进行了九点制评分。在第一轮评分后,专家组会议讨论了存在分歧的领域,并澄清了不确定的领域。在专家组会议后修订了临床陈述清单,并进行了第二轮评分。

结果

选择了 15 篇相关文章。基于第一版共识声明,制定了关于抗 TNFα mAbs 使用适应证的改进临床陈述。经过两轮改良 Delphi 方法,最终确定了第二版共识声明。

结论

除了第一版的标准治疗外,抗 TNFα mAbs(ADA 和 IFX)应被视为肠 BD 的标准治疗。秋水仙碱、沙利度胺、其他药物治疗、内镜治疗和白细胞吸附术被认为是实验性治疗。

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