背景:肠易激综合征(IBS),根据罗马四号诊断标准定义,是一种慢性功能性胃肠病,其特征是与排便习惯改变有关的复发性腹痛。一线推荐的治疗方法仅限于结合针对主要症状的药物,特别是疼痛(抗痉挛药),便秘(泻药),和腹泻(洛哌丁胺),仅产生有限的治疗增益。GASTRAP®DIRECT是由几丁质-葡聚糖和西甲硅油的组合组成的IIa类医疗制剂,用于通过结合不同的作用机制对症治疗与气体有关的胃肠道疾病。
目的:为了评估疗效,耐受性,以及对IBS患者进行4周GASTRAP®DIRECT治疗的安全性。
方法:在此前瞻性中,多中心,开放标签试用,120例IBS患者每天接受三片GASTRAP®DIRECT(1.5g/d的几丁质-葡聚糖和0.75mg/d的西甲硅油),持续4周。主要终点是响应者率,定义为从基线至第(W)4周腹痛评分降低≥30%的患者数量.使用符合方案组进行分析。主要症状,全球症状对日常生活的影响,大便稠度的变化,并评估排便障碍的改善情况。
结果:总体而言,对100名患者进行了评估。在W4时,67%(95CI:57-75)显示腹痛改善(评分:5.8±2.4vs2.9±2.0,P<0.0001)。腹胀观察到类似的改善[8.0±1.7vs4.7±2.9,P<0.0001;60%(95CI:50-70)反应者],腹胀[7.2±2.1vs4.4±3.1,P<0.0001;53%(95CI:43-63)反应者],整体症状对日常生活的影响[7.1±2.0vs4.6±2.9,P<0.0001;54%(95CI:44-64)应答者]。大多数患者的粪便一致性得到改善(对于有液体和硬便的患者,为90%和57%,分别)。总的来说,42%的排便障碍患者报告W2有很大/相当大的改善。无严重不良事件发生,93%的患者将耐受性评为“良好”或“非常好”。
结论:GASTRAP®DIRECT安全且耐受性良好,在2周内迅速缓解IBS症状。这项开放标签研究表明,几丁质-葡聚糖和西甲硅油的组合可能对IBS患者有益。
BACKGROUND: Irritable bowel syndrome (IBS), defined according to the Rome IV diagnostic criteria, is a chronic functional gastrointestinal disorder characterized by recurrent abdominal pain related to altered bowel habits. First-line recommended treatments are limited to combining drugs targeting predominant symptoms, particularly pain (antispasmodics), constipation (laxatives), and diarrhea (loperamide), yielding only a limited therapeutic gain. GASTRAP® DIRECT is a class IIa medical formulation composed of a combination of chitin-glucan and simethicone indicated for the symptomatic treatment of gas-related gastrointestinal disorders by combining different mechanisms of action.
OBJECTIVE: To evaluate the efficacy, tolerability, and safety of 4-week GASTRAP® DIRECT treatment in patients with IBS.
METHODS: In this prospective, multicenter, open-label trial, 120 patients with IBS received three sticks of GASTRAP® DIRECT (1.5 g/d of chitin-glucan and 0.75 mg/d of simethicone) per day for 4 weeks. The primary endpoint was the responder rate, defined as the number of patients whose abdominal pain score decreased by ≥ 30% from baseline to week (W) 4. The analysis was performed using the per-protocol set. Cardinal symptoms, impact of global symptoms on daily life, change in stool consistency, and improvement in defecatory disorders were evaluated.
RESULTS: Overall, 100 patients were evaluated. At W4, 67% (95%CI: 57-75) showed improvement in abdominal pain (score: 5.8 ± 2.4 vs 2.9 ± 2.0, P < 0.0001). Similar improvements were observed for bloating [8.0 ± 1.7 vs 4.7 ± 2.9, P < 0.0001; 60% (95%CI: 50-70) responders], abdominal distension [7.2 ± 2.1 vs 4.4 ± 3.1, P < 0.0001; 53% (95%CI: 43-63) responders], and impact of global symptoms on daily life [7.1 ± 2.0 vs 4.6 ± 2.9, P < 0.0001; 54% (95%CI: 44-64) responders]. Stool consistency improved in most patients (90% and 57% for patients with liquid and hard stools, respectively). Overall, 42% of patients with defecatory disorders reported very much/considerable improvements by W2. No severe adverse event occurred, and tolerability was rated \"good\" or \"very good\" by 93% of patients.
CONCLUSIONS: GASTRAP® DIRECT is safe and well tolerated, alleviating IBS symptoms rapidly in 2 weeks. This open-label study suggests that the combination of chitin-glucan and simethicone could be beneficial in patients with IBS.