Rebecca Maria Neye, Gerald Kircheis, Daria Stratmann, Norbert Hilger, Stefan Lüth
Introduction: An early detection of low-grade hepatic encephalopathy (HE) is of high importance. The aim of the study was to compare a neuropsychological with a psychophysical test on the basis of the psychometric hepatic encephalopathy score (PHES) regarding effectiveness in diagnosing minimal HE (MHE).
Methods: In our prospective controlled observational study, we examined a total of 103 patients with liver cirrhosis for HE. The PHES, CFF, and EncephalApp were performed in all patients. Graduation was based on the result of the PHES. Patients without evidence for HE 1&2 according to the mental state (West-Haven criteria) with a PHES <-4 value points and no clinical symptoms were defined as having MHE. Patients were considered as HE0 when in the PHES none of the psychometric subtest results was abnormal or with a PHES ≥-4 value points. Patients with clinical symptoms were considered HE 1&2 patients. Different cut-off values were determined, and their specificity and sensitivity were calculated.
Results: Ninety-six of the involved patients had liver cirrhosis and 25 acted as a healthy control group. The ROC analysis for the classification resulted in an AUC of 0.806, with the highest Youden index for the cut-off time >224 s, for which the sensitivity was 82% and the specificity 75%. Cases of withdrawals were seen in 10.74% of all tested patients.
Conclusion: The EncephalApp distinguishes well between HE0 and MHE but has its limitations in grading higher forms of HE. Diagnosis using only the EncephalApp is not sufficient.
简介早期发现低度肝性脑病(HE)非常重要。本研究的目的是在心理测量肝性脑病评分(PHES)的基础上,比较神经心理学测试和心理物理学测试在诊断轻度肝性脑病(MHE)方面的有效性:在前瞻性对照观察研究中,我们共对 103 名肝硬化患者进行了肝性脑病检查。所有患者均接受了 PHES、CFF 和 EncephalApp 检查。根据 PHES 的结果进行分级。根据精神状态(West-Haven 标准)无证据表明患有 HE 1 和 HE 2,且 PHES < -4 值点且无临床症状的患者被定义为 MHE。在心理测验中,如果没有一项心理测验的结果出现异常,或心理测验的 PHES -4 值点,则患者被视为 HE 0。有临床症状的患者被视为 HE 1 和 HE 2 患者。确定了不同的临界值,并计算了其特异性和敏感性:结果:96 名患者患有肝硬化,25 名患者为健康对照组。分类的 ROC 分析得出的 AUC 为 0.806,截止时间为 224 秒时的尤登指数最高,灵敏度为 82%,特异度为 75%。在所有接受测试的患者中,有 10.74% 的患者出现了停药情况。讨论/结论EncephalApp 能很好地区分 HE0 和 MHE,但在分级更高级别的 HE 时有其局限性。仅使用 EncephalApp 进行诊断是不够的。
{"title":"Assessment of Cirrhotic Patients by the EncephalApp Fails to Predict Low-Grade Hepatic Encephalopathy.","authors":"Rebecca Maria Neye, Gerald Kircheis, Daria Stratmann, Norbert Hilger, Stefan Lüth","doi":"10.1159/000538924","DOIUrl":"10.1159/000538924","url":null,"abstract":"<p><strong>Introduction: </strong>An early detection of low-grade hepatic encephalopathy (HE) is of high importance. The aim of the study was to compare a neuropsychological with a psychophysical test on the basis of the psychometric hepatic encephalopathy score (PHES) regarding effectiveness in diagnosing minimal HE (MHE).</p><p><strong>Methods: </strong>In our prospective controlled observational study, we examined a total of 103 patients with liver cirrhosis for HE. The PHES, CFF, and EncephalApp were performed in all patients. Graduation was based on the result of the PHES. Patients without evidence for HE 1&2 according to the mental state (West-Haven criteria) with a PHES <-4 value points and no clinical symptoms were defined as having MHE. Patients were considered as HE0 when in the PHES none of the psychometric subtest results was abnormal or with a PHES ≥-4 value points. Patients with clinical symptoms were considered HE 1&2 patients. Different cut-off values were determined, and their specificity and sensitivity were calculated.</p><p><strong>Results: </strong>Ninety-six of the involved patients had liver cirrhosis and 25 acted as a healthy control group. The ROC analysis for the classification resulted in an AUC of 0.806, with the highest Youden index for the cut-off time >224 s, for which the sensitivity was 82% and the specificity 75%. Cases of withdrawals were seen in 10.74% of all tested patients.</p><p><strong>Conclusion: </strong>The EncephalApp distinguishes well between HE0 and MHE but has its limitations in grading higher forms of HE. Diagnosis using only the EncephalApp is not sufficient.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Edward J Ciaccio, Anne R Lee, Jessica Lebovits, Randi L Wolf, Suzanne K Lewis, Carolina Ciacci, Peter H R Green
Introduction: Celiac disease is an autoimmune condition that affects approximately 1% of the population worldwide. Although its main impact often concerns the small intestine, resulting in villous atrophy and nutrient malabsorption, it can also cause systemic manifestations, particularly when undiagnosed or left untreated.
Method: Attention is directed to the possible psychological, psychiatric, and organic brain manifestations of celiac disease. Specific topics related to the influence and risk of such manifestations with respect to celiac disease are defined and discussed. Overall, eighteen main topics are considered, sifted from over 500 references.
Results: The most often studied topics were found to be the effect on quality of life, organic brain dysfunction and ataxia, epilepsy, Down syndrome, generalized psychological disorders, eating dysfunction, depression, and schizophrenia. For most every topic, although many studies report a connection to celiac disease, there are often one or more contrary studies and opinions. A bibliographic analysis of the cited articles was also done. There has been a sharp increase in interest in this research since 1990. Recently published articles tend to receive more referencing, up to as many as 15 citations per year, suggesting an increasing impact of the topics. The number of manuscript pages per article has also tended to increase, up to as many as 12 pages. The impact factor of the publishing journal has remained level over the years.
Conclusion: This compendium may be useful in developing a consensus regarding psychological, psychiatric, and organic brain manifestations that can occur in celiac disease and for determining the best direction for ongoing research focus.
{"title":"Psychological, Psychiatric, and Organic Brain Manifestations of Celiac Disease.","authors":"Edward J Ciaccio, Anne R Lee, Jessica Lebovits, Randi L Wolf, Suzanne K Lewis, Carolina Ciacci, Peter H R Green","doi":"10.1159/000534219","DOIUrl":"10.1159/000534219","url":null,"abstract":"<p><strong>Introduction: </strong>Celiac disease is an autoimmune condition that affects approximately 1% of the population worldwide. Although its main impact often concerns the small intestine, resulting in villous atrophy and nutrient malabsorption, it can also cause systemic manifestations, particularly when undiagnosed or left untreated.</p><p><strong>Method: </strong>Attention is directed to the possible psychological, psychiatric, and organic brain manifestations of celiac disease. Specific topics related to the influence and risk of such manifestations with respect to celiac disease are defined and discussed. Overall, eighteen main topics are considered, sifted from over 500 references.</p><p><strong>Results: </strong>The most often studied topics were found to be the effect on quality of life, organic brain dysfunction and ataxia, epilepsy, Down syndrome, generalized psychological disorders, eating dysfunction, depression, and schizophrenia. For most every topic, although many studies report a connection to celiac disease, there are often one or more contrary studies and opinions. A bibliographic analysis of the cited articles was also done. There has been a sharp increase in interest in this research since 1990. Recently published articles tend to receive more referencing, up to as many as 15 citations per year, suggesting an increasing impact of the topics. The number of manuscript pages per article has also tended to increase, up to as many as 12 pages. The impact factor of the publishing journal has remained level over the years.</p><p><strong>Conclusion: </strong>This compendium may be useful in developing a consensus regarding psychological, psychiatric, and organic brain manifestations that can occur in celiac disease and for determining the best direction for ongoing research focus.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141305682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: This study aimed to investigate the prevalence of disorders of gut-brain interaction (DGBI) and life stress in college students, and explore risk factors of DGBI in college students and the role of life stress.
Methods: A total of 2,578 college students filled up validated questionnaires assessing GI symptoms, lifestyle, and life stress. Participants were diagnosed as DGBI based on the Rome III criteria. Multivariate ordinal logistic regression analysis and mediation effect model were employed to explore potential risk factors of DGBI and the mediating role of life stress and lifestyle in DGBI.
Results: A total of 437 of 2,578 (17.0%) college students were diagnosed with DGBI. College students with DGBI had higher levels of life stress, including eight specific categories. Females (1.709 [1.437, 2.033]), staying up late (1.519 [1.300, 1.776]), and life stress (1.008 [1.006, 1.010]) were risk factors for DGBI, while postgraduates (0.751 [0.578, 0.976]) and regular diet (0.751 [0.685, 0.947]) were protective factors. Males and poor family economic were associated with a higher risk of DGBI after controlling stress, while an association between grade and DGBI was mediated by stress, regular diet, and sleep habits.
Conclusion: DGBI was common among college students. Life stress and lifestyle were associated with DGBI and mediated partial association between grade and DGBI in college students. More attention should be paid to undergraduates.
{"title":"Potential Risk Factors of Disorders of Gut-Brain Interaction in Undergraduates and Postgraduates: Partially Mediated by Life Stress and Lifestyle.","authors":"Likun Zhong, Yunxiao Liang, Huikuan Chu, Xiujing Zhang, Jingzhi Zhang, Xiaohua Hou, Zhiyue Xu","doi":"10.1159/000539552","DOIUrl":"10.1159/000539552","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to investigate the prevalence of disorders of gut-brain interaction (DGBI) and life stress in college students, and explore risk factors of DGBI in college students and the role of life stress.</p><p><strong>Methods: </strong>A total of 2,578 college students filled up validated questionnaires assessing GI symptoms, lifestyle, and life stress. Participants were diagnosed as DGBI based on the Rome III criteria. Multivariate ordinal logistic regression analysis and mediation effect model were employed to explore potential risk factors of DGBI and the mediating role of life stress and lifestyle in DGBI.</p><p><strong>Results: </strong>A total of 437 of 2,578 (17.0%) college students were diagnosed with DGBI. College students with DGBI had higher levels of life stress, including eight specific categories. Females (1.709 [1.437, 2.033]), staying up late (1.519 [1.300, 1.776]), and life stress (1.008 [1.006, 1.010]) were risk factors for DGBI, while postgraduates (0.751 [0.578, 0.976]) and regular diet (0.751 [0.685, 0.947]) were protective factors. Males and poor family economic were associated with a higher risk of DGBI after controlling stress, while an association between grade and DGBI was mediated by stress, regular diet, and sleep habits.</p><p><strong>Conclusion: </strong>DGBI was common among college students. Life stress and lifestyle were associated with DGBI and mediated partial association between grade and DGBI in college students. More attention should be paid to undergraduates.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kara DiJoseph, Scott Weismiller, Paddy Ssentongo, Shannon Dalessio, Kofi Clarke
Introduction: Celiac disease (CD) is a chronic immune-mediated disorder triggered by gluten ingestion in genetically predisposed individuals. Historically, CD was primarily recognized and described as a disease of the Caucasian population. Data from a national survey in 2015 revealed that 0.79% of the population was formally diagnosed with celiac disease, with the non-Hispanic white population having a prevalence of 4-8 times higher than other underrepresented races. Although there is evidence that CD affects minorities at higher than reported rates, there is little data on its effects on minority populations. Our study aimed to characterize celiac-related complications among underrepresented populations in a large health database.
Methods: We performed a cohort study among patients aged ≥18, utilizing the TriNetX US Collaborative Network. Two cohorts of patients (minority and non-Hispanic white) with CD were identified between 2016 and 2021. Cohorts were propensity scores matched on demographics and baseline clinical characteristics. Outcomes were assessed up to 1 year after the index event (CD diagnosis), including vitamin/mineral deficiencies and hospital visits. Data were analyzed using the TriNetX Analytics function.
Results: Each group was matched with 817 patients. Compared to the non-Hispanic white population, the minority group had a similar incidence of iron, vitamin B, and zinc deficiencies. The minority group had a higher risk of vitamin D deficiency, anemia secondary to iron deficiency, inpatient hospital stays, and emergency department visits.
Conclusion: Our results indicate that minority patients with celiac disease have a higher incidence of vitamin D and iron deficiency.
导言:乳糜泻(CD)是一种由免疫介导的慢性疾病,由易感基因个体摄入麸质引发。从历史上看,乳糜泻主要被认为是白种人的疾病。2015 年的一项全国调查数据显示,0.79% 的人口被正式诊断为乳糜泻,其中非西班牙裔白人的患病率比其他代表性不足的种族高出 4-8 倍。虽然有证据表明,乳糜泻对少数族裔的影响高于报告的比例,但有关它对少数族裔影响的数据却很少。我们的研究旨在从大型健康数据库中找出代表性不足人群中乳糜泻相关并发症的特征。方法 我们利用 TriNetX 美国协作网络对年龄≥ 18 岁的患者进行了一项队列研究。在 2016 年至 2021 年期间,我们确定了两个队列的 CD 患者(少数民族和非西班牙裔白人)。组群在人口统计学和基线临床特征方面进行了倾向评分匹配。在指数事件(CD 诊断)发生后一年内对结果进行评估,包括维生素/矿物质缺乏症和医院就诊情况。数据使用 TriNetX Analytics 功能进行分析。结果 每个组都有 817 名患者。与非西班牙裔白人相比,少数族裔群体的铁、维生素 B 和锌缺乏症发生率相似。少数族裔群体发生维生素 D 缺乏症、继发性缺铁性贫血、住院和急诊就诊的风险更高。结论 我们的研究结果表明,少数群体乳糜泻患者维生素 D 和铁缺乏症的发病率较高。
{"title":"Celiac Disease and the Risk of Micronutrient Deficiencies in Ethnic Minority Populations: A Retrospective Cohort Study.","authors":"Kara DiJoseph, Scott Weismiller, Paddy Ssentongo, Shannon Dalessio, Kofi Clarke","doi":"10.1159/000539179","DOIUrl":"10.1159/000539179","url":null,"abstract":"<p><strong>Introduction: </strong>Celiac disease (CD) is a chronic immune-mediated disorder triggered by gluten ingestion in genetically predisposed individuals. Historically, CD was primarily recognized and described as a disease of the Caucasian population. Data from a national survey in 2015 revealed that 0.79% of the population was formally diagnosed with celiac disease, with the non-Hispanic white population having a prevalence of 4-8 times higher than other underrepresented races. Although there is evidence that CD affects minorities at higher than reported rates, there is little data on its effects on minority populations. Our study aimed to characterize celiac-related complications among underrepresented populations in a large health database.</p><p><strong>Methods: </strong>We performed a cohort study among patients aged ≥18, utilizing the TriNetX US Collaborative Network. Two cohorts of patients (minority and non-Hispanic white) with CD were identified between 2016 and 2021. Cohorts were propensity scores matched on demographics and baseline clinical characteristics. Outcomes were assessed up to 1 year after the index event (CD diagnosis), including vitamin/mineral deficiencies and hospital visits. Data were analyzed using the TriNetX Analytics function.</p><p><strong>Results: </strong>Each group was matched with 817 patients. Compared to the non-Hispanic white population, the minority group had a similar incidence of iron, vitamin B, and zinc deficiencies. The minority group had a higher risk of vitamin D deficiency, anemia secondary to iron deficiency, inpatient hospital stays, and emergency department visits.</p><p><strong>Conclusion: </strong>Our results indicate that minority patients with celiac disease have a higher incidence of vitamin D and iron deficiency.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: In the post-Helicobacter pylori era, autoimmune gastritis (AIG) is attracting increasing attention as an origin of gastric cancer. Here, we performed clinicopathological examination of gastric cancer complicating AIG treated in our hospital.
Methods: Eighty-six early gastric cancer lesions complicating AIG in 50 patients were treated by endoscopic submucosal dissection (ESD) at our hospital in 2008-2022. Their clinicopathological characteristics were compared with those of a control group comprising 2,978 early gastric cancer lesions (excluding lesions in the remnant stomach after surgery) in 2,278 patients treated by ESD during the same period.
Results: Mean age was significantly higher in the AIG group than in the control group (74.7 years vs. 70.9 years; p < 0.01). In the respective groups, the occurrence rate of synchronous/metachronous lesions was 38.0% and 20.4% (p < 0.01), the ratio of longitudinal cancer locations (upper/middle/lower third [U/M/L]) was 27/32/27 and 518/993/1,467 (p < 0.01), the ratio of circumferential cancer locations (lesser curvature/greater curvature/anterior wall/posterior wall) was 25/31/12/18 and 1,259/587/475/657 (p < 0.01), the ratio of major macroscopic types (I/IIa/IIb/IIc) was 13/38/5/30 and 65/881/220/1,812 (p < 0.01). The rates of multiple gastric cancer and cancers in the U region, at the greater curvature, and of protruding types were significantly higher in the AIG group.
Conclusion: The occurrence rate of multiple gastric cancer was significantly higher in gastric cancer complicating AIG (approximately 40%), and compared with the control group, the proportions of cancers at the U region, at the greater curvature, and of protruding types were significantly higher.
{"title":"Clinicopathological Features of Early Gastric Cancer Complicated by Autoimmune Gastritis.","authors":"Kosuke Nomura, Daisuke Kikuchi, Yusuke Kawai, Yorinari Ochiai, Takayuki Okamura, Yugo Suzuki, Junnosuke Hayasaka, Yutaka Mitsunaga, Hiroyuki Odagiri, Satoshi Yamashita, Akira Matsui, Shu Hoteya","doi":"10.1159/000539639","DOIUrl":"10.1159/000539639","url":null,"abstract":"<p><strong>Introduction: </strong>In the post-Helicobacter pylori era, autoimmune gastritis (AIG) is attracting increasing attention as an origin of gastric cancer. Here, we performed clinicopathological examination of gastric cancer complicating AIG treated in our hospital.</p><p><strong>Methods: </strong>Eighty-six early gastric cancer lesions complicating AIG in 50 patients were treated by endoscopic submucosal dissection (ESD) at our hospital in 2008-2022. Their clinicopathological characteristics were compared with those of a control group comprising 2,978 early gastric cancer lesions (excluding lesions in the remnant stomach after surgery) in 2,278 patients treated by ESD during the same period.</p><p><strong>Results: </strong>Mean age was significantly higher in the AIG group than in the control group (74.7 years vs. 70.9 years; p < 0.01). In the respective groups, the occurrence rate of synchronous/metachronous lesions was 38.0% and 20.4% (p < 0.01), the ratio of longitudinal cancer locations (upper/middle/lower third [U/M/L]) was 27/32/27 and 518/993/1,467 (p < 0.01), the ratio of circumferential cancer locations (lesser curvature/greater curvature/anterior wall/posterior wall) was 25/31/12/18 and 1,259/587/475/657 (p < 0.01), the ratio of major macroscopic types (I/IIa/IIb/IIc) was 13/38/5/30 and 65/881/220/1,812 (p < 0.01). The rates of multiple gastric cancer and cancers in the U region, at the greater curvature, and of protruding types were significantly higher in the AIG group.</p><p><strong>Conclusion: </strong>The occurrence rate of multiple gastric cancer was significantly higher in gastric cancer complicating AIG (approximately 40%), and compared with the control group, the proportions of cancers at the U region, at the greater curvature, and of protruding types were significantly higher.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141247602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Infliximab (IFX) is a standard, inpatient salvage therapy for the treatment of refractory acute severe ulcerative colitis (ASUC). Remicade™ is the originator IFX. Its biosimilar Renflexis™ offers a reduced cost structure. We performed a cost-minimization analysis to compare costs with Remicade™ and Renflexis™ for the inpatient treatment of ASUC.
Methods: Retrospective clinical and financial data were obtained from 34 inpatients with refractory ASUC who received Renflexis™ (n = 17) or Remicade™ (n = 17) between 2019 and 2021. Clinical data included admission and discharge laboratory values. Financial data included a decision support drug cost (DSDC), constituting the total cost associated with inpatient IFX administration, and total inpatient cost of care. The following equation generated a ratio (rDSDC) representing the percentage of drug cost (or DSDC) of the total inpatient cost of care, after controlling for IFX dose and length of stay: [DSDC of IFX/Number of Units of IFX] ÷ [Total Inpatient Cost of Care/Length of Stay in Days]. Median and non-parametric Wilcoxon ranked sum test were used for analyzing patient demographics, clinical, and financial data.
Results: No differences were found in baseline or discharge clinical parameters. The median unadjusted ratio of DSDC to total inpatient cost of care was 0.387 versus 0.241 in the Remicade™ versus Renflexis™ groups (p = 0.0025), respectively, representing an absolute difference of ∼14%. Median adjusted rDSDC were 0.04 versus 0.024 in the Remicade™ versus Renflexis™ groups, respectively, representing a relative cost reduction of ∼40% (p = 0.0001).
Discussion: The unadjusted absolute cost reduction and adjusted relative cost reduction were, respectively, 14% and 40% in the Renflexis™ group as compared to Remicade™, when treating inpatient ASUC. Our calculation included median DSDC as a percentage of the total inpatient cost of care, controlling for IFX dose and length of stay. This reduced cost structure promotes use of Renflexis™ for ASUC inpatients and may reduce costs systemically.
{"title":"Inpatient Infliximab Biosimilar Cost-Savings: Cost Analysis of Inpatient Treatment with Originator Infliximab (Remicade™) versus Biosimilar Infliximab (Renflexis™) for Acute Severe Ulcerative Colitis.","authors":"Joseph M Cappuccio, Neev Mehta, Randall Pellish","doi":"10.1159/000536303","DOIUrl":"10.1159/000536303","url":null,"abstract":"<p><strong>Introduction: </strong>Infliximab (IFX) is a standard, inpatient salvage therapy for the treatment of refractory acute severe ulcerative colitis (ASUC). Remicade™ is the originator IFX. Its biosimilar Renflexis™ offers a reduced cost structure. We performed a cost-minimization analysis to compare costs with Remicade™ and Renflexis™ for the inpatient treatment of ASUC.</p><p><strong>Methods: </strong>Retrospective clinical and financial data were obtained from 34 inpatients with refractory ASUC who received Renflexis™ (n = 17) or Remicade™ (n = 17) between 2019 and 2021. Clinical data included admission and discharge laboratory values. Financial data included a decision support drug cost (DSDC), constituting the total cost associated with inpatient IFX administration, and total inpatient cost of care. The following equation generated a ratio (rDSDC) representing the percentage of drug cost (or DSDC) of the total inpatient cost of care, after controlling for IFX dose and length of stay: [DSDC of IFX/Number of Units of IFX] ÷ [Total Inpatient Cost of Care/Length of Stay in Days]. Median and non-parametric Wilcoxon ranked sum test were used for analyzing patient demographics, clinical, and financial data.</p><p><strong>Results: </strong>No differences were found in baseline or discharge clinical parameters. The median unadjusted ratio of DSDC to total inpatient cost of care was 0.387 versus 0.241 in the Remicade™ versus Renflexis™ groups (p = 0.0025), respectively, representing an absolute difference of ∼14%. Median adjusted rDSDC were 0.04 versus 0.024 in the Remicade™ versus Renflexis™ groups, respectively, representing a relative cost reduction of ∼40% (p = 0.0001).</p><p><strong>Discussion: </strong>The unadjusted absolute cost reduction and adjusted relative cost reduction were, respectively, 14% and 40% in the Renflexis™ group as compared to Remicade™, when treating inpatient ASUC. Our calculation included median DSDC as a percentage of the total inpatient cost of care, controlling for IFX dose and length of stay. This reduced cost structure promotes use of Renflexis™ for ASUC inpatients and may reduce costs systemically.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141155196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muzaffer Reha Ümütlü, Osman Öcal, Daniel Puhr-Westerheide, Matthias P Fabritius, Moritz Wildgruber, Sinan Deniz, Stefanie Corradini, Maya Rottler, Franziska Walter, Paul Rogowski, Ricarda Seidensticker, Alexander B Philipp, Daniel Rössler, Jens Ricke, Max Seidensticker
Introduction: CT-guided interstitial brachytherapy (iBT) radiotherapy has been established in the treatment of liver tumors. With iBT, hepatocellular carcinoma (HCC) lesions can be treated beyond the limits of thermal ablation (i.e., size and location). However, a comprehensive analysis of the efficacy of iBT in patients within and beyond thermal ablation limits is lacking.
Materials and methods: A total of 146 patients with 216 HCC lesions have been analyzed retrospectively. Clinical and imaging follow-up data has been collected. Lesions were evaluated in terms of suitability for thermal ablation or not. The correlation between local tumor control (LTC), time to progression (TTP), overall survival (OS), and clinical and imaging parameters have been evaluated using univariable and multivariable Cox regression analyses.
Results: LTC rates at 12 months, 24 months, and 36 months were 87%, 75%, and 73%, respectively. 65% of lesions (n = 141) were not suitable for radiofrequency ablation (RFA). The median TTP was 13 months, and the median OS was not reached (3-year OS rate: 70%). No significant difference in LTC, TTP, or OS regarding RFA suitability existed. However, in the overall multivariable analysis, lesion diameter >5 cm was significantly associated with lower LTC (HR: 3.65, CI [1.60-8.31], p = 0.002) and shorter TTP (HR: 2.08, CI [1.17-3.70], p = 0.013). Advanced BCLC stage, Child-Pugh Stage, and Hepatitis B were associated with shorter OS.
Conclusion: iBT offers excellent LTC rates and OS in local HCC treatment regardless of the limits of thermal ablation, suggesting further evidence of its alternative role to thermal ablation in patients with early-stage HCC.
{"title":"Efficacy and Safety of Local Liver Radioablation in Hepatocellular Carcinoma Lesions within and beyond Limits of Thermal Ablation.","authors":"Muzaffer Reha Ümütlü, Osman Öcal, Daniel Puhr-Westerheide, Matthias P Fabritius, Moritz Wildgruber, Sinan Deniz, Stefanie Corradini, Maya Rottler, Franziska Walter, Paul Rogowski, Ricarda Seidensticker, Alexander B Philipp, Daniel Rössler, Jens Ricke, Max Seidensticker","doi":"10.1159/000538788","DOIUrl":"10.1159/000538788","url":null,"abstract":"<p><strong>Introduction: </strong>CT-guided interstitial brachytherapy (iBT) radiotherapy has been established in the treatment of liver tumors. With iBT, hepatocellular carcinoma (HCC) lesions can be treated beyond the limits of thermal ablation (i.e., size and location). However, a comprehensive analysis of the efficacy of iBT in patients within and beyond thermal ablation limits is lacking.</p><p><strong>Materials and methods: </strong>A total of 146 patients with 216 HCC lesions have been analyzed retrospectively. Clinical and imaging follow-up data has been collected. Lesions were evaluated in terms of suitability for thermal ablation or not. The correlation between local tumor control (LTC), time to progression (TTP), overall survival (OS), and clinical and imaging parameters have been evaluated using univariable and multivariable Cox regression analyses.</p><p><strong>Results: </strong>LTC rates at 12 months, 24 months, and 36 months were 87%, 75%, and 73%, respectively. 65% of lesions (n = 141) were not suitable for radiofrequency ablation (RFA). The median TTP was 13 months, and the median OS was not reached (3-year OS rate: 70%). No significant difference in LTC, TTP, or OS regarding RFA suitability existed. However, in the overall multivariable analysis, lesion diameter >5 cm was significantly associated with lower LTC (HR: 3.65, CI [1.60-8.31], p = 0.002) and shorter TTP (HR: 2.08, CI [1.17-3.70], p = 0.013). Advanced BCLC stage, Child-Pugh Stage, and Hepatitis B were associated with shorter OS.</p><p><strong>Conclusion: </strong>iBT offers excellent LTC rates and OS in local HCC treatment regardless of the limits of thermal ablation, suggesting further evidence of its alternative role to thermal ablation in patients with early-stage HCC.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141086544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Superficial non-ampullary duodenal epithelial tumors (SNADETs) include low-grade adenoma (LGA) and high-grade adenoma or carcinoma (HGA/Ca) and are classified into two different epithelial subtypes, gastric-type (G-type) and intestinal-type (I-type). We attempted to distinguish them by endoscopic characteristics including magnifying endoscopy with narrow-band imaging (M-NBI).
Methods: Various endoscopic and M-NBI findings of 286 SNADETs were retrospectively reviewed and compared between G- and I-types and histological grades. M-NBI findings were divided into four patterns based on the following vascular patterns; absent, network, intrastructural vascular (ISV), and unclassified. Lesions displaying a single pattern were classified as mono-pattern and those displaying multiple patterns as mixed-pattern. Lesions showing CDX2 positivity were categorized as I-types and those showing MUC5AC or MUC6 positivity were categorized as G-types based on immunohistochemistry.
Results: Among 286 lesions, 23 (8%) were G-type and 243 (85%) were I-type. More G-type lesions were located oral to papilla (91.3 vs. 45.6%, p < 0.001), and had protruding morphology compared to those of I-types (65.2 vs. 14.4%, p < 0.001). The major M-NBI pattern was ISV in G-type (78.2 vs. 26.3%, p < 0.001), and absent for I-type (0 vs. 34.5%, p = 0.003). Three endoscopic characteristics; location oral to papilla, protruding morphology, and major M-NBI pattern (ISV) were independent predictors for G-type. Mixed-pattern was more common in HGA/Ca than LGA for I-type (77.0 vs. 58.8%, p = 0.01); however, there was no difference for those in G-type.
Conclusion: Endoscopic findings including M-NBI are useful to differentiate epithelial subtypes.
导言:浅表非髓质十二指肠上皮肿瘤(SNADETs)包括低级别腺瘤(LGA)和高级别腺瘤或癌(HGA/Ca),分为胃型(G型)和肠型(I型)两种不同的上皮亚型。我们试图通过内镜特征(包括放大内镜和窄带成像(M-NBI))来区分它们:方法:我们回顾性研究了286例SNADET的各种内镜和M-NBI结果,并对G型和I型以及组织学分级进行了比较。根据以下血管模式将 M-NBI 结果分为四种模式:无血管、网络状血管、结构内血管(ISV)和未分类。显示单一模式的病变被归类为单一模式,显示多种模式的病变被归类为混合模式。根据免疫组化结果,显示 CDX2 阳性的病变被归为 I 型,显示 MUC5AC 或 MUC6 阳性的病变被归为 G 型:在286个病灶中,23个(8%)为G型,243个(85%)为I型。与 I 型病变相比,更多的 G 型病变位于乳头口腔(91.3% vs 45.6%,P<0.001),且形态突出(65.2% vs 14.4%,P<0.001)。G 型的主要 M-NBI 模式是 ISV(78.2% vs 26.3%,P<0.001),而 I 型则没有(0% vs 34.5%,P=0.003)。三个内镜特征:乳头口腔位置、突出形态和主要 M-NBI 模式(ISV)是 G 型的独立预测因素。就 I 型而言,混合型在 HGA/Ca 比 LGA 中更为常见(77.0% vs 58.8%,P=0.01);但在 G 型中没有差异:结论:包括 M-NBI 在内的内镜检查结果有助于区分上皮亚型。
{"title":"Endoscopic Diagnosis of Epithelial Subtypes of Superficial Non-Ampullary Duodenal Epithelial Tumors using Magnifying Narrow-Band Imaging.","authors":"Yoshiyuki Kurata, Takashi Hirose, Naomi Kakushima, Masato Nakaguro, Yuki Okumura, Hitoshi Tanaka, Mitsuhiro Fujishiro, Hiroki Kawashima","doi":"10.1159/000539308","DOIUrl":"10.1159/000539308","url":null,"abstract":"<p><strong>Introduction: </strong>Superficial non-ampullary duodenal epithelial tumors (SNADETs) include low-grade adenoma (LGA) and high-grade adenoma or carcinoma (HGA/Ca) and are classified into two different epithelial subtypes, gastric-type (G-type) and intestinal-type (I-type). We attempted to distinguish them by endoscopic characteristics including magnifying endoscopy with narrow-band imaging (M-NBI).</p><p><strong>Methods: </strong>Various endoscopic and M-NBI findings of 286 SNADETs were retrospectively reviewed and compared between G- and I-types and histological grades. M-NBI findings were divided into four patterns based on the following vascular patterns; absent, network, intrastructural vascular (ISV), and unclassified. Lesions displaying a single pattern were classified as mono-pattern and those displaying multiple patterns as mixed-pattern. Lesions showing CDX2 positivity were categorized as I-types and those showing MUC5AC or MUC6 positivity were categorized as G-types based on immunohistochemistry.</p><p><strong>Results: </strong>Among 286 lesions, 23 (8%) were G-type and 243 (85%) were I-type. More G-type lesions were located oral to papilla (91.3 vs. 45.6%, p < 0.001), and had protruding morphology compared to those of I-types (65.2 vs. 14.4%, p < 0.001). The major M-NBI pattern was ISV in G-type (78.2 vs. 26.3%, p < 0.001), and absent for I-type (0 vs. 34.5%, p = 0.003). Three endoscopic characteristics; location oral to papilla, protruding morphology, and major M-NBI pattern (ISV) were independent predictors for G-type. Mixed-pattern was more common in HGA/Ca than LGA for I-type (77.0 vs. 58.8%, p = 0.01); however, there was no difference for those in G-type.</p><p><strong>Conclusion: </strong>Endoscopic findings including M-NBI are useful to differentiate epithelial subtypes.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140944072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The discovery of the hepatitis C virus (HCV) and direct-acting antiviral (DAA) drugs is one of the major milestones in the last 3 decades of medicine. These discoveries encouraged the World Health Organization (WHO) to set an ambitious goal to eliminate HCV by 2030, meaning "a 90% reduction in new cases of chronic HCV, a 65% reduction in HCV deaths, and treatment of 80% of eligible people with HCV infections."
Summary: This review summarizes the key achievements from the discovery of HCV to the development of effective treatment and global elimination strategies. A better understanding of HCV structure, enzymes, and lifecycle led to the introduction of new drug targets and the discovery of DAA. Massive public health interventions are required, such as screening, access to care, treatment, and post-care follow-up, to make the most of DAA's potential. Screening must be supported by fast, accessible, sensitive, specific HCV diagnostic tests and noninvasive methods to determine the stage of liver disease. Linkage to care and treatment access are critical components of a comprehensive HCV elimination program, and decentralization plays a key role in ensuring their effectiveness.
Key messages: Effective and simple screening strategies, rapid diagnostic tools, linkage to health care, and accessible treatment are key elements to achieving the WHO's goal. Incorporating treatment as prevention strategies into elimination programs together with preventive education and harm reduction interventions can have a profound and lasting impact on reducing both the incidence and prevalence of HCV. However, WHO's goal can be challenging to implement because of the need for high financial resources and strong political commitment.
{"title":"Viral Hepatitis C: From Unraveling the Nature of Disease to Cure and Global Elimination.","authors":"Viktorija Basyte-Bacevice, Limas Kupcinskas","doi":"10.1159/000539210","DOIUrl":"10.1159/000539210","url":null,"abstract":"<p><strong>Background: </strong>The discovery of the hepatitis C virus (HCV) and direct-acting antiviral (DAA) drugs is one of the major milestones in the last 3 decades of medicine. These discoveries encouraged the World Health Organization (WHO) to set an ambitious goal to eliminate HCV by 2030, meaning \"a 90% reduction in new cases of chronic HCV, a 65% reduction in HCV deaths, and treatment of 80% of eligible people with HCV infections.\"</p><p><strong>Summary: </strong>This review summarizes the key achievements from the discovery of HCV to the development of effective treatment and global elimination strategies. A better understanding of HCV structure, enzymes, and lifecycle led to the introduction of new drug targets and the discovery of DAA. Massive public health interventions are required, such as screening, access to care, treatment, and post-care follow-up, to make the most of DAA's potential. Screening must be supported by fast, accessible, sensitive, specific HCV diagnostic tests and noninvasive methods to determine the stage of liver disease. Linkage to care and treatment access are critical components of a comprehensive HCV elimination program, and decentralization plays a key role in ensuring their effectiveness.</p><p><strong>Key messages: </strong>Effective and simple screening strategies, rapid diagnostic tools, linkage to health care, and accessible treatment are key elements to achieving the WHO's goal. Incorporating treatment as prevention strategies into elimination programs together with preventive education and harm reduction interventions can have a profound and lasting impact on reducing both the incidence and prevalence of HCV. However, WHO's goal can be challenging to implement because of the need for high financial resources and strong political commitment.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140891083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: The Baveno criteria for assessing advanced liver fibrosis were mainly determined by transient elastography (TE), and its pathology-based validation studies in two-dimensional shear wave elastography (2D-SWE) remain limited. We aimed to validate the Baveno criteria through use of 2D-SWE.
Method: Consecutive patients who underwent liver biopsies for various benign liver diseases were prospectively recruited. Liver stiffness measurement (LSM) was simultaneously evaluated by TE and 2D-SWE. The optimal cutoff value to predict advanced liver fibrosis was determined by the Youden Index, and the diagnostic performance was estimated using area under the receiver operating characteristic (AUROC) analysis.
Results: A total of 101 patients were enrolled having a median age of 55.0 (IQR: 46.0-63.5) years, with 53 (52.48%) of them being male. Using <9 and >14 kPa as the optimal dual cutoffs, the AUROC values in TE and 2D-SWE were 0.92 (95% CI: 0.83-0.97) and 0.93 (95% CI: 0.84-0.98), respectively (p = 0.61). The sensitivity and specificity of LSM by TE/2D-SWE achieved rates of 94.44%/94.44% and 86.00%/88.00%, respectively. However, using the Baveno criteria, the AUROC values in TE and 2D-SWE could remain achieving 0.91 (95% CI: 0.82-0.97) and 0.93 (95% CI: 0.84-0.98), respectively (p = 0.36). The sensitivity and specificity in TE/2D-SWE were 88.24%/88.24% and 86.79%/90.57%, respectively.
Conclusion: This study establishes the compatibility of the Baveno dual cutoff criteria with 2D-SWE, positioning it as an easily used criteria in clinical practice and research.
{"title":"Validating the Baveno Elastography Criteria of Advanced Liver Fibrosis in Two-Dimensional Shear Wave Elastography: A Prospective Pathology-Based Study.","authors":"Chia-Chang Chen, Yao-Kuang Huang, Ren-Ching Wang, Jing-Tong Fu, Shou-Wu Lee, Hsin-Ju Tsai, Sheng-Shun Yang, Teng-Yu Lee","doi":"10.1159/000539167","DOIUrl":"10.1159/000539167","url":null,"abstract":"<p><strong>Introduction: </strong>The Baveno criteria for assessing advanced liver fibrosis were mainly determined by transient elastography (TE), and its pathology-based validation studies in two-dimensional shear wave elastography (2D-SWE) remain limited. We aimed to validate the Baveno criteria through use of 2D-SWE.</p><p><strong>Method: </strong>Consecutive patients who underwent liver biopsies for various benign liver diseases were prospectively recruited. Liver stiffness measurement (LSM) was simultaneously evaluated by TE and 2D-SWE. The optimal cutoff value to predict advanced liver fibrosis was determined by the Youden Index, and the diagnostic performance was estimated using area under the receiver operating characteristic (AUROC) analysis.</p><p><strong>Results: </strong>A total of 101 patients were enrolled having a median age of 55.0 (IQR: 46.0-63.5) years, with 53 (52.48%) of them being male. Using <9 and >14 kPa as the optimal dual cutoffs, the AUROC values in TE and 2D-SWE were 0.92 (95% CI: 0.83-0.97) and 0.93 (95% CI: 0.84-0.98), respectively (p = 0.61). The sensitivity and specificity of LSM by TE/2D-SWE achieved rates of 94.44%/94.44% and 86.00%/88.00%, respectively. However, using the Baveno criteria, the AUROC values in TE and 2D-SWE could remain achieving 0.91 (95% CI: 0.82-0.97) and 0.93 (95% CI: 0.84-0.98), respectively (p = 0.36). The sensitivity and specificity in TE/2D-SWE were 88.24%/88.24% and 86.79%/90.57%, respectively.</p><p><strong>Conclusion: </strong>This study establishes the compatibility of the Baveno dual cutoff criteria with 2D-SWE, positioning it as an easily used criteria in clinical practice and research.</p>","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140849969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}