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Editorial: Rebuilding Rome-Revising Diagnostic Criteria for Irritable Bowel Syndrome. 社论:重建罗马--修订肠易激综合征诊断标准。
IF 6.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-14 DOI: 10.1111/apt.18400
Mohsin F Butt, Maura Corsetti
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引用次数: 0
Meta-Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials. 元分析:评估嗜酸性粒细胞性食管炎随机对照试验结果中的安慰剂比例。
IF 6.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-14 DOI: 10.1111/apt.18382
Angelica Rivas, Newaz Shubidito Ahmed, Yuhong Yuan, Anila Qasim, David B O'Gorman, Brian G Feagan, Vipul Jairath, Albert J Bredenoord, Evan S Dellon, Christopher Ma

Background: High placebo responses have limited drug development in eosinophilic oesophagitis. The optimal configuration of trial outcomes is uncertain.

Aims: To inform more efficient future trial designs, to characterise clinical, endoscopic and histologic placebo responses in eosinophilic oesophagitis randomised controlled trials (RCTs).

Methods: We updated a Cochrane systematic review and meta-analysis, searching multiple databases to January 1, 2024, to identify placebo-controlled RCTs evaluating medical therapies for patients with eosinophilic oesophagitis. The primary outcome was the pooled proportion of study-defined clinical, endoscopic and histologic responders and remitters randomised to placebo, using an intention-to-treat approach and random-effects model. Sources of heterogeneity were explored using meta-regression.

Results: We included 25 RCTs. The pooled proportion of clinical response was 41.0% [95% CI: 29.7%-52.8%] with substantial heterogeneity (I2 = 74.9%). On meta-regression, older age and a higher probability of being randomised to placebo reduced the likelihood of clinical response to placebo. The pooled proportion of histologic remission defined as a peak eosinophil count [PEC] ≤ 6 eosinophils per high power field [HPF] or ≤ 1 eosinophil/HPF was 4.3% [95% CI: 2.6%-6.2%] (I2 = 23.6%) and 1.3% [95% CI: 0.5%-2.5%] (I2 = 0%), respectively. The standardised mean difference in the Eosinophilic Oesophagitis Endoscopic Reference Score to placebo was -0.25 [95% CI: -0.41, -0.10].

Conclusions: Over 40% of patients in eosinophilic oesophagitis trials respond clinically to placebo, and this is associated with trial design factors such as randomisation ratio and trial population. Objective endoscopic and histologic measures are associated with very low placebo responses.

背景:高安慰剂反应限制了嗜酸性粒细胞性食管炎的药物开发。目的:为了给未来更有效的试验设计提供信息,描述嗜酸性粒细胞性食管炎随机对照试验(RCT)中临床、内镜和组织学安慰剂反应的特征:我们更新了 Cochrane 系统综述和荟萃分析,搜索了多个数据库(截至 2024 年 1 月 1 日),以确定对嗜酸性粒细胞性食管炎患者的药物疗法进行评估的安慰剂对照 RCT。采用意向治疗法和随机效应模型,主要结果是研究定义的临床、内镜和组织学应答者和缓解者与安慰剂随机对照的汇总比例。采用元回归法探讨了异质性的来源:结果:我们纳入了 25 项研究。临床反应的汇总比例为 41.0% [95% CI:29.7%-52.8%],异质性很大(I2 = 74.9%)。在元回归中,年龄越大、被随机分配到安慰剂的概率越高,对安慰剂产生临床反应的可能性就越小。嗜酸性粒细胞峰值计数[PEC]≤6个/高倍视野[HPF]或≤1个/HPF的组织学缓解率分别为4.3%[95% CI:2.6%-6.2%](I2 = 23.6%)和1.3%[95% CI:0.5%-2.5%](I2 = 0%)。嗜酸性粒细胞食管炎内镜参考评分与安慰剂的标准化平均差异为-0.25 [95% CI:-0.41, -0.10]:在嗜酸性粒细胞性食管炎试验中,超过40%的患者对安慰剂有临床反应,这与试验设计因素(如随机化比率和试验人群)有关。客观的内镜和组织学指标与极低的安慰剂反应有关。
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引用次数: 0
Editorial: Assessing the Prognosis of Patients With HBV and ACLF—Comorbidities Matter. Authors' Reply 社论:评估 HBV 和 ACLF 患者的预后--合并症很重要。作者回复
IF 7.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-13 DOI: 10.1111/apt.18392
Jiong Yu, Xinyi Chen, Guoqiang Cao, Qiaoling Pan, Chenjie Huang, Rui Luo, Xiaoqing Lu, Xiaoxiao Chen, Tan Li, Haijun Huang, Jian Wu, Lanjuan Li, Hongcui Cao
<p>We extend our sincere gratitude to Dr. Francesco Paolo Russo and Alberto Ferrarese for their thorough evaluation and professional insights on our study [<span>1</span>]. We are gratified by their recognition of the potential of the age-adjusted Charlson Comorbidity Index for Hepatitis B Virus-Related Acute-on-Chronic Liver Failure (aCCI-HBV-ACLF) score in enhancing the accuracy of short-term and medium-term prognostic predictions, particularly in integrating comorbidity factors and reducing variability among clinicians [<span>2</span>].</p><p>Previous research has established that multiple comorbidities are strongly associated with poor prognosis, with extrahepatic complications such as chronic renal failure and diabetes significantly elevating the mortality risk in patients with liver disease [<span>3-5</span>]. However, the relatively low incidence of these comorbidities presents challenges in fully incorporating them into prognostic models. Although the aCCI was initially designed for long-term prognostic evaluation, study has underscored its relevance in evaluating the prognosis of liver disease patients [<span>6</span>]. Similarly, our further analysis demonstrated that in the short-term prognosis of patients with HBV-related ACLF, nearly all comorbidities included in the aCCI are significantly correlated with short-term survival outcomes (Table 1). For instance, cardiovascular diseases were associated with a 287% increase in the 28-day mortality risk and a 267% increase in the 90-day mortality risk. Additionally, patients with chronic obstructive pulmonary disease, connective tissue diseases, diabetes, moderate to severe renal disease, tumours and haematological diseases exhibited substantially increased mortality risks. In contrast, although peptic ulcer disease showed a certain increase in risk, it did not reach statistical significance (<i>p</i> > 0.05).</p><div><header><span>TABLE 1. </span>Relationships between comorbidity and 28-day mortality and 90-day mortality in patients with HBV-ACLF.</header><div tabindex="0"><table><thead><tr><th rowspan="2">Variables</th><th rowspan="2">Total (<i>n</i>)</th><th colspan="3">28-day mortality</th><th colspan="3">90-day mortality</th></tr><tr><th style="top: 41px;">Events (%)</th><th style="top: 41px;">HR (95% CI)</th><th style="top: 41px;"><i>p</i> value</th><th style="top: 41px;">Events (%)</th><th style="top: 41px;">HR (95% CI)</th><th style="top: 41px;"><i>p</i> value</th></tr></thead><tbody><tr><td>Total</td><td>1238</td><td>295 (23.8)</td><td></td><td></td><td>397 (32.1)</td><td></td><td></td></tr><tr><td colspan="8">Cardiovascular diseases<sup>a</sup></td></tr><tr><td style="padding-left:2em;">Yes</td><td>31</td><td>22 (71.0)</td><td rowspan="2">3.87 (2.51, 5.98)</td><td rowspan="2">< 0.001</td><td>24 (77.4)</td><td rowspan="2">3.67 (2.42, 5.56)</td><td rowspan="2">< 0.001</td></tr><tr><td style="padding-left:2em;">No</td><td>1207<
他们的反馈进一步阐明了 aCCI-HBV-ACLF 评分在不同人群中的适用性和优化途径。我们坚信,aCCI-HBV-ACLF 评分能为临床实践中 ACLF 患者的治疗和管理提供更准确的预后评估工具。
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引用次数: 0
Letter: Insulin-Like Growth Factor-1 in Cirrhosis Is Linked to Hepatic Dysfunction and Fibrogenesis and Predicts Liver-Related Mortality 信肝硬化患者体内的胰岛素样生长因子-1与肝功能异常和纤维化有关,并可预测肝脏相关死亡率
IF 7.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-13 DOI: 10.1111/apt.18366
Okasha Tahir, Muhammad Muzamil Rafique, Abdul Ghani Khan, Asia Rajab, Umama Alam, Muhammad Umar, Laiba Shamim, Ayesha Hidayat

We read the article published in your esteemed journal titled, “Insulin-like growth factor-1 in cirrhosis is linked to hepatic dysfunction and fibrogenesis and predicts liver-related mortality” by Hartl et al. with great interest. We appreciate the authors for investigating the prognostic role of insulin-like growth factor-1 (IGF-1) in advanced chronic liver disease (ACLD) patients [1]. While the study provides valuable insights, we believe certain limitations warrant further discussion.

Firstly, the small sample size of 269 patients does not reflect the global heterogeneity of cirrhosis patients, which potentially limits the generalizability of the findings. Studies with larger sample sizes, ideally ranging from 500 to 1000 patients, would offer more statistically robust conclusions. This is particularly important given the various etiologies of cirrhosis, such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol-related liver disease, and viral hepatitis, which affect IGF-1 levels differently [2]. Expanding the cohort to include a more diverse population could improve the validity of the findings.

Secondly, the potential confounding variables such as obesity and diabetes are not addressed by the authors, which could distort the interpretation of IGF-1 as a measure of the severity of liver diseases. For instance, Aleidi et al. found that type 2 diabetes is associated with significantly lower IGF-1 levels, irrespective of liver function. By not controlling for these metabolic factors, the study may misattribute changes in IGF-1 levels to liver dysfunction alone. Future studies should include these factors in multivariate models to provide a clearer understanding of IGF-1's role in cirrhosis [3].

Lastly, the median follow-up period of 604 days may be insufficient to capture the full progression of cirrhosis and its complications, such as hepatocellular carcinoma and liver-related mortality. Studies like Saeki et al. have demonstrated the importance of long-term follow-up, using a median duration of 57.1 months to assess the prognostic value of IGF-1 [4]. Given the slow progression of cirrhosis, a follow-up period of at least 5 years would provide a more comprehensive evaluation of IGF-1's predictive power and help capture critical outcomes such as development of hepatocellular carcinoma, survival rates, and complications like hepatic encephalopathy.

Future studies should address these limitations by incorporating a larger sample size, extending follow-up periods, and accounting for potential confounding factors such as diabetes and obesity. Doing so will not only strengthen the study's findings but also provide deeper insights into the long-term outcomes of cirrhosis management and the prognostic value of IGF-1 across diverse populations. Ultimately, this will contribute to improved patient outcomes and more refined therapeutic approaches.

我们饶有兴趣地阅读了哈特尔(Hartl)等人在贵刊上发表的题为《肝硬化中的胰岛素样生长因子-1与肝功能异常和纤维化有关,并可预测肝脏相关死亡率》的文章。我们感谢作者研究胰岛素样生长因子-1(IGF-1)在晚期慢性肝病(ACLD)患者中的预后作用[1]。虽然该研究提供了有价值的见解,但我们认为某些局限性值得进一步讨论。首先,269 例患者的样本量较小,不能反映肝硬化患者的整体异质性,这可能会限制研究结果的推广性。样本量更大的研究(最好是 500 到 1000 名患者)将能提供统计学上更可靠的结论。这一点尤为重要,因为肝硬化的病因多种多样,如代谢功能障碍相关性脂肪性肝炎(MASH)、酒精相关性肝病和病毒性肝炎,这些病因对 IGF-1 水平的影响各不相同 [2]。其次,作者没有考虑肥胖和糖尿病等潜在的混杂变量,这可能会扭曲IGF-1作为肝病严重程度测量指标的解释。例如,Aleidi等人发现,无论肝功能如何,2型糖尿病都与IGF-1水平显著降低有关。由于没有控制这些代谢因素,该研究可能会将IGF-1水平的变化错误地归因于肝功能异常。最后,604 天的中位随访期可能不足以反映肝硬化及其并发症(如肝细胞癌和肝脏相关死亡率)的全部进展。Saeki等人的研究证明了长期随访的重要性,他们用57.1个月的中位随访时间来评估IGF-1的预后价值[4]。鉴于肝硬化进展缓慢,至少 5 年的随访期将能更全面地评估 IGF-1 的预测能力,并有助于捕捉肝细胞癌的发展、存活率以及肝性脑病等并发症等重要结果。未来的研究应通过纳入更大样本量、延长随访期以及考虑糖尿病和肥胖等潜在混杂因素来解决这些局限性。未来的研究应通过纳入更大的样本量、延长随访时间并考虑糖尿病和肥胖等潜在混杂因素来解决这些局限性。这样做不仅能加强研究结果,还能更深入地了解肝硬化管理的长期结果以及IGF-1在不同人群中的预后价值。最终,这将有助于改善患者的预后和改进治疗方法。
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引用次数: 0
Editorial: Assessing the Prognosis of Patients With HBV and ACLF—Comorbidities Matter 社论:评估 HBV 和 ACLF 患者的预后--并发症很重要
IF 7.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-13 DOI: 10.1111/apt.18361
Francesco Paolo Russo, Alberto Ferrarese
<p>Acute-on-chronic liver failure (ACLF) is a severe condition characterised by high short-term mortality, requiring rapid diagnosis, prompt treatment of trigger factors and appropriate prognostic evaluation to guide patients towards the best therapeutic options. Although several scores, such as the model for end-stage liver disease (MELD) and the CLIF-C ACLF score, have been proposed over time to assess short-term prognosis, their predictive accuracy remains suboptimal, partly due to heterogeneous diagnostic criteria and the inability to account for underlying comorbidities that significantly affect patient outcomes [<span>1, 2</span>].</p><p>Chen et al. [<span>3</span>] aimed to improve prognostic accuracy in patients with hepatitis B (HBV)-related ACLF. They analysed a retrospective cohort of 906 HBV patients with ACLF according to the Asian Pacific criteria and proposed a new score, the age-adjusted Charlson Comorbidity Index (aCCI)-HBV-ACLF score. This score incorporates the aCCI [<span>4</span>] along with key clinical indicators (neutrophil count, INR, serum bilirubin). The novel score accurately predicted short- and mid-term mortality, with areas under the ROC curve of 0.859, 0.869 and 0.868 for 28-day mortality, and 0.822, 0.850 and 0.888 for 90-day mortality in the training, internal validation and external validation cohorts, respectively, outperforming all available scores. Major strengths of this predictive model include the objective assessment of clinical and laboratory values, which reduces inter-clinician variability, and the inclusion of comorbidities. Moreover, although the score demonstrated only a slight increase in prognostic accuracy compared to the CLIF-C ACLF score in predicting 28-day outcomes, the clinical gain was more significant at 90 days, underscoring the potential impact of comorbidities on medium-term outcomes.</p><p>While the findings are promising, the score has several limitations. First, it has been tested only in Asian populations, raising questions about its generalizability across other ethnicities. Moreover, ACLF was diagnosed according to the Asian Pacific criteria [<span>5</span>], where liver failure is the primary factor. This explains why the new score identified two of the four factors as liver-specific (bilirubin and INR), whereas other factors that carry significant weight in other prognostic scores were not included.</p><p>Regarding the aCCI score, it appears that most points were derived from underlying liver disease across all analysed cohorts. Except for diabetes, none of the other factors included in the aCCI had a prevalence greater than 3%. This may partially undermine the aCCI's effectiveness as a tool for assessing extrahepatic comorbidities in HBV-ACLF patients. Furthermore, it should be noted that the aCCI was originally designed to estimate long-term mortality but has been considered a short-term prognostic tool in the manuscript by Chen et al. Some variables (e.g. AIDS, lymphoma) m
急性慢性肝衰竭(ACLF)是一种严重的疾病,其特点是短期死亡率高,需要快速诊断、及时治疗诱发因素并进行适当的预后评估,以指导患者选择最佳治疗方案。尽管随着时间的推移,人们提出了一些评估短期预后的评分标准,如终末期肝病模型(MELD)和CLIF-C ACLF评分,但其预测准确性仍不理想,部分原因是诊断标准不统一,且无法考虑对患者预后有显著影响的潜在合并症[1, 2]。他们根据亚太地区标准分析了 906 名患有 ACLF 的 HBV 患者的回顾性队列,并提出了一种新的评分方法,即年龄调整后的夏尔森合并症指数(aCCI)-HBV-ACLF 评分。该评分结合了 aCCI [4] 和主要临床指标(中性粒细胞计数、INR、血清胆红素)。新评分能准确预测短期和中期死亡率,在训练、内部验证和外部验证队列中,28 天死亡率的 ROC 曲线下面积分别为 0.859、0.869 和 0.868,90 天死亡率的 ROC 曲线下面积分别为 0.822、0.850 和 0.888,优于所有可用评分。该预测模型的主要优点包括客观评估临床和实验室数值,从而减少了医生之间的差异,并纳入了合并症。此外,虽然与 CLIF-C ACLF 评分相比,该评分在预测 28 天预后方面的准确性仅略有提高,但在 90 天时的临床增益更为显著,凸显了合并症对中期预后的潜在影响。首先,该方法仅在亚洲人群中进行过测试,这就对其在其他种族中的通用性提出了质疑。此外,ACLF 是根据亚太地区标准[5]诊断的,其中肝功能衰竭是主要因素。这就解释了为什么新的评分将四个因素中的两个确定为肝脏特异性因素(胆红素和 INR),而其他在其他预后评分中具有重要权重的因素却没有被包括在内。除糖尿病外,其他纳入 aCCI 的因素的患病率均未超过 3%。这可能会部分削弱 aCCI 作为评估 HBV-ACLF 患者肝外合并症工具的有效性。此外,应该注意的是,aCCI 最初是用于估算长期死亡率的,但在 Chen 等人的手稿中却被认为是一种短期预后工具。最后,该评分仅适用于未接受过肝移植的患者,因此应仅限于这一特定人群。总之,该研究提供了一种新的评分方法,能够准确预测 HBVACLF 患者的预后。然而,在正确识别合并症对 ACLF 患者短期预后的影响方面,aCCI 的实际效果还有待进一步研究。
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引用次数: 0
Letter: Bowel Preparation Quality in Patients With Crohn's Disease 信克罗恩病患者的肠道准备质量
IF 7.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-12 DOI: 10.1111/apt.18350
Tamar Schildkraut, Nik (John) S. Ding, John David Chetwood
<p>Adequate bowel preparation is crucial for optimal visualisation and lesion detection and remains a key determinant of colonoscopy quality [<span>1, 2</span>]. Up to one-quarter of colonoscopies are conducted with inadequate bowel preparation, leading to reduced diagnostic yield and detection of nonpolypoid flat lesions, prolonged procedure time and an increased burden of repeat colonoscopies [<span>2, 3</span>].</p><p>Several validated scales exist for the assessment of bowel preparation quality, however, an area of unmet need is validated scores for patients with inflammatory bowel disease (IBD), where endoscopy is essential to diagnosis, disease assessment, management and cancer surveillance. The presence of strictures, severe inflammation and insufficient bowel preparation may present a unique challenge to colonoscopy quality in IBD. Additionally, various adverse predictors of poor bowel preparation have been identified in IBD patients [<span>4-6</span>]. There is a clear need for robust and reproducible colonoscopy quality control measures in this sub-population [<span>7</span>].</p><p>Solitano et al. evaluated the performance of four existing bowel preparation quality instruments—Boston Bowel Preparation Scale (BBPS), a modified BBPS (mBBPS), Harefield Cleansing Scale, and Bowel Cleansing Assessment Scale—in 50 endoscopy videos with Crohn's disease (CD) [<span>8</span>]. Their findings demonstrated ‘moderate’ to ‘substantial’ inter-rater and intra-rater reliability, and high correlation coefficients between instruments and the visual analogue scale. An important finding is that all instruments performed well in terms of overall reliability and the authors concluded that instrument selection for use in clinical practice should be based on familiarity and local practice.</p><p>This is an important study to support the use of these instruments as reliable and valid measures of bowel preparation quality in CD—particularly in those with active luminal disease, with 72.5% of the procedures having an SES-CD score > 3. Areas for further exploration include the instruments' ease of use, and the degree of ambiguity in interpreting the scores for each instrument. These factors were not discussed in this paper, however, would be highly relevant in clinical practice and informing consensus guidelines. Furthermore, the observed numerical differences in correlation scores would be of interest to explore in further large studies.</p><p>Important study limitations include the small sample size, which makes it challenging to comment on the applicability of these findings to specific CD subgroups. We look forward to further studies evaluating the reliability of quality scales particularly in penetrating, stricturing, and perianal fistulising CD cohorts with active proctitis. The cohort heterogeneity presents another limitation in applying these data to the general CD population. For instance, assessing colon preparation scores in a cohort that includ
充分的肠道准备对于获得最佳视野和病变检测至关重要,也是决定结肠镜检查质量的关键因素[1, 2]。多达四分之一的结肠镜检查是在肠道准备不充分的情况下进行的,这导致诊断率降低、非息肉样扁平病变的检出率降低、手术时间延长以及重复结肠镜检查的负担加重[2, 3]。狭窄、严重炎症和肠道准备不足的存在可能会给 IBD 患者的结肠镜检查质量带来独特的挑战。此外,在 IBD 患者中还发现了肠道准备不足的各种不良预测因素 [4-6]。Solitano 等人评估了现有的四种肠道准备质量工具--波士顿肠道准备量表 (BBPS)、改良 BBPS (mBBPS)、Harefield 清洁量表和肠道清洁评估量表--在 50 个克罗恩病(CD)内镜检查视频中的表现[8]。他们的研究结果表明,评分者之间和评分者内部的可靠性为 "中等 "到 "相当高",工具与视觉模拟量表之间的相关系数很高。这是一项重要的研究,它支持使用这些工具作为 CD 肠道准备质量的可靠有效的测量方法,尤其是在管腔疾病活跃的患者中,72.5% 的手术中 SES-CD 评分为 3 分。需要进一步探讨的领域包括工具的易用性以及解释每种工具评分时的模糊程度。本文未对这些因素进行讨论,但这些因素与临床实践和共识指南的制定高度相关。此外,在进一步的大型研究中,观察到的相关性评分的数字差异也值得探讨。重要的研究局限性包括样本量较小,因此很难对这些研究结果是否适用于特定的 CD 亚组进行评论。我们期待着进一步的研究来评估质量量表的可靠性,尤其是在患有活动性直肠炎的穿透性、狭窄性和肛周瘘性 CD 队列中。队列异质性是将这些数据应用于普通 CD 患者的另一个限制因素。例如,在包括许多孤立回肠疾病患者(占手术的 14.3%)的队列中评估结肠准备评分会带来解释上的复杂性。总之,这项研究为在 CD 中使用现有的肠道准备质量工具提供了支持。需要进一步的研究来解决与样本量和亚组适用性相关的局限性。
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引用次数: 0
Letter: Bowel Preparation Quality in Patients With Crohn's Disease—Authors' Reply 信:克罗恩病患者的肠道准备质量--作者的回复
IF 7.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-12 DOI: 10.1111/apt.18394
Virginia Solitano, Guangyong Zou, Vipul Jairath
<p>We thank Dr. Schildkraut et al. for their thoughtful commentary and the acknowledgment of the importance of our study in demonstrating that existing bowel preparation quality assessment instruments, typically used in the general population, are also reliable and valid for patients with Crohn's disease (CD) [<span>1</span>]. The implications of these findings are that instrument selection for use in clinical practice should be based on familiarity and local practice. The ease of use and interpretability of these instruments are critical for effective clinical application and need further exploration. Instruments that are simple to administer and reduce ambiguity in score interpretation could significantly enhance clinician confidence, making them more suitable for routine practice and future guideline development. Our results also support the inclusion of patients with CD in studies to evaluate novel bowel preparation formulations, which are historically conducted on healthy subjects [<span>2</span>].</p><p>The 50 endoscopy videos evaluated in our study included recordings of 34 colonoscopies with terminal ileal evaluation, 14 colonoscopies, and two flexible sigmoidoscopies, involving a total of 40 patients with CD. We rigorously justified the sample size using formal sample size calculation as outlined by Zou [<span>3</span>]. We adhered to the fundamental principle that a study too small may lack the power to adequately address the research question, while an overly large study can result in unnecessary use of resources and may raise ethical concerns. In this study, assuming an intraclass correlation coefficient of 0.80, scoring 50 videos by three central readers provided over 86% probability of obtaining a one-sided 95% lower bound exceeding 0.65, meeting the “substantial” agreement threshold per Landis and Koch's criteria [<span>4</span>]. We also highlight that this estimate was conservative, as we ultimately analysed the data using a two-way random effects model, which is more efficient and yields stronger reliability estimates [<span>3</span>].</p><p>At diagnosis, disease location was ileocolonic in 38.5%, colonic in 15.4% and ileal in 12.8% of patients. Disease behaviour was non-stricturing/non-penetrating in 46.1%, penetrating in 20.5%, and stricturing in 7.7% of patients. We acknowledge that our study population was heterogeneous, reflecting the real-world diversity of patients with CD compared to the general population. This heterogeneity, while presenting interpretive challenges, is an inherent characteristic of CD and underscores the importance of evaluating novel bowel preparation formulations within this group [<span>5</span>]. We concur with the authors that there is a need for further research specifically targeting the CD population to better understand not only the reliability of bowel preparation instruments but also the effectiveness of novel bowel preparation formulations, particularly in subgroups such as those with pen
我们感谢 Schildkraut 博士等人深思熟虑的评论,感谢他们承认我们的研究在证明现有的肠道准备质量评估工具(通常用于普通人群)对克罗恩病 (CD) 患者同样可靠有效方面的重要性 [1]。这些发现的意义在于,临床实践中应根据熟悉程度和当地实际情况选择使用的工具。这些工具的易用性和可解释性是有效临床应用的关键,需要进一步探讨。简便易行且能减少评分解释模糊性的工具可显著增强临床医生的信心,使其更适合常规实践和未来指南的制定。我们的研究结果还支持将 CD 患者纳入评估新型肠道制剂的研究中,而这些研究历来都是在健康受试者身上进行的[2]。我们的研究评估了 50 个内窥镜检查视频,包括 34 个带有回肠末端评估的结肠镜检查、14 个结肠镜检查和 2 个柔性乙状结肠镜检查的录像,共涉及 40 名 CD 患者。我们按照邹氏(Zou)[3]提出的正规样本量计算方法,对样本量进行了严格的论证。我们坚持的基本原则是,过小的研究可能缺乏充分解决研究问题的能力,而过大的研究可能导致不必要的资源使用,并可能引发伦理问题。在本研究中,假定类内相关系数为 0.80,由三名中心阅读者对 50 部视频进行评分,获得单侧 95% 下限超过 0.65 的概率超过 86%,达到了 Landis 和 Koch 标准[4]规定的 "实质性 "一致阈值。我们还强调,这一估计值是保守的,因为我们最终使用了双向随机效应模型来分析数据,该模型效率更高,可靠性估计值也更强[3]。在诊断时,38.5% 的患者疾病部位为回结肠,15.4% 的患者为结肠,12.8% 的患者为回肠。46.1%的患者的疾病表现为非狭窄性/非穿透性,20.5%为穿透性,7.7%为狭窄性。我们承认,我们的研究对象具有异质性,这反映了与普通人群相比,CD 患者在现实世界中的多样性。这种异质性虽然带来了解释上的挑战,但却是 CD 的固有特征,并强调了在该群体中评估新型肠道制剂配方的重要性[5]。我们同意作者的观点,即有必要专门针对 CD 群体开展进一步研究,以便更好地了解肠道准备工具的可靠性以及新型肠道准备配方的有效性,尤其是在患有穿透性、狭窄性或肛周瘘疾病的亚群体中。总之,我们的研究为将 CD 患者纳入评估新型肠道准备剂型的临床试验提供了有力证据,并支持在新型疗法试验中对肠道准备质量进行标准化评估。我们期待未来的研究能以这些发现为基础,进一步探索它们在更大和更特殊的 CD 亚群中的适用性。
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引用次数: 0
Real-Time Assessment of H. pylori Infection to Guide Molecular Antibiotic Resistance Testing: A Combined Endoscopy-Gastric Juice Analysis Approach 实时评估幽门螺杆菌感染以指导分子抗生素耐药性测试:内窥镜检查与胃液分析相结合的方法
IF 7.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-12 DOI: 10.1111/apt.18378
Riccardo Vasapolli, Florent Ailloud, Beate Spießberger, Peter Malfertheiner, Sebastian Suerbaum, Christian Schulz
Helicobacter pylori antibiotic resistance is the most relevant cause of treatment failure. Antibiotic susceptibility testing (AST) allows for selecting the appropriate eradication regimen.
幽门螺杆菌的抗生素耐药性是治疗失败的最主要原因。通过抗生素药敏试验(AST)可以选择适当的根除方案。
{"title":"Real-Time Assessment of H. pylori Infection to Guide Molecular Antibiotic Resistance Testing: A Combined Endoscopy-Gastric Juice Analysis Approach","authors":"Riccardo Vasapolli, Florent Ailloud, Beate Spießberger, Peter Malfertheiner, Sebastian Suerbaum, Christian Schulz","doi":"10.1111/apt.18378","DOIUrl":"https://doi.org/10.1111/apt.18378","url":null,"abstract":"<i>Helicobacter pylori</i> antibiotic resistance is the most relevant cause of treatment failure. Antibiotic susceptibility testing (AST) allows for selecting the appropriate eradication regimen.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"42 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142599904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Favourable Prognosis of Patients With Untreated HBeAg‐Negative Chronic Hepatitis B Virus Infection With HBsAg < 100 IU/mL 未经治疗的 HBeAg 阴性、HBsAg < 100 IU/mL 的慢性乙型肝炎病毒感染患者的良好预后
IF 7.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-11 DOI: 10.1111/apt.18383
Jian Wang, Zhiyi Zhang, Shengxia Yin, Shaoqiu Zhang, Li Zhu, Yifan Pan, Tao Fan, Fei Cao, Ye Xiong, Chao Jiang, Guiyang Wang, Yue Yang, Bei Jia, Jiacheng Liu, Juan Xia, Xiaomin Yan, Jie Li, Chuanwu Zhu, Xingxiang Liu, Yuxin Chen, Chao Wu, Rui Huang
BackgroundSerum hepatitis B surface antigen (HBsAg) < 100 IU/mL has been recently proposed as one of the key criteria of ‘partial cure’ in patients with chronic hepatitis B virus (HBV) infection. We analysed the clinical prognosis of hepatitis B e antigen (HBeAg)‐negative untreated patients with HBsAg < 100 IU/mL and normal alanine aminotransferase (ALT) levels.MethodsFive hundred and twenty‐one untreated patients with HBeAg negativity, HBsAg < 100 IU/mL and normal ALT levels were included from three hospitals. Spontaneous HBsAg seroclearance, phase transition, liver fibrosis progression and hepatocellular carcinoma (HCC) development were analysed.ResultsThe median age was 43.0 years, and 62.2% of the patients were male. After a median follow‐up of 25.0 months, 52 (10.0%) patients achieved spontaneous HBsAg seroclearance. The annual HBsAg seroclearance rate is 4.2%. Patients with baseline HBsAg ≤ 10 IU/mL (adjusted hazard ratio [aHR] = 3.490, p < 0.001) and male sex (aHR = 1.980, p = 0.041) were more likely to achieve HBsAg seroclearance. Only 4 (0.8%) and 23 (4.8%) patients transitioned to the immune escape phase and HBeAg‐negative indeterminate phase, respectively. Baseline serum HBsAg > 10 IU/mL (aHR = 3.846, p = 0.034) and detectable HBV DNA (aHR = 2.672, p = 0.023) were associated with transition to the HBeAg‐negative indeterminate phase. No patient developed HCC or had fatal outcomes.ConclusionsHBeAg‐negative patients with serum HBsAg < 100 IU/mL and normal ALT levels had a favourable prognosis. HBsAg ≤ 10 IU/mL and male sex were associated with a higher rate of HBsAg seroclearance, while HBsAg > 10 IU/mL and detectable HBV DNA were associated with a higher risk of transition to the indeterminate phase.
背景最近,有人提出将血清乙型肝炎表面抗原(HBsAg)< 100 IU/mL作为慢性乙型肝炎病毒(HBV)感染患者 "部分治愈 "的关键标准之一。我们分析了乙型肝炎e抗原(HBeAg)阴性、HBsAg< 100 IU/mL且丙氨酸氨基转移酶(ALT)水平正常、未经治疗的患者的临床预后。结果 中位年龄为 43.0 岁,62.2% 的患者为男性。中位随访 25.0 个月后,52 例(10.0%)患者自发清除了 HBsAg。每年的 HBsAg 血清清除率为 4.2%。基线 HBsAg ≤ 10 IU/mL (调整后危险比 [aHR] = 3.490,p < 0.001)和男性(aHR = 1.980,p = 0.041)的患者更有可能实现 HBsAg 血清清除。分别只有 4 例(0.8%)和 23 例(4.8%)患者转入免疫逃逸期和 HBeAg 阴性不确定期。基线血清 HBsAg > 10 IU/mL (aHR = 3.846, p = 0.034) 和可检测到的 HBV DNA (aHR = 2.672, p = 0.023) 与转入 HBeAg 阴性不确定期相关。结论血清 HBsAg≥lt; 100 IU/mL 且 ALT 水平正常的 HBeAg 阴性患者预后良好。HBsAg≤10 IU/mL和男性与较高的HBsAg血清清除率有关,而HBsAg > 10 IU/mL和可检测到的HBV DNA与较高的转入不确定期的风险有关。
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引用次数: 0
Meta‐Analysis: Prevalence of Frailty and Associated Adverse Events in Inflammatory Bowel Diseases 元分析:炎症性肠病患者体弱多病及相关不良事件的发生率
IF 7.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-11 DOI: 10.1111/apt.18390
Isabel Carbery, Oliver Todd, Matthew Hale, Christopher J. Black, Andrew Clegg, Christian P. Selinger
BackgroundThe number of adults aged over 60 years with inflammatory bowel disease (IBD) is increasing. Frailty, rather than chronological age, may be a better predictor of adverse health outcomes.AimsTo summarise current knowledge about frailty in adults with IBD including the prevalence and associations of frailty and IBD‐related adverse outcomes.MethodsWe performed an electronic search of MEDLINE, EMBASE and EMBASE Classic databases using search terms for IBD and frailty from inception to 14 February 2024. All studies involving adults aged ≥ 16 with a confirmed diagnosis of IBD that included a frailty assessment were eligible for inclusion.ResultsWe included 23 observational studies involving 1,893,448 adults. Risk of bias was low for 18 studies and moderate for five. Twelve methods of frailty assessment were used, the most common being the Hospital Frailty Risk Score. Pooled prevalence of frailty in IBD patients was 18% (95% confidence interval (CI) 12.4%–25.6%). Meta‐analysis of unadjusted events data demonstrated that frailty increased the risk of infection‐related admissions following treatment in two studies (relative risk (RR) 1.9; 95% CI 1.2–3.0), post‐operative morbidity in three (RR 2.0; 95% CI 1.4–2.7) and mortality in seven (RR 4.3; 95% CI 2.6–7.4).ConclusionsFrailty is common in patients with IBD and is associated with IBD‐related adverse outcomes including infection‐related admissions following treatment, post‐operative morbidity and death. Future work should focus on developing risk assessment tools to better support decision making for older people with frailty and IBD.
背景60岁以上患有炎症性肠病(IBD)的成年人越来越多。方法我们使用 IBD 和虚弱的检索词对 MEDLINE、EMBASE 和 EMBASE Classic 数据库进行了电子检索,检索时间从开始到 2024 年 2 月 14 日。所有涉及年龄≥16 岁、确诊 IBD 且包含虚弱评估的成人的研究均符合纳入条件。结果我们纳入了 23 项观察性研究,涉及 1,893,448 名成人。18项研究的偏倚风险较低,5项研究的偏倚风险中等。共使用了 12 种虚弱评估方法,其中最常用的是医院虚弱风险评分法。汇总的 IBD 患者体弱患病率为 18%(95% 置信区间 (CI) 12.4%-25.6%)。对未经调整的事件数据进行的 Meta 分析表明,在两项研究中,虚弱增加了治疗后感染相关入院的风险(相对风险 (RR) 1.9;95% CI 1.2-3.0),在三项研究中增加了术后发病率(RR 2.0;95% CI 1.4-2.7),在七项研究中增加了死亡率(RR 2.0;95% CI 1.4-2.7)。结论虚弱在 IBD 患者中很常见,并与 IBD 相关不良后果有关,包括治疗后感染相关入院、术后发病和死亡。未来的工作重点应放在开发风险评估工具上,以便更好地为患有体弱和 IBD 的老年人提供决策支持。
{"title":"Meta‐Analysis: Prevalence of Frailty and Associated Adverse Events in Inflammatory Bowel Diseases","authors":"Isabel Carbery, Oliver Todd, Matthew Hale, Christopher J. Black, Andrew Clegg, Christian P. Selinger","doi":"10.1111/apt.18390","DOIUrl":"https://doi.org/10.1111/apt.18390","url":null,"abstract":"BackgroundThe number of adults aged over 60 years with inflammatory bowel disease (IBD) is increasing. Frailty, rather than chronological age, may be a better predictor of adverse health outcomes.AimsTo summarise current knowledge about frailty in adults with IBD including the prevalence and associations of frailty and IBD‐related adverse outcomes.MethodsWe performed an electronic search of MEDLINE, EMBASE and EMBASE Classic databases using search terms for IBD and frailty from inception to 14 February 2024. All studies involving adults aged ≥ 16 with a confirmed diagnosis of IBD that included a frailty assessment were eligible for inclusion.ResultsWe included 23 observational studies involving 1,893,448 adults. Risk of bias was low for 18 studies and moderate for five. Twelve methods of frailty assessment were used, the most common being the Hospital Frailty Risk Score. Pooled prevalence of frailty in IBD patients was 18% (95% confidence interval (CI) 12.4%–25.6%). Meta‐analysis of unadjusted events data demonstrated that frailty increased the risk of infection‐related admissions following treatment in two studies (relative risk (RR) 1.9; 95% CI 1.2–3.0), post‐operative morbidity in three (RR 2.0; 95% CI 1.4–2.7) and mortality in seven (RR 4.3; 95% CI 2.6–7.4).ConclusionsFrailty is common in patients with IBD and is associated with IBD‐related adverse outcomes including infection‐related admissions following treatment, post‐operative morbidity and death. Future work should focus on developing risk assessment tools to better support decision making for older people with frailty and IBD.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"740 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142599313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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