Azmi Shazli, Ferdousi Maryam, Kalteniece Alise, Al-Muhannadi Hamad, Al-Mohamedi Abdulrahman, Hadid Nebras H, Mahmoud Salah, Bhat Harun A, Gad Hoda Y A, Khan Adnan, Ponirakis Georgios, Petropoulos Ioannis N, Alam Uazman, Malik Rayaz A
Institute of Cardiovascular Sciences, University of Manchester and Central Manchester NHS Foundation Trust, Manchester, UK.
Weill Cornell Medicine-Qatar, Qatar Foundation, Doha, Qatar.
Ther Adv Endocrinol Metab. 2019 Feb 4;10:2042018819826890. doi: 10.1177/2042018819826890. eCollection 2019.
The diagnosis and management of diabetic neuropathy can be a major challenge. Late diagnosis contributes to significant morbidity in the form of painful diabetic neuropathy, foot ulceration, amputation, and increased mortality. Both hyperglycaemia and cardiovascular risk factors are implicated in the development of somatic and autonomic neuropathy and an improvement in these risk factors can reduce their rate of development and progression. There are currently no US Food and Drug Administration (FDA)-approved disease-modifying treatments for either somatic or autonomic neuropathy, as a consequence of multiple failed phase III clinical trials. While this may be partly attributed to premature translation, there are major shortcomings in trial design and outcome measures. There are a limited number of partially effective FDA-approved treatments for the symptomatic relief of painful diabetic neuropathy and autonomic neuropathy.
糖尿病神经病变的诊断和管理可能是一项重大挑战。延迟诊断会导致以疼痛性糖尿病神经病变、足部溃疡、截肢和死亡率增加等形式出现的显著发病率。高血糖和心血管危险因素都与躯体和自主神经病变的发生有关,改善这些危险因素可以降低其发展和进展速度。由于多项III期临床试验失败,目前美国食品药品监督管理局(FDA)尚未批准用于治疗躯体或自主神经病变的疾病改善疗法。虽然这可能部分归因于过早转化,但试验设计和结果测量存在重大缺陷。对于缓解疼痛性糖尿病神经病变和自主神经病变的症状,FDA仅批准了少数几种部分有效的治疗方法。