Savarino Vincenzo, Marabotto Elisa, Zentilin Patrizia, Furnari Manuele, Bodini Giorgia, Giovanni Giannini Edoardo, Vincenzo Savarino Edoardo
Department of Internal Medicine, University of Genoa, Genoa, Italy.
Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Veneto, Italy.
Front Drug Saf Regul. 2023 Feb 24;3:1119353. doi: 10.3389/fdsfr.2023.1119353. eCollection 2023.
Medical devices made of substances (MDMS) have recently gained great popularity in several specialties of internal medicine, including gastroenterology. In the last decades this discipline has known relevant advances in the cure of severe diseases, such as peptic ulcer, gastroesophageal reflux disease and chronic hepatitis C, thanks to the revolutionary development of new drugs able to act on single receptors changing a particular cell function or blocking microbial and viral replication. However, there are many gastroenterological illnesses that are difficult to treat with traditional medicinal products because of their complex and poorly known pathophysiology, which comprises altered motility, visceral hypersensitivity, gut dysbiosis, intestinal mild inflammation with impaired immune function, increased mucosal permeability and abnormal brain-gut interaction. They are mainly represented by esophageal functional disorders (reflux hypersensitivity, functional heartburn), functional dyspepsia, irritable bowel syndrome, functional constipation and functional diarrhea. Traditional drugs do not provide a definitive resolution of these disorders with a multifactorial pathogenesis and they can benefit from the use of MDMS, which seem to have the ability to act on different factors thanks to the synergistic action of their various components. International medical literature already reports many clinical trials performed with the well-known standards for evaluating their efficacy and safety in a great part of the above-mentioned conditions.
由物质制成的医疗设备（MDMS）最近在包括胃肠病学在内的多个内科专业中广受欢迎。在过去几十年里，由于能够作用于单一受体、改变特定细胞功能或阻断微生物和病毒复制的新药的革命性发展，该学科在严重疾病（如消化性溃疡、胃食管反流病和慢性丙型肝炎）的治疗方面取得了显著进展。然而，由于许多胃肠病的病理生理学复杂且鲜为人知，包括运动改变、内脏超敏反应、肠道菌群失调、伴有免疫功能受损的肠道轻度炎症、粘膜通透性增加和脑-肠相互作用异常，传统药物难以治疗这些疾病。它们主要表现为食管功能障碍（反流超敏反应、功能性烧心）、功能性消化不良、肠易激综合征、功能性便秘和功能性腹泻。传统药物无法彻底解决这些具有多因素发病机制的疾病，而MDMS似乎因其各种成分的协同作用能够作用于不同因素，使用MDMS可能会使这些疾病受益。国际医学文献已经报道了许多按照知名标准进行的临床试验，以评估MDMS在上述大部分病症中的疗效和安全性。
