Therapeutic Advances in Gastroenterology最新文献

{"title":"Cost-effectiveness analysis of Cadonilimab in first-line treatment of advanced HER2-negative gastric cancer or gastroesophageal junction cancer.","authors":"Kaiqi Zhu, Mengyao Qin, Zhaoyi Pan, Jin Huang","doi":"10.1177/17562848251381143","DOIUrl":"10.1177/17562848251381143","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs), including Pembrolizumab, Nivolumab, Sintilimab, Tislelizumab, and Sugemalimab, have been approved in China as first-line treatments for advanced HER2-negative gastric cancer (GC) and gastroesophageal junction cancer (GEJC). However, the latest COMPASSION 15 study showed that Cadonilimab in combination with chemotherapy provided significant survival benefits.</p><p><strong>Objective: </strong>This study aims to evaluate the cost-effectiveness of Cadonilimab plus chemotherapy versus chemotherapy alone and the ICIs approved in China for first-line treatment of advanced HER2-negative gastric cancer or gastroesophageal junction carcinoma (GC/GEJC) from the perspective of Chinese payers.</p><p><strong>Design: </strong>The cost-effectiveness analysis.</p><p><strong>Methods: </strong>Based on the research data from COMPASSION-15, KEYNOTE-859, CheckMate-649, ORIENT-16, RATIONALE-305, and GEMSTONE-303, we constructed a 15-year Markov model to evaluate the cost and health outcomes of Cadonilimab combined with chemotherapy versus chemotherapy alone and other ICIs in advanced HER2-negative GC and GEJC. This evaluation includes total cost, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).</p><p><strong>Results: </strong>Cadonilimab produced 0.73 QALYs (1.10 LYs) at a cost of $26,591. It required an additional investment of $17,826 to gain 0.25 QALYs (0.37 LYs), resulting in an ICER of $72,492.29 per QALY compared to chemotherapy alone. In comparison, other ICIs approved in China-Pembrolizumab, Nivolumab, Sintilimab, Tislelizumab, and Sugemalimab-incurred total costs of $11,735, $13,970, $16,346, $10,765, and $14,857, respectively, generating 0.68 QALYs (1.04 LYs), 0.69 QALYs (1.04 LYs), 0.73 QALYs (1.12 LYs), 0.82 QALYs (1.26 LYs), and 0.81 QALYs (1.25 LYs). Sensitivity analysis revealed that the cost of Cadonilimab, the utility value of progressive disease, and the risk of platelet decline in the Cadonilimab group were the most influential factors affecting the model's stability. At a willingness-to-pay threshold of $37,386, Cadonilimab is not a cost-effective option for the first-line treatment of advanced GE/GEJC.</p><p><strong>Conclusion: </strong>Cadonilimab is not a cost-effective option for the first-line treatment of advanced HER2-negative GC/GEJC. In comparison to other ICIs approved in China, Tislelizumab appears to be a more favorable option.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251381143"},"PeriodicalIF":3.4,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12497967/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A targeted review of clinical outcomes of advanced IBD therapies in Latin America.","authors":"Ieshaan S Kumar, Rahul S Dalal","doi":"10.1177/17562848251383799","DOIUrl":"10.1177/17562848251383799","url":null,"abstract":"<p><p>There exists a significant care gap in the diagnosis, treatment, and management of inflammatory bowel diseases (IBD) in Latin America compared to the United States and Europe. This review aims to assess the clinical effectiveness of advanced therapies for patients with moderate to severe ulcerative colitis (UC) and Crohn's disease (CD) in Latin America. We conducted a targeted literature review of studies reporting clinical outcomes of advanced IBD therapies in Latin American countries. After applying pre-defined inclusion and exclusion criteria, 14 articles were included. Data were extracted regarding patient populations, therapeutic agents, clinical outcomes, and geographic distribution. The majority of studies focused on biologic therapies, including adalimumab, infliximab, ustekinumab, and vedolizumab. These therapies demonstrated favorable clinical remission and response rates in Brazil, Argentina, Mexico, and Colombia for both UC and CD. Reported outcomes were largely consistent with observational data from North America and Europe, supporting the generalizability of therapeutic efficacy across regions. Advanced therapies for IBD appear to be effective in Latin American populations, with clinical outcomes comparable to those reported globally. Increasing access to these treatments may improve patient outcomes, reduce disease burden, and potentially decrease long-term healthcare costs in the region.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251383799"},"PeriodicalIF":3.4,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12497969/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intravenous ustekinumab maintenance in Crohn's disease: a single-center retrospective cohort study.","authors":"Yuting Wang, Shiyuan Lu, Wen Hu, Shuyan Li, Yan Chen","doi":"10.1177/17562848251375356","DOIUrl":"10.1177/17562848251375356","url":null,"abstract":"<p><strong>Background: </strong>Despite the established efficacy of ustekinumab (UST) in Crohn's disease (CD), real-world studies reveal suboptimal treatment persistence and limited endoscopic healing. Current optimization paradigms remain constrained by suboptimal durability and escalating therapeutic demands.</p><p><strong>Objectives: </strong>To evaluate the clinical utility and safety of intravenous (IV) ustekinumab maintenance therapy in CD.</p><p><strong>Design: </strong>This was a single-center retrospective cohort study.</p><p><strong>Methods: </strong>This study included CD patients receiving ⩾2 IV-UST maintenance infusions between June 2020 and October 2023 (<i>N</i> = 234). The protocol featured weight-based induction-equivalent dosing (260-520 mg) at response-guided intervals. The primary endpoint was the corticosteroid-free clinical remission rate at Week 24.</p><p><strong>Results: </strong>At 24 weeks, 88.1% (185/210) achieved steroid-free remission with C-reactive protein (CRP) normalization in 90.0% (44/88). Median Harvey-Bradshaw Index decreased from 4 (interquartile range (IQR) 2-5) to 2 (IQR 1-3; <i>p</i> < 0.001). 52-week endoscopic remission (simplified endoscopic score for Crohn's disease ⩽3) reached 48.7% (56/115), with fecal calprotectin normalization in 33.6% (35/104). Multivariate analysis identified baseline CRP >5 mg/L (adjusted odds ratio (aOR) 3.62, 1.16-11.25), intensive dosing (⩾6 cycles/year; aOR 12.06, 1.99-73.05), and disease duration ⩾1 year (aOR 3.53, 1.08-11.54) as predictors of endoscopic non-remission. Safety analysis demonstrated 44.4% adverse event incidence (104/234) and 3.0% serious adverse events (7/234).</p><p><strong>Conclusion: </strong>IV-UST maintenance demonstrates high rates of corticosteroid-free clinical remission and endoscopic healing with manageable safety in CD.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251375356"},"PeriodicalIF":3.4,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12497971/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The role of rapid on-site evaluation in pancreatic lesion: a systematic review and meta-analysis of randomized control trials.","authors":"Bing Chen, Hanbei Lv, Zhangpeng Feng, Guoping Jiang","doi":"10.1177/17562848251381182","DOIUrl":"10.1177/17562848251381182","url":null,"abstract":"<p><strong>Background: </strong>Endoscopic ultrasonography is crucial for diagnosing solid pancreatic lesions. Tissue acquisition using rapid on-site evaluation (ROSE) significantly improves diagnostic efficiency.</p><p><strong>Objectives: </strong>This study evaluates the efficacy of tissue acquisition from pancreatic tumors with and without ROSE.</p><p><strong>Design: </strong>Systematic review and meta-analysis.</p><p><strong>Data sources and methods: </strong>A search was conducted in PubMed and other databases covering the period up to February 2024. Eligible randomized control trials (RCTs) reporting data on comparing the efficacy of ROSE and no ROSE were included in this study. We compare the two groups using odd ratios (OR) and mean difference approach.</p><p><strong>Results: </strong>This meta-analysis included seven RCTs, including 1723 patients (909 in the ROSE and 814 in the no-ROSE group) with pancreatic masses. The fundamental characteristics of the studies were almost identical in both groups. There was no significant difference (<i>p</i> > 0.05) in the mean procedure time (1.49 min, 95% CI: -2.76, 5.75), needle passes (-0.34 passes, 95% CI: -1.00, 0.32), The OR of sample adequacy 1.34 (95% CI: 0.29, 6.25), diagnostic sensitivity 1.95 (95% CI: -0.79, 4.82), accuracy 1.28 (95% CI 0.54, 3.00), negative predictive value 1.05 (95% CI 0.54, 2.06), and adverse events 0.87 (95% CI 0.16, 4.87) with significant higher heterogeneity. Subgroup analysis also showed no difference between the FNA + ROSE versus FNA and FNB.</p><p><strong>Conclusion: </strong>The ROSE and non-ROSE approaches showed similar outcomes regarding mean needle passes, sample adequacy, diagnostic accuracy, and adverse event rates.</p><p><strong>Trial registration: </strong>This systematic review and meta-analysis was registered at PROSPERO (https://www.crd.york.ac.uk/PROSPERO/) with PROSPERO Number CRD42024520977.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251381182"},"PeriodicalIF":3.4,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12497979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of music and distraction on pain and anxiety during colonoscopy: a systematic review and meta-analysis.","authors":"Jabed F Ahmed, Hutan Ashrafian, Ara Darzi, Ferdinando R Baena, Nisha Patel","doi":"10.1177/17562848251378236","DOIUrl":"10.1177/17562848251378236","url":null,"abstract":"<p><strong>Background: </strong>Music has been shown to reduce pain and anxiety in patients undergoing colonoscopy. Distraction, a newer technique with less available evidence, has shown similar effective outcomes.</p><p><strong>Objectives: </strong>This systematic review and meta-analysis evaluate the current evidence available on music and task distraction and its potential to reduce pain in colonoscopy.</p><p><strong>Design: </strong>The study was performed within PRISMA guidelines and registered with PROSPERO. Inclusion criteria comprised peer-reviewed randomised controlled trial publications in English. Exclusion criteria comprised duplicate studies, non-peer-reviewed and non-English studies.</p><p><strong>Methods: </strong>A literature search was conducted with Medline, Embase, Cochrane and Google. Two independent clinicians reviewed the studies to avoid inclusion bias. Visual analogue score mean pain and Spielberger State-Trait Anxiety Inventory (STAI) mean anxiety were collected. Inverse variance DerSimonian-led meta-analytical approach was conducted using a random effects model and statistical software STATA.</p><p><strong>Results: </strong>Music intervention reported a significant (<i>p</i> < 0.05) weighted mean reduction of 1.50 for pain scores (95% CI 0.69-2.31) and a significant weighted mean reduction of 3.56 for anxiety scores (95% CI 0.86-6.27).Distraction intervention reported a significant weighted mean reduction of 1.59 for pain scores (95% CI 0.79-2.39) and a significant weighted mean reduction of 7.49 for anxiety scores (95% CI 3.64-11.35). There was high heterogeneity recorded for both pain and anxiety studies (<i>I</i>² >90%).</p><p><strong>Conclusion: </strong>Music and distraction intervention has the ability to be introduced at minimal cost. Furthermore, no changes to endoscopy infrastructure are required. This allows a clinical real-world option that is immediately implementable for patients. This meta-analysis has demonstrated that there is a potential role for music and task distraction to reduce pain and anxiety for patients undergoing a colonoscopy. It supports a low cost and safe option for patients who may not be eligible for sedation. Whilst the body of evidence is growing, it is plausible to claim these interventions can be implemented and established into daily clinical practice.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251378236"},"PeriodicalIF":3.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491824/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145233844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Systematic review and network meta-analysis comparing the efficacy of conventional therapy and biologics to prevent endoscopic postoperative recurrence in patients with Crohn's disease.","authors":"Marianne Hupé, Bruno Pereira, Anthony Buisson","doi":"10.1177/17562848251374240","DOIUrl":"10.1177/17562848251374240","url":null,"abstract":"<p><strong>Background: </strong>As no direct comparison is available between drugs to prevent endoscopic postoperative recurrence (POR) in Crohn's disease (CD), hierarchizing these therapeutic options remains challenging.</p><p><strong>Objectives: </strong>We aimed to compare the effectiveness of treatments to prevent CD endoscopic POR.</p><p><strong>Design: </strong>Systematic review and network meta-analysis using a random-effects model.</p><p><strong>Data sources and methods: </strong>We include studies comparing treatments to prevent CD POR according to PRISMA guidelines. The primary endpoint was endoscopic POR (Rutgeerts score ⩾i2). Surface under the cumulative ranking (SUCRA) was used to hierarchize the treatments.</p><p><strong>Results: </strong>Twenty studies were included (2414 patients). Overall heterogeneity was moderate (τ = 0.34). Ustekinumab (odds ratio (OR) = 0.23 (0.07-0.70); OR = 0.29 (0.08-0.99)), vedolizumab (OR = 0.17 (0.05-0.59); OR = 0.22 (0.06-0.85)), infliximab (OR = 0.18 (0.36-0.88); OR = 0.23 (0.09-0.54)), and adalimumab (OR = 0.17 (0.07-0.42); OR = 0.22 (0.08-0.59)) were more effective to prevent endoscopic POR than placebo or 5-ASA, respectively, contrary to thiopurines (OR = 0.52 (0.22-1.24); OR = 0.66 (0.25-1.76)). Adalimumab (OR = 0.33 (0.15-0.74)) and infliximab (OR = 0.34 (0.13-0.87)) were more effective than thiopurines. While no difference was observed between the four biologics, adalimumab (SUCRA = 0.81), infliximab (SUCRA = 0.80), vedolizumab (SUCRA = 0.79), and ustekinumab (SUCRA = 0.72) had the highest likelihood of being the most effective drug, contrary to thiopurines (SUCRA = 0.41), 5-ASA (SUCRA = 0.24), or placebo (SUCRA = 0.16).</p><p><strong>Conclusion: </strong>This network meta-analysis confirms the efficacy of anti-TNF agents, vedolizumab, and ustekinumab in preventing endoscopic CD POR without any difference between them. When a prophylactic therapy is needed, biologics should be preferred to 5-ASA or thiopurines.</p><p><strong>Trial registration: </strong>PROSPERO registration number CRD42024555528.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251374240"},"PeriodicalIF":3.4,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145214177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine learning-based prediction of response to Ustekinumab with Crohn's disease.","authors":"Ziyi Xiong, Pan Gong, Tianjing Meng, Zili Xiong, Mingmei Ye, Yuanyuan Huang, Xiayu Mao, Panpan Zhao, Yu Zhang, Weiwei Zhou, Xuefeng Li, Li Tian","doi":"10.1177/17562848251382749","DOIUrl":"10.1177/17562848251382749","url":null,"abstract":"<p><strong>Background: </strong>A reliable approach to predict the response to Ustekinumab (UST) in patients with Crohn's disease (CD) is lacking.</p><p><strong>Objectives: </strong>This study aims to develop and validate machine learning (ML) models to predict the response to UST and further achieve personalized therapy.</p><p><strong>Design: </strong>Retrospective multi-center study.</p><p><strong>Methods: </strong>This study included 162 CD patients treated with UST between May 2022 and May 2024. Four ML algorithms (extreme gradient boosting, random forest, logistic regression, and support vector machine) were integrated to identify the optimal model, and Shapley Additive exPlanations (SHAP) interpretation was used for visual explainability. Two models were established to forecast the response to UST, with the outcomes of the response situation at week 26 and secondary loss of response (sLOR) status at week 52, respectively. Eighty-two CD patients from the other five centers were applied for the week-26 model's external validation.</p><p><strong>Results: </strong>XGBoost performed excellently among the four ML algorithms. The week-26 model exhibited good performances of 0.88 area under the receiver operating characteristic curve (AUC), 0.92 area under the precision-recall curve, and 0.86 F1 score. The sLOR model demonstrated acceptable predictive performance with 0.74 AUC.</p><p><strong>Conclusion: </strong>We developed and validated models to predict UST response for CD patients and interpreted related factors by the SHAP method. We hope that the models can assist physicians in identifying patients who are suitable for UST at baseline and further explore who are at high risk for sLOR.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251382749"},"PeriodicalIF":3.4,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145201789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hypnotherapy self-exercises with audio files for children and adolescents with disorders of gut-brain interaction-a study of feasibility and preliminary effects in Sweden.","authors":"Tea Soini, Frida Andersson, Maria Lalouni, Marianne Bonnert, Siri Voghera, Brjánn Ljótsson, Marc A Benninga, Arine M Vlieger, Helena J Rolandsdotter, Agneta Uusijärvi, Ola Olén","doi":"10.1177/17562848251381141","DOIUrl":"10.1177/17562848251381141","url":null,"abstract":"<p><strong>Background: </strong>Gut-directed hypnotherapy is effective for treating children with disorders of gut-brain interaction, but is currently unavailable in Sweden.</p><p><strong>Objectives: </strong>To evaluate the within-group effect and feasibility of a Swedish adaptation of an audio-based gut-directed hypnotherapy program.</p><p><strong>Design: </strong>Uncontrolled within-group feasibility study.</p><p><strong>Methods: </strong>Children and adolescents (aged 8-17) diagnosed with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia (per Rome IV criteria) participated in a 12-week online hypnotherapy program. The program used audio files that were translated and adapted from a validated Dutch protocol. Data were collected at baseline, during treatment, and post-treatment. The primary outcome was gastrointestinal symptoms, measured by the PedsQL Gastrointestinal Symptoms Short Scale. Secondary outcomes included pain intensity and frequency, quality of life, stress, depression, anxiety, school absenteeism, and treatment credibility and satisfaction. Analyses with linear mixed models were used to estimate means, standard deviations, and effect sizes (Cohen's <i>d</i>).</p><p><strong>Results: </strong>Of the 32 patients included in the study, 25 (78%) completed the program and provided post-treatment data. Significant improvements in PedsQL gastro score were observed, with moderate effect size in child reports (<i>d</i> = 0.63, <i>p</i> < .001) and large effect size in parent reports (<i>d</i> = 0.81, <i>p</i> < .001). Clinically significant improvement (>30%) in gastrointestinal symptoms was achieved by 40% of completers. Pain intensity showed a modest decrease, with small effect sizes in both child (<i>d</i> = 0.24, <i>p</i> < .005) and parent reports (<i>d</i> = 0.28, <i>p</i> < .005).</p><p><strong>Conclusion: </strong>The Swedish version of audio-based gut-directed hypnotherapy appears feasible and acceptable, with promising symptom improvements in children with functional gastrointestinal disorders. A randomized controlled trial should be conducted to confirm efficacy and identify predictors of treatment response.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251381141"},"PeriodicalIF":3.4,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145201572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of Shouhui Tongbian Capsules, a traditional Chinese medicine, combined with 2L polyethylene glycol for bowel preparation before colonoscopy: a multicenter, randomized, single-blind, parallel-controlled clinical trial.","authors":"Feng Ye, Ni Guo, Yaping Wang, Baochun Wang, Chunyan Niu, Zujin Ji, Ming Guo, Yilin Hou, Yi Jian, Jianhua Cui, Dazhi Chen, Shuhui Li, Dongxia Wang, Hongping Guo, Junlei Jiu, Chunlei Qiu, Hui Cao, Ying He, Ming Chen, Hua Li, Xuezhi Xin, Rongjuan Zheng, Wei Chen, Dongya Chen, Lingyun Niu, Zhenqin Cui, Zhanquan Zou, Bin Jia, Leyao Zhang, Yinming Bai, Wanyu Li, Xiaojun Yang, Min Hua, Shaoming Long, Guoliang Cheng, Zhiyan Huang, Enhua Yang, Jinjin Shi, Guoxin Zhang","doi":"10.1177/17562848251378043","DOIUrl":"10.1177/17562848251378043","url":null,"abstract":"<p><strong>Background: </strong>High-volume polyethylene glycol (PEG) solutions are commonly used for bowel preparation but are often poorly tolerated, reducing patient compliance. Shouhui Tongbian Capsules (SHTBC), a traditional Chinese medicine known to promote gastrointestinal motility, may offer an alternative approach. However, its role in bowel preparation remains unclear.</p><p><strong>Objectives: </strong>To evaluate the efficacy, safety, and tolerability of a novel bowel preparation regimen combining SHTBC with low-volume PEG (2L) compared to conventional high-volume PEG (3L).</p><p><strong>Design: </strong>Multicenter, randomized, single-blind, parallel-controlled trial.</p><p><strong>Methods: </strong>A total of 404 participants scheduled for colonoscopy across 34 medical centers in China were randomized into two groups: the experimental group (SHTBC + 2L PEG, <i>n</i> = 202) and the control group (3L PEG, <i>n</i> = 202). Bowel preparation quality was assessed using the Boston Bowel Preparation Scale (BBPS), with successful cleansing defined as a total BBPS score ⩾6. The secondary outcomes included time to adequate bowel movement, number of bowel movements, patient tolerance, acceptance, and incidence of adverse drug reactions (ADRs).</p><p><strong>Results: </strong>The success rate of bowel preparation was comparable between groups (<i>p</i> = 0.7454). The experimental group had a slightly longer time to first adequate bowel movement on the day of colonoscopy (<i>p</i> = 0.0013) but experienced fewer bowel movements the day before (<i>p</i> < 0.0001). The experimental group reported significantly fewer ADRs (<i>p</i> = 0.0311) and better tolerance, including reduced bloating, nausea, and sleep disturbance (<i>p</i> < 0.01 for all). Patient acceptance was higher in the experimental group (92.89% vs 88.32%), although the difference was not statistically significant (<i>p</i> = 0.4170).</p><p><strong>Conclusion: </strong>SHTBC combined with 2L PEG is a safe, effective, and better-tolerated alternative to 3L PEG for bowel preparation before colonoscopy, offering a promising strategy to improve patient compliance.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2300069962.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251378043"},"PeriodicalIF":3.4,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477385/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145201646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Single and multiple switches, swap and retransitioning among 28,073 biological drug users with inflammatory bowel diseases: results from the Italian VALORE network.","authors":"Giorgia Pellegrini, Andrea Spini, Chiara Bellitto, Luca L'Abbate, Ylenia Ingrasciotta, Federica Soardo, Olivia Leoni, Arianna Mazzone, Domenica Ancona, Paolo Stella, Anna Cavazzana, Angela Scapin, Sara Lopes, Valeria Belleudi, Stefano Ledda, Paolo Carta, Paola Rossi, Lucian Ejlli, Ester Sapigni, Aurora Puccini, Rita Francesca Scarpelli, Giovambattista De Sarro, Marco Tuccori, Rosa Gini, Alessandra Allotta, Sebastiano Addario Pollina, Roberto Da Cas, Giampaolo Bucaneve, Antea Maria Pia Mangano, Francesco Balducci, Carla Sorrentino, Ilenia Senesi, Francesca Futura Bernardi, Ugo Trama, Stefania Spila Alegiani, Flavia Mayer, Marco Massari, Edoardo Vincenzo Savarino, Angela Variola, Gianluca Trifirò","doi":"10.1177/17562848251378080","DOIUrl":"10.1177/17562848251378080","url":null,"abstract":"<p><strong>Background: </strong>The increasing availability of biological drugs (originators and biosimilars) in the last decade for inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC), has led to complex switching patterns in real-world settings.</p><p><strong>Objectives: </strong>To describe the switching/swapping patterns of biological drugs in IBD patients in Italy over the last decade.</p><p><strong>Design: </strong>A retrospective cohort study was conducted using administrative data from 14 Italian regions (2010-2023) in the VALORE distributed database network.</p><p><strong>Methods: </strong>Patients with at least 1 year of look-back and follow-up, who initiated biological therapy with ⩾2 dispensations for IBD, were included. Switches, swaps (between biologic classes), multiple switches (⩾2), switch-backs, and re-transitioning (biosimilar to originator) were described. Predictors of multiple switches at 3 years were identified through COX regression analysis.</p><p><strong>Results: </strong>Among 28,073 first-ever users (55.8% Crohn's disease and 44.2% ulcerative colitis), most started with adalimumab (45.3%) or infliximab (39.6%). The F/M ratio was 0.79, with a median age of 41.0 years (IQR: 27.0-54.0). At 1, 3, and 5 years, switch/swap rates were 12.0%, 35.6%, and 52.6%, respectively, while multiple switches occurred in 18.7% at 5 years. Re-transitioning from biosimilar to originator occurred in 10% of patients who initially switched from originator to biosimilar of the same molecule. Tumor necrosis factor alpha (TNF-α) inhibitors switched more frequently and more rapidly than ustekinumab or vedolizumab. Depression and corticosteroid use were identified as predictors of multiple switches at 3 years of follow-up.</p><p><strong>Conclusion: </strong>About half of first-ever users of biological drugs who were treated because of IBDs switched or swapped within 5 years from treatment start. TNF-α drugs were more likely to switch or swap. They also swapped or switched more rapidly than vedolizumab and ustekinumab. Notably, 1 out of 5 had changed biologic therapy more than once at 5 years and, among those who switched to a biosimilar, 1 out of 10 re-transitioned to the originator.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251378080"},"PeriodicalIF":3.4,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477396/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145201846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}