BACKGROUND The aim of this study was to investigate the efficacy and safety of the novel complex drug, consisting of released-active form of antibodies to S-100 protein, tumor necrosis factor-α and histamine, (Kolofort) under outpatient conditions in patients with functional dyspepsia (FD), irritable bowel syndrome (IBS), and FD-IBS overlap. METHODS The subjects of the observational noninterventional retrospective program were the data of 14,362 outpatient records of patients with diagnosed FD, IBS, and/or overlap, who were observed by gastroenterologists from November 01, 2017, through March 30, 2018, who received the drug Kolofort in monotherapy for 12 weeks, 2 tablets twice a day. To assess the presence and severity of symptoms of functional gastrointestinal disorders (FGID), the "7*7" questionnaire developed by a working group from the Russian Gastroenterological Association was used. The evaluated parameters included the proportion of patients: who had a 50% or more reduction in the total score; who have switched to the less severe category of the condition; who have switched to the "healthy" or "borderline ill" severity categories; and the change in the score in domains 1-7. RESULTS The final efficacy analysis included data from 9254 patients. A decrease in the total score by 50% or more was observed in 80.45% of patients with FD, 79.02% of patients with IBS, and in 83% of patients with both IBS and FD. Switch to a lower severity category of the condition at the end of therapy was noted in 93.35% of patients with FD, in 93.80% of cases in patients with IBS, and in 96.17% of cases in patients with a combination of IBS and FD. A total of 94 adverse events (AEs) were reported in 80 patients (0.65%). CONCLUSION The COMFORT program has demonstrated the positive effect of treatment in the majority of patients with IBS and FD and their combination in real clinical practice.

中文翻译：

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治疗胃肠道功能性疾病及其交叉点的发病机制：俄罗斯观察回顾性计划 COMFORT 的结果。

背景 本研究的目的是研究新型复合药物（Kolofort）在门诊条件下对患有 S-100 蛋白、肿瘤坏死因子-α 和组胺的抗体的释放活性形式的疗效和安全性。功能性消化不良 (FD)、肠易激综合征 (IBS) 和 FD-IBS 重叠。方法 观察性非干预性回顾性项目的研究对象是 2017 年 11 月 1 日至 2018 年 3 月 30 日期间胃肠病专家对 14,362 例诊断为 FD、IBS 和/或重叠患者的门诊记录数据进行观察，这些患者接受了该药物治疗。 Kolofort 单药治疗 12 周，每次 2 片，每天两次。为了评估功能性胃肠病（FGID）症状的存在和严重程度，使用了俄罗斯胃肠病协会工作组开发的“7*7”调查问卷。评估参数包括患者比例：总分下降50%或以上；已转入病情较轻的类别的人；已切换至“健康”或“濒临患病”严重程度类别的人；以及域 1-7 中分数的变化。结果 最终疗效分析包括 9254 名患者的数据。80.45% 的 FD 患者、79.02% 的 IBS 患者以及 83% 的 IBS 和 FD 患者总分下降 50% 或更多。治疗结束时，93.35% 的 FD 患者、93.80% 的 IBS 患者以及 96.17% 的 IBS 和 FD 合并患者转为较低严重程度的病情类别。80 名患者 (0.65%) 总共报告了 94 起不良事件 (AE)。结论 COMFORT 计划在实际临床实践中证明了对大多数 IBS 和 FD 患者及其联合治疗的积极效果。