Hostiuc Sorin, Perlea Paula, Marinescu Mihai, Dogaroiu Catalin, Drima Eduard
Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
University of Medicine and Pharmacy, Galaţi, Romania.
Front Pharmacol. 2019 Jan 7;9:1495. doi: 10.3389/fphar.2018.01495. eCollection 2018.
Tideglusib, a GSK-3 inhibitor, was initially tested for the treatment of Alzheimer's disease. However, a recent report has suggested its potential off-label use for the treatment of dental cavities. Even if this effect is not yet confirmed, this off-label use can have significant public/dental health consequences, mainly because of the large number of patients with cavities. The purpose of this mini-review is to perform an ethical analysis of the use of Tideglusib in dentistry. The ethical analysis identified three main areas in which ethical breaches could be significant: 1) respect for the autonomy of the patient, 2) issues raised by horizontal shifts in the translational research process, and 3) the conflict between dental beneficence and general non-maleficence. In conclusion, the use of Tideglusib in dentistry should respect the same strict ethical and regulatory criteria from clinical medicine. A translation of the potential risks should be done only after large-scale, phase-III/IV clinical trials, explicitly designed to test the usefulness of this drug in dental medicine.
Tideglusib是一种糖原合成酶激酶-3(GSK-3)抑制剂,最初被用于阿尔茨海默病的治疗测试。然而,最近有报告表明其可能存在用于治疗龋齿的未获批准的用法。即便这种效果尚未得到证实,但这种未获批准的用法可能会对公众/口腔健康产生重大影响,主要原因在于患龋齿的患者数量众多。本小型综述的目的是对Tideglusib在牙科领域的应用进行伦理分析。伦理分析确定了三个可能存在重大伦理违规行为的主要领域:1)对患者自主性的尊重;2)转化研究过程中横向转移引发的问题;3)牙科领域的有益性与一般无害性之间的冲突。总之,Tideglusib在牙科领域的应用应遵循与临床医学相同严格的伦理和监管标准。只有在专门设计用于测试该药物在牙科医学中有效性的大规模III/IV期临床试验之后,才应进行潜在风险的说明。