肠内吸附剂 Silicol®gel 对肠易激综合征亚型 IBS-D 或混合型成人的疗效:观察性开放标签研究

IF 2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY
Gordon Crawford, Rory Taylor, David Young, Chris G. Hatton
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Eligible participants were assessed at baseline (visit 1; in-clinic) and after 1 (visit 2; telephone), 2 (visit 3; telephone), and 4 (visit 4; in-clinic) weeks of treatment. The primary endpoint was the proportion of participants with an overall reduction in the IBS severity scoring system <span><svg height=\"11.5564pt\" style=\"vertical-align:-2.26807pt\" version=\"1.1\" viewbox=\"-0.0498162 -9.28833 59.297 11.5564\" width=\"59.297pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,4.498,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,8.931,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,16.575,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,24.981,0)\"><use xlink:href=\"#g190-84\"></use></g><g transform=\"matrix(.013,0,0,-0.013,31.143,0)\"><use xlink:href=\"#g190-84\"></use></g><g transform=\"matrix(.013,0,0,-0.013,37.305,0)\"><use xlink:href=\"#g190-84\"></use></g><g transform=\"matrix(.013,0,0,-0.013,43.536,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,51.666,0)\"></path></g></svg><span></span><span><svg height=\"11.5564pt\" style=\"vertical-align:-2.26807pt\" version=\"1.1\" viewbox=\"62.8791838 -9.28833 12.689 11.5564\" width=\"12.689pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,62.929,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,69.169,0)\"></path></g></svg>,</span></span> representing clinically meaningful improvement. Key secondary endpoints were a reduction in common IBS symptoms and improved quality of life (QoL). <i>Results</i>. Among the 67 treated participants (IBS-D: 37; IBS-M: 30), 65 completed the study. At visit 4, 83.6% (56/67) of participants achieved a reduction in IBS <span><svg height=\"9.39034pt\" style=\"vertical-align:-0.6370001pt\" version=\"1.1\" viewbox=\"-0.0498162 -8.75334 29.818 9.39034\" width=\"29.818pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"><use xlink:href=\"#g190-84\"></use></g><g transform=\"matrix(.013,0,0,-0.013,6.162,0)\"><use xlink:href=\"#g190-84\"></use></g><g transform=\"matrix(.013,0,0,-0.013,12.324,0)\"><use xlink:href=\"#g190-84\"></use></g><g transform=\"matrix(.013,0,0,-0.013,22.187,0)\"><use xlink:href=\"#g117-92\"></use></g></svg><span></span><span><svg height=\"9.39034pt\" style=\"vertical-align:-0.6370001pt\" version=\"1.1\" viewbox=\"33.4001838 -8.75334 12.655 9.39034\" width=\"12.655pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,33.45,0)\"><use xlink:href=\"#g113-54\"></use></g><g transform=\"matrix(.013,0,0,-0.013,39.69,0)\"><use xlink:href=\"#g113-49\"></use></g></svg>.</span></span> The mean (standard deviation [SD]) IBS SSS was 323.4 (55.7) at visit 1 and 160.3 (90.3) at visit 4 (overall change: -163.1 (101.7); 95% confidence interval [CI] 138.3, 187.9, <span><svg height=\"11.7782pt\" style=\"vertical-align:-3.42938pt\" version=\"1.1\" viewbox=\"-0.0498162 -8.34882 18.973 11.7782\" width=\"18.973pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,11.342,0)\"></path></g></svg><span></span><span><svg height=\"11.7782pt\" style=\"vertical-align:-3.42938pt\" version=\"1.1\" viewbox=\"22.555183800000002 -8.34882 28.184 11.7782\" width=\"28.184pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,22.605,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,28.845,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,31.809,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,38.049,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,44.289,0)\"></path></g></svg>).</span></span> Compared with visit 1, significant reductions in the severity of all key IBS symptoms and overall improvement in QoL were observed at visit 4 (<span><svg height=\"11.7782pt\" style=\"vertical-align:-3.42938pt\" version=\"1.1\" viewbox=\"-0.0498162 -8.34882 18.973 11.7782\" width=\"18.973pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"><use xlink:href=\"#g113-113\"></use></g><g transform=\"matrix(.013,0,0,-0.013,11.342,0)\"><use xlink:href=\"#g117-91\"></use></g></svg><span></span><span><svg height=\"11.7782pt\" style=\"vertical-align:-3.42938pt\" version=\"1.1\" viewbox=\"22.555183800000002 -8.34882 28.184 11.7782\" width=\"28.184pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,22.605,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,28.845,0)\"><use xlink:href=\"#g113-47\"></use></g><g transform=\"matrix(.013,0,0,-0.013,31.809,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,38.049,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,44.289,0)\"><use xlink:href=\"#g113-50\"></use></g></svg>),</span></span> with improvements observed from visits 1 and 2. <i>Conclusions</i>. In this open-label study of participants with IBS-D and IBS-M, Silicol®gel provided clinically significant improvement in IBS symptoms, demonstrating that enteroadsorbents may be clinically beneficial in this population.","PeriodicalId":12597,"journal":{"name":"Gastroenterology Research and Practice","volume":"19 1","pages":""},"PeriodicalIF":2.0000,"publicationDate":"2023-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy of the Enteroadsorbent Silicol®gel in Adults with Irritable Bowel Syndrome Subtypes IBS-D or Mixed: Observational Open-Label Study\",\"authors\":\"Gordon Crawford, Rory Taylor, David Young, Chris G. Hatton\",\"doi\":\"10.1155/2023/3432763\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<i>Background</i>. Irritable bowel syndrome (IBS) is a common chronic gut-brain interaction disorder with limited effective treatment options. Intestinal adsorbents have a high adsorption capacity for gut irritants and may provide nonpharmacological alternatives. <i>Objectives</i>. This post marketing study is aimed at providing up-to-date evidence to support the safety and efficacy in normal use of an established medical device for IBS treatment. <i>Methods</i>. In this open-label, observational study, adults with IBS with predominant diarrhoea (IBS-D) or IBS with mixed bowel habits (IBS-M), according to Rome IV criteria, received 4 weeks of treatment with the enteroadsorbent Silicol®gel, a CE-certified, licenced, medical device containing colloidal silicic acid. Eligible participants were assessed at baseline (visit 1; in-clinic) and after 1 (visit 2; telephone), 2 (visit 3; telephone), and 4 (visit 4; in-clinic) weeks of treatment. 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Key secondary endpoints were a reduction in common IBS symptoms and improved quality of life (QoL). <i>Results</i>. Among the 67 treated participants (IBS-D: 37; IBS-M: 30), 65 completed the study. At visit 4, 83.6% (56/67) of participants achieved a reduction in IBS <span><svg height=\\\"9.39034pt\\\" style=\\\"vertical-align:-0.6370001pt\\\" version=\\\"1.1\\\" viewbox=\\\"-0.0498162 -8.75334 29.818 9.39034\\\" width=\\\"29.818pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,0,0)\\\"><use xlink:href=\\\"#g190-84\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,6.162,0)\\\"><use xlink:href=\\\"#g190-84\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,12.324,0)\\\"><use xlink:href=\\\"#g190-84\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,22.187,0)\\\"><use xlink:href=\\\"#g117-92\\\"></use></g></svg><span></span><span><svg height=\\\"9.39034pt\\\" style=\\\"vertical-align:-0.6370001pt\\\" version=\\\"1.1\\\" viewbox=\\\"33.4001838 -8.75334 12.655 9.39034\\\" width=\\\"12.655pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,33.45,0)\\\"><use xlink:href=\\\"#g113-54\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,39.69,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g></svg>.</span></span> The mean (standard deviation [SD]) IBS SSS was 323.4 (55.7) at visit 1 and 160.3 (90.3) at visit 4 (overall change: -163.1 (101.7); 95% confidence interval [CI] 138.3, 187.9, <span><svg height=\\\"11.7782pt\\\" style=\\\"vertical-align:-3.42938pt\\\" version=\\\"1.1\\\" viewbox=\\\"-0.0498162 -8.34882 18.973 11.7782\\\" width=\\\"18.973pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,0,0)\\\"></path></g><g transform=\\\"matrix(.013,0,0,-0.013,11.342,0)\\\"></path></g></svg><span></span><span><svg height=\\\"11.7782pt\\\" style=\\\"vertical-align:-3.42938pt\\\" version=\\\"1.1\\\" viewbox=\\\"22.555183800000002 -8.34882 28.184 11.7782\\\" width=\\\"28.184pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,22.605,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,28.845,0)\\\"></path></g><g transform=\\\"matrix(.013,0,0,-0.013,31.809,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,38.049,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,44.289,0)\\\"></path></g></svg>).</span></span> Compared with visit 1, significant reductions in the severity of all key IBS symptoms and overall improvement in QoL were observed at visit 4 (<span><svg height=\\\"11.7782pt\\\" style=\\\"vertical-align:-3.42938pt\\\" version=\\\"1.1\\\" viewbox=\\\"-0.0498162 -8.34882 18.973 11.7782\\\" width=\\\"18.973pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,0,0)\\\"><use xlink:href=\\\"#g113-113\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,11.342,0)\\\"><use xlink:href=\\\"#g117-91\\\"></use></g></svg><span></span><span><svg height=\\\"11.7782pt\\\" style=\\\"vertical-align:-3.42938pt\\\" version=\\\"1.1\\\" viewbox=\\\"22.555183800000002 -8.34882 28.184 11.7782\\\" width=\\\"28.184pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,22.605,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,28.845,0)\\\"><use xlink:href=\\\"#g113-47\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,31.809,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,38.049,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,44.289,0)\\\"><use xlink:href=\\\"#g113-50\\\"></use></g></svg>),</span></span> with improvements observed from visits 1 and 2. <i>Conclusions</i>. 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引用次数: 0

摘要

背景:肠易激综合征(IBS肠易激综合征(IBS)是一种常见的慢性肠脑交互障碍,有效的治疗方法有限。肠道吸附剂对肠道刺激物有很强的吸附能力,可提供非药物治疗方法。研究目的这项上市后研究旨在提供最新证据,以支持正常使用一种成熟的医疗设备治疗肠易激综合征的安全性和有效性。研究方法在这项开放标签的观察性研究中,根据罗马IV标准,患有以腹泻为主的肠易激综合征(IBS-D)或混合排便习惯的肠易激综合征(IBS-M)的成人接受了为期4周的肠道吸附剂 Silicol®gel 治疗。符合条件的参与者在基线(第 1 次就诊;诊所内)和治疗 1 周(第 2 次就诊;电话)、2 周(第 3 次就诊;电话)和 4 周(第 4 次就诊;诊所内)后接受评估。主要终点是肠易激综合征严重程度评分系统总体下降的参与者比例,这代表了有临床意义的改善。主要次要终点是常见肠易激综合征症状的减轻和生活质量(QoL)的提高。研究结果在接受治疗的 67 名参与者中(IBS-D:37 人;IBS-M:30 人),65 人完成了研究。在第 4 次就诊时,83.6% 的参与者(56/67)的肠易激综合征症状有所减轻。第 1 次就诊时,IBS SSS 平均值(标准差 [SD])为 323.4 (55.7),第 4 次就诊时为 160.3 (90.3)(总体变化:-163.1 (101.7);95% 置信区间 [CI] 138.3,187.9,)。与第 1 次就诊时相比,第 4 次就诊时所有主要肠易激综合征症状的严重程度均明显减轻,生活质量总体改善(),第 1 次和第 2 次就诊时的情况也有所改善。研究结论在这项对患有肠易激综合征(IBS-D)和肠易激综合征(IBS-M)的患者进行的开放标签研究中,Silicol®凝胶对肠易激综合征症状有明显的临床改善,证明肠吸收剂可能对这类人群有临床益处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of the Enteroadsorbent Silicol®gel in Adults with Irritable Bowel Syndrome Subtypes IBS-D or Mixed: Observational Open-Label Study
Background. Irritable bowel syndrome (IBS) is a common chronic gut-brain interaction disorder with limited effective treatment options. Intestinal adsorbents have a high adsorption capacity for gut irritants and may provide nonpharmacological alternatives. Objectives. This post marketing study is aimed at providing up-to-date evidence to support the safety and efficacy in normal use of an established medical device for IBS treatment. Methods. In this open-label, observational study, adults with IBS with predominant diarrhoea (IBS-D) or IBS with mixed bowel habits (IBS-M), according to Rome IV criteria, received 4 weeks of treatment with the enteroadsorbent Silicol®gel, a CE-certified, licenced, medical device containing colloidal silicic acid. Eligible participants were assessed at baseline (visit 1; in-clinic) and after 1 (visit 2; telephone), 2 (visit 3; telephone), and 4 (visit 4; in-clinic) weeks of treatment. The primary endpoint was the proportion of participants with an overall reduction in the IBS severity scoring system , representing clinically meaningful improvement. Key secondary endpoints were a reduction in common IBS symptoms and improved quality of life (QoL). Results. Among the 67 treated participants (IBS-D: 37; IBS-M: 30), 65 completed the study. At visit 4, 83.6% (56/67) of participants achieved a reduction in IBS . The mean (standard deviation [SD]) IBS SSS was 323.4 (55.7) at visit 1 and 160.3 (90.3) at visit 4 (overall change: -163.1 (101.7); 95% confidence interval [CI] 138.3, 187.9, ). Compared with visit 1, significant reductions in the severity of all key IBS symptoms and overall improvement in QoL were observed at visit 4 (), with improvements observed from visits 1 and 2. Conclusions. In this open-label study of participants with IBS-D and IBS-M, Silicol®gel provided clinically significant improvement in IBS symptoms, demonstrating that enteroadsorbents may be clinically beneficial in this population.
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来源期刊
Gastroenterology Research and Practice
Gastroenterology Research and Practice GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
4.40
自引率
0.00%
发文量
91
审稿时长
1 months
期刊介绍: Gastroenterology Research and Practice is a peer-reviewed, Open Access journal which publishes original research articles, review articles and clinical studies based on all areas of gastroenterology, hepatology, pancreas and biliary, and related cancers. The journal welcomes submissions on the physiology, pathophysiology, etiology, diagnosis and therapy of gastrointestinal diseases. The aim of the journal is to provide cutting edge research related to the field of gastroenterology, as well as digestive diseases and disorders. Topics of interest include: Management of pancreatic diseases Third space endoscopy Endoscopic resection Therapeutic endoscopy Therapeutic endosonography.
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