α-D-甘露糖-天然己醛糖的性质,C-2葡萄糖差向异构体,其预期用途是用于预防尿路感染-在与大肠杆菌的相互作用中被解决,以驱动其作为医药产品或医疗装置的监管分类的问题。采用PRISMA系统审查方法;DelphiPanel方法用于针对从证据中检索到的陈述达成共识。根据监管定义和研究证据,D-甘露糖的机制不涉及代谢或免疫作用,而药理作用存在不确定性。产品与体内细菌之间发生特定的相互作用,但它的性质是惰性的:它不会引起激活或抑制身体过程的直接反应。此外,D-甘露糖的作用发生,即使在膀胱里,上皮外的细菌尚未侵入尿路上皮组织。因此,其作用机制不是针对宿主结构,而是针对宿主组织外部的结构(细菌)。根据现行规定,关于α-D-甘露糖的药理作用的不确定性使其医疗器械分类成为可能:新的法规和法律判决可以增加进一步的考虑.从药理学的角度来看,与合成甘露糖苷相比,研究是驱动的:预计对α-D-甘露糖没有进一步的考虑。
The nature of alpha-D-
mannose-natural aldohexose sugar, C-2 glucose epimer, whose intended use is for preventing urinary tract infections-in the interaction with E. coli is addressed in order to drive the issue of its regulatory classification as a medicinal product or medical device. PRISMA systematic review approach was applied; Delphi Panel method was used to target
consensus on statements retrieved from evidence. Based on regulatory definitions and research evidence, the mechanism of D-
mannose does not involve a metabolic or immunological action while there is uncertainty regarding the pharmacological action. Specific interaction between the product and the bacteria within the body occurs, but its nature is inert: it does not induce a direct response activating or inhibiting body processes. Moreover, the action of D-
mannose takes place, even if inside the bladder, outside the epithelium on bacteria that have not yet invaded the urothelial tissue. Therefore, its mechanism of action is not directed to host structures but to structures (bacteria) external to the host\'s tissues. On the basis of current regulation, the uncertainty as regard a pharmacological action of alpha-D-
mannose makes possible its medical device classification: new regulations and legal judgments can add further considerations. From a pharmacological perspective, research is driven versus synthetic mannosides: no further considerations are expected on alpha-D-mannose.