Jeffrey D McCurdy, Blair Macdonald, Greg Rosenfeld, Talat Bessissow, Vipul Jairath, David H. Bruining, Siddharth Singh
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Despite this, we acknowledge that subclinical abscesses, those that drain spontaneously, or those that are less severe and treated with antibiotics alone would have been missed. Therefore, future prospective studies with patient-reported outcome measures and access to point of care imaging modalities such as endoanal or transperineal ultrasound would help to determine more accurately if the rates of abscess recurrence differ substantially based on the presence of setons.</p><p>There are a number of variables that clinicians should consider when selecting potential candidates to forgo seton placement. First, our study design included patients who initiated their first anti-TNF therapy for active perianal Crohn's disease. As a result, our study population mainly comprised patients who were early on in their disease course. Second, we observed a potential protective role of setons (although not statistically significant) in a subgroup of patients with abscesses detected by pre-treatment MRI. As a result, the ability to forgo seton insertion may be most applicable for patients with first presentation PFCD without an abscess, or those with an abscess that drains spontaneously and where the goal of treatment is curative. Due to a paucity of literature pertaining to patterns of PFCD on initial presentation and the natural history of PFCD in the era of biologic therapies, it is unclear what proportion of patients with new PFCD would meet these criteria.</p><p>Future studies characterising the breadth of variability in PFCD complexity and severity, along with the proportion with associated abscesses in modern day PFCD at the time of disease onset, will help to determine the proportion of patients who might be suitable to forgo seton insertion. Finally, due to the potential for residual uncontrolled confounding, our results should be interpreted with caution. As a result, we agree with Mr. Anand and Mr. Tozer that future randomised controlled studies are needed to confirm our findings.</p><p>The authors declarations of personal and financial interests are unchanged from those in the original article [<span>2</span>].</p><p><b>Jeffrey D McCurdy:</b> conceptualization, writing – original draft. <b>Blair Macdonald:</b> writing – review and editing. <b>Greg Rosenfeld:</b> writing – review and editing. <b>Talat Bessissow:</b> writing – review and editing. <b>Vipul Jairath:</b> writing – review and editing. <b>David H. Bruining:</b> writing – review and editing. <b>Siddharth Singh:</b> writing – review and editing.</p><p>This article is linked to McCurdy et al. papers. 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引用次数: 0
摘要
我们感谢Anand先生和Tozer先生对我们研究的兴趣[1,2],以及他们通过TOpClass联盟对肛周瘘管性克罗恩病(PFCD)领域的持续贡献。他们在社论中提出了几个需要进一步解释的重要问题。我们同意我们回顾性研究的一个局限性是我们无法直接评估脓肿复发。然而,大多数与临床相关的脓肿患者都到医院就诊或接受手术引流。由于这些参数都包括在我们的主要不良瘘结局(MAFO)的复合主要终点中,我们相信我们的研究很可能捕获了大多数临床相关的脓肿。尽管如此,我们承认亚临床脓肿,那些自发流出的脓肿,或者那些不太严重且仅用抗生素治疗的脓肿可能会被遗漏。因此,未来的前瞻性研究采用患者报告的结果测量和获得护理点成像模式,如肛门内或经会阴超声,将有助于更准确地确定脓肿复发率是否因脓肿的存在而有很大差异。临床医生在选择放弃塞顿植入的潜在候选人时应考虑许多变量。首先,我们的研究设计纳入了首次针对活动性肛周克罗恩病进行抗肿瘤坏死因子治疗的患者。因此,我们的研究人群主要包括处于病程早期的患者。其次,我们观察到seons在治疗前MRI检测的脓肿患者亚组中具有潜在的保护作用(尽管没有统计学意义)。因此,放弃缝线插入的能力可能最适用于首次出现无脓肿的PFCD患者,或那些脓肿自发引流且治疗目标是治愈的患者。由于缺乏关于PFCD的初始表现模式和生物治疗时代PFCD的自然史的文献,目前尚不清楚新发PFCD患者中有多少比例符合这些标准。未来的研究将描述PFCD复杂性和严重程度的变异性,以及现代PFCD在发病时伴有脓肿的比例,这将有助于确定可能适合放弃seton插入的患者比例。最后,由于潜在的残余非控制混杂,我们的结果应该谨慎解释。因此,我们同意Anand先生和Tozer先生的观点,即需要未来的随机对照研究来证实我们的发现。作者的个人和经济利益声明与原文b[2]没有变化。杰弗里D麦科迪:概念化,写作-原稿。布莱尔麦克唐纳:写作-评论和编辑。格雷格·罗森菲尔德:写作-评论和编辑。Talat Bessissow:写作-评论和编辑。Vipul Jairath:写作-评论和编辑。David H. Bruining:写作-评论和编辑。悉达多·辛格:写作-评论和编辑。本文链接到McCurdy等人的论文。要查看这些文章,请访问https://doi.org/10.1111/apt.70081和https://doi.org/10.1111/apt.70094。
Editorial: Seton Use in Perianal Fistulising Crohn's Disease. Authors' Reply
We thank Mr. Anand and Mr. Tozer for their interest in our study [1, 2] and for their ongoing contributions to the field of perianal fistulising Crohn's disease (PFCD) through the TOpClass consortium. Several important considerations were raised in their editorial that require further explanation.
We agree that a limitation of our retrospective study was our inability to assess for abscess recurrence directly. However, most patients with clinically relevant abscesses present to hospital or undergo surgical drainage. Since each of these parameters was included in our composite primary endpoint of major adverse fistula outcomes (MAFO), we believe it is likely that our study captured most clinically relevant abscesses. Despite this, we acknowledge that subclinical abscesses, those that drain spontaneously, or those that are less severe and treated with antibiotics alone would have been missed. Therefore, future prospective studies with patient-reported outcome measures and access to point of care imaging modalities such as endoanal or transperineal ultrasound would help to determine more accurately if the rates of abscess recurrence differ substantially based on the presence of setons.
There are a number of variables that clinicians should consider when selecting potential candidates to forgo seton placement. First, our study design included patients who initiated their first anti-TNF therapy for active perianal Crohn's disease. As a result, our study population mainly comprised patients who were early on in their disease course. Second, we observed a potential protective role of setons (although not statistically significant) in a subgroup of patients with abscesses detected by pre-treatment MRI. As a result, the ability to forgo seton insertion may be most applicable for patients with first presentation PFCD without an abscess, or those with an abscess that drains spontaneously and where the goal of treatment is curative. Due to a paucity of literature pertaining to patterns of PFCD on initial presentation and the natural history of PFCD in the era of biologic therapies, it is unclear what proportion of patients with new PFCD would meet these criteria.
Future studies characterising the breadth of variability in PFCD complexity and severity, along with the proportion with associated abscesses in modern day PFCD at the time of disease onset, will help to determine the proportion of patients who might be suitable to forgo seton insertion. Finally, due to the potential for residual uncontrolled confounding, our results should be interpreted with caution. As a result, we agree with Mr. Anand and Mr. Tozer that future randomised controlled studies are needed to confirm our findings.
The authors declarations of personal and financial interests are unchanged from those in the original article [2].
Jeffrey D McCurdy: conceptualization, writing – original draft. Blair Macdonald: writing – review and editing. Greg Rosenfeld: writing – review and editing. Talat Bessissow: writing – review and editing. Vipul Jairath: writing – review and editing. David H. Bruining: writing – review and editing. Siddharth Singh: writing – review and editing.
This article is linked to McCurdy et al. papers. To view these articles, visit https://doi.org/10.1111/apt.70081 and https://doi.org/10.1111/apt.70094.
期刊介绍:
Alimentary Pharmacology & Therapeutics is a global pharmacology journal focused on the impact of drugs on the human gastrointestinal and hepato-biliary systems. It covers a diverse range of topics, often with immediate clinical relevance to its readership.